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Re: OMER Comparators, Competitors, VALUATION & potential partners

OK, I can see why you want AUPH to close above $18.  Even $18.01 would be good enough, I guess.  Once I get some cash, I think I will give this strategy a try.  I like that the boundaries of the trade (the risks taken) are well-defined, relatively speaking.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Perhaps of some interest as Omeros may pursue a GVHD indication for Narsoplimab in the future.  You will note treatment results with Ruxolitinib (Jakafi, Incyte) are an improvement over best available care, but certainly not striking.

Healing News

FDA grants priority review to Jakafi for chronic GVHD

The FDA granted priority review to ruxolitinib for the treatment of adults and children aged 12 years or older with steroid-refractory chronic graft-versus-host disease, according to a manufacturer-issued press release.

The agency based the decision, in part, on data from the randomized phase 3 REACH3 study — presented in December at the virtual ASH Annual Meeting and Exposition — which included 329 patients (median age, 49 years; range, 12-76; 61% male) who underwent allogeneic hematopoietic stem cell transplant and developed moderate or severe chronic GVHD.

As Healio previously reported, patients who received ruxolitinib (Jakafi, Incyte) — an oral Janus kinase 1/2 inhibitor — demonstrated a higher overall response rate at week 24, the study’s primary endpoint, compared with patients who received best available therapy (49.7% vs. 25.6%; P < .0001).

Ruxolitinib also was associated with longer median failure-free survival (not reached vs. 5.7 months; HR = 0.37; 95% CI, 0.268-0.51) and greater improvement in modified Lee Symptom Score response rate (24% vs. 11%; OR = 2.62; 95% CI, 1.42-4.82).

“Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options,” Peter Langmuir, MD, group vice president of oncology targeted therapies at Incyte, said in the press release. "The acceptance of this supplemental new drug applications represents an important milestone for Incyte as we continue our work toward helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States.”

Ruxolitinib received FDA approval in 2019 for the treatment of steroid-refractory acute GVHD among adults and children aged 12 year or older.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I always wondered why OMER didn't go for GVHD already, given the number of times Greg mentioned it.

I would guess because it is an immune attack that is the responsibility of the parts of the immune system that is not (or in addition to) the Lectin pathway.

Meanwhile TA-TMA is probably from endothelial damage from all the prior treatments, including the drugs administered conditioning for the transplants and to KILL the bone marrow (which by definition is damaging)... and so much more MASP2 Lectin endothelial.

These are just my somewhat uneducated guesses. Knowing Greg he'd start off with a target as pure as possible to maximize success.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Here's a competitor from Canada, using a similar approach to IgAN, targeting the endothelium.
In Phase 3.

=============

GlobeNewswire
Chinook Therapeutics Announces First Patient Enrolled in Pivotal Phase 3 ALIGN Study of Atrasentan for Patients with IgA Nephropathy
Chinook Therapeutics, Inc.
March 16, 2021, 7:15 am
Phase 2 AFFINITY Trial of Atrasentan for Patients with Glomerular Diseases Also on Track to Begin Enrollment in the First Half of 2021

VANCOUVER, British Columbia and SEATTLE, March 16, 2021 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (NASDAQ: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the ALIGN Study, a pivotal phase 3 clinical trial evaluating the efficacy and safety of atrasentan, a potent and selective inhibitor of the endothelin A receptor.

“The initiation of the phase 3 ALIGN Study is an important milestone for Chinook as we advance our pipeline of programs for rare, severe chronic kidney diseases,” said Alan Glicklich, M.D., chief medical officer of Chinook. “Atrasentan has been studied in over 5,300 diabetic kidney disease patients in the phase 2 RADAR and phase 3 SONAR studies, demonstrating rapid, sustained proteinuria reductions of approximately 30 to 35 percent as well as improved eGFR. Importantly, treatment with atrasentan also resulted in a reduction in clinical outcomes of development of end-stage kidney disease and doubling of serum creatinine. We look forward to exploring the proteinuria-lowering, anti-inflammatory and anti-fibrotic effects of atrasentan in patients with IgA nephropathy, a serious progressive disease for which there are no approved therapies.”

“I am pleased to see Chinook kick off the well-designed phase 3 ALIGN Study of atrasentan in IgA nephropathy. Given the strong correlation between endothelin system activation and disease progression, and the drug’s demonstrated impact on proteinuria in patients with diabetic nephropathy, I believe atrasentan will be a beneficial therapeutic treatment option for patients with IgA nephropathy,” said Jonathan Barratt, Ph.D., F.R.C.P, the Mayer professor of renal medicine at University of Leicester, honorary consultant nephrologist at Leicester General Hospital and co-chair of the ALIGN Study steering committee.

About the ALIGN Study
The ALIGN Study (see www.clinicaltrials.gov, identifier NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial comparing the efficacy and safety of atrasentan versus placebo in patients with IgAN at risk of progressive loss of kidney function. Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo as a once-daily oral pill for approximately 2.5 years. Patients will continue receiving a maximally tolerated and stable dose of a RAS inhibitor as standard of care. The study will also include a cohort of patients that are unable to tolerate RAS inhibitor therapy.

