The Week Ahead In Biotech (April 3-April 9): BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight

Zinger Key Points
  • The FDA is scheduled to rule on BioXcel Therapeutics, Inc.'s new drug application for BXCL501.
  • Akebia Therapeutics and Amylyx Pharmaceuticals came under selling pressure due to adverse regulatory tidings.

Biopharma stocks outperformed the broader market in the week ending April 2, thereby recouping the losses from the previous week. Clinical readouts and FDA decisions were among the chief catalysts that moved stocks during the week.

Longeveron Inc. LGVN jumped over 100% after the biopharma announced the publication of positive Phase 1 data for its Lomecel-B in Alzheimer's disease. Clovis Oncology, Inc. CLVS also benefited from a positive data readout.

On the other hand, Akebia Therapeutics, Inc. AKBA and Amylyx Pharmaceuticals, Inc. AMLX came under selling pressure due to adverse regulatory tidings. The former's vadadustat was rejected by the Food and Drug Administration as a treatment option for anemia in chronic kidney disease patients, while the latter's amyotrophic lateral sclerosis treatment candidate wasn't recommended for approval by an Adcom panel.

Here are the key catalysts for the unfolding week:

Conferences

The American College of Cardiology, or ACC,'s 71st Annual Scientific Session & Expo: April 2-4, in Washington, DC

American Academy of Neurology, or AAN, Annual Meeting: April 2-7, in Seattle, Washington

Goldman Sachs The New Guard: Privates Leading The Disruption In Healthcare conference: April 7

American Association for Cancer Research, or AACR, Annual Meeting 2022: April 8-13, in New Orleans, Louisiana

PDUFA Dates

The FDA is scheduled to rule on BioXcel Therapeutics, Inc.'s BTAI new drug application for BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. The PDUFA goal date is scheduled for Tuesday, April 5.

Related Link: Know The 2 Healthcare Companies Cathie Wood's Ark Invest Bought On Friday

Clinical Readouts

AAN Meeting Presentations

Biohaven Pharmaceutical Holding Company Ltd. BHVN: Phase 1 data for intranasal zavegepant in migraine

Revance Therapeutics, Inc. RVNC: Phase 3 data from the study evaluating long-term safety and efficacy of repeat treatments of doxibotulinumtoxin A for injection in adults with isolated cervical dystonia

Amneal Pharmaceuticals, Inc. AMRX: results from the pivotal Phase 3 study of IPX-203, in Parkinson's disease patients with motor fluctuations

Viatris Inc. VTRS: Phase 2 study for GA Depot in primary progressive multiple sclerosis

Fulcrum Therapeutics, Inc. FULC: Phase 2 data for losamapimod in patients with facioscapulohumeral muscular dystrophy (Tuesday)

Sage Therapeutics, Inc. SAGE: data from the Phase 2 Luminary study of SAGE-718 in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (Tuesday)

ACADIA Pharmaceuticals Inc. ACAD: Phase 3 efficacy and safety of trofinetide for the treatment of Rett syndrome (Tuesday)

Satsuma Pharmaceuticals, Inc. STSA: Phase 3 data for STS101 in migraine (Wednesday)

Longboard Pharmaceuticals, Inc. LBPH: single ascending dose and multiple ascending dose data from the Phase 1 study evaluating LP352 in healthy volunteers (Wednesday)

Scholar Rock Holding Corporation SRRK: Phase 2 data for apitegromab in patients with Types 2 and 3 spinal muscular atrophy (Wednesday)

AACR Meeting Presentations

IO Biotech, Inc. IOBT: Phase 1/2 study of IO102-IO103 in combination with Bristol-Myers Squibb Company's BMY Opdivo in metastatic melanoma (Friday)

Earnings

Precipio, Inc. PRPO (Monday, after the close)
AngioDynamics, Inc. ANGO (Thursday, before the market open)

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

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