NEW YORK, April 19, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) for potential violations of the federal securities laws. If you invested in Aldeyra Therapeutics, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/aldeyra-therapeutics-inc. Why is Aldeyra Therapeutics being Investigated? Aldeyra Therapeutics is a biotechnology company focused o ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Aldeyra Therapeutics, Inc. following a significant stock price drop after the FDA's response regarding their investigational drug candidate reproxalap [1][2]. Group 1: Company Overview - Aldeyra Therapeutics, Inc. is focused on developing reproxalap for the treatment of dry eye disease [2]. - The company received a Complete Response Letter from the FDA indicating that the New Drug Application (NDA) for reproxalap did not demonstrate adequate efficacy [2]. Group 2: FDA Response and Stock Impact - The FDA's Complete Response Letter highlighted that no manufacturing or safety issues were found, but the NDA failed to show efficacy in well-controlled studies [2]. - Following the FDA's announcement, Aldeyra's stock price plummeted by $3.90, a decrease of 73.31%, closing at $1.42 per share on April 3, 2025 [2]. Group 3: Legal Investigation - Pomerantz LLP is conducting an investigation on behalf of investors regarding potential securities fraud by Aldeyra and its officers or directors [1]. - The firm has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3].

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its lead drug candidate, reproxalap, to demonstrate efficacy in treating dry eye disease, leading to a significant stock price decline [1][4][5]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate aimed at treating dry eye disease [2]. Clinical Trial Results - The company announced success in its Phase III clinical trial for reproxalap, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application (NDA) resubmission [3]. - However, the trial ultimately failed to demonstrate the drug's efficacy, with methodological issues identified, including differences in baseline scores across treatment arms, which did not satisfy FDA requirements [4]. Stock Market Reaction - Following the FDA's issuance of a Complete Response Letter stating that the NDA for reproxalap failed to demonstrate efficacy, Aldeyra's stock price plummeted nearly 75% in a single trading day, dropping from $5.33 per share on April 2, 2025 [5].

Core Insights - Bragar Eagel & Squire, P.C. is investigating potential claims against Aldeyra Therapeutics for possible violations of federal securities laws and unlawful business practices [1] - Aldeyra received a Complete Response Letter from the FDA regarding its New Drug Application for reproxalap, indicating that the application failed to demonstrate efficacy in treating dry eye disease and requires additional studies [2] Company Summary - Aldeyra Therapeutics is facing scrutiny after the FDA's response highlighted concerns about the efficacy of reproxalap, which may impact the company's stock performance [2] - The FDA's letter pointed out methodological issues in the trial data submitted, which could have affected the interpretation of results [2] Legal and Investor Relations - The law firm is reaching out to Aldeyra stockholders who may have suffered losses and is encouraging them to participate in the investigation [3] - Bragar Eagel & Squire, P.C. specializes in representing investors in complex litigation, indicating a focus on protecting shareholder rights [4]

SAN FRANCISCO, April 10, 2025 /PRNewswire/ -- On April 3, 2025 investors in Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter ("CRL") from the FDA for the resubmission of the New Drug Application ("NDA") of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. This stark regulatory rejection, which contradicted Aldeyra's repeated assurances of imminent approval, erased ...

SAN FRANCISCO, April 09, 2025 (GLOBE NEWSWIRE) -- On April 3, 2025 investors in Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter (“CRL”) from the FDA for the resubmission of the New Drug Application (“NDA”) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.   This stark regulatory rejection, which contradicted Aldeyra’s repeated assurances of imminent approval, e ...

Core Viewpoint - Aldeyra Therapeutics, Inc. experienced a significant decline of 74% on April 3rd following the receipt of a Complete Response Letter from the FDA regarding its New Drug Application for reproxalap, intended for the treatment of dry eye disease [1] Company Summary - Aldeyra Therapeutics, Inc. is focused on developing reproxalap for dry eye disease, but faced a setback with the FDA's Complete Response Letter [1] - The company's stock performance was severely impacted, indicating potential investor concerns regarding the future of reproxalap and its market viability [1] Industry Context - The incident highlights the challenges faced by biotech companies in obtaining FDA approval, which can significantly affect stock prices and investor sentiment [1]

Core Insights - Aldeyra Therapeutics is under investigation by Kirby McInerney LLP for potential violations of federal securities laws and unlawful business practices [1][3] - The FDA issued a Complete Response Letter for Aldeyra's New Drug Application for reproxalap, indicating that the application did not demonstrate efficacy in treating ocular symptoms associated with dry eyes [3] - Following the FDA's announcement, Aldeyra's stock price plummeted by approximately 73%, dropping from $5.32 to $1.42 per share [3] Company Developments - The investigation by Kirby McInerney LLP focuses on whether Aldeyra and its officers engaged in unlawful practices [1] - The FDA's concerns regarding the NDA included methodological issues and differences in baseline scores across treatment arms [3] - The significant decline in share price reflects investor reaction to the FDA's findings and the implications for Aldeyra's lead drug candidate [3]

NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) (NASDAQ: ALDX). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Aldeyra and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Ap ...

NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) for potential violations of the federal securities laws. If you invested in Aldeyra Therapeutics, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/aldeyra-therapeutics-inc. Why is Aldeyra Therapeutics being Investigated? Aldeyra Therapeutics is a biotechnology company focused o ...