FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adult...
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.These approvals are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. Results, which were presented at the recent European Society for Medical Oncology (ESMO) Congress, showed that afte
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- Merck & Co., Inc. (NYSE:MRK) had its price target raised by analysts at Scotiabank from $105.00 to $120.00. They now have a "sector outperform" rating on the stock.MarketBeat
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- FDA Conditionally Approves Merck Animal Health's EXZOLT™ CATTLE-CA1 for the Prevention and Treatment of New World Screwworm (Cochliomyia hominivorax) Larvae (myiasis)Business Wire
- Merck & Co., Inc. (NYSE:MRK) had its "hold (c)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Merck & Co., Inc. (NYSE:MRK) had its price target raised by analysts at The Goldman Sachs Group, Inc. from $92.00 to $120.00. They now have a "buy" rating on the stock.MarketBeat
MRK
Earnings
- 10/30/25 - Beat
MRK
Sec Filings
- 12/4/25 - Form 8-K
- 12/3/25 - Form 424B5
- 12/2/25 - Form FWP
- MRK's page on the SEC website