The Week Ahead In Biotech: Light Calendar In Abbreviated Week Features 1 IPO, 1 FDA Decision

Biotech stocks extended their weekly gains for the fourth straight week, thanks to broader market buoyancy, positive FDA decisions and vaccine news.

In a widely expected decision, Moderna Inc's MRNA coronavirus vaccine candidate was cleared for emergency use by the FDA.

MacroGenics Inc MGNX received a regulatory nod for its breast cancer treatment, while the FDA also approved Amgen, Inc.'s AMGN Rituxan biosimilar and Myovant Sciences Ltd's MYOV relugolix for the treatment of metastatic prostate cancer.

Arvinas Inc ARVN was among the best performing biotech stocks of the week after it issued an update on two of its pipeline assets.

The week also witnessed some M&A activity. Eli Lilly And Co LLY announced a deal to buy gene therapy company Prevail Therapeutics Inc PRVL for a little over $1 billion.

Three biopharma companies debuted on Wall Street, raising $463 million in combined gross proceeds.

Here are the key catalysts for the unfolding, holiday-shortened week:

Related Link: Sarepta, Amicus Top Biotech Picks Ahead Of Key Binary Events: Analyst

PDUFA Dates

The FDA is scheduled to give its verdict on Urovant Sciences Ltd's UROV new drug application for vibegron on Dec. 26. The company is seeking approval for once-daily 75 mg vibegron for the treatment of overactive bladders.

IPOs

Netherlands-based specialty pharma Pharming Group N.V. has filed to offer 899,802 ADSs, each representing 10 ordinary shares, in an initial public offering estimated to be priced at $12.10 per ADS. The company has applied for listing its ADSs on the Nasdaq under the ticker symbol PHAR.

IPO Quiet Period Expiry

Lixte Biotechnology Holdings Inc LIXT