|Over a week ago|
BioXcel Therapeutics completes enrollment in Phase 3 SERENITY trials » 07:2805/1405/14/20
BioXcel Therapeutics announced full enrollment of its pivotal Phase 3 SERENITY trials evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. The Company expects to report topline data from both trials in July of 2020. The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients, 18 to 75 years of age. SERENITY I is evaluating patients with agitation associated with schizophrenia, with each of three arms receiving BXCL501 at 120 micrograms, 180 micrograms or placebo, respectively. SERENITY II is evaluating patients with agitation associated with bipolar disorder, also in three arms, receiving BXCL501 at 120 micrograms, 180 micrograms or placebo, respectively. The primary endpoint of the trials is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component change from baseline compared to placebo. A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score.
BioXcel Therapeutics says cash position sufficient to fund operations into 2021 » 07:0605/1205/12/20
In February 2020, the…
In February 2020, the Company raised net proceeds of approximately $60 million in connection with its common stock offering. BTI believes that proceeds from this offering, together with current reserves, provide cash runway to fund key clinical, regulatory and operational milestones into 2021.
BioXcel Therapeutics expects data from Phase 1b/2 study of BXCL701 in Q4 » 07:0505/1205/12/20
After completing the…
After completing the Phase 1b safety lead-in, the Company has initiated the Phase 2 portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab for treatment emergent Neuroendocrine Prostate Cancer 0.3 mg of BXCL701 twice daily was found to be the recommended dose when used in combination with KEYTRUDA and this dose regime will be used for the efficacy assessment of the clinical program. The Company expects to report initial data from this trial in the fourth quarter of 2020. The open label Phase 2 basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid cancers has been initiated. This study, which is being conducted at the MD Anderson Cancer Center, is following the dosing schedule used in the Phase 1b/2 study for tNEPC. The BXCL701 phase of the triple combination study of BXCL701, bempegaldesleukin and BAVENCIO in pancreatic cancer is expected to begin following Nektar and Pfizer's Phase 1b safety trial of a double combination of bempegaldesleukin and avelumab and the outcome of that trial.
BioXcel Therapeutics expects BXCL501 Phase 3 trial data in mid-2020 » 07:0405/1205/12/20
The company said,…
The company said, "The SERENITY program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, is ongoing, with more than one-third of the patients enrolled and treated as of March 19, 2020. Enrollment is progressing as planned, and the Company is on track to report topline data from both Phase 3 trials in mid-2020. In January 2020, the first patient was enrolled in the TRANQUILITY study, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia. BTI is currently assessing safety and tolerability data in order to choose the next tested dose, and the Company expects to report topline results in mid-2020. Our Investigational New Drug application for the treatment of opioid withdrawal symptoms, a fourth indication for BXCL501, received clearance from the U.S. Food and Drug Administration in February 2020. The Company is planning to initiate the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms shortly. In February 2020, researchers at Yale University initiated a Phase 2 study designed to measure biomarkers associated with agitation in patients with schizophrenia and their response to treatment with BXCL501. The Company is currently completing the clinical planning stage for its fifth indication, agitation associated with hyperactive delirium, and is preparing to initiate a Phase 1b/2 trial of BXCL501 in the second half of 2020."
BioXcel Therapeutics says has not experienced 'significant' delays to trials » 07:0305/1205/12/20
During the first quarter…
During the first quarter of 2020, the Company took steps in line with guidance from the U.S. Centers for Disease Control and Prevention and the State of Connecticut to protect the health and safety of its employees and the community. In particular, the Company implemented a work-from-home policy for all employees and has restricted on-site activities to certain chemical, manufacturing and control and clinical trial activities. To date, the Company has not experienced any significant delays to its ongoing or planned clinical trials; however, this could rapidly change.
BioXcel Therapeutics reports Q1 EPS (79c), consensus (59c) » 07:0205/1205/12/20
"BioXcel continued to advance on its key milestones for 2020," stated Vimal Mehta, Chief Executive Officer of BTAI. "Beginning with our neuroscience program, we have made significant progress advancing BXCL501, as evidenced by our three ongoing clinical trials, SERENITY I & II and TRANQUILITY, and our Phase 1b/2 RELEASE trial initiating shortly. In parallel, we are investigating biomarkers associated with agitation in hopes of expanding the potential market for BXCL501 to additional indications. These significant achievements showcase the versatility of this candidate and we believe provides the foundation for creating a highly valuable neuroscience franchise. In addition, we have made great strides with our immuno-oncology program, identifying the recommended dose of BXCL701 when used in combination with KEYTRUDA for our Phase 2 efficacy trial for treatment emergent Neuroendocrine Prostate Cancer. We believe this candidate has the potential to provide a treatment for this advanced prostate cancer that currently does not have an effective standard of care. In light of the COVID-19 pandemic, we are continuously monitoring the safety of our team, as well as its potential impact on our clinical and corporate plans. To date, we have not experienced any significant delays with our ongoing clinical trials and have developed a risk mitigation strategy to manage business operations."
