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Applied Therapeutics Faces Legal Action Over Alleged Securities Violations
In a significant development, Bleichmar Fonti & Auld LLP, a prominent securities law firm, has initiated a lawsuit against Applied Therapeutics, Inc., alongside several of its executives, citing possible infringements of federal securities regulations.
Investors who have put their money into Applied Therapeutics are encouraged to gather more information regarding the case by visiting this link.
The deadline for investors wishing to seek court appointment as lead plaintiffs in this case is February 18, 2025. The lawsuit claims violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and is currently before the U.S. District Court for the Southern District of New York, listed as Alexandru v. Applied Therapeutics, Inc., et al., No. 24-cv-09715.
Overview of the Allegations
Applied Therapeutics is a clinical-stage biopharmaceutical firm dedicated to creating innovative drug therapies for rare diseases. Its flagship candidate, govorestat, is designed to address central nervous system (CNS) rare metabolic conditions, including Galactosemia.
Throughout the period in question, the company had assured stakeholders that its New Drug Applications (NDAs) for govorestat were backed by substantial clinical data, showing significant and sustained reductions in galactitol levels, thus promising improved clinical outcomes particularly among pediatric patients. Furthermore, Applied Therapeutics claimed close adherence to proper testing protocols, asserting that extensive monitoring had been conducted, including video documentation and instructor oversight for the key 10-meter walk-run test used in the Phase III INSPIRE trial of govorestat.
Market Reaction and Subsequent Developments
The situation escalated on November 27, 2024, when Applied Therapeutics disclosed that the FDA had sent a Complete Response Letter regarding its NDA for govorestat. This letter indicated that the FDA could not approve the application due to identified deficiencies in the clinical data.
This announcement triggered a dramatic decline in the company’s stock value, plummeting up to 80% over several trading days—from a closing price of $10.21 on November 26, 2024, to just $1.75 by December 2, 2024.
Compounding the turmoil, on December 2, 2024, the company revealed it had received a warning letter from the FDA that highlighted issues with electronic data capture and an error in dosing during the study’s escalation phase, which resulted in slightly lower doses administered to some patients. Following this, Applied Therapeutics saw its share price drop another 26%, falling to $1.29 by December 5, 2024.
What Investors Should Consider
For investors in Applied Therapeutics, there may be potential legal avenues available, and it is recommended to submit pertinent information to the legal firm handling the case.
Representation will be on a contingency fee basis, ensuring that shareholders will not incur any court fees or legal expenses unless recovery is obtained, as the firm will seek court approval for any associated fees and costs.
Interested parties can learn more by submitting their information at this website.
About Bleichmar Fonti & Auld LLP
Bleichmar Fonti & Auld LLP is recognized as a leading global law firm that specializes in representing plaintiffs in securities class actions and shareholder disputes. In 2023, the firm was ranked among the top five plaintiff-focused law firms by ISS SCAS. It has earned accolades from Law360 and Super Lawyers for its attorneys’ performances. The firm has also secured significant recoveries, including over $900 million from Tesla, Inc.’s Board of Directors and $420 million from Teva Pharmaceutical Industries Ltd.
For more detailed information about Bleichmar Fonti & Auld LLP and its team, please visit their official site.
For full details regarding the source of this report, refer to this press release.
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