BioXcel Therapeutics, Inc. (BTAI) stock soared 12.22% in the current market trading session at the price of $22.31 following the FDA approval of IGALMI for the treatment of bipolar disorder or schizophrenia.
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FDA Approved IGALMI
On 6th April 2022, BTAI announced the approval of IGALMI by the food and drug administration to treat bipolar disorder or schizophrenia in adult patients. The company has expected to launch the drug in the United States by the Q2 of 2022.
The FDA approval had established on results from two placebo-controlled, double-blinded, randomized Phase-III clinical trials assessing IGALMI. The drug satisfied the primary endpoint in both clinical trials after the first dose in patients, demonstrating substantial progress from the baseline. TIGALMI has also met the secondary endpoint, illustrating a quick onset of action.
BioXcel Therapeutics is a biopharma firm that employs artificial intelligence to devise transformative drugs in immuno-oncology and neuroscience. BTAI’s re-innovation technique leverages currently authorized drugs and clinically approved products combined with machine-learning codes to identify novel therapies.
The company’s product candidate, BXCL501, is FDA-approved sublingual dexmedetomidine that treats adults with agitation related to bipolar disorder or schizophrenia. Additionally, the company is producing BXCL701, an orally-administered, investigational, innate immunity activator to treat the chronic stage of solid tumors and prostate cancer.
Current Market Updates
The FDA approval of the company’s first marketed drug is a great milestone for BTAI. This approval will help the company expand its label usage for BXCL501 as the drug showed positive results in clinical trials. BTAI stock generated no revenue during the last two years. Now, the company will initiate spending funds for quick monetization of the drug.
According to research, there are above 150M individuals globally with bipolar disorder and schizophrenia, so the company seems to have a high potential for revenue growth. There are tangible grounds for investor optimism. The company has already started hiring sales agents and working on the commercialization of the drug.