Image source: BioXcel Therapeutics
Two weeks after receiving the first FDA approval, BioXcel Therapeutics ( BTAI) announced strategic financing agreements with Oaktree Capital Management and Qatar Investment Authority (QIA), through which these firms will provide up to $ 260 million in gross funding to support the commercialization of BioXcel sublingual film Igalmi (dexmedetomidine) for the treatment of acute arousal associated with schizophrenia or schizophrenia. disorder I or II.
In addition, funding is intended to support the expansion of clinical efforts to develop the BioXcel BXCL501 program, with which Igalmi was the first approved product. The company is planning a basic phase 3 study to treat acute agitation in patients with Alzheimer’s disease, as well as additional clinical programs in neurology and immunoancology.
Funding includes the following:
The company will receive the first tranches of funding of $ 100 million, with the condition being to satisfy Igalmi with FDA approval.
BioXcel Therapeutics uses artificial intelligence approaches to develop transformational drugs in neurology and immunoancology,
“Since our recent Igalmi approval and today’s funding announcement, we have never been in a better position to realize our vision of becoming a leading company in neuroscience with AI support,” said Vimal Mehta, Ph.D., CEO of BioXcel.
“We are excited to strengthen our monetary position primarily through non-diluting capital as we prepare for the launch of Igalmi and advance our three-pillar portfolio growth strategy for this franchise, which includes additional readings, expanding our geographical reach and expanding healthcare facilities where offered by Igalmi ”.
Igalmi for the acute treatment of agitation associated with schizophrenia or bipolar disorder I or II
Earlier this month, on April 6, BioXcel announced that the FDA had approved Igalmi sublingual film for the treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults.
An estimated 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorder, and up to a quarter of this population experiences arousal with high frequency, for a total of up to 25 million arousal episodes for these two groups of patients per year.
Episodes of arousal are associated with significant strain on patients, caregivers, and the health care system.
“This condition has been a long-standing problem for health professionals to treat,” said Dr. John Crystal, MD, Robert L. McNeill, junior professor of translational research and chairman of the Yale School of Psychiatry’s Department of Psychiatry.
“The approval of Igalmi, a film with a coveted start, is an important point. It gives health care teams an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option. ”
Igalmi is the first new treatment in almost ten years for schizophrenia or bipolar disorder.
BioXcel Therapeutics was separated from BioXcel in 2018. In 2021, the action became a definition of irrational riots and has since returned to earth. Although we found that stocks were inflated at high levels last year, here they may be undervalued and we believe that investors with a high risk tolerance may consider stocks now.
- As of December 31, 2021, the company had $ 233 million in cash and cash equivalents. Full implementation of this latest funding will lead to the operation of the runway in 2025.
- With a current market capitalization of $ 377 million, investors are paying only a modest sum for the commercial growth of Igalmi and the rest of the pipeline.
- BioXcel has demonstrated a very fast path to its first FDA-approved therapy, from a groundbreaking appointment to Igalmi’s commercial approval in just four years.
- The company has several potential catalytic developments to take place in 2022:
- Commercial launch of Igalmi
- Progress in the case of Alzheimer’s campaign
- Progress in the trial of major depressive disorder.
- Interim efficacy data will be available in the second half of this year to test for recurrence of solid tumors BioXcel
- BioXcel focuses on very large target markets, including agitation related to other neurological diseases as well as immunoancology.
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