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
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 0.71% 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 0.39% also faced a rejection, with the FDA turning down the regulatory application for its schizophrenia drug.
Meanwhile, Eli Lilly And Co LLY 1.47% 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 1.35% and BioNTech SE – ADR BNTX 9.63% 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 0.57% 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 7.65% awaits FDA word on its NDA for LIQ861, an investigational, inhaled dry powder formulation of Treprostinil for the treatment of pulmonary arterial hypertension. (Tuesday)
Revance Therapeutics Inc's RVNC 1.6% 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 2.11% new drug application for setmelanotide in genetically-induced obesity. (Friday)
Earnings
- Twist Bioscience Corp TWST 0.93% (Monday, before the market open)
- Arrowhead Pharmaceuticals Inc ARWR 0.17% (Monday, after the close)
- Enanta Pharmaceuticals Inc ENTA 1.31% (Monday, after the close)
- Medtronic PLC MDT 0.78% (Tuesday, before the market open)
- China Biologic Products Holdings Inc CBPO 0.21% (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 6.41%
- Galecto, Inc. GLTO 0.5%
- Atea Pharmaceuticals, Inc. AVIR 1.9%
- SQZ Biotechnologies Co SQZ 4.98%
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