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SPECULATION OF ALL CANCER NATIONS BREAKTHROUGH DECLARED
Cancer breakthrough in the clinic broski Rnaz https://www.eurekalert.org/news-releases/1055915
MRK 2Q24 results:
https://www.businesswire.com/news/home/20240730509685/en
MRK’s RSV prophylactic, Clesrovimab meets_all_endpoints_in_phase-2/3_trial:
https://www.businesswire.com/news/home/20240723229019/en
If approved, Clesrovimab will compete against GSK’s Beyfortus.
Beyfortus and Clesrovimab are effective at preventing RSV for one season, but they do not confer lasting immunity. Patients taking these drugs are likely to contract RSV infection in a subsequent season, and hence the need for RSV treatments, such as those being developed by ENTA, is not diminished.
MRK is doing really well. Wish I invested two years ago. Personalized Immunotherapy is going to be a huge thing very soon. So maybe it's not too late.
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
FDA approves MRK’s Capvaxive—(f/k/a V116)—pneumococcal vaccine for adults:
https://www.businesswire.com/news/home/20240614126575/en
With this approval, MRK should finally get a decent share of the market for adult pneumococcal vaccines, where PFE’s Prevnar franchise has long been dominant.
Please see #msg-173458310 and #msg-172452293 for related info.
KEYTRUDA plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients
KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind Phase 3 trial
https://www.biospace.com/article/releases/merck-s-keytruda-pembrolizumab-plus-chemoradiotherapy-crt-significantly-improved-overall-survival-os-versus-crt-alone-in-patients-with-newly-diagnosed-high-risk-locally-advanced-cervical-cancer/?keywords=pancreatic+cancer+phase+3
MRK reports 2Q23 results…
PR:
https://www.businesswire.com/news/home/20230801830764/en
Reuters:
https://finance.yahoo.com/news/1-merck-beats-quarterly-sales-104937970.html
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):
https://www.businesswire.com/news/home/20230727120762/en
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”:
https://www.wsj.com/articles/merck-challenges-u-s-governments-new-powers-to-negotiate-drug-prices-127d4b0c
MRK reports 1Q23 results—raises non-GAAP EPS guidance:
https://finance.yahoo.com/news/merck-announces-first-quarter-2023-103000788.html
https://finance.yahoo.com/news/merck-earnings-better-expected-keytruda-103855413.html
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:
https://finance.yahoo.com/news/bayer-defeats-merck-lawsuit-over-215120183.html
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:
https://www.businesswire.com/news/home/20230327005147/en
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:
https://www.businesswire.com/news/home/20230223006077/en
MRK 4Q22 results—2023 guidance:
https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Merck-News-Release-02-02-23-Merck-Announces-4Q-and-FY-2022-Financial-Results.pdf
2023 guidance for non-GAAP EPS is $6.80-6.95; at the midpoint, this is an 8% decline from 2022’s $7.48.
CC slides:
https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Q4-2022-Merck-Earnings-Deck-(Final).pdf
Prepared remarks:
https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Q4-2022-Merck-Earnings-Prepared-Remarks-(Final).pdf
FDA approves Keytruda for adjuvant NSCLC following adjuvant treatment with platinum chemo:
https://www.businesswire.com/news/home/20230127005078/en
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:
https://www.businesswire.com/news/home/20230124006084/en/Merck-Announces-KEYNOTE-991-Trial-Evaluating-KEYTRUDA%C2%AE-pembrolizumab-Plus-Enzalutamide-and-Androgen-Deprivation-Therapy-in-Patients-With-Metastatic-Hormone-Sensitive-Prostate-Cancer-to-Stop-for-Futility
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:
https://finance.yahoo.com/news/merck-kelun-biotech-announce-exclusive-114500834.html
MRK/MRNA cancer vaccine shines in adjuvant melanoma (RFS HR=0.56):
https://www.accesswire.com/731571/Moderna-and-Merck-Announce-mRNA-4157V940-an-Investigational-Personalized-mRNA-Cancer-Vaccine-in-Combination-with-KEYTRUDAR-pembrolizumab-Met-Primary-Efficacy-Endpoint-in-Phase-2b-KEYNOTE-942-Trial
MRK acquires IMGO for $36.00/sh cash—a 107% premium to Friday’s close:
https://finance.yahoo.com/news/merck-acquire-imago-biosciences-inc-114500059.html
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!
Ehhhhh seems a lot more likely today
Unlikely, haha.
MRK exercises option_to_commercialize MRNA cancer vaccine:
https://www.accesswire.com/720004/Merck-and-Moderna-Announce-Exercise-of-Option-by-Merck-for-Joint-Development-and-Commercialization-of-Investigational-Personalized-Cancer-Vaccine
https://finance.yahoo.com/news/1-merck-opts-jointly-develop-113551661.html
MRNA receives $250M in immediate cash from MRK’s opt-in.
Sotatercept phase-3 in PAH hits primary endpoint:
https://finance.yahoo.com/news/merck-announces-positive-top-line-104500840.html
Sotatercept is the drug MRK picked up in the $11.5B XLRN acquisitions last year (#msg-166156870).
Lagevrio misses_primary_endpoint_in_large_Oxford_U_trial:
https://ca.finance.yahoo.com/news/merck-ridgeback-biotherapeutics-clinical-non-235000071.html
FDA allows some Islatravir trials to_resume_at_a lower dose:
https://finance.yahoo.com/news/merck-initiate-phase-3-clinical-104500524.html
Keytruda narrowly_misses_statsig OS/PFS as_addend_to Lenvina in_ first-line HCC:
https://finance.yahoo.com/news/merck-eisai-present-results-phase-063000955.html
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
MCL 95%
CLL 95%
Uterus 96%
Lymphoma 90%
Prostate 90%
Skin 89%
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.
https://www.fiercebiotech.com/biotech/boehringer-inks-1-5b-nbe-buyout-joining-merck-ror1-adc-race
$MRK
Keytruda fails phase-3 in CRPC:
https://www.businesswire.com/news/home/20220803005334/en
FDA approves MRK’s pneumococcal vaccine, Vaxneuvance for infants/children:
https://finance.yahoo.com/news/u-fda-approves-merck-vaxneuvance-104500312.html
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.
MRK slides from ASCO webcast:
https://s21.q4cdn.com/488056881/files/doc_events/2022/06/ASCO-2022-Slide-Presentation-Final.pdf
Synopsis of (anti-LAG-3) favezelimab data from ASCO abstract:
https://www.biopharmadive.com/news/asco-merck-favezelimab-lag3-hodgkin-trial/624457/
Favezelimab might eventually compete with BMY’s Opdualag (#msg-168259768), but it has a long way to go.
Please see #msg-168259803 and https://twitter.com/DewDiligence/status/1395141087413538822 for related info.
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