MRK reports 2Q23 results…
MRK’s V116 shows non-inferiority to Prevnar-20 in two phase-3 trials (one for pneumococcal-vaccine naïve patients and one for patients who received a prior pneumococcal vaccine):
V116 is a 21-valent pneumococcal vaccine intended for the adult market only. PFE’s Prevnar-20 currently owns virtually the entire adult market for pneumococcal vaccines because CDC/ACIP’s recommendations give preferential treatment to Prevnar-20 vs MRK’s 15-valent V114 (a/k/a Vaxneuvance) (#msg-166441188).
The V116 results announced today put MRK back in the ballgame for the adult segment of the market.
See #msg-168548763 for related info.
MRK sues US over IRA drug-price “negotiation”:
MRK reports 1Q23 results—raises non-GAAP EPS guidance:
2023 non-GAAP EPS guidance was raised to $6.88-7.00 (from $6.80-6.95).
A Delaware judge ruled today that MRK remains liable for talc lawsuits relating to Dr. Scholl’s foot powder, even though MRK sold its OTC- healthcare business to Bayer in 2014:
MRK inherited Dr. Scholl’s in the 2009 takeover of Schering-Plough.
Keytruda shows statsig-superior PFS as addend to chemo in Stage-III/IV (or recurrent) endometrial cancer:
The HR for PFS was 0.54 in the pMMR subgroup and 0.30(!) in the dMMR subgroup.
The OS results are not disclosed in the PR, so they are presumably not mature. (OS was a secondary endpoint.)
EMA rejects MRK’s MAA for Molnipiravir:
MRK 4Q22 results—2023 guidance:
2023 guidance for non-GAAP EPS is $6.80-6.95; at the midpoint, this is an 8% decline from 2022’s $7.48.
FDA approves Keytruda for adjuvant NSCLC following adjuvant treatment with platinum chemo:
Keytruda’s HR for DFS (compared to placebo) was 0.73 [95% CI: 0.60-0.89]. This is slightly better than the HR=0.76 that MRK reported when the KEYNOTE-091 trial reported in Mar 2022 (#msg-168241140); I do not know the reason for the discrepancy.
Curiously, in an exploratory analysis of patients (n=167) who did not receive adjuvant chemo, Keytruda’s HR for DFS (relative to placebo) was 1.25 (i.e. the Keytruda arm did worse than placebo), but the 95% confidence interval was wide [0.76-2.05].
That would be the best , most productive purchase they could ever make , but Merck mgt is too stupid. They try to build equivalent to DCVax with every asinine purchase they make. Maybe a new mgt team at Merck with common sense, would get DCVax , the most incredible advancement in GBM and immunology in history.
Keytruda fails again in prostate cancer—one of the few cancer indications where it has not seen a positive outcome:
The MRK-SGEN deal reputed to be nearly done last summer (#msg-169332904) can probably be dismissed after MRK’s ADC collaboration with China’s Kelun-Biotech today:
MRK/MRNA cancer vaccine shines in adjuvant melanoma (RFS HR=0.56):
MRK acquires IMGO for $36.00/sh cash—a 107% premium to Friday’s close:
The nominal deal value is $1.35B. The buyout price is a 125% premium to IMGO’s IPO price 16 months ago (#msg-164945919).
I would take the other side of that bet!
MRK exercises option_to_commercialize MRNA cancer vaccine:
MRNA receives $250M in immediate cash from MRK’s opt-in.
FDA allows some Islatravir trials to_resume_at_a lower dose:
Keytruda narrowly_misses_statsig OS/PFS as_addend_to Lenvina in_ first-line HCC:
Merck snatched up ROR1 veslobio for 2.75 Billion I think they may try and Buy ONCT better acting drug partnered with ABBV ibrutinib the combo works 50% better than the drug alone. Pcyc ibrutinib now ABBV is going to do 9.5-10 Billion in sales next year. I think Merck might buy ONCT more data further along in trials very robust pipeline. ROR1 expression on many tumor types
• Potential safety and efficacy advantages
• MK-2140 ADC data at ASH 2021: no apparent off-
tumor, on-target ROR1 toxicities.
ROR1 Expressed on Multiple
Solid and Liquid Tumor's
Insiders have been buying it up just broke the 50 day moving average. I think Merck might come in to add to there Ror1 portfolio.
Keytruda fails phase-3 in CRPC:
FDA approves MRK’s pneumococcal vaccine, Vaxneuvance for infants/children:
Vaxneuvance was already FDA-approved for adults (#msg-164961310), but I don’t think Vaxneuvance will compete effectively with PFE’s Prevnar-20, which has broader coverage of pneumococcal serotypes and a simpler (one-shot) treatment course (#msg-166441188).
PFE's Prevnar-20 is FDA approved for adults, but is not yet approved for infants/children, so MRK does have a head start in the pediatric market.
MRK pays PFE a royalty of 7.25% on worldwide Vaxneuvance sales during 2022-2026 and a 2.5% royalty during 2027-2035 (#msg-166075692).
WHAT ARE YOU TALKING ABOUT??? COVID-19 IS JUST RENAMED INFLUENZA.... ITS A TOTAL SCAM!!!!!
BIG PHARMA ARE CRIMINALS DUPING THE PUBLIC!!!!!!!!
ENOUGH WITH THE MINDLESS HYSTERIA ALREADY!!!!!!!
Pay attention, looks like we have a change in the last immune escape variants. They may have also become more heat tolerant, or more stupid monkeys are hanging out with eachother. Uptick in Delta.
Synopsis of (anti-LAG-3) favezelimab data from ASCO abstract:
Favezelimab might eventually compete with BMY’s Opdualag (#msg-168259768), but it has a long way to go.
Please see #msg-168259803 and
for related info.
$BMY's LAG-3 result in first-line melanoma looks like a fairly modest medical advance, but one that will probably make serious money for the company in the coming years. (I'm long.)— Roy Friedman (@DewDiligence) May 19, 2021
CHMP approves Keytruda/chemo in the neoadjuvant setting followed by Keytruda monotherapy in the adjuvant setting for non-metastatic TNBC:
Approval based on KEYNOTE-522 trial.
MRK’s V116—(follow-on_to Vaxneuvance)—receives FDA BTD for prevention of pneumococcal disease in adults:
The phase-3 trial is expected to start during 2022.
V116 is a 21-valent vaccine; the 21 strains are: 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B.
MRK—Vaxneuvance sBLA for pediatrics gets 3-month extension to 7/1/22:
Vaxneuvance is already FDA-approved for adults (#msg-164961310), but I don’t think Vaxneuvance will compete effectively with PFE’s Prevnar-20, which has broader coverage of pneumococcal serotypes and a simpler (one-shot) treatment course (#msg-166441188).
p.s. MRK pays PFE a royalty of 7.25% on worldwide Vaxneuvance sales during 2022-2026 and a 2.5% royalty during 2027-2035 (#msg-166075692).
FDA approves Keytruda monotherapy for recurrent endometrial cancer with MSI-H or dMMR:
The approval is based on ORR from single-arm cohorts of the KEYNOTE-158 trial.
Note: Keytruda plus Lenvima is already FDA-approved in the same setting for patients without either MSI-H or dMMR.