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

Clinical Readouts — Pending Q4 Releases

  • RedHill Biopharma Ltd. (RDHL): Top-line data from the U.S. Phase 2 study of opaganib in 40 severe COVID-19 patients.
  • Dynavax Technologies Corporation (DVAX): Final immunogenicity data from the Phase 1 study of Heplisav-B in patients on hemodialysis.
  • Immunic Inc. (IMUX): Phase 2 data for IMU-838 in primary sclerosing cholangitis.
  • Altimmune Inc. (ALT): Results from this Phase 1b study NasoShield intranasal anthrax vaccine.

Pending 2020 Year-End Releases

  • Catalyst Pharmaceuticals Inc. (CRPX): Top-line proof-of-concept data from the Phase 2 study of Firdapse in spinal muscular atrophy type-3.
  • Aprea Therapeutics Inc. (APRE): Top-line data from the Phase 3 study of eprenetapopt with Bristol-Myers Squibb Co. (BMY)'s azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes patients.
  • Bellerophon Therapeutics Inc. (BLPH): Top-line data from the Phase 2 dose escalation study of INOpulse in pulmonary hypertension-sarcoidosis.
  • Merus NV (MRUS): Clinical update on the Phase 1 trial of MCLA-158 in patients with solid tumors.
  • Ultragenyx Pharmaceutical Inc. (RARE): Data from Cohort 4 of the Phase 1/2 study of investigational gene therapy DTX401 for glycogen storage disease Type Ia (a prophylactic steroid regimen is added to the same dose as used for Cohort 2 and 3).

IPO Quiet Period Expiries

  • Kinnate Biopharma Inc. (KNTE).
  • Seer, Inc. (SEER).
  • Sigilon Therapeutics, Inc. (SGTX).
  • Silverback Therapeutics Inc. (SBTX).
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