The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials


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M&A momentum is building in the pharma space, with more deals announced last week, including Eli Lilly And Co (NYSE:LLY)'s $8-billion move to acquire Loxo Oncology Inc (NASDAQ:LOXO).

The following catalysts could impact sentiment toward biotech stocks in the unfolding week. 

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Conferences

  • 2019 ASCO Gastrointestinal Cancers Symposium: Jan.17-19 in San Francisco, California.
  • 21st Annual Needham Growth Conference: Jan. 15-16 in New York City.

PDUFA Dates

Exelixis, Inc. (NASDAQ:EXEL) awaits the FDA's verdict on its sNDA for cabozantinib, which is being evaluated for patients with previously treated advanced hepatocellular carcinoma. The D-day is Monday.

The FDA is set to rule Friday on Immunomedics, Inc. (NASDAQ:IMMU)'s BLA for sactuzumab govitecan, its investigational candidate for metastatic triple-negative breast cancer in patients who have previously received at least two prior therapies.

Adcom Meetings

The Bone, Reproductive and Urologic Drugs Advisory Committee is scheduled for a discussion Wednesday about Amgen, Inc. (NASDAQ:AMGN)'s BLA for romosozumab injections for osteoporosis in postmenopausal women at high risk of fracture.


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The Endocrinologic and Metabolic Drugs Advisory Committee will discuss Thursday the NDA for sotagliflozin oral tablets, codeveloped by Sanofi and Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX). The candidate is being evaluated as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes mellitus.

Clinical Trial Results

ASCO-GI Presentations

Rexahn Pharmaceuticals, Inc. (NYSE:RNN) will present updated Phase 2 data for its RX-3117, in combination with Abraxane, which is being evaluated as a first-line treatment for pancreatic cancer.

TRACON Pharmaceuticals Inc (NASDAQ:TCON) is due to present full Phase 2 data for TRC105 and Nexavar in hepatocellular carcinoma.

ASLAN PHARMACEU/ADR (NASDAQ:ASLN) is expected to present new Phase 1/2 data for its Varlitinib plus gemcitabine and cisplatin in biliary tract cancer.

Tyme Technologies Inc (NASDAQ:TYME) will present interim Phase 2 data for its pancreatic cancer treatment candidate SM-88.

Five Prime Therapeutics Inc (NASDAQ:FPRX) and Zai Lab Ltd (NASDAQ:ZLAB) are due to present Phase 1 data for their gastric and gastro-esophageal junction cancer treatment candidate FPA144 along with chemotherapy.

Related Links:

5 Top-Selling Drugs With Growth Potential In 2019

Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates


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