The Week Ahead In Biotech (Feb. 7-13): Regeneron FDA Decision, Earnings, IPOs, And Conference Presentations In The Spotlight

The Week Ahead In Biotech Feb. 7-13: Regeneron FDA Decision, Earnings, IPOs and Conference Presentations In The Spotlight

Photo by National Cancer Institute on Unsplash

Biopharma stocks advanced in the week ended Feb. 5, driven higher by a slew of catalysts. Large-cap pharma earnings, vaccine updates, M&A activity, IPO news flow, and follow-on offerings all served to lift stocks higher.

In an unexpected move, Jazz Pharmaceuticals PLC (JAZZagreed to buy plant-derived cannabinoid drug maker GW Pharmaceuticals PLC- ADR (GWPH) for $7.2 billion.

Novavax, Inc. (NVAX) shares found follow-up buying interest amid vaccine updates. Earnings from large-cap biopharma companies can at best be qualified as mixed. The IPO calendar of the week was heavy, with 10 healthcare stocks making their Wall Street debuts this week.


  • Transplantation and Cellular Therapy, or TCT, Meeting of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research: Feb. 8-12.
  • 17th Annual WORLDSymposium: Feb. 8-12.
  • Guggenheim Healthcare Talks: 2021 Oncology Days: Feb. 11-12.
  • 2021 ASCO Genitourinary Cancers Symposium: Feb. 11-13.
  • Angiogenesis, Exudation, and Degeneration 2021 conference: Feb. 12-13.


The Food and Drug Administration is scheduled to rule on Regeneron Pharmaceuticals Inc (REGN)'s biologic license application for evinacumab, which is being evaluated for the treatment of homozygous familial hypercholesterolemia, an ultra-rare, inherited form of high cholesterol. The decision is expected by Thursday, Feb. 11.

Clinical Readouts

17th Annual WORLDSymposium Presentations:

  • Regenxbio Inc (RGNX): interim results from the Phase 1/2 clinical trial of RGX-121 for the treatment of mucopolysaccharidosis type II (Monday, Feb. 8, at 10:06 a.m.).
  • Orchard Therapeutics PLC – ADR (ORTX): updated Phase 1/2 data for ex-vivo autologous stem cell gene therapy for mucopolysaccharidosis type IIIA; Phase 1/2 data for ex vivo hematopoietic stem cell gene therapy for mucopolysaccharidosis type I (Tuesday, Feb. 9).
  • Protalix Biotherapeutics Inc (PLX): one year of treatment data from BRIDGE, a phase 3 open-label study of pegunigalsidase alfa to treat patients with Fabry disease (Wednesday, Feb. 10, at 2:30-3:30 p.m.).
  • Avrobio Inc (AVRO): new phase 1/2 data for AVR-RD-02 ex-vivo lentiviral vector, autologous gene therapy for Gaucher disease (Thursday, Feb. 11, 2:30-3:30 p.m.); updated results from a phase 1/2 study of hematopoietic stem cell gene therapy for cystinosis (Friday, Feb. 12, 11 a.m.); updated Phase 2 data for AVR-RD-01 in Fabry disease (Friday, Feb. 12).
  • Abeona Therapeutics Inc (ABEO): updated results from Phase 1/2 study of ABO-101 gene therapy for mucopolysaccharidosis IIIB and Phase 1/2 study of ABO-102 gene therapy for mucopolysaccharidosis IIIA (Friday, Feb. 12).
  • Denali Therapeutics Inc (DNLI): data from Phase 1/2 study of DNL310 in mucopolysaccharidosis II patients.
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