The primary efficacy endpoint of the ALIGN Study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by urine protein to creatinine ratio (UPCR) from baseline to 24 weeks. Secondary and exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability, as well as quality of life. Chinook expects to report top-line data from the 24-week primary endpoint efficacy analysis in 2023.

About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease globally and a leading cause of chronic kidney disease (CKD), with up to 45 percent of IgAN patients progressing to end-stage renal disease (ESRD), requiring dialysis or kidney transplantation. There are currently no approved therapies for IgAN and only limited treatment options for high-risk patients. IgAN is characterized by the deposition of IgA-containing immune complexes in the glomeruli of the kidney, which initiates an inflammatory response that results in protein and blood leaking into the urine, called proteinuria and hematuria, respectively. Proteinuria levels are the strongest predictor of kidney function loss and clinical outcomes in IgAN patients, and lowering proteinuria is associated with important clinical benefit. Blockade of the endothelin A receptor by atrasentan has potential to reduce proteinuria as well as kidney inflammation and fibrosis to preserve kidney function in IgAN.

About Chinook Therapeutics, Inc.
Chinook Therapeutics, Inc. is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, an investigational phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other primary glomerular diseases. BION-1301, an investigational anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an investigational oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases, including polycystic kidney disease. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. To learn more, visit www.chinooktx.com.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

This stock is up $9 premarkt because of their ISPY CV19 trial. I have to study it before I give some commentary.
========================

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Lenzilumab improved the relative likelihood of survival without need for invasive mechanical ventilation (IMV) by 54%, achieving the primary endpoint of the Phase 3 study

Clinical improvement was observed over and above other treatments, including steroids and/or remdesivir

Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. These results are statistically significant.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/ … 005301/en/

"The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes in hospitalized hypoxic COVID-19 patients who had not yet progressed to the point of requiring IMV," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "Additionally, the trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population. Our next step is to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) as soon as possible. We are also sharing these results with US governmental agencies and other authorities worldwide."

"Mayo Clinic is pleased to have been part of the investigation of lenzilumab from the earliest days of the development program in COVID-19 and are excited by these data," said Andrew Badley, MD, Professor of Infectious Diseases, and Professor and Chair of the Department of Molecular Medicine at Mayo Clinic. "If lenzilumab is authorized for emergency use by FDA, and based on our clinical trial experience to date, it may then be considered a part of our treatment armamentarium for newly hospitalized patients with COVID-19."

Study results demonstrate that lenzilumab significantly improved patient outcomes. The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365). Ventilator-free survival is a validated and reliable measure used in studies that evaluate respiratory distress.1 The Kaplan-Meier estimate for IMV and/or death was 15.6% (95%CI: 11.5-21.0) in the lenzilumab arm versus 22.1% (95%CI: 17.4-27.9) in the placebo arm, representing a 54% improvement in the relative likelihood of survival without the need for IMV. Although this study was not powered to demonstrate a difference in mortality, a favorable trend in mortality was observed: 9.6% (95%CI: 6.4-14.2) in the lenzilumab arm compared with 13.9% (95%CI: 10.1-19.0) in the placebo arm (HR: 1.39; 95%CI: 0.82-2.39; p=0.2287). Approximately 88% of patients received dexamethasone (or other steroids), 62% received remdesivir, and 57% received both, balanced across both arms of the study. Serious adverse events (SAEs) were balanced in both study arms and the SAE profile was similar to that previously documented in prior lenzilumab studies. In this study, lenzilumab appeared to be safe and well-tolerated; no new SAEs were identified, and none were attributed to lenzilumab.

"The data strongly suggest that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia," said Zelalem Temesgen, MD, Professor of Medicine at Mayo Clinic and Principal Investigator of the Phase 3 trial. "The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy. Lenzilumab could make the difference between going on a ventilator, which reduces one’s chance of survival, and leaving the hospital alive."

"It is impressive to see lenzilumab achieve this milestone. At Emory University, a key center in the National Institutes of Health (NIH) ACTIV-5 study, which is currently enrolling, we are hopeful that lenzilumab will emerge as a valuable therapy for newly hospitalized patients. We believe there may be future opportunities to study lenzilumab in even larger trials, and further explore lenzilumab’s impact on mortality rates," added Vincent Marconi, MD, Professor of Medicine at Emory University School of Medicine.

About the Lenzilumab Phase 3 Study

This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival. Ventilator-free survival is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.1 The trial enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment. Key secondary endpoints, also measured through 28 days, included ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial are planned to be submitted for potential publication in a peer-reviewed journal.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also working to create next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T-cell-engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Over 500 patients and no strong result and no significance on survival. Patients varied too much to start with from no oxygen support to being on CPAP (stage before ventilator).

Endorsements by KOLs are weak and meaningless.

Apparently they change Primary Endpoint to some obscure and meaningless hybrid DURING the Trial, which is a NO NO.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Yeah, I’ve never heard of ventilator free survival before.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

It is a "compound" endpoint.

