Biotech week ahead, Dec. 21

 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 2.62% coronavirus vaccine candidate was cleared for emergency use by the FDA.

MacroGenics Inc MGNX 2.52% received a regulatory nod for its breast cancer treatment, while the FDA also approved Amgen, Inc.'s AMGN 1.19% Rituxan biosimilar and Myovant Sciences Ltd's MYOV 4.49% relugolix for the treatment of metastatic prostate cancer.

Arvinas Inc ARVN 3.23% 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 0.8% announced a deal to buy gene therapy company Prevail Therapeutics Inc PRVL 0.39% 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:

PDUFA Dates

The FDA is scheduled to give its verdict on Urovant Sciences Ltd's UROV 0.06% 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 4.58%  

https://www.benzinga.com/general/biotech/20/12/18858552/the-week-ahead-in-biotech-light-calendar-in-abbreviated-week-features-1-ipo-1-fda-decision