The PDUFA dates are a key catalyst for any pharma company, especially biotechs, as this is the date when the FDA gives its verdict on the drug’s NDA. The Prescription Drug User Fee Act typically calls for a period of 10 months to review such applications.
March is a month Merck & Co., Inc.MRK investors were keenly focusing as the company faces key PDUFA catalysts.
Merck’s Keytruda has a PDUFA priority review date on March 8 for Microsatellite Instability-High Cancer and the same drug will have a PDUFA review date on March 15 for Relapsed or Refractory Classical Hodgkin Lymphoma.
Regeneron Pharmaceuticals Inc REGN is having a PDUFA review date on March 29 for Dupixent (dupilumab) for the treatment of Atopic dermatitis.
In addition, Radius Health Inc RDUS’s PDUFA date for Abaloparatide-SC to treat Osteoporosis is on March 30.
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