BioXcel Therapeutics Inc (BTAI)

BioXcel posts encouraging Phase 2 results for opioid withdrawal therapy BXCL501March 5, 2026 9:53 AM
IH Market News
BioXcel Therapeutics (NASDAQ:BTAI) reported positive topline results from a Phase 2 investigator-sponsored trial evaluating its experimental therapy BXCL501 for the treatment of opioid withdrawal symptoms in adults undergoing methadone tapering.The study, funded by the National Institute on Drug Abuse, enrolled 80 participants diagnosed with opioid use disorder. Researchers compared BXCL501 administered at doses of 180 µg and 240 µg twice daily with placebo and with lofexidine 0.54 mg given four times daily as an active comparator.According to the company, the higher BXCL501 dose of 240 µg twice daily significantly reduced withdrawal symptoms compared with placebo during a seven-day methadone taper, as measured using the Short Opiate Withdrawal Scale-Gossop. Patients recorded a reduction in scores of more than 30%, with the strongest improvements observed on days three and four of treatment. The reduction in symptoms also numerically exceeded the improvement seen in patients receiving lofexidine.The trial also reported lower rates of orthostatic hypotension in patients treated with BXCL501 compared with the active comparator. Orthostatic hypotension occurred in 18% of patients receiving BXCL501 at 180 µg twice daily and in 37% of those receiving the 240 µg dose, versus 50% among patients treated with lofexidine. No cases of sedation or somnolence were reported in the BXCL501 groups, compared with 5% in the lofexidine arm.The data comes at a challenging time for BioXcel. The company’s shares have declined about 56% over the past six months, recently trading around $1.65 and giving the biotech a market capitalization of roughly $36 million.The trial population included patients predominantly exposed to fentanyl, with a large share also exposed to fentanyl contaminated with xylazine.Dr. Sandra Comer, Principal Investigator and Professor of Neurobiology at Columbia University, said the findings highlight the drug’s potential in treating opioid withdrawal. “The results demonstrate the potential of BXCL501 for reducing opioid withdrawal symptoms.”BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine. The company estimates that approximately 5.9 million people in the United States have been diagnosed with opioid use disorder.BioXcel Therapeutics supplied the BXCL501 drug used in the NIDA-sponsored study.Separately, the company continues to advance regulatory efforts for its drug IGALMI. BioXcel recently submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking approval for the therapy to be used in at-home settings to treat acute agitation linked to bipolar disorder or schizophrenia.IGALMI is currently approved for use under healthcare provider supervision. If the application is approved, the expanded indication allowing at-home treatment could be granted later in 2026.BioXcel has also introduced milestone and retention bonus agreements for key executives following the filing, aiming to maintain leadership continuity during the regulatory review process as the company pursues broader use of the treatment.

Original: BioXcel posts encouraging Phase 2 results for opioid withdrawal therapy BXCL501

So much for that

BTAI......................................A/H

News will send this past old highs of $13.36

as i said, bouncy, great for flipping.

this one is very bouncy.

BTAI..............................................................a/h

Dump coming no cash dilution time 

BTAI,getting found/trending now ,fda approval expected soon,zero borrow/152% fee,buyout could send it around $50.00 is the greed,green dragon 🐉 possible,is the buy and hold fomo,dd this low floater

Earnings Summary

For their last quarter, BioXcel Therapeutics (BTAI) reported earnings of -$1.50 per share, beating the Zacks Consensus Estimate of $-2.72 per share. This reflects a positive earnings surprise of 44.85%. Look out for BTAI's next earnings release expected on August 12, 2025. For the next earning release, we expect the company to report earnings of -$2.30 per share, reflecting a year-over-year increase of 31.55%.

Yep,ka and boom to 4.60,jumping nickels,let’s see dimes and quarters lol

Continuing strength thru death hr,this could really fly as death hr ends in 13 min, I bought 4.30 just incase

Earnings report today? 8-7-25 ...awfully quiet ,,,,,,

Don't see any picks on this before the move...

BTAI FUC THAT UP

BTAI..THATS TOP

BTAI VOLUME SURGE

BTAI BIO BEAST

BTAI.............................................................p/m

BTAI.............................................https://stockcharts.com/h-sc/ui?s=BTAI&p=W&b=5&g=0&id=p86431144783

BTAI under $2

BTAI, under $2

BTAI, recent 52 week low

BTAI, new 52 week low

$BTAI > HA !

Rodman & Renshaw analyst Elemer Piros initiates coverage on BioXcel Therapeutics ( BTAI ) with a Buy rating and announces Price Target of $65.

$BTAI takin' it in the shorts ...

BTAI...............................https://stockcharts.com/h-sc/ui?s=BTAI&p=W&b=5&g=0&id=p86431144783

Fukers didn't waste any time getting another "funding" out there ... ($3.50) .

BTAI....................................https://stockcharts.com/h-sc/ui?s=BTAI&p=W&b=5&g=0&id=p86431144783

$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.

NVDA at $118 like clockwork by the financial masters who run the markets. Bottom in for me trading ..all out of shorting NVDA. Bonus if it hits $116

BTAI...................................................................................p/m

Most obvious exit $$$$ at $2.98 if breaks $2.64 solid 

... the Company has regained compliance with the minimum closing bid price requirement under Nasdaq Listing Ru...

Pump it $2.46 now +'50%

BTAI, new 52/week low

Flip back out .53 will revisit 

BTAI .49 on the move in some 

And now the fist . "Consolidation" just around the corner .

https://www.otcmarkets.com/filing/html?id=18054739&guid=avY-kFsEBNqfJth

BTAI, new 52 week low

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

Up .12 now up .01; Oh well, still on the positive side.

It's is up .12 so far so it doesn't look like a cliff dropper. Trying to get people to sell so you can buy?

This Friday it closed at .69 so it is not very encouraging. Is it?

This thing gonna fall off a cliff tomorrow lol

BTAI new 52 week low

BTAI new 52 week low

UBS Adjusts Price Target on BioXcel Therapeutics to $1 From $3.50, Maintains Neutral Rating

$BTAI .76 disaster >>>

Shorts gonna choke it to death now ...

BTAI under $2

BTAI............................https://stockcharts.com/h-sc/ui?s=BTAI&p=W&b=5&g=0&id=p86431144783