The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.

The week was a quiet one from the perspective of news flow. Johnson & Johnson (JNJ) was in the news for both right and wrong reasons. The company's Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.

Pfizer Inc. (PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate. Avenue Therapeutics Inc. (ATXI) shares fell from $11 to just under $4 after the FDA rejected its opioid pain drug on safety concerns.

Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (VRTX) and Cyclerion Therapeutics Inc. (CYCN) shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.

The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds. Here are the key catalysts for the unfolding week.

Conferences

  • American College of Chest Physicians' CHEST Annual Meeting 2020, being held virtually: October 18-21.
  • The Prostate Cancer Foundation's 27th Annual Scientific Retreat: October 20-23.
  • IDWeek 2020: October 20-25.
  • American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: October 22-25 (early programs scheduled for October 19-21).
  • 32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: October 24-25.

PDUFA Dates

Zosano Pharma Corp. (ZSAN)'s NDA for its migraine drug Qtrypta has a PDUFA action date of October 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.

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