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The Week Ahead In Biotech: Focus On Epizyme, Merck Ahead Of PDUFA Dates, J&J To Kickstart Big Pharma Earnings

The Week Ahead In Biotech: Focus On Epizyme, Merck Ahead Of PDUFA Dates, J&J To Kickstart Big Pharma Earnings

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.


American Society of Clinical Oncology, or ASCO, Gastrointestinal Cancers Symposium: Jan. 23-25 in San Francisco, California


The FDA is scheduled to rule on Epizyme Inc's (NASDAQ: 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 (NYSE: 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 (NASDAQ: BLCM): Phase 1 Cohort 5B new translational data for its pancreatic cancer experimental drug BPX-601 (Friday)

Forty Seven Inc (NASDAQ: FTSV): Phase 1b data for magrolimab in combination with cetuximab in colorectal cancer



Abbott Laboratories (NYSE: ABT) (before the market open)
Johnson & Johnson (NYSE: JNJ) (before the market open)


Intuitive Surgical, Inc. (NASDAQ: ISRG) (after the market close)


Related Articles (MRK + EPZM)

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