The Week Ahead In Biotech: Avadel, Epizyme In Focus In A Quiet Week

Biotech stocks were seen consolidating last week after advancing in the previous week. The iShares NASDAQ Biotechnology Index IBB reached a 52-week high of 121.16 Monday, although it has come off this level since then.

The week saw huge moves in reaction to presentations at the American Society of Hematology annual meeting. A few M&A announcements were made, including Merck & Co., Inc.'s MRK deal to buy ArQule, Inc. ARQL and Sanofi SA's SNY proposed purchase of Synthorx Inc THOR.

Correvio Pharma Corp CORV fell sharply in the week following an FDA panel snub of its atrial fibrillation treatment Brinavess.

The following are key catalytic events expected in the week ahead: 

PDUFA Date

The FDA is set to rule on Avadel Pharmaceuticals PLC's AVDL NDA for AV001, a sterile injectable product for the hospital market. The PDUFA date is scheduled for Sunday following a three-month extension from the original decision date of Sept. 15.

Adcom Meeting

FDA's Oncologic Drugs Advisory Committee will discuss Wednesday Epizyme Inc's EPZM NDA for tazemetostat tablets for treating patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative surgery.

Earnings

Anavex Life Sciences Corp AVXL (Monday, after the market close)

The week could see clinical readouts from companies that have given a timeline of December/fourth quarter/second half of 2019/year-end 2019.

Related Links:

Regeneron Shares Swing On Sanofi's Hint At Sale Of Ownership Stake, Amendments To Drug Collaborations

Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates