Biotech stocks advanced in the week ended Jan. 15, defying the softness experienced by the broader market. Pre-announcements continued to pour in, with most companies suggesting better-than-forecast revenues. The week also witnessed a slew of follow-on offerings and licensing deals.
Stocks also reacted to presentations at the JPMorgan Healthcare Conference and the ASCO Gastrointestinal Cancers Symposium.
Lexicon Pharmaceuticals, Inc. LXRX 14.66% was among the biggest advancers in the group after it said the FDA deemed that the results of two Phase 3 studies of sotagliflozin can support NDA submission for the investigational asset as a treatment option for heart failure.
Here are the key catalysts for the unfolding week:
Conferences
ASCO Gastrointestinal Cancers Symposium (virtual event): Jan. 15-17
B. Riley Securities Virtual Oncology Investor Conference: Jan. 20
PDUFA Dates
The FDA is scheduled to announce its verdict on Merck & Co., Inc.'s MRK 1.47% new drug application for vericiguat as a treatment option for heart failure. The PDUFA goal date is Wednesday, Jan. 20.
The agency is also expected to rule on Aurinia Pharmaceuticals Inc's AUPH 7.95% NDA for voclosporin as a treatment option for lupus nephritis, an autoimmune disorder that leads to inflammation of kidney. The decision is expected by Friday, Jan. 22.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
Clinical Readouts:
At the ASCO Gastrointestinal Cancers Symposium, Tyme Technologies Inc TYME 5.09% is scheduled to make a poster presentation of data from the Phase 2/3 study of its lead candidate SM-88 in patients with metastatic pancreatic cancer. (Sunday, 3:30 p.m. to 4:15 p.m.)
IPOs
Philadelphia, Pennsylvania-based Vallon Pharmaceuticals, Inc. has filed with the SEC a preliminary prospectus to offer 1.67 million shares at an estimated price range of $8-$10. The biopharma develops prescription drugs for central nervous system disorders and has applied for listing its shares on the Nasdaq under the ticker symbol VLON.
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