The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications

The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications

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) 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. (MRK)'s 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. (AUPH)'s 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.

Clinical Readouts

At the ASCO Gastrointestinal Cancers Symposium, Tyme Technologies Inc. (TYME) 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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