Biotech news flow remained light last week, although there were some notable developments such as FDA panel reviews of opioid pain drugs, a few clinical data readouts, presentations and updates at the JPMorgan Healthcare conference.
Here are the key catalysts that could prove market moving in the unfolding week.
Conferences
American Society of Clinical Oncology, or ASCO, Gastrointestinal Cancers Symposium: Jan. 23-25 in San Francisco, California
PDUFA Dates
The FDA is scheduled to rule on Epizyme Inc's EPZM tazemetostat, an experimental drug to treat metastatic or locally advanced, unresectable epithelioid sarcoma. FDA's Oncologic Drugs Advisory Committee, which met Dec. 18 to discuss the NDA for tazemetostat, unanimously recommended approval of the drug. The PDUFA date is set for Thursday.
The regulatory agency will announce Thursday its verdict on Merck & Co., Inc.'s MRK NDA and sNDA for DIFICID (fidaxomicin) to treat Clostridium difficile infections. The NDA pertains to an oral suspension formulation and the sNDA is for the label expansion of the indication to treat children, ages six and older. Dificid, in tablet formulation, has already been approved to treat Clostridium difficile infections in adults 18 years and older.
See Also: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates
Clinical Readouts
ASCO Gastrointestinal Cancers Symposium Presentations
Bellicum Pharmaceuticals Inc BLCM: Phase 1 Cohort 5B new translational data for its pancreatic cancer experimental drug BPX-601 (Friday)
Forty Seven Inc FTSV: Phase 1b data for magrolimab in combination with cetuximab in colorectal cancer
Earnings
Wednesday
Abbott Laboratories ABT (before the market open)
Johnson & Johnson JNJ (before the market open)
Thursday
Intuitive Surgical, Inc. ISRG (after the market close)
Date | ticker | name | Actual EPS | EPS Surprise | Actual Rev | Rev Surprise |
---|
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.