Merck and Co Inc News - MRK

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Merck Closes Exclusive Global License Agreement for LM-299, An Investigational Anti-PD-1/VEGF Bispecific Antibody

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the closing of the exclusive global license agreement...

Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection

Trials met efficacy success criteria for non-inferiority of DOR/ISL to comparator antiretroviral therapies in adults with virologically...

Merck Enters into Exclusive Global License Agreement with Hansoh Pharma for Investigational Oral GLP-1 Receptor Agonist

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced...

Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season

If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season...

Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs...

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC

This approval marks the fourth non-small cell lung cancer (NSCLC) indication and the first indication in earlier stages of NSCLC for KEYTRUDA in...

Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma

If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the...

LYNPARZA® (olaparib) Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer in OlympiA Phase 3 Trial

87.5% of patients treated with LYNPARZA were alive at six-years vs. 83.2% in the comparator arm First and only PARP inhibitor to improve overall...

Merck Announces Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Advanced Epithelial Ovarian Cancer

KEYTRUDA® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, demonstrated a...

Merck’s Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrates Complete Response Rate of 100% at 1.75 mg/kg Dose in Phase 2 Trial of Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate Merck (NYSE:...

Merck and Ridgeback Biotherapeutics Announce Initiation of Phase 3 Study (MOVe-NOW) Evaluating LAGEVRIO™ (molnupiravir) for the Treatment of COVID-19 in High-Risk Adults

MOVe-NOW will build on existing LAGEVRIO data to assess efficacy in the current COVID-19 environment and support applications for licensure Merck...

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations

First breakthrough therapy designation for investigational sac-TMT in the U.S. Merck (NYSE: MRK), known as MSD outside of the United States and...

Merck to Participate in the Citi 2024 Global Healthcare Conference

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive...

Merck Announces Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint at Interim Analysis

WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension...

BLACKBIRDSR-71 4 months ago

SPECULATION OF ALL CANCER NATIONS BREAKTHROUGH DECLARED

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BLACKBIRDSR-71 4 months ago

Cancer breakthrough in the clinic broski Rnaz https://www.eurekalert.org/news-releases/1055915

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ZLAZARUS 4 months ago

Picked up a few hundred shares today

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DewDiligence 5 months ago

MRK 2Q24 results:

https://www.businesswire.com/news/home/20240730509685/en

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DewDiligence 5 months ago

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.

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ShadowVolcano37 6 months ago

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.

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DewDiligence 6 months ago

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
• Adults 65 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

• Adults 19-64 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

• Adults 19 years of age and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) [PFE’s Prevnar-13] but have not received all recommended PPSV23 [MRK’s Pneumovax]…;

• Additionally, shared clinical decision-making is recommended regarding use of a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 [Prevnar-13] and PPSV23 [Pneumovax]. These ACIP recommendations are essentially the same as the CDC’s existing recommendations for PFE’s Prevnar-20, and hence they should allow MRK’s Capvaxive to gain a meaningful share in the adult portion of the pneumococcal vaccine market. PFE has had an overwhelming (>90%) share of this market in the US because MRK’s other conjugated pneumococcal vaccine, Vaxneuvance, received a less favorable recommendation from the CDC than PFE’s Prevnar-13.

Please see #msg-166441188 and #msg-172452293 for related info.

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DewDiligence 6 months ago

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.

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avxl_going_long 8 months ago

https://www.sciencetimes.com/articles/50071/20240508/anavex-life-sciences-alzheimers-treatment-brings-hope-to-millions.htm

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axelvento 9 months ago

https://www.onclive.com/view/pembrolizumab-plus-concurrent-crt-meets-os-end-point-in-high-risk-locally-advanced-cervical-cancer

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axelvento 9 months ago

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

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Monksdream 11 months ago

snoopycomic 1 year ago

Why Red fonts?

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DewDiligence 1 year ago

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 Merck & Co raised its full-year revenue forecast on Tuesday as second-quarter sales of its top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil, sailed past Wall Street estimates.

Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion.

…Sales of Gardasil…surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. MRK sharply lowered 2023 non-GAAP EPS guidance due to a $10.2B charge ($4.02/sh) relating to in-process R&D from the acquisition of RXDX (#msg-171696785). The new guidance range is $2.95-3.05.

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DewDiligence 1 year ago

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.

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DewDiligence 2 years ago

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 Drugmaker Merck & Co. filed a lawsuit on Tuesday challenging the U.S. government’s plan to negotiate drug prices, saying it is unconstitutional.

Drugmakers were expected to file lawsuits challenging the program, especially as Medicare neared the date later this year when it began naming some drugs it would target for price negotiations.

Among the drugs that analysts expected to face price negotiations are Merck’s top-selling product, the cancer immunotherapy Keytruda.

Merck’s complaint takes issue with the negotiation program’s enforcement rules, which include the power to levy an excise tax of up to 95% of a drug’s U.S. sales if a pharmaceutical company refuses to sell the drug to Medicare patients. Merck said the tax would be coercive and violate the constitution’s Fifth Amendment ban on private property being taken for public use without just compensation. [The so-called “takings” clause.]

Merck also said the law would force companies to agree that the government-mandated prices are “fair,” violating its free speech rights under the First Amendment. For biotech investors, there’s a lot riding on the outcome of this lawsuit and related cases.

Want more details? See https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf (91 pages).

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DewDiligence 2 years ago

MRK’s ASCO lineup:

https://finance.yahoo.com/news/merck-present-extensive-research-demonstrating-104500565.html

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DewDiligence 2 years ago

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).

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DewDiligence 2 years ago

MRK acquires RXDX for $10.8B…

PR:
https://www.merck.com/news/merck-strengthens-immunology-pipeline-with-acquisition-of-prometheus-biosciences-inc/

CC slides:
https://s21.q4cdn.com/488056881/files/doc_presentations/2023/04/Acquisition-of-Prometheus-Biosciences-Investor-Event-Slides-FINAL.pdf

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DewDiligence 2 years ago

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.

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DewDiligence 2 years ago

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.)

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DewDiligence 2 years ago

EMA rejects MRK’s MAA for Molnipiravir:

https://www.businesswire.com/news/home/20230223006077/en Merck and Ridgeback Biotherapeutics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion. The appeal would seem to be fruitless. Molnupiravir is simply a bad drug that doesn’t deserve (non-emergency) marketing authorization.

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DewDiligence 2 years ago

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

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DewDiligence 2 years ago

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].

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extrooper 2 years ago

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.

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DewDiligence 2 years ago

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 Merck…today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA…in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

…At the interim analysis, KEYTRUDA in combination with enzalutamide [Xtandi] and ADT did not demonstrate an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT. This is Keytruda’s third recent phase-3 in prostate cancer. In the KEYNOTE-921 trial, which reported results in Aug 2021, Keytruda failed to show a statsig benefit when added to chemo in CRPC (#msg-169574792). In the KEYLINK-010 study, which reported results in Mar 2022, the combination of Keytruda and Lynparza (a PARP inhibitor) failed to show a statisig benefit compared to Xtandi or Zytiga in mCPRC refractory to chemo and either of Xtandi or Zytiga (https://www.clinicaltrials.gov/ct2/show/NCT03834519 ).

Keytruda is a great drug, but it’s not invincible.

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Pattyloco 2 years ago

Why

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DewDiligence 2 years ago

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

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DewDiligence 2 years ago

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 …the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA…demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection.

Adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p-value=0.0266) compared with KEYTRUDA alone. Note: If this had been a phase-3 trial, it would’ve been considered a failure since the standard cutoff for a one-sided p-value is 0.025. For a phase-2b, however, these results are just fine.

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DewDiligence 2 years ago

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).

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DewDiligence 2 years ago

I would take the other side of that bet!

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Pattyloco 2 years ago

Ehhhhh seems a lot more likely today

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DewDiligence 2 years ago

Unlikely, haha.

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Pattyloco 2 years ago

NWBO next purchase of Merck?

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DewDiligence 2 years ago

MRK 3Q22 CC slides:

https://s21.q4cdn.com/488056881/files/doc_financials/2022/q3/Q3-2022-Merck-Earnings-Deck-(Final).pdf

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DewDiligence 2 years ago

MRK 3Q22 results:

https://finance.yahoo.com/news/merck-announces-third-quarter-2022-103000305.html

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DewDiligence 2 years ago

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.

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DewDiligence 2 years ago

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).

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DewDiligence 2 years ago

Lagevrio misses_primary_endpoint_in_large_Oxford_U_trial:

https://ca.finance.yahoo.com/news/merck-ridgeback-biotherapeutics-clinical-non-235000071.html The PANORAMIC study, a UK-based clinical trial sponsored by the University of Oxford, included 25,783 participants who were randomized to open label treatment with LAGEVRIO plus usual care (n=12,821) or usual care alone (n=12,962); mean age of participants was 56.6 years. Primary outcome data were available in 25,000 (97%) participants. Nearly all (>98%) participants were vaccinated, with approximately 95% receiving three or more doses of a SARS-CoV-2 vaccine.

