The Week Ahead in Biotech (April 3-April 9): FDA BioXcel Decision, Neurology Conference Presentations Take Center Stage

Biopharma stocks outperformed the broader market in the week ending April 2, recouping losses from the previous week. Clinical readings and FDA rulings were among the main catalysts that moved stocks during the week.

Longeveron Inc. LGVN jumped more than 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 reading.

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

Here are the main catalysts for the week that is unfolding:

Conferences

71st Annual Session and Scientific Exposition of the American College of Cardiology, or ACC,: April 2-4, in Washington, DC

American Academy of Neurology, or AAN, annual meeting: April 2-7, in Seattle, Washington

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

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

PDUFA Dates

The FDA must rule on BioXcel Therapeutics, Inc. BTAI New Drug Application for BXCL501, an investigational, proprietary, orally disintegrating 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 readings

Presentations from the AAN meeting

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

Revance Therapeutics, Inc. RVNC: Phase 3 Data from the Study Assessing the Long-Term Safety and Efficacy of Repeated Courses of Doxibotulinumtoxin A for Injection in Adults With Isolated Cervical Dystonia

Amneal Pharmaceuticals, Inc. CDMA: results of the pivotal Phase 3 study of IPX-203, in parkinsonian patients with motor fluctuations

Viatris inc. TRV: 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 Luminary Phase 2 Study of SAGE-718 in Patients with Mild Cognitive Impairment (MCI) and Mild Dementia Due to Alzheimer’s Disease (Tuesday)

ACADIA Pharmaceuticals Inc. CADA: 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 spinal muscular atrophy types 2 and 3 (Wednesday)

Presentations at AACR meetings

IO Biotech, Inc. IOBT: Phase 1/2 study of IO102-IO103 in association with Bristol-Myers Squibb Company BMY Opdivo in Metastatic Melanoma (Friday)

Earnings

Precipio, Inc. OPRP (Monday, after closing)

AngioDynamics, Inc. NGO (Thursday, before the market opens)

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

About Catherine Wilson

Check Also

Short-term stake in Veritex Holdings, Inc. (NASDAQ:VBTX) increases 33.3%

Veritex Holdings, Inc. (NASDAQ:VBTX – Get a rating) recorded a sharp increase in short-term interest …