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 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 ...

BOSTON, April 03, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) for potential securities law violations. Investors who have lost money in their Aldeyra Therapeutics, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/aldx. What is this all about? Shares of Aldeyra Therapeutics, Inc. fell nearly 75% in intraday trading, after the company disclosed that the ...

BOSTON, April 03, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) for potential securities law violations. Investors who have lost money in their Aldeyra Therapeutics, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/aldx. What is this all about? Shares of Aldeyra Therapeutics, Inc. fell nearly 75% in intraday trading, after the company disclosed that the ...

The U.S. Food and Drug Administration (FDA) on Thursday issued a Complete Response Letter for Aldeyra Therapeutics, Inc.’s ALDX resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for dry eye disease.The FDA stated that the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the trea ...

My last Aldeyra (NASDAQ: ALDX ) article from September 2023 didn’t age well because, despite my positive coverage, ALDX stock crashed within a month on the news that the FDA would not approve reproxalap’s NDA for dry eye disease in itsAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material ...

Collaboration and Licensing Agreements - The company has entered into an exclusive option agreement with AbbVie Inc., granting AbbVie an exclusive option to obtain a co-exclusive license for reproxalap in the U.S. and an exclusive license outside the U.S., with an initial non-refundable payment of $1.0 million[20]. - AbbVie extended the option exercise period by paying an additional non-refundable fee of $5.0 million, which will be credited against the upfront cash payment if the collaboration agreement is executed[21]. - Upon execution of the collaboration agreement, AbbVie will pay a $100 million upfront cash payment, with potential for up to $300 million in regulatory and commercial milestone payments, including a $100 million milestone for FDA approval[23]. - AbbVie will pay a $100 million upfront cash payment and is eligible for up to $300 million in milestone payments related to reproxalap[98]. - Profit and loss sharing for reproxalap in the U.S. is set at 60% for AbbVie and 40% for the company[98]. - The company has entered into an exclusive option agreement with AbbVie, which includes a non-refundable payment of $1.0 million and an extension fee of $5.0 million for further collaboration[94][96]. Product Development and Clinical Trials - The RASP modulator platform is being developed to target multiple pathways simultaneously, with reproxalap showing broad-based activity and consistent safety in clinical trials involving approximately 2,500 patients[32]. - ADX-2191, a novel formulation of methotrexate, is being developed for the treatment of retinitis pigmentosa, a rare genetic eye disease with no current treatment options[38]. - In Phase 1 trials, ADX-629 demonstrated no treatment-related adverse events and showed statistically significant reductions in RASP levels compared to controls[41]. - Phase 2 clinical trials of ADX-629 indicated preliminary pharmacodynamic activity across various conditions, with no serious adverse events reported[42]. - The company plans to continue developing its RASP modulator pipeline, including ADX-629, ADX-248, ADX-743, ADX-631, and ADX-246, to address immune-mediated and metabolic diseases[36]. - ADX-629 demonstrated a statistically significant reduction in psoriasis area and severity index (PASI) scores, with a peak PASI 50% responder percentage of 57% (P=0.001) after 12 weeks of treatment[47]. - In a Phase 2 trial for chronic cough, ADX-629 achieved statistical significance in reducing awake cough frequency (P=0.01) and 24-hour cough frequency (P=0.001) compared to placebo[52]. - The Phase 2 clinical trial for atopic dermatitis showed a significant improvement in Eczema Area and Severity Index (EASI) with a p-value of 0.0006, and 50% of patients met the EASI-50 threshold[54]. - ADX-629 treatment resulted in significant reductions in plasma levels of pro-inflammatory cytokines IL-5 (P=0.02) and TNFα (P<0.0001) in asthma patients compared to placebo[48]. - In the Phase 2 trial for retinitis pigmentosa, ADX-2191 achieved statistical significance in improving best corrected visual acuity (P<0.0001) and low-light visual acuity (P=0.0001)[66]. - The chamber crossover trial for dry eye disease achieved the primary endpoint of reducing patient-reported ocular discomfort with a p-value of 0.004[59]. - ADX-629 is currently in Phase 2 trials for moderate alcohol-associated hepatitis and Sjögren-Larsson Syndrome, with further trials expected in 2025[57]. Regulatory and Approval Processes - The FDA has accepted for review a resubmitted NDA for reproxalap, with a Prescription Drug User Fee Act (PDUFA) date set for April 2, 2025[24]. - The FDA issued a Complete Response Letter for reproxalap's NDA for dry eye disease, stating that additional studies are required to demonstrate efficacy[58]. - Aldeyra plans to resubmit the NDA for reproxalap, including results from the chamber crossover trial, with a PDUFA date set for April 2, 2025[59]. - The FDA's Complete Response Letter for reproxalap stated that at least one additional adequate and well-controlled study is required to demonstrate a positive effect on treating ocular symptoms of dry eye[170]. - The FDA approval process requires extensive testing and compliance with regulations before marketing a new drug[114]. - The FDA's fast track program allows for expedited review of drugs intended for serious conditions, with the goal of