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

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

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

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. 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. 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. AMGN's BLA for romosozumab injections for osteoporosis in postmenopausal women at high risk of fracture.

The Endocrinologic and Metabolic Drugs Advisory Committee will discuss Thursday the NDA for sotagliflozin oral tablets, codeveloped by Sanofi and Lexicon Pharmaceuticals, Inc. 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. 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 TCON is due to present full Phase 2 data for TRC105 and Nexavar in hepatocellular carcinoma.

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

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

Five Prime Therapeutics Inc FPRX and Zai Lab Ltd 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