BioXcel Bets on At-Home Agitation Drug Amid Financial Strain

NEW HAVEN, Conn. – January 12, 2026 – BioXcel Therapeutics is making a bold push to bring the treatment of acute agitation out of the clinic and into the living room, a high-stakes move that could redefine care for millions while testing the company's financial resilience. The AI-driven biopharmaceutical firm announced today it has hired veteran commercial leader Mark Pavao as Acting Chief Commercial Officer to spearhead preparations for a potential at-home launch of its drug, IGALMI®.

This strategic leadership expansion comes as the company prepares to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) this month. The application seeks approval for IGALMI®, a sublingual film formulation of dexmedetomidine, to be used by patients at home for the acute treatment of agitation associated with bipolar disorders or schizophrenia. If approved, it could be available as early as year-end 2026, marking a significant milestone in mental healthcare.

“We are taking important steps in planning and solidifying our optionality for the potential launch of IGALMI for at-home use,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics, in a statement. “Mark brings enormous experience in CNS drug launches and brand building, which will enable us to determine the best approaches to commercializing this important treatment option.”

A New Frontier in Mental Healthcare

The potential approval would position IGALMI® as the first and only FDA-approved at-home therapy for this indication, addressing a massive unmet need. BioXcel estimates that 23 million episodes of agitation related to bipolar disorder or schizophrenia occur annually in patients' homes across the United States. Currently, managing these often-distressing episodes can require costly and traumatic emergency room visits or police intervention.

An at-home, fast-acting treatment could empower patients and their caregivers, offering a less disruptive and more accessible way to manage acute symptoms. This aligns with a broader shift across medicine towards decentralized care, fueled by advancements in telemedicine and a growing preference for home-based health solutions. The home healthcare market has seen substantial growth, with the segment for neurological and mental disorders consistently commanding a significant share, highlighting the demand for such innovations.

Mr. Pavao commented on the opportunity, stating, “Based on the strong clinical data, no FDA-approved medicines available for use in the home-setting, and market feedback to-date, IGALMI has the potential to address a meaningful unmet need and impact the treatment paradigm.” His extensive background includes contributing to the commercialization of major central nervous system (CNS) therapies like Abilify®, Paxil®, and Nurtec ODT.

A High-Stakes Bet Amid Financial Headwinds

While the clinical and patient promise is significant, BioXcel's strategic pivot is also a critical gambit to shore up its financial position. The company has faced considerable challenges, with its stock trading near the low end of its 52-week range and its overall financial health scored as "WEAK" by some market analysts. In February 2025, the company executed a 1-for-16 reverse stock split to maintain its Nasdaq listing.

The company’s financial filings paint a picture of a firm under pressure. Net revenue from IGALMI® in its currently approved institutional setting has declined through 2025, with Q3 revenue at just $98,000. Meanwhile, net losses have widened, reaching $30.9 million in the third quarter of 2025. The company’s Q2 2025 regulatory filing included a “going concern” warning, citing an accumulated deficit of $676.6 million and total debt of $108.7 million as of June 30, 2025.

Against this backdrop, the at-home launch represents a crucial effort to unlock a substantially larger market and create a new revenue stream that could reverse the company's fortunes. Success would not only validate its AI-driven drug re-innovation platform but also provide the capital needed to sustain its operations and pipeline development. The company has been actively raising capital, securing around $14 million through a direct offering in March 2025 and utilizing an at-the-market program to bolster its cash reserves, which stood at $37.3 million as of September 30, 2025.

The Tightrope of Safety and Accessibility

Bringing a potent CNS drug from the controlled environment of a hospital to the unpredictability of a patient's home presents formidable safety and regulatory hurdles. IGALMI®'s label carries warnings for serious side effects, including decreased blood pressure, slower heart rate, and potential heart rhythm changes (QT interval prolongation). The most common side effect is significant sleepiness or drowsiness, which has led to warnings against driving or operating machinery for at least eight hours after taking the drug.

These risks are why the current formulation must be administered under the supervision of a healthcare provider who can monitor vital signs. Convincing the FDA that the drug can be used safely without this direct oversight is the central challenge of the upcoming sNDA review.

BioXcel appears to be addressing this head-on. The sNDA is supported by data from the SERENITY At-Home pivotal Phase 3 trial, a study involving 200 patients who self-administered the drug. The company reported that the trial met its primary endpoint, demonstrating that the 120 mcg dose was well-tolerated. Furthermore, BioXcel held a pre-sNDA meeting with the FDA in August 2025 to align on the submission's content, suggesting a proactive approach to navigating the complex regulatory pathway. The agency has already granted Fast Track designation for the at-home use investigation, signaling its recognition of the urgent need for such a treatment.

Even with approval, practical questions will remain regarding caregiver training, emergency protocols for adverse events, and ensuring patient adherence to safety guidelines. Balancing the promise of greater access with the imperative of patient safety will be the defining challenge of this potential new treatment paradigm.