HGEN is pumping these results and shorts are covering, helped by ENDPOINTS biotech news that gave it glowing raves, probably because HGEN used to be Martin Shkreli's company and John Carroll, the Endpoint Founder was in a feud with Shkreli.

I note again, there is a NONsignificant survival value.

And though they advertise a >50% increase in survival, it is only about a 6%, from 15.something% to 22%.

Large variance between groups and very varying population from people not on ANY breathing help to people on CPAP which is one step from end-stage ventilation,

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

59

Re: OMER Comparators, Competitors, VALUATION & potential partners

Yahoo wrote:

Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) disorders in the United States. Its product pipeline includes AXS-05 for the treatment major depressive disorder and resistant depression disorders; and that is in the Phase III clinical trial for the treatment of Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation. The company is also developing AXS-07 for the treatment of migraine; AXS-12 for the treatment of narcolepsy; and AXS-14 for the treatment of fibromyalgia. Axsome Therapeutics, Inc. has a research collaboration agreement with Duke University for evaluating AXS-05 in smoking cessation.

Market Cap (intraday)    1.98B
Enterprise Value    1.85B
Trailing P/E    none
Forward P/E 1    -27.60
Revenue (ttm)    0
Revenue Per Share (ttm)    0
Quarterly Revenue Growth (yoy)    0
Gross Profit (ttm)    0
EBITDA    -88.86M
Net Income Avi to Common (ttm)    -102.9M
Diluted EPS (ttm)    -2.77
Quarterly Earnings Growth (yoy)    0

Balance Sheet
Total Cash (mrq)    183.88M
Total Cash Per Share (mrq)    4.92
Total Debt (mrq)    50.12M

OMEROS
Market Cap (intraday    1.13B
Enterprise Value    1.26B
Trailing P/E    none
Forward P/E     -16.28

Revenue (ttm)    73.81M
Revenue Per Share (ttm)    1.29
Quarterly Revenue Growth (yoy)    -68.20%
Gross Profit (ttm)    6.17M
EBITDA    -108.98M
Net Income Avi to Common (ttm)    -138.06M
Diluted EPS (ttm)    -2.41
Quarterly Earnings Growth (yoy)    none

Balance Sheet
Total Cash (mrq)    134.95M
Total Cash Per Share (mrq)    2.18
Total Debt (mrq)    268.84M

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

This is interesting, my name is in the "income to common" line.....

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Re: OMER Comparators, Competitors, VALUATION & potential partners

LOL
It is short for "Available" for some reason.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AKTX, OMER competitor, announces initiation of pivotal phase 3 Nomacopan trial and is down 11.2%

Market cap AKTX ~$80M
yearend cash only $12M

Their complement drug Coversin is in a phase 2 basket trial for PNH and aHUS (and others), hoping to find something that works well.

They only spend about $18M/year so by end of Q2 they should have about $3M left, which means they will have to sell something (like shares). Of course, with these metrics it is obvious they have no approved drugs.

And cannot afford to run this new trial without raising money.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AKTX article outlines its complement drugs and its pursuit of HSCT-TMA etc.

https://seekingalpha.com/article/441886 … erapeutics

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Alan Robert Ross wrote:

AKTX article outlines its complement drugs and its pursuit of HSCT-TMA etc.

Nice to see this comment by the author in the article ......

"Nomacopan also could have potential in TMA-HSCT. However, I prefer Omeros (OMER) as a TMA-HSCT play right now as it already is in priority review status for that indication."

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AKTX targets downstream complement and should be more dangerous than narsoplimab.
And AKTX doesn't really have the money to make a success of a complement franchise, although it could make them a buyout target for someone who wants to compete with Omeros... like the buyer of ALXN, Astra Zeneca.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I guy I follow on Twitter tweeted that we should use Danaher and ThermoFisher instead of the XBI and IBB as Biotech standards.

ThermoFisher is a competitor of Larry's pick Icon, so I decided to run a comparative  chart with these three companies and Omeros:

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=OMER&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=1&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=7&amp;rand=146409280&amp;compidx=aaaaa%3a0&amp;comp=tmo+dhr+iclr&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

The 6 month chart makes Omeros look great.
The 3 month chart makes Omeros look crappy.

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=OMER&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=1&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=6&amp;rand=184372631&amp;compidx=aaaaa%3a0&amp;comp=tmo+dhr+iclr&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

How about ARKK for 3 months?
ARKK is similar to OMER, which means crappy.

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=ARKK&amp;uf=0&amp;type=2&amp;size=2&amp;sid=17139661&amp;style=320&amp;freq=1&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=6&amp;rand=218728296&amp;compidx=aaaaa%3a0&amp;comp=tmo+dhr+iclr&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

Icon and Danaher (which some time ago I suggested was a good stock to own if you are a longterm investor as I used to know a guy who did M&A for them, which is a big part of their strategy) (not ThermoFisher) are the outperformers lately, so let's see them for the 3 months of ARKK and OMER weakness.

