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HUMACAO, PUERTO RICO AND NEW YORK, NY - Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP), a pharmaceutical company specializing in drug delivery technologies with a current market capitalization of $34.42 million, has announced updates on its patent applications for a new aspirin formulation. According to InvestingPro data, the company’s stock currently trades at $0.74, having experienced significant volatility over the past year. The applications, filed with the U.S. Patent and Trademark Office on March 31, 2023, and October 2, 2024, relate to Oral Mucosal Formulations of Aspirin using Aspire’s proprietary technology.
The company’s CEO, Kraig Higginson, expressed that the patent filings are critical to reinforcing their intellectual property portfolio and offer a scalable solution for producing a novel sublingual form of aspirin. This development comes as the company faces financial challenges, with InvestingPro analysis indicating a weak financial health score and a current ratio of 0.19, suggesting potential liquidity constraints. The technology aims to enhance the efficacy and safety of medications by allowing rapid absorption directly into the bloodstream, bypassing the gastrointestinal tract.
Aspire’s leading product candidate is a high-dose sublingual aspirin designed for emergency cardiac care and pain management. The company suggests that the rapid absorption feature of their aspirin could provide immediate treatment effects and is currently planning to initiate a bioavailability study in healthy volunteers around April 2025. A pre-IND meeting with the FDA is expected in the second quarter of 2025, followed by a final clinical trial to evaluate the pharmacodynamic effect of their aspirin product.
Aspire plans to request "fast track" approval for its high-dose aspirin product and anticipates FDA approval through a New Drug Application (NDA) later in 2025. For investors following this development, InvestingPro offers 11 additional investment tips and comprehensive financial analysis tools to better understand the company’s potential. The next earnings report is expected on June 6, 2025, which could provide crucial updates on the company’s development progress. The company is also preparing for clinical trials of a low-dose sublingual aspirin for preventative care in Fall 2025.
The patent-pending technology is claimed to be groundbreaking due to its fast-acting, water-soluble, and easy-to-administer properties, potentially offering an alternative for those who have difficulty swallowing pills. This innovation comes at a critical time for the company, which has seen its stock decline by approximately 93% over the past year, according to InvestingPro data.
Aspire Biopharma is headquartered in Humacao, Puerto Rico, and focuses on developing technologies that address drug efficacy, dosage management, and response time.
This update is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. Aspire Biopharma has made no commitment to update these statements following the date of this release.
In other recent news, Aspire Biopharma Holdings, Inc. has announced the completion of an initial feasibility study for its high-dose sublingual aspirin product, with plans to enter Phase 1 clinical trials in April. The study, conducted by Glatt Air Techniques, confirmed the feasibility of the aspirin formulation, which is designed for rapid absorption in emergencies. Aspire’s CEO emphasized the significance of this milestone, highlighting the company’s plans for further clinical trials and potential FDA meetings in 2025. Additionally, Aspire Biopharma has completed its merger with PowerUp Acquisition Corp., allowing its stock and warrants to begin trading on the Nasdaq Global Market and Nasdaq Capital Market. This merger is expected to enhance Aspire’s access to capital markets and support its product development efforts. Legal counsel for the merger was provided by Dykema Gossett, PLLC and Sichenzia Ross Ference Carmel LLP. The company aims to leverage the established safety and efficacy data of aspirin to expedite product approval. Investors are encouraged to review the transaction details filed with the U.S. Securities and Exchange Commission.
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