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RVNC
RSV vaccine may slightly increase of Guillain-Barré syndrome
https://www.nytimes.com/2024/02/29/health/rsv-vaccine-guillain-barre.html?unlocked_article_code=1.3U0.VXUM.Z3reDzXMHe-N&smid=url-share
As previously discussed here:
RDGL-Vivos submits application to FDA to initiate Human Trials at Mayo Clinic.
I don’t think today’s “Chevron” decision will affect the FDA to anywhere near the same degree as the SEC and certain other federal agencies. Within the healthcare sector, the biggest impact of the decision may fall on CMS (Medicare/Medicaid).
Re: “Chevron” decision /clinical-trial disclosures
When quoting, you didn't include my FWIW disclaimer. [eos]
Some reverse-mergers work out well—e.g. MDGL (#msg-121919321).
ALMS IPOs 15.1M* shares @$16.00:
https://www.globenewswire.com/news-release/2024/06/28/2905639/0/en/Alumis-Announces-Pricing-of-Initial-Public-Offering.html
reverse-mergers - the easy way to get listed.
https://www.investopedia.com/articles/stocks/09/introduction-reverse-mergers.asp
From Wikipedia:
CHMP rejects APLS’ Syfovre again—APLS plans appeal:
https://www.globenewswire.com/news-release/2024/06/28/2905763/0/en/Apellis-Plans-to-Seek-Re-Examination-Following-Negative-CHMP-Opinion-for-Pegcetacoplan-for-Geographic-Atrophy-GA-in-the-EU.html
In short, the CHMP is not convinced that Syfovre offers patients a meaningful clinical benefit.
I’ve long been bearish on APLS’ Syfovre—see, for instance, #msg-171260849.
Savvy Pick 10 Contest #1 Deadline a Little more than 3 Hour Away
Remember to get your picks in before Today's Market Close. Below is the link to the board.
https://investorshub.advfn.com/Savvy-Pick-10-Contest-1-43057
ACIP endorses MRK’s Capvaxive pneumococcal vaccine for certain groups—creating parity with PFE’s Prevnar-13 for adult market:
https://www.businesswire.com/news/home/20240627540619/en
MindMed to be Included in Russell 2000® and Russell 3000® Indexes
https://www.businesswire.com/news/home/20240628586419/en/MindMed-to-be-Included-in-Russell-2000%C2%AE-and-Russell-3000%C2%AE-Indexes
June 28, 2024 07:00 AM Eastern Daylight Time
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced today that as part of the annual reconstitution of the Russell stock indexes, the Company will be included in the Russell 2000® Index and the broad-market Russell 3000® Index, effective today.
“We are pleased to join the Russell Indexes and look forward to continuing to share our story with a broader audience of investors.”
Post this
“MindMed’s inclusion in the Russell Indexes mark an exciting milestone and reflects growing recognition of our commitment to addressing the unmet medical needs for people with brain health disorders by advancing MM120 for the treatment of general anxiety disorder and MM402 for the treatment of autism spectrum disorder,” said Rob Barrow, Chief Executive Officer of MindMed. “We are pleased to join the Russell Indexes and look forward to continuing to share our story with a broader audience of investors.”
Membership in the Russell 3000® Index means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as in the appropriate growth and value style indexes. The Russell 3000® Index encompasses the 3,000 largest U.S.-traded stocks by objective, market-capitalization rankings, and style attributes. Membership in these indexes is updated annually and remains in place for one year.
The Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9.1 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.
For more information on the Russell Indexes and the Russell U.S. Indexes Reconstitution, visit the "Russell Reconstitution" section on the FTSE Russell website.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.
EYPT
Further, both companies issuing today's purportedly-positive results were the products of reverse-mergers! (Check the posts that today's posts were in reply to.)
You use the word “purportedly.”
DVAX's best opportunity may be internationally.
