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Business Wire
05-05-2025
- Business
- Business Wire
Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA Resubmission
LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap (n=58) was statistically significantly superior to vehicle (n=58) on ocular discomfort symptom score (0‑100) from 80 to 100 minutes after chamber entry (LS mean difference [95% confidence interval] ‑6.5 [‑10.5, ‑2.5], P=0.002). Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the U.S. Food and Drug Administration (FDA) feedback in a Complete Response Letter received in April 2025 in response to the prior New Drug Application (NDA). The Complete Response Letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results, including a baseline difference across treatment arms. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid‑2025, and the review period is expected to be six months. A recently completed dry eye disease field trial, which was numerically supportive of reproxalap and consistent with prior field trials, did not reach statistical significance, and is expected to be submitted to the planned NDA resubmission as supportive. 'The dry eye chamber results announced today are representative of a number of clinical trials that highlight the potential rapid clinical effect of reproxalap on reducing ocular discomfort,' stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. 'With no notable baseline differences across treatment arms and highly statistically significant results in favor of reproxalap over vehicle, Aldeyra believes the data potentially address the FDA feedback in the Complete Response Letter received last month and we look forward to meeting with the FDA shortly.' To Aldeyra's knowledge, in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing exacerbation of ocular redness. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Consistent with prior clinical trials, the most commonly reported adverse event was mild and transient instillation site discomfort. Reproxalap has now been studied in over 2,900 patients. Conference Call & Webcast Information Aldeyra will host a conference call at 8:00 a.m. ET tomorrow, May 6, 2025, to discuss the clinical trial results and the plan for resubmission of the NDA for reproxalap in dry eye disease. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 127477. A live webcast of the conference call will be available on the Investor Relations page of the company's website at After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days. About Reproxalap Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. About Aldeyra Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-629, ADX‑248, ADX-743, ADX-631, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa. Safe Harbor Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Aldeyra's future expectations, plans, and prospects, including without limitation statements regarding: the goals, opportunity, and potential for reproxalap; the outcome and expected timing of discussions with the FDA; the potential and the timing of a potential NDA resubmission; the outcome and timing of the FDA's acceptance, review, or approval of the potential NDA resubmission for reproxalap and the adequacy of the data included in the initial NDA and resubmitted NDA, and expected to be included in the potential resubmitted NDA; the likelihood and timing of the exercise of the Option; and Aldeyra's expectations regarding the labeling for reproxalap, if approved. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' "could," 'can,' 'would,' 'expect,' 'believe,' 'anticipate,' 'project,' 'on track,' 'scheduled,' 'target,' 'design,' 'estimate,' 'predict,' 'contemplates,' 'likely,' 'potential,' 'continue,' 'ongoing,' 'aim,' 'plan,' or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors that could delay the initiation, enrollment, or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; delay in or failure to obtain regulatory approval of Aldeyra's product candidates, including as a result of the FDA not accepting Aldeyra's regulatory filings, issuing a complete response letter, or requiring additional clinical trials or data prior to review or approval of such filings or in connection with resubmissions of such filings; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or different indications; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) and obtain reimbursement for Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and future revenue, the timing of future revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's commercialization, marketing and manufacturing capabilities and strategy; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state, and foreign regulatory requirements; political, economic, legal, social, and health risks, public health measures, and war or other military actions, that may affect Aldeyra's business or the global economy; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, expected to be filed with the SEC in the second quarter of 2025, and Aldeyra's other filings with the SEC. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Associated Press
21-04-2025
- Business
- Associated Press
Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA's Reproxalap Complete Response Letter
SAN FRANCISCO, April 21, 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, erased over $200 million from the company's market capitalization, prompting investor rights law firm Hagens Berman to launch an investigation into potential securities law violations. Hagens Berman urges investors who purchased Aldeyra shares and suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge that may assist the firm's investigation to contact its attorneys. Visit: Contact the Firm Now: [email protected] 844-916-0895 Aldeyra Therapeutics, Inc. (ALDX) Investigation: The investigation is focused on the propriety of Aldeyra's statements about the prospects for FDA approval of the NDA of reproxalap. In the past, Aldeyra touted the success of its Phase 3 dry eye clinical chamber trial for the drug and said the 'results are uniquely supportive of the potential acute clinical effect of reproxalap on reducing ocular discomfort[.]' More recently, the company assured investors that 'reproxalap is going to get approved on April 2[.]' Instead, on April 3, 2025, Aldeyra announced that it received the FDA's CRL. Aldeyra revealed that: In response to this news, the market swiftly reacted by sending the price of Aldeyra shares down over 70%, wiping out over $200 million of shareholder value. Reed Kathrein, the Hagens Berman Partner leading the investigation, stated, 'We are investigating whether Aldeyra may have misrepresented the propriety of its reproxalap study and results to investors.' If you invested in Aldeyra and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the Aldeyra investigation, read more» Whistleblowers: Persons with non-public information regarding Aldeyra should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at Follow the firm for updates and news at @ClassActionLaw. Contact: Reed Kathrein, 844-916-0895
Associated Press
17-02-2025
- Business
- Associated Press
DEADLINE TOMORROW: Kaplan Fox Reminds Investors of a Deadline for a Securities Class Action Lawsuit Against Applied Therapeutics (APLT)
NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP announces that a class action lawsuit has been filed against Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ: APLT) on behalf of investors that purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024 and December 2, 2024 (the 'Class Period'). If you are an investor in Applied Therapeutics and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571. DEADLINE REMINDER: If you are a member of the proposed Class, you may move the court no later than February 18, 2025 to serve as a lead plaintiff for the purported class. If you have losses we encourage you to contact us to learn more about the lead plaintiff process. You need not seek to become a lead plaintiff in order to share in any possible recovery. According to the complaint, on November 27, 2024, the Company disclosed that the U.S. Food and Drug Administration ('FDA') issued a Complete Response Letter ('CRL') for its new drug application for govorestat, AT-007-1002, for treatment of classic galactosemia (the 'NDA'). The Company's press release states that the 'CRL indicate[d] that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.' Following this news, on November 29, 2024, Applied Therapeutics stock fell $6.54 per share, over 76%, to close at $2.03 per share on heavy trading volume. Then, on December 2, 2024 after the markets closed, the Company disclosed in a Form 8-K filing that following issuance of the CRL, the Company received a 'warning letter' limited to the AT-007-1002 study and that the 'warning letter' identified issues relating to 'electronic data capture' and a 'dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients, which was remedied prior to achieving maintenance dosing.' According to the complaint, Applied Therapeutics' stock price declined from a closing market price of $1.75 per share on December 2, 2024 to close at $1.29 per share on December 5, 2024. WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Jeffrey P. Campisi 800 Third Avenue, 38th Floor New York, New York 10022 (212) 329-8571 1999 Harrison Street, Suite 1560 Oakland, California 94612 (415) 772-4704
Associated Press
05-02-2025
- Business
- Associated Press
APLT DEADLINE ALERT: Kirby McInerney LLP Alerts Applied Therapeutics, Inc. Investors of Important Lead Plaintiff Deadline in Class Action Lawsuit
The law firm of Kirby McInerney LLP alerts investors of the imminent February 18, 2025 deadline, to seek the role of lead plaintiff in a federal securities class action filed on behalf of those who acquired Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ:APLT) securities between January 3, 2024, to December 2, 2024 ('the Class Period'). The firm encourages investors to contact the firm as soon as possible to be appointed lead plaintiff. [LEARN MORE ABOUT THE CLASS ACTION] On November 27, 2024, Applied Therapeutics issued a press release announcing that it had received a Complete Response Letter ('CRL') for the New Drug Application ('NDA') for govorestat, the Company's lead product candidate. The CRL indicated that the FDA had completed its review of the application and