BioXcel Therapeutics initiates Phase 2 study of BXCL701 » 07:2704/2804/28/20
BioXcel Therapeutics announced the initiation of the Phase 2 efficacy portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab for treatment emergent Neuroendocrine Prostate Cancer. Initial interim data from this study is expected in the fourth quarter of 2020. Results from the Phase 1b safety assessment of BXCL701, an investigational oral innate immunity activator, indicated that a split dose totaling 0.6 mg per day is the recommended dose when used in combination with KEYTRUDA, a PD-1 inhibitor. The 0.6 mg total daily dose has shown on-target side effects consistent with cytokine activation. Splitting the daily dose can be associated with an improved safety profile and will be used in the efficacy portion of the clinical program. The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 administered orally and daily, combined with pembrolizumab, in men with tNEPC. With the initial assessment of safety and the identification of the recommended Phase 2 BXCL701/PEMBRO dose schedule complete, the Company can now initiate the Phase 2 efficacy portion of the trial. Approximately 30 eligible tNEPC patients will receive 0.3 mg of BXCL701 twice daily on days 1 through 14 of a 21-day cycle plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary endpoint of the trial is the composite response rate, with a target of achieving a greater than 15% composite response rate. Secondary endpoints include duration of response, overall survival and progression-free survival.
|Over a month ago|
BioXcel Therapeutics falls 11% after providing COVID-19 update » 12:2904/1504/15/20
On April 14, the company…
On April 14, the company provided the following updates regarding its clinical trials and business operations in light of the COVID-19 pandemic:The company has taken steps in line with guidance from the U.S. Centers for Disease Control and Prevention and the State of Connecticut to protect the health and safety of its employees and the community. In particular, the Company has implemented a work-from-home policy for all employees. and has restricted on-site activities to certain chemical, manufacturing and control and clinical trial activities. The company is continuing to assess the impact of the COVID-19 pandemic to best mitigate risk and continue the operations of its business. Consistent with existing guidance, the Company continues to enroll patients in its two Phase 3 SERENITY trials and assess data for dose escalation in its Phase 1b/2 TRANQUILITY trial. The Company expects to provide data readouts for trials involving its product candidates BXCL501 and BXCL701 as summarized in slides 19 and 26 in Exhibit 99.1 attached hereto, which slides 19 and 26 are incorporated herein by reference. Notwithstanding the Company's current expected timing and milestones, the ability to continue to enroll patients, conduct patient follow-up and provide data readouts as planned may be impacted by the COVID-19 pandemic. As a result of the COVID-19 pandemic or other pandemic, epidemic or outbreak of an infectious disease, we may experience disruptions that could severely impact our business, preclinical studies and clinical trials..." Shares of BioXcel Therapeutics are 11% lower in afternoon trading on Wednesday to $22.30 per share.
Fly Intel: Top five analyst initiations » 10:1704/0104/01/20
ZM, BTAI, PROF, AEO, HBI, ESPR, KNSA
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Zoom Video (ZM) initiated with a Neutral at DA Davidson. 2. BioXcel Therapeutics (BTAI) initiated with a Buy at BofA. 3. Profound Medical (PROF) initiated with an Outperform at Cowen. 4. American Eagle (AEO) and Hanesbrands (HBI) initiated with a Market Perform at Raymond James. 5. Esperion (ESPR) and Kiniksa (KNSA) initiated with a Buy at BofA. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
BioXcel Therapeutics initiated with a Buy at BofA » 06:1904/0104/01/20
BofA analyst Geoff…
BofA analyst Geoff Meacham initiated coverage of BioXcel Therapeutics with a Buy rating and $45 price target. The company's lead asset BXCL501 for mild-to-moderate acute agitation is largely de-risked as IV dexmedetomidine is already approved with a known efficacy and safety profile, Meacham tells investors in a research note. Further, the analyst believes BXCL501's development program could have enhanced visibility in the next three months driven by data from two Phase 3 trials in schizophrenia/bipolar patients and Phase 1b/2 data in dementia patients.