The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates

Biotech stocks reversed course last week, dragged lower by the broader market weakness. The week's news flow was headlined by Johnson & Johnson (JNJkickstarting a Phase 3 trial of its coronavirus vaccine candidate.

A few clinical readouts released during the week triggered strong moves. Vaccinex Inc. (VCNX) and AC Immune SA (ACIU) were among the worst decliners of the week, with the former reacting to a failed mid-stage trial of lead drug in Huntington's disease, while the latter plunged after an out-licensed Alzheimer's drug flunked a mid-stage trial.

Here are the key catalysts for the unfolding week.

Conferences

  • World Muscle Society, or WMS, 25: Virtual Congress: September 28 - October 2.
  • Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, meeting: September 30 - October 1.
  • Heart Failure Society of America, or HFSA, Virtual Annual Scientific Meeting 2020: September 30 - October 6.
  • virtual Jefferies Cell Therapy Summit: October 5-6.
  • Virtual Jefferies Gene Therapy/Editing Summit: October 1-2.
  • North American Neuroendocrine Tumor Society, or NANETS', Multidisciplinary NET Medical Virtual Symposium: October 2-3.
  • Virtual 7th Immunotherapy of Cancer Conference, or ITOC7: October 2-3.
  • EURETINA 2020 Virtual Meeting: October 2-4.

PDUFA Dates

  • The FDA is set to rule on Aquestive Therapeutics Inc. (AQST)'s NDA for libervant (AQST-203) in seizure clusters on Sunday, October 4.
  • The regulatory agency is also scheduled on Tuesday, September 29 to give its verdict on Eton Pharmaceuticals Inc. (ETON)'s NDA for Alkindi Sprinkle, which is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.
  • Mesoblast limited (MESO) awaits FDA decision on Wednesday, September 30 on its BLA for remestemcel-L (MSC-100-IV) in steroid-refractory acute graft versus host disease in children.
  • Roche Holdings AG's Basel (RHHBY) regulatory application seeking label expansion for Xolair to be used for chronic rhinosinusitis with nasal polyps has a PDUFA timeline of Q3
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