The Week Ahead In Biotech (Dec. 27-Jan. 2): Data Releases, Regulatory Filings To Move Stocks

The Week Ahead In Biotech Dec. 27-Jan. 2: Data Releases, Regulatory Filings To Move Stocks

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Biotech stocks advanced for a fifth straight week in thin holiday trading. The gains, however, were more modest amid worries concerning the emergence of a new strain of coronavirus in the U.K. The news flow of the week comprised mixed clinical trial readouts, COVID-19 drug and vaccine announcements, a few M&A announcements, and a small-ticket IPO.

Gene therapy stocks uniQure N.V. (QURE) and Voyager Therapeutics, Inc. (VYGR) came under pressure after the Food and Drug Administration placed their respective clinical programs on hold.

Ocugen Inc. (OCGN) was some of the big news of the week, with the strength stemming from an agreement to co-develop a vaccine against SARS-CoV-2. Here are the key catalysts for the week ahead:

PDUFA Dates

Viatris Inc. (VTRS), which was formed following the merger of the erstwhile generic pharma company Mylan and Pfizer Inc. (PFE)'s Upjohn generic unit, awaits FDA approval for its BLA for MYL-1402O, a proposed biosimilar to Avastin from Roche Holdings AG Basel ADR Common Stock (RHHBY). This is being developed in partnership with India's Biocon. The PDUFA goal date is Sunday, Dec. 27.

The FDA is scheduled to rule on Osmotica Pharmaceuticals PLC (OSMT)'s NDA for Ontinua (arbaclofen) ER for treating spasticity in patients with multiple sclerosis. The investigational asset had faced an earlier rejection in 2016 due to manufacturing issues at clinical trial sites. Following a resubmission, the FDA has set a PDUFA action date of Tuesday, Dec. 29.

Proposed Regulatory Filings

  • Atara Biotherapeutics Inc. (ATRA): Rolling biologic license approval, or BLA, submission of tab-cel for Epstein-Barr virus-positive post-transplant disorder planned to be initiated by end of 2020, with finalization of the submission planned for the third quarter of 2021.
  • Vertex Pharmaceuticals Incorporated (VRTX): Submission of a supplemental new drug application for Trikafta is planned for the fourth quarter. Trikafta is a triple combination of elexacaftor, tezacaftor/ivacaftor, and ivacaftor, in children aged 6-11 years with cystic fibrosis with certain mutations. It was approved for people, aged 12 years and older in late October.
  • Incyte Corporation (INCY): A new drug application, or NDA, for ruxolitinib cream in atopic dermatitis is planned for the end of 2020.
  • Oyster Point Pharma Inc. (OYST): The company is on track to submit an NDA for OC-01 for dry eye disease in the fourth quarter.
  • Eyenovia Inc. (EYEN): An NDA submission for MicroStat (brand name: Mydcombi) for pharmacologic mydriasis is planned for the end of 2020.
  • Coherus Biosciences Inc. (CHRS): A BLA for the internally developed Humira biosimilar, CHS-1420, is expected by the end of 2020.
  • Stealth BioTherapeutics Corp. (MITO): An NDA submission for elamipretidein Barth syndrome is anticipated by year-end.
  • Cara Therapeutics Inc. (CARA): An NDA submission for Korsuva injection for the treatment of pruritus in hemodialysis patients, is planned for the fourth quarter.
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