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AMGN contends that they couldn’t give out more details about the phase-2 MariTide trial because they have to “protect the integrity of the trial,” which is still blinded to patients and investigators. However, this claim does not entirely ring true; merely disclosing (as AMGN did) that the efficacy is “differentiating” could in itself cause patients who haven’t yet lost weight to conclude that they are in the placebo arm and drop out.
IMHO, AMGN should have either: a) reported the topline interim data; or b) refrained from making any comments other than to say that the program will advance to phase-3.
There remains a scientific question—whether GIP activity should be boosted or impeded—and we probably won’t get the answer anytime soon. Both approaches cannot be right—i.e. both approaches cannot be better than simply ignoring GIP (as GLP-1 monotherapy and certain dual-acting compounds do).
VIR 1Q24 CC transcript:
https://finance.yahoo.com/news/vir-biotechnology-inc-nasdaq-vir-170535096.html
I concur that Paxlovid 1Q24 sales and 2024 guidance are not surprising; however, I think some investors were confused by PFE's 4Q23 writeoff and didn't realize that the 2023 figure was an accounting artifact rather than a reflection of product demand.
Musk may have gone to China to ask for money—i.e. the “robotaxi” story could be misdirection to hide a liquidity squeeze.
This is not my own thesis, but rather one from someone who knows TSLA much better than I do.
AMGN's CC was a big tease insofar as management took 7-8 questions on MariTide and didn't say anything illuminating in response to any of them. The CC is still worth a listen for anyone long VKTX or other obesity stocks.
Is ENTA getting a delayed bounce from PFE’s $3B 2024 sales guidance for Paxlovid?
AMGN obesity update: AMG736 terminated; MariTide—>full_speed_ahead:
https://www.fiercebiotech.com/biotech/amgen-axes-obesity-asset-after-ph-1-results-zooms-maritide
AMG736 is (was) an oral non-peptide drug. MariTide (a/k/a AMG133) is an injectable dual-acting agent (#msg-173774152, #msg-173783936, #msg-173784595).
On AMGN’s 1Q24 CC yesterday afternoon, executives said that AMGN conducted an unblinded interim analysis of the MariTide phase-2 in obesity and saw a “highly differentiated” profile relative to both approved and pipeline obesity meds from other companies. They also said the phase-2 has had “no problem with patient dropouts.”
As a result of the above, AMGN plans to start a phase-3 MariTide trial during 2024. The dosing interval will be monthly, or even less often, using a “patient friendly” auto-injection device.
AMGN is +12% today, boosting the stock’s market cap by more than $15B!
AEON—(-53%)—reports failed phase-2 in migraine prevention:
https://finance.yahoo.com/news/aeon-biopharma-announces-preliminary-top-110000987.html
AEON—(-53%)—reports failed phase-2 in migraine prevention:
https://finance.yahoo.com/news/aeon-biopharma-announces-preliminary-top-110000987.html
AEON—(-53%)—reports failed phase-2 in migraine prevention:
https://finance.yahoo.com/news/aeon-biopharma-announces-preliminary-top-110000987.html
In response to your question: 1Q24 PFE Comirnaty sales were $118M US, $236M ex-US; 1Q24 MRNA Spikevax sales were: $100M US; $67M ex-US.
So PFE’s 1Q24 mRNA-COVID-vaccine market share was 54% in the US and 78% ex-US.
VIR reports 1Q24 results—3/31/24 cash=$1.51B(!):
https://www.businesswire.com/news/home/20240502260564/en
VIR re-iterated guidance for 2024 operating expenses of $650-680M.
CC slides:
https://investors.vir.bio/files/doc_financials/2024/q1/Vir-Corporate-Presentation_Q1-2024.pdf
VIR reports 1Q24 results—3/31/24 cash=$1.51B:
https://www.businesswire.com/news/home/20240502260564/en
VIR re-iterated guidance for 2024 operating expenses of $650-680M.
CC slides:
https://investors.vir.bio/files/doc_financials/2024/q1/Vir-Corporate-Presentation_Q1-2024.pdf
SHEL reports 1Q24 results—starts_another $3.5M buyback:
https://finance.yahoo.com/news/shell-plc-1st-quarter-2024-060000060.html
The new $3.5B buyback will be completed by the time SHEL reports 2Q24 results on 8/1/24 (https://finance.yahoo.com/news/shell-announces-commencement-share-buyback-060300825.html ).
SHEL has already repurchased $3.5B of stock during 2024 to date.
SHEL reports 1Q24 results—starts_another $3.5M buyback:
https://finance.yahoo.com/news/shell-plc-1st-quarter-2024-060000060.html
The new $3.5B buyback will be completed by the time SHEL reports 2Q24 results on 8/1/24 (https://finance.yahoo.com/news/shell-announces-commencement-share-buyback-060300825.html ).
SHEL has already repurchased $3.5B of stock during 2024 to date.
ZBH reports 1Q24 results—reiterates 2024 guidance:
https://finance.yahoo.com/news/zimmer-biomet-announces-first-quarter-103000875.html
2024 guidance remains non-GAAP EPS of $8.00-8.15; constant-currency YoY revenue growth of 5-6%; and a negative 0.5% hit to YoY sales growth from exchange rates.
More_on_the_same_topic—quality of weight loss:
https://www.fiercebiotech.com/biotech/regeneron-lilly-grapple-clinical-endpoints-obesity-space-moves-improving-weight-loss
PFE/MRNA—1Q24 COVID-vaccine worldwide_market_share—>68/32 in favor of PFE.
https://www.accesswire.com/858697/moderna-reports-first-quarter-2024-financial-results-and-provides-business-updates
PFE’s 2024 guidance for Comirnaty sales is $5.0B (#msg-174337807); MRNA has not issued 2024 guidance for Spikevax, but rather for total corporate revenue including the not-yet-approved RSV vaccine.
Zebra's Law: #msg-23784371.
PFE/MRNA—1Q24 COVID-vaccine worldwide_market_share—>68/32 in favor of PFE.
https://www.accesswire.com/858697/moderna-reports-first-quarter-2024-financial-results-and-provides-business-updates
PFE’s 2024 guidance for Comirnaty sales is $5.0B (#msg-174337807); MRNA has not issued 2024 guidance for Spikevax, but rather for total corporate revenue including the not-yet-approved RSV vaccine.
PFE/MRNA—1Q24 COVID-vaccine worldwide_market_share—>68/32 in favor of PFE.
https://www.accesswire.com/858697/moderna-reports-first-quarter-2024-financial-results-and-provides-business-updates
PFE’s 2024 guidance for Comirnaty sales is $5.0B (#msg-174337807); MRNA has not issued 2024 guidance for Spikevax, but rather for total corporate revenue including the not-yet-approved RSV vaccine.
NVO 1Q24 sales for T2D/obesity drugs:
https://ml-eu.globenewswire.com/Resource/Download/01af84ed-a119-435a-9553-ddd08340ba2d
• Ozempic $3.9B, +43% YoY in constant currency
• Wegovy $1.3B, +107% YoY in constant currency
• Rybelsus $0.7B, +17% YoY in constant currency
Note: Ozempic and Wegovy are the same drug (at different recommended doses) for T2D and obesity, respectively. Rybelsus is an oral formulation of the same drug approved for T2D.
I'm referring to your tag line in #msg-174343047: "I want to see replication. Too many completely novel things in one paper."
Yet another approach to HBV:
https://www.businesswire.com/news/home/20240502003325/en
Speaking of buzzwords/phrases…this PR claims 22x “enrollment velocity”:
https://www.globenewswire.com/news-release/2024/05/02/2874122/0/en/Science-37-Delivers-22x-Faster-Enrollment-than-Traditional-Methods-in-Phase-3-Asthma-Clinical-Trial.html
LOL
We need a buzzword—or phrase—to signify Zebra’s Law being applied to obesity programs!
Suggestions?
I strongly concur with the tag line in your post.
PTN tests Vyleesi—a_drug_approved_for_female HSDD*—for obesity as_adjunct_to Zepbound:
https://www.prnewswire.com/news-releases/palatin-announces-fda-clearance-of-ind-application-for-the-co-administration-of-bremelanotide-with-tirzepatide-glp-1-for-the-treatment-of-obesity-302134204.html
Vyleesi, which was approved by the FDA for FSDD in 2019, has had minimal sales to date.
*Hypoactive Sexual Desire Disorder (low libido).
[OT]—CLF CEO bought $1M of stock on the open market today:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174340346
He has a ~$100M equity stake in the company.
What Vin means is that EDP-235 is not an embodiment of the patent in question. I.e., ENTA will have legal clearance to advance EDP-235 regardless of the outcome of the patent litigation with PFE.
Instead of selling the company, might LG contemplate forming a consortium to buy it?
LG’s $1M stock purchase on the open market today—when he already owned a very sizable stake—is not something you often see.
LG bought $1M of stock on_the_open_market_today:
https://www.sec.gov/Archives/edgar/data/764065/000076406524000128/xslF345X05/wk-form4_1714592930.xml
Lourenco Goncalves now owns 5.76M shares, worth close to $100M at the current share price.
See #msg-174141720 for related info.
LG bought $1M of stock on_the_open_market_today:
https://www.sec.gov/Archives/edgar/data/764065/000076406524000128/xslF345X05/wk-form4_1714592930.xml
Lourenco Goncalves now owns 5.76M shares, worth close to $100M at the current share price.
See #msg-174141720 for related info.