In the preliminary analysis, the primary endpoint of reduction of hospitalizations and deaths within 28 days of randomization, compared to usual care, was not met; 0.8% of patients in both the LAGEVRIO group (n=103/12,516) and the usual care group (n=96/12,484) were hospitalized or died in the first 28 days. Separately, in a retrospective study based on electronic medical records of high-risk patients in Israel, Lagevrio showed a benefit in reducing hospitalizations and death in the patients age 65+ but not in patients age 40-64.

Bottom line: Legevrio (molnupiravir) remains a poor choice for treating COVID. It is being prescribed only when Paxlovid is either unavailable or contra-indicated due to drug-drug interactions (from ritonavir).

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DewDiligence 2 years ago

FDA allows some Islatravir trials to_resume_at_a lower dose:

https://finance.yahoo.com/news/merck-initiate-phase-3-clinical-104500524.html

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DewDiligence 2 years ago

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

In the final analysis of the trial, there was a trend toward improvement for one of the study’s dual primary endpoints, overall survival (OS), for patients treated with KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (HR=0.84 [95% CI: 0.71-1.00]; p=0.0227). The median OS was 21.2 months (95% CI: 19.0-23.6) for KEYTRUDA plus LENVIMA and 19.0 months (95% CI: 17.2-21.7) for LENVIMA monotherapy.

Additionally, treatment with KEYTRUDA plus LENVIMA resulted in a trend toward improvement in the trial’s other dual primary endpoint of progression-free survival (PFS) versus LENVIMA monotherapy; however, the results did not meet the pre-specified threshold at the first interim analysis for statistical significance (HR=0.87 [95% CI: 0.73-1.02]; p=0.0466). These results were presented at ESMO.

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TechandBio 2 years ago

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

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DewDiligence 2 years ago

Keytruda fails phase-3 in CRPC:

https://www.businesswire.com/news/home/20220803005334/en Merck…today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. Keytruda will soon overtake Humira as the biggest-selling non-COVID drug from any company; however, it is not invincible.

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DewDiligence 3 years ago

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).

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Agoura Guy 3 years ago

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!!!!!!!

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Lowjack 3 years ago

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.

Don't forget to order your Ivermectin while everyone is distracted by idiot Joe.

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DewDiligence 3 years ago

MRK slides from ASCO webcast:

https://s21.q4cdn.com/488056881/files/doc_events/2022/06/ASCO-2022-Slide-Presentation-Final.pdf

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DewDiligence 3 years ago

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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DewDiligence 3 years ago

MRK 1Q22 results:

https://finance.yahoo.com/news/merck-announces-first-quarter-2022-103000567.html

https://finance.yahoo.com/news/merck-quarterly-profit-tops-expectations-104117628.html

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Form SCHEDULE 13G - Statement of Beneficial Ownership by Certain Investors

Merck Closes Exclusive Global License Agreement for LM-299, An Investigational Anti-PD-1/VEGF Bispecific Antibody

Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection

Merck Enters into Exclusive Global License Agreement with Hansoh Pharma for Investigational Oral GLP-1 Receptor Agonist

Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season

Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC

Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma

LYNPARZA® (olaparib) Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer in OlympiA Phase 3 Trial

Merck Announces Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Advanced Epithelial Ovarian Cancer

Merck’s Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrates Complete Response Rate of 100% at 1.75 mg/kg Dose in Phase 2 Trial of Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Merck and Ridgeback Biotherapeutics Announce Initiation of Phase 3 Study (MOVe-NOW) Evaluating LAGEVRIO™ (molnupiravir) for the Treatment of COVID-19 in High-Risk Adults

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations

Merck to Participate in the Citi 2024 Global Healthcare Conference

Merck Announces Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint at Interim Analysis

MRK Discussion

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Merck and Co Inc (MRK) News

Merck and Co Inc (MRK)

Your Hub for Real-Time streaming quotes, Ideas and Live Discussions

MRK News

Form SCHEDULE 13G - Statement of Beneficial Ownership by Certain Investors

Merck Closes Exclusive Global License Agreement for LM-299, An Investigational Anti-PD-1/VEGF Bispecific Antibody

Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection

Merck Enters into Exclusive Global License Agreement with Hansoh Pharma for Investigational Oral GLP-1 Receptor Agonist

Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season

Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC

Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma

LYNPARZA® (olaparib) Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer in OlympiA Phase 3 Trial

Merck Announces Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Advanced Epithelial Ovarian Cancer

Merck’s Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrates Complete Response Rate of 100% at 1.75 mg/kg Dose in Phase 2 Trial of Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Merck and Ridgeback Biotherapeutics Announce Initiation of Phase 3 Study (MOVe-NOW) Evaluating LAGEVRIO™ (molnupiravir) for the Treatment of COVID-19 in High-Risk Adults

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations

Merck to Participate in the Citi 2024 Global Healthcare Conference

Merck Announces Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint at Interim Analysis

MRK Discussion

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