Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus Acadia Announces FDA AdComm For Pimavanserin In Alzheimer's-Related Psychosis The FDA's Psychopharmacologic Drugs Advisory Committee will review Acadia Pharmaceuticals Inc (NASDAQ: ACAD) resubmitted supplemental marketing application for pimavanserin on June 17.
The application seeks approval for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis.
The target action date for the application is Aug. 4.
Ipsen, Exelixis' Cabometyx Scores European Approval As Second-Line Treatment For Thyroid Cancer The European Commission has approved Ipsen SA's (OTC: IPSEY) Cabometyx (cabozantinib) as monotherapy in differentiated thyroid carcinoma (DTC) setting.
The approval covers adult patients with locally advanced or metastatic DTC that is refractory or not eligible for radioactive iodine who have progressed during or after systemic therapy.
This EC approval follows the FDA approval announced by Exelixis Inc (NASDAQ: EXEL) in September 2021 of Cabometyx for adult and pediatric patients with locally advanced or metastatic DTC.
Cortexyme Announces Further Layoffs, Chief Medical Officer Leaves Cortexyme Inc (NASDAQ: CRTX) has announced a further reduction to its headcount by 36%, bringing the total reduction to 67% from the January 2022 headcount levels.
The majority of the employees will leave by the end of May 2022, and the remainder will leave by July 2022.
In connection with this current reduction in force, the company estimates to incur approximately $700,000 in expenses.
Sesen Bio Explores Strategic Alternatives Sesen Bio (NASDAQ: SESN) has initiated a process to review strategic alternatives.
As of March 31, 2022, the company held $169.8 million in cash and cash equivalents.
Shares are down 3.65% at 38 cents during the premarket session.
FDA Identifies Review Issues For Spero's Tebipenem Application Spero Therapeutics Inc (NASDAQ: SPRO) will defer commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting with the FDA.
The discussion suggested that the data package may be insufficient to support approval during this review cycle.
With this development, Spero will reduce its workforce by approximately 75%.
Shares are slipping 11.8% at $4.49 during the premarket session.
Belite Bio's Lead Candidate Get US Fast Track Tag For Genetic Eye Disease The FDA has granted Fast Track Designation to Belite Bio Inc's (NASDAQ: BLTE) LBS-008 for Stargardt disease (STGD1).
The decision was based upon the FDA's review of non-clinical data and preliminary clinical data from studies of LBS-008.
A two-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing.
Shares are up 15.6% at $10.25 during the premarket session Tuesday.
Taysha's Neurodegenerative Gene Therapy Gets Orphan Drug Tag In Europe The European Commission has granted orphan drug designation to Taysha Gene Therapies Inc's (NASDAQ: TSHA) TSHA-120, an intrathecally dosed AAV9 gene therapy for giant axonal neuropathy (GAN).
GAN is a rare inherited genetic disorder, a progressive neurodegenerative disease that affects both the central and peripheral nervous systems.
BioXcel Starts Dosing In Late-Stage Agitation Trial BioXcel Therapeutics Inc (NASDAQ: BTAI) has dosed the first patient in the Phase 3 TRANQUILITY II study of BXCL501 for the acute treatment of agitation in Alzheimer's disease.
BXCL501 is a proprietary, orally dissolving thin film formulation of dexmedetomidine.
Top-line data for TRANQUILITY II is anticipated in Q4 2022/early Q1 2023.
Graphite Bio's Sickle Cell Candidate Secures FDA Fast Track Tag The FDA has granted Fast Track Designation to Graphite Bio Inc's (NASDAQ: GRPH) GPH101 for sickle cell disease (SCD).
GPH101 is an investigational gene-edited autologous hematopoietic stem cell therapy designed to correct the genetic mutation that causes SCD directly.
Shares are up 7.23% at $4.30 during the premarket session.
Pliant's Pulmonary Fibrosis Candidate Fast Tracked In US Pliant Therapeutics' (NASDAQ: PLRX) PLN-74809 has received FDA Fast Track designation for idiopathic pulmonary fibrosis.
PLN-74809 is the company's lead drug candidate and is in a Phase 2a trial. Topline data is anticipated in mid-2022.
Shares are up 6.19% at $6 during the premarket session.
Data Presentations Association for Research in Vision and Ophthalmology (ARVO)
Ocular Therapeutix Inc (NASDAQ: OCUL): Preclinical data of OTX-TIC (travoprost intracameral implant) in primary open-angle glaucoma or ocular hypertension.
Kodiak Sciences Inc (NASDAQ: KOD): Efficacy, durability, and safety of KSI-301 in wet AMD.
Offerings Tarsus Pharmaceuticals Inc (NASDAQ: TARS) has priced an upsized underwritten public offering of 5.6 million shares at $13.50 per share for gross proceeds of $75.6 million.
On The Radar PDUFA Dates
Phathom Pharmaceuticals Inc (NASDAQ: PHAT): Vonoprazan-based treatment regimens for adults with H. pylori infection.
Earnings Pfizer Inc (NYSE: NYSE:PFE): (Before Market Open)
Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) (Before Market Open)
Teva Pharmaceutical Industries Ltd (NYSE: NYSE:TEVA) (Before Market Open)
Incyte (NASDAQ:INCY) Corporation (NASDAQ: INCY) (Before Market Open)
Esperion Therapeutics Inc (NASDAQ: ESPR) (Before Market Open)
Biogen Inc (NASDAQ: NASDAQ:BIIB) (Before Market Open)
Blueprint Medicines Corp (NASDAQ: BPMC) (Before Market Open)
SAGE Therapeutics Inc (NASDAQ: SAGE) (Before Market Open)
Veracyte Inc (NASDAQ: VCYT) (After Market Close)
Rigel Pharmaceuticals Inc (NASDAQ: RIGL) (After Market Close)
Aquestive Therapeutics Inc (NASDAQ: AQST) (After Market Close)
Lantern Pharma Inc (NASDAQ: LTRN) (After Market Close)
Infinity Pharmaceuticals Inc (NASDAQ: INFI) (After Market Close)
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