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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: ALKS) also faced a rejection, with the FDA turning down the regulatory application for its schizophrenia drug.

Meanwhile, Eli Lilly And Co (NYSE: 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.

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Notable news of the week included the decision by Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: 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 (OTC: 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 (NASDAQ: 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)

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Revance Therapeutics Inc's (NASDAQ: 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 (NASDAQ: RYTM) new drug application for setmelanotide in genetically-induced obesity. (Friday)

Earnings

• Twist Bioscience Corp (NASDAQ: TWST) (Monday, before the market open)

• Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) (Monday, after the close)

• Enanta Pharmaceuticals Inc (NASDAQ: ENTA) (Monday, after the close)

• Medtronic PLC (NYSE: MDT) (Tuesday, before the market open)

• China Biologic Products Holdings Inc (NASDAQ: 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 (NASDAQ: BDSX)

• Galecto, Inc. (NASDAQ: GLTO)

• Atea Pharmaceuticals, Inc. (NASDAQ: AVIR)

• SQZ Biotechnologies Co (NYSE: SQZ)

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