There’s room on the tolerability side but it’s hard to catch up to a vaccine with over a decade of efficacy (which makes GSK also a victim of their own success bc even now there is no clear need for revaccination)
By the time DVAX would be on the market the United States will already be vaccinated. That leaves the 4-5M annual patient pool that enter the age cohort plus any holdovers who are for vaccination but were scared of the safety profile which can’t be all that significant
FDA authorizes first point-of-care HCV diagnostic:
https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-point-of-care-hepatitis-c-rna-test-302185013.html
CARM—(+50%/AH)—selects lead candidate in MRNA collaboration:
https://www.prnewswire.com/news-releases/carisma-therapeutics-announces-nomination-of-first-in-vivo-car-m-development-candidate-for-hepatocellular-carcinoma-under-collaboration-with-moderna-302185002.html
DVAX seeks to challenge Shingrix:
https://www.prnewswire.com/news-releases/dynavax-initiates-phase-12-study-of-novel-shingles-vaccine-program-302185089.html
WBA—(-25%)—plans_to_close many Walgreens pharmacies:
https://www.wsj.com/health/walgreens-plans-major-u-s-store-closures-0b04a96e
This news is more than tangentially related to the PBM story in #msg-174644394.
Does anyone recognize a theme in the two preceding posts? LOL
XFOR -35% on purportedly-positive phase-2 data in chronic neutropenia:
https://www.globenewswire.com/news-release/2024/06/27/2905026/0/en/X4-Pharmaceuticals-Announces-Positive-Interim-Clinical-Data-from-Ongoing-Six-Month-Phase-2-Trial-of-Mavorixafor-in-Chronic-Neutropenia-CN-and-Initiation-of-Pivotal-Phase-3-CN-Trial.html
CALC -31% on purportedly-positive phase-2b data in acute pancreatitis:
https://www.prnewswire.com/news-releases/calcimedica-announces-positive-topline-data-from-phase-2b-carpo-trial-of-auxora-in-acute-pancreatitis-ap-302183843.html
Re: “Materiality” /partial data disclosure
I do not know of a practical alternative to the SEC’s defining “materiality” for disclosure purposes as a percentage change in a stock’s share price. Although materiality has not been formally quantified in regulations, the de facto standard applied by the SEC has been +/- 5%. Unless this changes, Big Pharma/Big Biotech companies will be able to continue releasing partial datasets, despite the much larger effect these releases may have on small- and mid-cap competitors and prospective competitors such as VKTX.
Another factor enabling partial data releases is the longstanding practice of drug/biotech companies to hold back full clinical-trial datasets for presentation at a medical conference. Indeed, releasing too much data ahead of a medical conference may cause the conference organizers to scrap the clinical trial in question from the roster of presentations at the conference.
I agree with your overall point that nothing is going to happen at regulatory agencies in the near term to get large pharma to provide disclosure of negative AE’s in early trials. But I maintain that this is "material" to the same companies making the disclosures.
Please consider the actual PART 240—GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934:
Dew
This is a typical Ligand deal.
Ligand earns $5.8M milestone payment following FDA approval of Ohtuvayre
Ligand (LGND) announced that its partner Verona Pharma (VRNA) has received approval from the FDA for Ohtuvayre. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease in adult patients in more than 20 years.
Ligand has earned a $5.8M milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre.
Read more at:
https://thefly.com/n.php?id=3938748
VKTX recent weakness could also be because of Russell index rebalancing. 9m shares out of a total of 110m outstanding is a lot.
$VKTX 9m extra shares being sold into a weak market explains a lot of the weakness as of late. pic.twitter.com/VFJcB7mDuI
— J (@jayabacus) June 26, 2024
VKTX- An in initiation endorsement by one of the more respected firms on Wall street
Viking Therapeutics initiated with an Overweight at Morgan Stanley 04:57
VKTX Morgan Stanley analyst Michael Ulz initiated coverage of Viking Therapeutics with an Overweight rating and $105 price target. The analyst believes the Phase 2 data for VK2735 and VK2809 suggest a "potential best-in-class profile" in obesity and non-alcoholic steatohepatitis, respectively, supporting two separate blockbuster market opportunities for Viking. The firm expects the company's near-term updates to drive further share upside. Obesity represents a large and rapidly growing market with opportunity for differentiated agents, Morgan Stanley contends.
