Merck (MRK) Announces KEYTRUDA Approved in Japan in Combination With Chemotherapy for First-Line Treatment of Patients With Radically Unresectable, Advanced or Recurrent Esophageal Carcinoma

U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill

November 30, 2021 6:12 AM EST

By Michael Erman and Manas Mishra

(Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19.

If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency.

Merck published data last week suggesting the drug was significantly less effective than... More

Adagio Therapeutics (ADGI) Stock Now Up 70%, Stifel Says Merck's (MRK) Molnupiravir is not a Competitive Threat to ADG20

November 29, 2021 11:08 AM EST

Adagio Therapeutics (NASDAQ: ADGI) stock is up around 70% today as investors continue to bet that alternative cures are needed and vaccines alone are unlikely to sufficiently address the COVID-19 pandemic.

Adagio shares soared in pre-open Monday after the company said its lead candidate ADG20 will retain activity against the new COVID variant Omicron.

None of the mutations present in the spike protein of the Omicron variant have been... More

Pre-Open Stock Movers 11/29: (KRYS) (ADGI) (TWTR) Higher; (MRK) (UPS) Lower (more...)

November 29, 2021 9:30 AM EST

Pre-Open Stock Movers:

Krystal Biotech, Inc., (NASDAQ: KRYS) 142.6% HIGHER; announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB). The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTM compared to placebo at six-month timepoints and met statistical significance. VYJUVEKTM is the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective... More

Merck (MRK) Announces European Commission Approves KEYTRUDA Plus LENVIMA for Patients With Certain Types of Endometrial Carcinoma

November 29, 2021 6:50 AM EST

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the European Commission has approved the combination of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for... More

Merck (MRK) Announces European Commission Approves KEYTRUDA Plus LENVIMA as First-Line Treatment for Adult Patients With Advanced RCC

November 29, 2021 6:46 AM EST

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the European Commission has approved the combination of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA (KISPLYX® in the European Union [EU] for the treatment of advanced renal cell... More

2 Reasons Why Citi Downgraded Merck (MRK) to Neutral Today, Opened a Negative Catalyst Watch

November 29, 2021 6:45 AM EST

Shares of Merck (NYSE: MRK) are down 1.7% in pre-open Monday after Citi analyst Andrew Baum downgraded to Neutral from Buy with a price target of $85.00 per share from the prior $105.00.

First, the analyst sees a high probability that Merck will terminate islatravir development in the coming months amid strong regulatory... More