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=OMER&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=1&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=6&amp;rand=626568738&amp;compidx=aaaaa%3a0&amp;comp=arkk+iclr&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

But remember OMER beat them all over 6 months because of the extraordinary run in early 2021.

Was that ALL FROM increased value from OMIDRIA reimbursement?

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Long Omer short ARKK could be a decent neutral strategy.

68

Re: OMER Comparators, Competitors, VALUATION & potential partners

I like the concept, but you can lose on both ends.
You really want to short the most overvalued stocks (meaning the favorites) in a market that has been overvalued for years because you can time the decline?

Are the ARKK stocks going to remain in the doghouse? The Market doesn't strike me as consistent or reliable, but I am more wary than most.

I point out to everyone that the last time Omeros was about $10/share was during the pandemic crash.

Will it not decline with almost everything else, in the next market crash?
Will its association with Covid treatment make it not decline?
It is down 25% from the recent high despite being in a CV19 trial.
Certainly, getting approval for narso is no guarantee of being unaffected by a market crash.
Look at Auph and its DECLINE after getting it ONLY product approved by the FDA, declining from a pop to $20 down to under $12!

If I was going to use ARKK to hedge, I'd try to use options on 1 or both sides.
I would hedge to not only make more money but to lose less, if I could.

I could go long a PUT spread on ARKK for example (assuming they have liquid options) to protect an existing OMER position or a bullish position in OMER options.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

69

Re: OMER Comparators, Competitors, VALUATION & potential partners

In some ways, the pricing "problem" outlined in this STAT piece is similar to Omeros'delimma.
====================
Amgen’s unapproved cancer drug might already have a pricing problem

Last week, investors balked at the news that Amgen had begun studying a lower dose of its cancer treatment already under FDA review, deducing that there might be a safety problem that could stand in the way of approval. But there’s a simpler explanation, one that wouldn’t change the FDA process but that could create a headache for Amgen down the road.

As STAT’s Adam Feuerstein reports, the FDA asked Amgen to run the new trial based on data suggesting that a lower dose of the drug, sotorasib, could be just as effective as a higher dose previously tested but with fewer side effects. The good news, for Amgen, is that there were no new safety concerns that could delay approval of the higher dose.

The potential downside relates to drug pricing. Amgen is expecting to win approval for a 960 mg dose of sotorasib, at which point it will set a list price. Some time after that, the new study on a lower, 240 mg dose of sotorasib will read out. If it turns out that 240 mg works just as well, one bottle of sotorasib would last four months instead of one month — cutting the effective price of the medicine by 75%.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

70

Re: OMER Comparators, Competitors, VALUATION & potential partners

CCXI no news today

DOWN 20%
38.80-10.02 (-20.52%)
As of 10:04AM EDT. Market open.

Reported latest financials a few days ago.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CCXI on Twitter says there is a problem with its Phase 3 trial
ADCOM this week for the company

Must be negative comments from FDA or ???

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I saw some material (can't post it) that indicates that the company has misrepresented the data. The take away may be that the trial will be scrapped and that the FDA will be angry because they have wasted their time and effort. CCXI's drug is Avacopan, an orally administered selective complement C5a receptor inhibitor.

I believe the trial is the one most advanced for Avacopan and the stock is now down 41%
BUT ITS MARKET CAP IS STILL $2 BILLION

Way more than Omeros, without any approvals.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

73

Re: OMER Comparators, Competitors, VALUATION & potential partners

You'd think that the market would gravitate to OMER, but as you pointed out yesterday, the fact that OMER isn't going up, and can't maintain gains, is all that is needed to discredit the stock in the eyes of many folks.

I don't have a good feel for whether this is the base case for emerging biotechs, and we just see a few loud counter examples of unreasonable hype and valuations, or whether OMER is truly an unusual situation of lack of love from the market.

74

Re: OMER Comparators, Competitors, VALUATION & potential partners

I doubt that OMER is unique.
There are have been many small biotechs tormented by shorts, some surely destroyed by them... espectially the ones attacked by those who owned their convertible debt that gave them a lien on the assets,, I suppose. Other current stocks that get no love from the Market are ADMA and CFRX.... IOW ANYTHING considered a VALUE stock.

There is a slew of names, including CCXI, that have strong sponsorship, high valuation that makes it easy to have loads of cash, lack of approvals but drugs that capture the fancy of the money guys and  then there are the opposite...

OMER threatened a BIG favorite: Alexion

But any company that is UNDERvalued must have reasons.
If the reasons are not because of its science/technology/business/country risk/cyclicality/or some idiosyncratic risk, there still must be some reason.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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An Omeros investor I know related that he had spoken with Greg about the CCXI data that just caused the FDA problem... and Greg was aware something was wrong with the trial, last year... which is comforting.
==========================
May 5, 2021 06:37 AM EDTUpdated 08:58 AM PharmaFDA+
ChemoCentryx plunges as FDA raises questions about rare disease drug ahead of adcomm
Zachary Brennan Senior Editor

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

The application for avacopan, a small molecule antagonist of the C5a receptor, is based primarily on Phase III results that the FDA took issue with and said that they’d raised questions with in the past.

“Although primary efficacy comparisons were statistically significant, the review team has identified several areas of concern, raising uncertainties about the interpretability of these data and the clinical meaningfulness of these results,” FDA said.

The trial demonstrated non-inferiority of avacopan to a pre-specified prednisone taper at weeks 26 and 52 with both arms receiving background therapy and non-study specified glucocorticoids, the agency explained. But FDA said that throughout the development of the drug, the agency “reiterated that a non-inferiority comparison would not be sufficient to show that avacopan can replace glucocorticoids.”

While acknowledging that the avacopan arm demonstrated superiority over the prednisone arm in achieving sustained remission at week 52, FDA also said “it is not clear if the comparisons between the avacopan and prednisone arm beyond Week 26 are meaningful.”

Leerink biotech analyst Joseph Schwartz called the briefing documents “surprisingly critical,” saying the company has an “uphill battle” in convincing the adcomm to vote in its favor.

“The agency reviewers outline numerous issues that make the clinical data for avacopan difficult to interpret, in their view. These include the determination of the Birmingham Vasculitis Activity Score (BVAS) as the primary endpoint, calculation of the non-inferiority margin, characterization of glucocorticoid toxicity, liver safety, pharmacology, among others,” Schwartz wrote.

The FDA’s Arthritis Advisory Committee will meet Thursday to discuss the application and vote on three questions:

Do the efficacy data support approval of avacopan for the treatment of adult patients with AAV (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA))?

Is the safety profile of avacopan adequate to support approval of avacopan for the treatment of adult patients with AAV (GPA and MPA)?

Is the benefit-risk profile adequate to support approval of avacopan at the proposed dose of 30 mg twice daily for the treatment of adult patients with AAV (GPA and MPA)?

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CCXI has stabilized at about 40% down but I think they will plunge again.

The FDA pre-ADCOM presentation is apparently full of information but item#11 gives multiple examples of the FDA telling the company what they planned was inadequate.

Not only that, the FDA told them what to do to make the trial adequate and CCXI did not do it.

IMO this is going to be one huge lawsuit against the Company and its management, and the company deserves to lose. Even if the company believed their trial was adequate, the JUDGE was telling them the decision IN ADVANCE if CCXI were to carry out the pivotal trial they were proposing.

https://pbs.twimg.com/media/E0oPoy0WUAAD3R7?format=jpg&amp;name=medium

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CCXI did NOT trade during the regular session. It did trade after hours between $25 and $28.

I looked it up on Yahoo and the list of PRs by lawyers looking to sue the company and the management is VERY long.
As I already mentioned, it looks like a very good case this time.

You can only wonder why they did what they did after the FDA told them not to.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CCXI 10.28-17.21 (-62.60%)
As of 9:40AM EDT. Market open.
Advertisement

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Looks like easy money on the short side in retrospect. I think you predicted a further decline.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Easy in retrospect!
LOL

I would not be surprised to see the law suits wipe them out, completely.
And CCXI had a market cap OVER $4.5 Billion to Omeros'~1.1B.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

What is CCXI worth now?
They will never get a break from the FDA.
Their drug was obviously in the indication that they thought would be their "best shot".

But they have lots of money for lawsuits.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

https://endpts.com/adcomm-splits-slight … ease-drug/

May 6, 2021 05:16 PM EDT PharmaFDA+
Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug
Zachary Brennan
Senior Editor
The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.


John Sperati
There was a contentious debate over whether the one, relatively small Phase III trial comparing avacopan with prednisone was robust enough for a full approval. FDA raised concerns about the statistical analyses of the data in the trial and what effect the use of glucocorticoids on top of cyclophosphamide or rituximab in both treatment arms had on the avacopan efficacy. ChemoCentryx defended its trial design and explained how it met its primary endpoint and showed a reduction in the use of steroids with avacopan.

Those voting against approval raised concerns about relying on the single trial as evidence, the insufficient amount of safety data, and questions on whether the trial was statistically robust enough. Some panelists called for ChemoCentryx to run another trial.

AAC panelist John Sperati, associate professor of medicine at Johns Hopkins University School of Medicine, voted no on whether the FDA should approve the drug and said he had concerns with the study design and persuasiveness of the data. He explained how if avacopan is approved by the FDA, one would have to use it in a similar fashion as in the trial, but where its true efficacy lies remains unclear from that trial data.


Julia Lewis
Another panelist Julia Lewis, professor of medicine at Vanderbilt University Medical Center, also voted against approval and said the indication is too broad and far exceeds the data presented.

Those voting in favor of approval noted that the trial just cleared the bar to meet its primary endpoint and that trials in this population are difficult to conduct.

AAC panelist Walter Kraft, professor of medicine and surgery at Sidney Kimmel Medical College of Thomas Jefferson University, voted for avacopan to be approved, saying regulatory decisions are not made in a vacuum, but with existing therapeutics in mind, and that the trial met its goal. He also raised concerns about delays in access to avacopan if the FDA requires an additional trial.

