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BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting

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Mark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Ex...

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AI Summary

Mark Pavao appointed Interim Chief Commercial Officer for BTAI. BTAI plans to submit sNDA for IGALMI in at-home settings imminently. IGALMI addresses agitation in bipolar disorder or schizophrenia; potential market impact noted. Pavao's experience in CNS product marketing is expected to enhance launch strategies. No FDA-approved alternatives exist for at-home agitation treatment currently.

Sentiment Rationale

The imminent sNDA submission and experienced leadership could enhance IGALMI's market potential. Prior instances of successful drug launches often resulted in positive stock responses.

Trading Thesis

The full commercial effects from IGALMI's launch will unfold over several years. Historical drug launches demonstrate extended timelines for revenue realization and market penetration.

Market-Moving

  • Mark Pavao appointed Interim Chief Commercial Officer for BTAI.
  • BTAI plans to submit sNDA for IGALMI in at-home settings imminently.
  • IGALMI addresses agitation in bipolar disorder or schizophrenia; potential market impact noted.

Key Facts

  • Mark Pavao appointed Interim Chief Commercial Officer for BTAI.
  • BTAI plans to submit sNDA for IGALMI in at-home settings imminently.
  • IGALMI addresses agitation in bipolar disorder or schizophrenia; potential market impact noted.
  • Pavao's experience in CNS product marketing is expected to enhance launch strategies.
  • No FDA-approved alternatives exist for at-home agitation treatment currently.

Companies Mentioned

  • ABT (ABT)
  • PFE (PFE)
  • JNJ (JNJ)

Corporate Developments

The article discusses critical developments affecting commercialization and market strategy for a significant pipeline product, directly impacting BTAI’s stock performance.

BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting

Stock Symbol: BTAI

Date: January 12, 2026

BioXcel Therapeutics Announces New Leadership Appointment

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a pioneering biopharmaceutical company utilizing artificial intelligence to develop innovative therapies in neuroscience, has announced the appointment of Mark Pavao as the Interim Chief Commercial Officer. This strategic move comes as the company prepares to launch IGALMI® for at-home use, potentially by the end of 2026.

Key Plans for IGALMI®

The company is on track to submit a supplemental New Drug Application (sNDA) this month to the FDA, seeking approval for IGALMI® to be used in the acute treatment of agitation associated with bipolar disorders or schizophrenia.

“We are taking important steps in planning and solidifying our optionality for the potential launch of IGALMI for at-home use,” stated Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “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 and maximizing the value of the IGALMI franchise.”

Mark Pavao's Expertise

Mark Pavao joins BioXcel Therapeutics with over 30 years of experience in the biopharmaceutical industry, focusing on neuroscience sales and marketing. His previous roles include significant contributions to the commercialization of prominent CNS therapies such as Abilify®, Paxil®, Risperdal®, and Nurtec ODT.

“This is a great opportunity to drive the commercial strategic planning that can bring IGALMI to millions of patients,” said Pavao. “Based on strong clinical data and market feedback to date, IGALMI has the potential to address a meaningful unmet need.”

About IGALMI®

IGALMI® (dexmedetomidine) sublingual film is formulated for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. It is administered under health care provider supervision.

Important safety information includes:

  • Potential for decreased and low blood pressure, particularly in vulnerable populations.
  • Risk of heart rhythm changes, especially in patients with previous irregular heart conditions.
  • Common side effects include sleepiness, dizziness, and dry mouth.
  • Patients should not engage in activities requiring mental alertness for at least 8 hours post-administration.

Looking Ahead

BioXcel Therapeutics is committed to expanding the availability of IGALMI® to improve patient access to treatment options for acute agitation in bipolar disorder and schizophrenia, particularly in home settings.

Patients are encouraged to discuss any concerns or side effects with their healthcare providers and report any negative side effects to the FDA.

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