determined that it was unable to approve the NDA in its current form citing deficiencies in the clinical application. On this news, the price of Applied Therapeutics shares declined by $6.54 per share, or approximately 76%, from $8.57 per share on November 27, 2024, to close at $2.03 per share on December 2, 2024. Then, on December 2, 2024, after market hours, Applied Therapeutics disclosed that it had received a 'warning letter' from the FDA referring to the clinical trial issues underlying the CRL. According to the Company's description of the warning letter, the FDA stated in pertinent part that: 'The letter identified issues related to electronic data capture, which the Company believes were addressed in prior communications with the agency, including by providing detailed paper and video records. The letter also refers to a dosing error in the dose escalation phase of the study resulting in slightly lower levels that targeted in a limited number of patients, which were remedied prior to achieving maintenance dosing identified issues related to electronic data capture and a dosing error in the dose-escalation phase of the study, resulting in slightly lower levels than targeted in a limited number of patients. On this news, the price of Applied Therapeutics shares declined by $0.49 per share, or more than 25%, over 3 consecutive days, from $1.75 per share on December 2, 2024, to $1.69 on December 3, 2024, $1.38 on December 4, 2024, and finally, to close at $1.29 on December 5, 2024. The lawsuit alleges that Defendants, throughout the Class Period, misled investors by providing positive statements to investors, while at the same time concealing material adverse facts concerning the true state of Applied Therapeutic's trials; notably, electronic data capture issues and a dosing error in the dose-escalation phase of the study. If you purchased or otherwise acquired Applied Therapeutics securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at [email protected], or fill out the form below, to discuss your rights or interests with respect to these matters without any cost to you. Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Thomas W. Elrod, Esq. 212-699-1180 SOURCE: Kirby McInerney LLP Copyright Business Wire 2025. PUB: 02/04/2025 08:00 PM/DISC: 02/04/2025 08:01 PM
Associated Press
27-01-2025
- Business
- Associated Press
Deadline Alert: Applied Therapeutics, Inc. (APLT) Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit
LOS ANGELES, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Glancy Prongay & Murray LLP reminds investors of the upcoming February 18, 2025 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024, inclusive (the 'Class Period'). IF YOU SUFFERED A LOSS ON YOUR APPLIED THERAPEUTICS INVESTMENTS, TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS UNDER THE FEDERAL SECURITIES LAWS. CLICK HERE What Happened? On November 27, 2024, Applied Therapeutics disclosed that it had received a Complete Response Letter ('CRL') from the U.S. Food and Drug Administration ('FDA') regarding the New Drug Application ('NDA') for the Company's Classic Galactosemia drug, govorestat, stating that "[t]he CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.' On this news, Applied Therapeutics' stock price fell $6.54, or 76.3%, to close at $2.03 per share on November 29, 2024, thereby injuring investors. Then, on December 2, 2024, Applied Therapeutics disclosed that it had received a 'warning letter' from the FDA regarding 'issues related to electronic data capture, which the Company believes were addressed in prior communications with the agency, including by providing detailed paper and video records,' as well as 'a dosing error in the dose-escalation phase' of the govorestat clinical trial. On this news, Applied Therapeutics' stock price fell $0.46, or 26.3%, over the next few consecutive trading days to close at $1.29 per share on December 5, 2024, thereby injuring investors further. What Is The Lawsuit About? The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Applied Therapeutics was not adhering to trial protocol and good clinical practices which, in turn, created an exceedingly severe risk that the trial data would be rejected by the FDA in the context of an NDA; and (2) as a result, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times. If you purchased or otherwise acquired Applied Therapeutics securities during the Class Period, you may move the Court no later than February 18, 2025 to request appointment as lead plaintiff in this putative class action lawsuit. Contact Us To Participate or Learn More: If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Charles Linehan, Esq., Glancy Prongay & Murray LLP, 1925 Century Park East, Suite 2100, Los Angeles California 90067 Email: [email protected] Telephone: 310-201-9150, Toll-Free: 888-773-9224 Visit our website at Follow us for updates on LinkedIn, Twitter, or Facebook. If you inquire by email, please include your mailing address, telephone number and number of shares purchased. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Contact Us: Glancy Prongay & Murray LLP, 1925 Century Park East, Suite 2100 Los Angeles, CA 90067 Charles Linehan Toll-Free: 888-773-9224
