The Week Ahead In Biotech: Moderna Vaccine And Roche, Revance, Rhythm, Liquidia FDA Updates

Biotech stocks came under pressure in the week ended Nov. 20, reversing course from the previous week. The sector started the week on a strong note, thanks to positive vaccine data reported by Moderna Inc MRNA.

The momentum faltered through the week after the broader market came under pressure amid fresh COVID-19 restrictions.

Earnings news flow slowed considerably. On the regulatory front, Sanofi SA SNY was handed a complete response letter for its sutimlimab biologics license application. "The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing," the company said in a release. Sutimlimab is an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. Alkermes Plc ALKS also faced a rejection, with the FDA turning down the regulatory application for its schizophrenia drug.

Meanwhile, Eli Lilly And Co LLY received FDA approval for the emergency use of its in-licensed arthritis drug to treat COVID-19. The FDA also approved the first at-home COVID-19 diagnostic test during the week.

Notable news of the week included the decision by Pfizer Inc. PFE and BioNTech SE – ADR BNTX to file for emergency use authorization Friday. This increases the possibility of limited approval coming before the year end.

Conferences

Piper Sandler 32nd Annual Virtual Healthcare Conference: scheduled for Dec. 1-3; pre-recorded "fireside chat" by participating companies will be made available from Monday (Nov. 23).

PDUFA Dates

The FDA is scheduled to rule on Roche Holdings AG's RHHBY two sNDAs for its next-gen flu medication Xofluza. The company is seeking approval for an additional formulation of Xofluza — oral suspension granules for people with influenza who are age one or older — and another for post-exposure prophylaxis. (Monday)

Liquidia Technologies Inc LQDA awaits FDA word on its NDA for LIQ861, an investigational, inhaled dry powder formulation of Treprostinil for the treatment of pulmonary arterial hypertension. (Tuesday)

Related Link: Odds Of Vertex's Pipeline Success Aren't Dismal As Some Fear, Bernstein Says

Revance Therapeutics Inc's RVNC regulatory application for Daxi in the treatment of moderate to severe glabellar, or frown, lines has a FDA decision date of Nov. 25. (Wednesday)

The FDA is also expected to announce its verdict on Rhythm Pharmaceuticals Inc's RYTM new drug application for setmelanotide in genetically-induced obesity. (Friday)

Earnings

  • Twist Bioscience Corp TWST (Monday, before the market open)
  • Arrowhead Pharmaceuticals Inc ARWR (Monday, after the close)
  • Enanta Pharmaceuticals Inc ENTA (Monday, after the close)
  • Medtronic PLC MDT (Tuesday, before the market open)
  • China Biologic Products Holdings Inc CBPO (Tuesday, after the close)

Other Events

Moderna could announce final Phase 3 data for its mRNA vaccine candidate mRNA-1273, and then apply for emergency use authorization.

IPO Quiet Period Expiry

  • Biodesix Inc BDSX
  • Galecto, Inc. GLTO
  • Atea Pharmaceuticals, Inc. AVIR
  • SQZ Biotechnologies Co SQZ
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