Fellow panelist Margrit Wiesendanger, associate professor at Icahn School of Medicine at Mount Sinai, also voted in favor of approving the drug, but said judicious use of it will be warranted and additional guidance will be necessary to explain who exactly should receive it.


Walter Kraft
Those voting in favor of approval followed a series of concerns raised by FDA statistical reviewer Yura Kim on the company’s assessments of the data, noting, “Statistical analyses of the primary endpoint using the Investigator assessment of BVAS [a clinical scoring system of disease activity to identify active vasculitis in nine organ systems] remission resulted in smaller magnitude of treatment effect and would not support superiority of avacopan.”

The agency also questioned if the other drugs used in the study may have contributed to the efficacy seen for avacopan.

“In this case, both treatment arms received background therapy in the form of cyclophosphamide or rituximab. The benefit of glucocorticoids on top of cyclophosphamide or rituximab is not well understood,” Kim said. “As a result, it is difficult to determine if similar remission rates observed on both arms can support a conclusion that avacopan is effective or if similarities can be primarily attributed to both arms receiving rituximab or cyclophosphamide.”


Margrit Wiesendanger
The company defended its study design, noting that when rituximab won approval in this indication, it was primarily based on results from a single trial of about 200 patients, and was designed as a non-inferiority, comparator trial over 26 weeks.

Following that lead, ChemoCentryx in July 2016 initially proposed a 26-week randomized, double-blind trial comparing avacopan to prednisone in 232 patients receiving either rituximab or cyclophosphamide, Pirow Bekker, the clinical lead for the avacopan clinical development program, explained.

The European Medicines Agency agreed to the non-inferiority study, according to Bekker, with the demonstration of superiority in a secondary endpoint, such as glucocorticoid toxicity.

But in the US, FDA said a 26-week non-inferiority study was not sufficient, he noted. In order to address both FDA and EMA’s feedback, ChemoCentryx revised the study to be a 52-week study in about 300 patients, with the superiority assessment built in as well.

FDA’s Rachel Glaser confirmed that there was an expectation agreed to in the pre-submission discussions that superiority would need to be confirmed for avacopan and that non-inferiority would not be enough.

The FDA is not required to follow the advice of its advisory committee on ChemoCentryx’s avacopan, but in general, the agency usually does.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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It would be interesting to see how they do in their first Q WITH HELP FROM PFE.
Within 2 weeks of approval they signed a deal with PFE (see PR below).

This is Myovant's first product and approval and 1st Q with revenue. They have a current joint development deal with PFE

On December 18, 2020, the Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer.Dec 18, 2020

Myovant Sciences to Host Fourth Fiscal Quarter and Fiscal Year 2020 Earnings Conference Call at 8:30 a.m. Eastern Time on May 11, 2021
********************************
Myovant (MYOV) Up on Collaboration With Pfizer for Relugolix

MYOV
-1.37%

PFE
+1.00%
Zacks Equity Research
December 29, 2020·3 min read

MYOV
-1.37%

PFE
+1.00%
Myovant Sciences MYOV announced that it has signed a collaboration agreement with Pfizer PFE for development and commercialization of its recently approved oral GnRH receptor antagonist for advanced prostate cancer, Orgovy (relugolix). The companies will also jointly develop and commercialize Myovant’s relugolix combination tablet for uterine fibroids and endometriosis.

Earlier this month, the FDA approved the first and only oral GnRH receptor antagonist, Orgovy, as monotherapy for the treatment of men with advanced prostate cancer. Data from a phase III study evaluating the drug demonstrated a 97% responder rate and a lower incidence of major adverse cardiovascular events compared to the current standard of care, AbbVie’s ABBV Lupron (leuprolide acetate).

The relugolix combination tablet (relugolix + estradiol + norethindrone acetate) is also under review with the FDA for uterine fibroids and a decision is expected by Jun 1, 2021.

The collaboration agreement with Pfizer seems encouraging for Myovant as it will get strong support from an established pharma player for launch of its first commercial drug, Orgovy. Moreover, the agreement boosts Myovant funds significantly.

Per the terms of the agreement, Myovant will receive up to $4.2 million in upfront and milestone payments. This will include an upfront payment of $650 million, $200 million upon approval of relugolix combination tablet for uterine fibroids and tiered sales milestones on sales in both indications — prostate cancer and uterine fibroids — in the United States. The companies will also share profits and certain expenses for Orgovyx and relugolix combination tablet equally. Moreover, Pfizer will gain an exclusive option to commercialize relugolix in oncology outside the United States, Canada and certain Asian countries. The exercise of this option by Pfizer will trigger another $50 million payment to Myovant.

Shares of Myovant were up 20.5% on Dec 28 following the news.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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1 full Q of sales, with the help of PFE, only $3.6M for their new product.

https://finance.yahoo.com/news/myovant- … 00895.html
Myovant Sciences Announces Corporate Updates and Financial Results for Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021

MYOV
-3.32%
Myovant Sciences, Inc.
Tue, May 11, 2021, 5:58 AM

MYOV
-3.32%
Fourth fiscal quarter 2020 total revenues of $24.6 million; net product revenue from sales of ORGOVYX in the U.S. of $3.6 million

FDA review of New Drug Application for relugolix combination tablet for uterine fibroids remains on track for a decision by June 1, 2021 target action date; U.S. launch expected in June 2021, if approved

Remain on track to submit U.S. regulatory filing for endometriosis in the second quarter of calendar year 2021

European Commission decision on uterine fibroids Marketing Authorization Application remains on track for mid-calendar year 2021; Gedeon Richter to launch and commercialize, if approved

European Medicines Agency validated Marketing Authorization Application for relugolix for the treatment of advanced prostate cancer

Reported positive data for relugolix combination therapy from Phase 3 SPIRIT extension study in women with endometriosis and from Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids

Company remains well-capitalized with cash, cash equivalents, marketable securities and committed funding of $726.2 million as of March 31, 2021

BASEL, Switzerland, May 11, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the fourth fiscal quarter and fiscal year ended March 31, 2021.

“The ORGOVYX launch is off to a strong start and its differentiated clinical profile has the potential to redefine care for men with advanced prostate cancer. ORGOVYX demand accelerated over the course of the quarter, reflecting our ongoing efforts to educate urologists and medical oncologists about ORGOVYX while improving access and reimbursement for patients. In partnership with Pfizer, we continue to execute on our long-term goal of establishing ORGOVYX as the new standard of care androgen deprivation therapy,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “I am also pleased with the progress we have made in preparing for the U.S. launch of relugolix combination tablet in women with uterine fibroids, which is expected this June. In addition, we have advanced relugolix combination tablet toward a U.S. regulatory submission in endometriosis and our European regulatory submission for relugolix monotherapy for the treatment of advanced prostate cancer was validated by the European Medicines Agency.”

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

85

Re: OMER Comparators, Competitors, VALUATION & potential partners

OMER and ARKK are almost identical.
AUPH didn't get hit by the same degree of profit-taking

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=omer&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=6&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=1&amp;rand=1232765294&amp;compidx=aaaaa%3a0&amp;comp=ARKK%2c+AUPH%2c+MVOV&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Omeros outperforming the indexes and the tech-momentum players (ARKK)

Is the market justpaying attention to the latest patient report?
- the better Omidria outlook?
- or the chronic undervaluation in light of narso approval likely coming soon?

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=OMER&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=6&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=3&amp;rand=275388328&amp;compidx=aaaaa%3a0&amp;comp=ibb+xbi+arkk&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

And will people sell the good news and price increase like they seem to always do?  I'm tempted to sell some of my trading shares thinking the price will recede and allow me to buy them back again cheaper.

88

Re: OMER Comparators, Competitors, VALUATION & potential partners

yeah, i had the same thought, but the FOMO when the approval comes has prevented me from selling my so-called "trading shares"

89

Re: OMER Comparators, Competitors, VALUATION & potential partners

I write calls again trading shares, or really shares that are in excess of what I should hold, and don’t mind if they get called, and if they don’t get called I write more calls

90

Re: OMER Comparators, Competitors, VALUATION & potential partners

my thoughts exactly. made a tidy sum writing omer calls, even up to $35. if i get called at 35, i'm a happy camper!

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Today's outperformance

https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&amp;symb=OMER&amp;uf=0&amp;type=2&amp;size=2&amp;sid=3942233&amp;style=320&amp;freq=9&amp;entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&amp;time=1&amp;rand=1747944243&amp;compidx=NASDAQ&amp;comp=ibb+xbi+arkk&amp;ma=0&amp;maval=9&amp;lf=1&amp;lf2=0&amp;lf3=0&amp;height=335&amp;width=579&amp;mocktick=1

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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THE FDA CRIES BS on CYDY Drug Claims
========================================
Statement on Leronlimab
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FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment of COVID-19, especially those medicines that may provide a benefit to patients with the most severe forms of disease that can result in respiratory failure and death.  Leronlimab, a monoclonal antibody investigational drug under development by CytoDyn, Inc. (CytoDyn), is one of the potential medicines that has been studied to determine whether it is safe and effective in treating patients with COVID-19, including those with severe outcomes from COVID-19.

CytoDyn has conducted two separate clinical trials investigating leronlimab for the treatment of COVID-19.  A smaller trial, titled CD10, which included 86 patients, studied leronlimab’s effect on mild-to-moderate COVID-19 disease. A larger trial, titled CD12, which included 394 patients, studied leronlimab’s effect on severe symptoms of respiratory illness associated with COVID-19. CytoDyn has communicated information to the public about the results of these trials. Although FDA generally cannot disclose confidential information about unapproved products, we have concluded that given the significant public interest in leronlimab, it is important to provide summary information about the status of the CytoDyn development program.

First, we underscore the significance of a well-designed clinical trial when evaluating whether a medicine is safe and effective for a particular use. Well-designed trials have specific objectives, referred to as “endpoints”, that are documented (i.e., pre-specified) in the study protocol before the initiation of the investigation. Data obtained from the clinical trial are later analyzed using pre-specified statistical methodologies. If the analyses of the primary and secondary endpoints do not support conclusions of the medicine’s benefit, then FDA considers subgroup analyses to be exploratory, meaning they may inform the design of future trials, but do not support reliable conclusions about the medicine’s benefit. Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted. 

With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints. The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo.

The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).

CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19. 

If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program.

FDA recognizes the critical unmet medical need for new, effective treatments for COVID-19, especially for severe forms of the disease. We are committed to working with sponsors of novel therapies to facilitate development and approval of new treatments.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CYDY down 26% to $2.05 and it will continue.
It is OTCBB crap and always was.
Dishonest Management

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CYDY is fighting to counter the negative letters from both the US and Philippines FDAs saying they are going to be submitting "topline reports" to Regulators in India and elsewhere.

The CEO is a brazen scammer, apparently.
If anyone owns this, any increase in the share price from these CYDY counter-moves may be the best opportunity to exit, if you don't like the risk:reward of this company.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Humanigen Selects Chime Biologics as Manufacturing Partner
By Tim Wright, Editor, Contract Pharma | 05.17.21
Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.
     
Humanigen Selects Chime Biologics as Manufacturing Partner
Technical transfer work has already begun and commercial product is planned to be available in 2022.

Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, and Chime Biologics, a contract development and manufacturing organization (CDMO), have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the U.S. including Europe, the UK, India and Brazil.

“With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of lenzilumab, we are pleased to enter into a partnership with Chime to help with our anticipated commercial production of lenzilumab,” said Cameron Durrant, CEO, Humanigen. “Following a competitive process focused on quality, technical abilities, supply chain and economic criteria we selected Chime as our first foreign CDMO to supply lenzilumab to ex-U.S. markets.”

Under the terms of this agreement, Chime will use the state-of-the-art modular single use KuBio (Cytiva) biologics facility in China. The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually. Technical transfer work has already begun, and commercial product is planned to be available in 2022.

John Zeng, CEO of Chime Biologics,” said, “We are pleased to have been selected by Humanigen as a manufacturing partner for ex-U.S. supply of lenzilumab. Since 2013, Chime Biologics has developed and produced more than 30 products and supplied to over 20 countries from its latest generation single use facility. We are proud of our record for quality, compliance, bioprocessing expertise, and cost effectiveness, and very much look forward to supporting Humanigen in this important program.”

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Do they have an approval ANYWHERE? I don't follow them.

The MOA of the drug is not really explained in the PR so it is difficult to evaluate.
I have seen trolls on the ST OMER board telling people to sell their OMER and buy Humanigen.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

97

Re: OMER Comparators, Competitors, VALUATION & potential partners

OK, HGEN has "10 full time employees".
Market Cap is about the same as Omeros.

$92M in cash compared to OMER >$100M at the end of Q1
No approved drugs and no product revenue, compared to Omidria and what will probably be over $100M revenue in 2021

Humanigen calls themselves the Cytokine Storm Company.
https://www.humanigen.com/

Their lead drug candidate is lenzilumab an anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) monoclonal antibody. There is ONE of these drugs actually approved and it is not lenzilumab. See

https://www.leukine.com/
"LEUKINE efficacy has been demonstrated in a range of therapeutic settings for patients with hematologic malignancies" (Partner Therapeutics, Inc.)

Suggests to me that, if HGEN is successful, they will have at least 1 competitor.

I have seen this GM-CSF used before, in Cancer treatment. https://pubmed.ncbi.nlm.nih.gov/28303764/
It is approved to be used with at least one other cancer drug. I think it is a generic.

They have a PR that is entitled:

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

their trial: https://clinicaltrials.gov/ct2/show/NCT04351152
Considered Active NOT recruiting.

Primary and Secondary endpoints are mostly 28 days. Some secondaries last 60 days.

Patients do NOT have severe Covid.

Criteria include:

- Pneumonia diagnosed by Chest X-ray or Computed Tomography revealing infiltrates consistent with pneumonia

- SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV

- Hospitalized, not requiring invasive mechanical ventilation during this hospitalization

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

98

Re: OMER Comparators, Competitors, VALUATION & potential partners

What is sad is they have about the same market cap as Omeros. sad

99

Re: OMER Comparators, Competitors, VALUATION & potential partners

Yes, I said that in my 2nd sentence in the post above.
That is Pathetic.
Not that HGEN is valued at over $1B but that OMER is at about the same level.

As was the statement about lenzilumab by their KOL Principal Investigator from the Mayo Clinic ....He said it improved outcomes for hospitalized patients with Covid pneumonia... and could stop people from going onto a ventilator...hope it becomes a treatment for those NEWLY ADMITTED.

Also if authorized by the FDA "it may then be considered a port of our treatment armamentarium for newly hospitalized patients with COVID-19".

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I know and I was just reemphasizing that point that you made about their market caps and how Omeros continues to frustrate me and temp me to want to sell it and give up as I wonder if it will ever see any type of real valuation.