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

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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 (NASDAQ: MRNA) coronavirus vaccine candidate was cleared for emergency use by the FDA.

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

Arvinas Inc (NASDAQ: 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 (NYSE: LLYannounced a deal to buy gene therapy company Prevail Therapeutics Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: LIXT)

 

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