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ESTERO, FL - Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) announced Tuesday it has filed a provisional patent application for a sublingual powder formulation of meclizine, aiming to provide faster relief for motion sickness and vertigo symptoms. The micro-cap pharmaceutical company, currently valued at just $7.18 million, has seen its stock price decline by nearly 100% over the past year according to InvestingPro data.
The application, submitted to the U.S. Patent and Trademark Office, covers what the company describes as the first sublingual powder delivery system for meclizine, the active ingredient in Dramamine. The new formulation is designed to bypass the gastrointestinal tract, potentially reducing onset time from the typical one hour to "mere minutes," according to the company.
Meclizine was the most prescribed antiemetic/antivertigo medication in 2023 with approximately 4.09 million prescriptions in the United States. The global market for meclizine was valued at $450 million in 2023.
Traditional oral meclizine tablets can take up to three hours to reach peak plasma levels. Aspire’s sublingual formulation aims to address this delay while providing an alternative for patients who have difficulty swallowing pills or experience vomiting.
"For millions suffering from the sudden onset of vertigo or motion sickness, waiting an hour for a tablet to kick in is simply not an option," said Kraig Higginson, Interim CEO of Aspire, in the press release.
The company plans to pursue FDA approval through the 505(b)(2) regulatory pathway, which allows use of existing safety data from the reference drug to potentially accelerate development.
Aspire Biopharma Holdings develops drug delivery technologies designed to improve medication effectiveness while reducing side effects by delivering substances directly to the bloodstream. Despite its innovative approach, InvestingPro data shows the company is not profitable over the last twelve months, with a concerning current ratio of 0.17 indicating short-term obligations exceed liquid assets. The company’s financial health is rated as "WEAK" with an alarming Altman Z-Score of -24.09, suggesting potential financial distress. Investors seeking deeper insights into companies with similar profiles can access additional ProTips and financial metrics through an InvestingPro subscription.
In other recent news, Aspire Biopharma Holdings announced the filing of a Certificate of Designation for 25,000 shares of Series A Convertible Preferred Stock with the Delaware Secretary of State. The conversion terms allow each share to be converted into common stock at a price determined by recent trading prices, subject to certain caps on ownership. Additionally, Aspire Biopharma raised $2 million through the sale of debentures, which do not bear annual interest and are due in 90 days or upon receipt of $8 million from future financing. The company has also regained compliance with Nasdaq’s minimum bid price requirement, maintaining a closing bid price of at least $1.00 for ten consecutive business days. In a strategic move, Aspire Biopharma partnered with Microsize to advance the development of its sublingual aspirin powder, aimed at treating suspected heart attacks. Furthermore, Phillip Balatsos has been appointed to the company’s Board of Directors, joining the Audit and Compensation Committees. These developments reflect Aspire Biopharma’s ongoing efforts in financial management and product innovation.
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