Get 40% Off
👀 👁 🧿 All eyes on Biogen, up +4,56% after posting earnings. Our AI picked it in March 2024.
Which stocks will surge next?
Unlock AI-picked Stocks

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

Published 03/04/2022, 22:33
Updated 03/04/2022, 23:10
© Reuters.  The Week Ahead In Biotech (April 3-April 9): BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight

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. (NASDAQ: 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. (NASDAQ: CLVS) also benefited from a positive data readout.

On the other hand, Akebia Therapeutics, Inc. (NASDAQ: AKBA) and Amylyx Pharmaceuticals, Inc. (NASDAQ: 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 (NYSE:GS) 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 (NASDAQ: 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.

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

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. (NYSE: BHVN): Phase 1 data for intranasal zavegepant in migraine

Revance Therapeutics, Inc. (NASDAQ: 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. (NYSE: AMRX): results from the pivotal Phase 3 study of IPX-203, in Parkinson's disease patients with motor fluctuations

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

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

Sage Therapeutics, Inc. (NASDAQ: 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. (NASDAQ: ACAD): Phase 3 efficacy and safety of trofinetide for the treatment of Rett syndrome (Tuesday)

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

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

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

AACR Meeting Presentations

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

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

Earnings Precipio, Inc. (NASDAQ: PRPO) (Monday, after the close)

AngioDynamics, Inc. (NASDAQ: ANGO) (Thursday, before the market open)

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

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read at Benzinga

Read the original article on Benzinga

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.