Shares of clinical-stage biopharmaceutical company, BioXcel Therapeutics, Inc. BTAI surged significantly after the FDA granted Fast Track designation to its experimental drug, BXCL501.
BXCL501, a proprietary sublingual film of dexmedetomidine, is being evaluated for the treatment of acute agitation resulting from neurological and psychiatric disorders.
The fast track program from the agency is designed to provide certain benefits for new drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The designation should facilitate anticipated registration trials for BXCL501 in 2019, upon completion of pharmacokinetic (bioavailability) and safety study.
The candidate is currently being evaluated in a phase I placebo-controlled, single dose, dose-escalation study. The study is expected to enroll up to 60 healthy adult volunteers across various dosing groups. The primary endpoints are pharmacokinetics and safety, with secondary endpoints including assessment of pharmacodynamics (PD) and the relationship between BXCL501 concentrations and PD endpoints.
Top-line data from the study is expected in the first half of 2019.
A potential approval will boost prospects for the company. Approximately 5.0 million patients suffering from Alzheimer's disease, schizophrenia and bipolar disorder experience agitation in the United States. Approximately 1.1 million of these patients experience mild to moderate agitation and represent a potential patient population for treatment with BXCL501.
BioXcel’s other candidate, BXCL701 is an immuno-oncology agent designed for the treatment of a rare form of prostate cancer and also for pancreatic cancer.
In September 2018, the company entered an immuno-oncology partnership with Nektar Therapeutics NKTR to develop a combination of BXCL701, Nektar Therapeutics’ NKTR-214 and a checkpoint inhibitor as a potential treatment for pancreatic cancer. Around the same time, the company filed an IND application with the FDA for a phase Ib/II study to evaluate BXCL701 in combination with Merck’s MRK Keytruda in treatment emergent neuroendocrine prostate cancer (tNEPC).
In October, the company received notice from the FDA stating that it may proceed with its planned human clinical investigation, which is expected to be initiated prior to year-end. Data from the pharmacokinetic safety and efficacy study of BXCL701 in tNEPC are expected to be available throughout 2019.
Zacks Rank & Stock to Consider
BioXcel currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Bristol-Myers Squibb Co. BMY, which sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.84 to $3.87 for 2018 and $3.89 to $4.14 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.
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