The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Readouts And IPOs

Biotech stocks staged a recovery this week after being in the red in the previous two weeks.

AbbVie Inc ABBV 0.47%'s psoriasis drug Skyrizi received FDA nod. The week also saw the release of strong quarterly earnings by big European pharma giants such as Novartis AG NVS 0.86%, Sanofi SA SNY 3.52% and Roche Holdings AG Basel ADR RHHBY 0.65%.

Here are a few key catalysts a biotech investor should stay focused on in the unfolding week.

Conferences

  • 2019 The Association for Research In Vision and Ophthalmology annual meeting – April 28- May 2, in Vancouver, British Columbia
  • 17th International Conference on Pharmaceutical Microbiology and Biotechnology - April 29-30, in London
  • 4th World Heart Congress - April 29 - May 1 in Kyoto, Japan
  • 22nd American Society of Gene and Cell Therapy annual meeting – April 29- May 2, in Washington D.C.
  • 3rd International Conference on Medical and Clinical Microbiology - May 1-2, in Kyoto
  • 2019 American Academy of Neurology annual meeting – May 4-10, in Philadelphia, Pennsylvania

PDUFA Dates

Regeneron Pharmaceuticals Inc REGN 1.78% and Sanofi await FDA verdict on their sBLA for Praluent injection. The company is seeking label expansion for the drug to include effect of the drug in reducing the overall risk of major adverse cardiovascular events, or MACE. The PDUFA date has been scheduled for Sunday, April 28.

The FDA is set to rule on Heron Therapeutics Inc HRTX 1.6%'s HTX-001, a fixed-dose combination of the local anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam, for application into the surgical site to reduce postoperative pain. The decision date is April 30.

The FDA will announce its decision April 30 on Nabriva Therapeutics PLC – ADR NBRV 0.71%'s Contepo for complicated urinary tract infections.

Sanofi's dengue vaccine Dengvaxia will come before the FDA scanner, with the regulatory agency scheduled to announce its verdict on May 1.

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