Read more at:
https://thefly.com/n.php?id=3938508
Thanks & I do follow you and appreciate the updates on VKTX
Sorry you went through that. Appreciate your sharing and I hope you are well now.
CABA and others in CAR space for autoimmune diseases:
CABA last CC:
a) claims despite being behind others in some way (eg many fewer patients than Kyverna, probably many fewer than BMS) they are actually ahead in opening US trial sites adequate for NDA filing (not "basket sites" which accept random basket of autoimmune diseases, often with fuzzy admission protocols etc). This appears to be true - altho a quick browse thru Clinical Trials website indicates Kyverna is clearly starting this process (but most sites not yet enrolling). Comment: pretty much everyone else is far behind Kyverna, Cabaletta and BMS per ClinicalTrials (ie US based). Also, reminder that Kyverna (and probably BMS) are still in dose escalation, which CABA claims not to need to do because of similarity to Schett T-Cell.
b) However, as one analyst pointed out via question, the CABA data doesn't look exactly like the Schett data - the CAR-T peak expansion is about 6 days later, and in one case looks lower than equivalent Schett data. (CABA's answer to these was they use frozen cells which are slower to expand but don't impact efficacy (would need to check lit for this), and that the patient with the lower expansion had abnormally low blood counts of some form)
c) They have, subsequent to the 2 patients discussed in EULAR, enrolled 3 more patients. And opened up site for other Schett based diseases.
d) They are planning a trial experimenting with no pre-treatment (comment: there is a paper on which Schett is an author that shows similar efficacy with less pretreatment - but no pre-treatment seems a stretch)
General comment: There are a LOT of companies in this space on ClinicalTrials - a significant majority being in China (and a large fraction of them being BCMA instead of CD19 - so more severe side effects (eg forgetting past immunities) and unclear efficacy in autoimmune)
I wouldn't want you to not follow medical advice because of a message board. PFE is a more tolerable shot but GSk seems to have lower GBS risk, but with either the risk is lower than say a bad car accident. Are you not going to drive?
For some RSV can be severe and if you fall into an at risk category the risk benefit may clearly favor vaccination.
mufaso
I mentioned the terrible reaction to the RSV vaccination I received in 2023, but I think my personal experience was not well received here!
I blame myself for believing that the ads on tv were helpful, with my many medical problems and age I should have waited for some time to be sure that this would be a good thing; in my case, it was not.
I didn’t listen to the presentation either but I did find this online which seems to have been adopted by the vote.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf
“Work Group recommends a transition away from shared clinical decision-making (SCDM). What does this mean?
▪All adults aged 75 years and older should receive a single dose of RSV vaccination.
▪All adults aged 60–74 years with certain chronic medical conditions or other factors that increase risk of severe RSV disease should receive a single dose of RSV vaccination.
▪These recommendations would replace the SCDM recommendation, meaning that adults aged 60–74 years without risk factors for severe RSV disease, are no longer recommended to receive RSV vaccination”
So they removed the shared decision making model in favor of universal recommendation (bullish for vaccine makers) but narrowed the eligible population to only a subset of those 60-74 years of age with certain comorbidities (bearish)
Net net I’m not sure how this will affect sales
In case you think the defined group in the 60-74 age cohort is defined too narrowly there is this nugget which seems to give doctors amd patients some leeway on who is eligible
“Other chronic medical conditions that a
healthcare provider determines increases risk
of severe disease due to respiratory infection”
More_on_the topic_of skimpy—perhaps shady—data releases:
The "materiality" threshold for disclosing information applies only to a company's own stock—not to the stock of competitors and prospective competitors. So, Big Pharma are not violating SEC regs in the instances you cite. The behavior is somewhat shady, but it's not unlawful.
— Roy Friedman (@DewDiligence) June 26, 2024
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