makinezmoney
1 일 전
$BTAI: We calllled it didn't we................
You cant fight the Techncials when they are staring at you and biggest threat in the face of Tarriffs and other global pressures
is that highly inflated and irrational forward PE Multiple.
You can be a fanboy of NVDIA of it if you want to............ but why not be a fanboy when its at $85/sh rather than $120/sh.
$BTAI news is soooooooooooo good today.
Just tapped $6
BioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer’s Dementia
March 03, 2025 07:00 ET
| Source: BioXcel Therapeutics
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FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated
Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501
NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report. The FDA has designated “Voluntary Action Indicated” for the site.
“We believe this report and the closing of the investigation, together with the positive findings from the independent audit we announced in October 2023, further reaffirm the data integrity from the single site and the body of clinical evidence we intend to include in a potential sNDA submission,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We have already received FDA feedback on the protocol for our TRANQUILITY In-Care Phase 3 trial and look forward to advancing this program with our lead neuroscience asset BXCL501.”
About BXCL501
Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
About the TRANQUILITY In-Care Phase 3 Trial
The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 over a 12-week period for agitation associated with Alzheimer’s dementia in the care setting. The trial is expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer 60 mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional PEC and Clinical Global Impressions – Improvement Scale measurements will also be obtained during the trial.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com.
axelvento
5 월 전
Experimental therapy shows promise in pancreatic cancer clinical trial-
It acts by inflaming the microenvironment surrounding the tumour and thereby augmenting the activity of immunotherapies like pembrolizumab. BXCL701 has received Orphan Drug Designation from the U.S. Food and Drug Administration in pancreatic cancer and three other cancer types: acute myelogenous leukaemia, stage IIb to IV melanoma, and soft tissue sarcoma.
hree patients had significant reductions in a marker that indicates the presence of pancreatic cancer, CA19-9, with 100%, 97% and 73% reductions. Weinberg says that CA19-9 is the best marker they have in pancreatic cancer, but it is not as good a screening test as PSA is for prostate cancer. He believes, however, that it can be useful for monitoring disease activity in patients with advanced cancers.
“Historically, no one has responded to immunotherapy in pancreatic cancer so even one response and another with stable disease could be early signs of efficacy,” says Weinberg. “A third patient had an initial drop in their CA19-9 marker even though they had disease progression on imaging, and this may be more early evidence that this drug combination has anti-cancer effects.”
https://ecancer.org/en/news/24822-asco-2024-experimental-therapy-shows-promise-in-pancreatic-cancer-clinical-trial
subslover
1 년 전
BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)
Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence of microsatellite instability
BXCL701 is an investigational, oral innate immune activator designed to inflame the tumor microenvironment and augment CPI activity
Company to discuss registration path at upcoming meeting with FDA
NEW HAVEN, Conn., Feb. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions, fill unmet medical needs, and bring promising medicines to patients more quickly. Therapies granted this designation are given the opportunity for more frequent interactions with the FDA, a rolling review, and potential eligibility for accelerated approval and priority review.
“The FDA’s Fast Track designation for the investigation of BXCL701 in SCNC is an important recognition of our most advanced immuno-oncology asset and an acknowledgment of its potential to address the considerable unmet medical need in these patients. At the same time, it further validates the unique AI-based drug re-innovation approach that we used to discover this asset,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “BXCL701 has already demonstrated considerable potential in our clinical trials to date, and we plan to further define its development path while exploring strategic options for our OnkosXcel Therapeutics subsidiary.”
SCNC, classified as a “cold” tumor, represents an underserved, growing patient population, with cases increasing due to earlier and more widespread use of androgen receptor inhibitors. In 2024, the American Cancer Society estimates that 299,0101 men will be diagnosed with prostate cancer in the United States, with approximately 20% expected to progress to the more aggressive metastatic castration-resistant form, including an estimated 11,960 patients expected to progress to SCNC2.
“SCNC is characterized by poor prognosis and a low survival rate, and current treatment options are suboptimal,” said Vincent J. O’Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer of BioXcel Therapeutics. “We are encouraged by the potential of BXCL701, which has demonstrated clinical proof of concept in both SCNC and adenocarcinoma. Following the positive survival results from our Phase 2 trial that we reported at the end of last year, we look forward to further discussing the registration path at an upcoming meeting with the FDA.”
jgrabar
1 년 전
https://grabarlaw.com/the-latest/bioxcel-shareholder-investigation/
A recently filed securities fraud class action complaint alleges that BioXcel Therapeutics Inc. (NASDAQ: BTAI), via certain officers and directors, made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the complaint alleges Defendants failed to disclose to investors: (1) that the Company lacked adequate internal controls over protocol adherence and data integrity; (2) that, as a result, the Company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) that the Company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) that the Company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (5) that the foregoing would negatively impact the Company’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and (6) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
Current BioXcel shareholders who have held BioXcel stock since prior to December 15, 2021, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award at no cost to them whatsoever.
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