providing therapies where none exist or offering superior options[122]. - Standard Review NDAs are expected to be completed within a ten-month timeframe, while Priority Review has a goal of six months[124]. - The FDA may extend the review process by three additional months for clarification of information provided in the submission[125]. - Post-approval, the FDA may require ongoing compliance with regulatory standards, including potential Phase 4 studies to monitor safety and effectiveness[130]. - The FDA may require additional studies or clinical trials for reproxalap, which could increase costs and delay approval and commercialization[171]. - The approval procedures for foreign markets vary, and any delays in obtaining regulatory approvals could prevent commercialization of product candidates[187]. Financial and Operational Considerations - The company has no products approved for sale and has primarily funded operations through equity and debt, indicating a need for additional capital to support product development[26]. - The company anticipates incurring additional research and development expenses as it evaluates and potentially pursues the development of product candidates for additional indications[153]. - Research and development expenses totaled $48.2 million for the year ended December 31, 2024, compared to $29.5 million for the year ended December 31, 2023, indicating a significant increase in investment[152]. - The company has incurred significant operating losses since inception and anticipates continued losses over the next several years, raising concerns about future profitability[32]. - The company may require substantial additional financing to continue the development and commercialization of reproxalap, and failure to secure this capital could delay or terminate operations[32]. - The company must secure substantial additional funding to support its clinical trials and commercialization efforts[190]. - The company is heavily reliant on the successful commercialization of reproxalap, with significant risks associated with obtaining FDA marketing approval and potential delays in commercialization[32]. - The company has not received FDA or foreign regulatory marketing approval for any product candidates, making future cash inflows uncertain[157]. Market and Competitive Landscape - The company anticipates intense competition in the pharmaceutical industry, with competitors having greater financial and technical resources, which may impact the commercial success of its product candidates[79]. - The competitive landscape includes various marketed therapies for dry eye disease and allergic conjunctivitis, including topical immunomodulators and antihistamines, which may pose challenges for the company's product candidates[85][88]. - Current therapies for chronic dry eye disease are often considered inadequate, with many requiring weeks or months to achieve moderate clinical benefit[87]. - The company is concerned about the potential for generic competition affecting the commercial viability of ADX-2191, as it is based on the generic drug methotrexate[210]. - Future healthcare reforms may increase pressure on drug pricing, adversely affecting anticipated revenue from product candidates[211]. - Market acceptance of approved products among healthcare providers and payors is critical for revenue generation, and failure to achieve this could hinder profitability[212]. - The company estimates its addressable markets based on various inputs, but acknowledges that these estimates may prove incorrect, impacting revenue potential[214]. - The company faces risks related to inaccuracies in market projections, which could lead to misallocation of resources and harm its business[216]. Intellectual Property and Regulatory Compliance - The company holds 37 U.S. patents and 16 pending U.S. non-provisional patent applications related to reproxalap and other RASP modulators, with potential patent expirations ranging from 2026 to 2041[92][93]. - The company may face challenges in obtaining, maintaining, or enforcing intellectual property rights, which could impact its competitive position[168]. - The company intends to apply for patent term restorations to extend patent life beyond current expiration dates, depending on clinical trial lengths and other factors[147]. - Compliance with FDA regulations and cGMP requirements is critical for manufacturing, and failure to meet these standards could result in legal or regulatory actions[150]. - The company is subject to various laws and regulations regarding laboratory practices and environmental compliance, which could impact its operations and financial condition[151]. Risks and Challenges - The company faces numerous risks that could materially affect its business, financial condition, and future results, including regulatory changes and reimbursement pressures[161]. - The company is dependent on third parties for conducting clinical trials, and any failure by these parties to meet deadlines could adversely affect clinical development programs[32]. - The company faces potential delays in clinical trials due to regulatory inspections or violations, which could impact the commercial prospects of product candidates[184]. - Product development costs may increase if there are delays in testing or if larger clinical trials are required, affecting the timeline for generating product revenue[181]. - The results of earlier clinical trials may not predict future outcomes, leading to potential setbacks in later-stage trials[192]. - The company is developing novel product candidates, which may face challenges in obtaining regulatory approval due to a lack of historical clinical trial experience[194]. - The company may determine that it is not cost-effective to develop certain products in specific indications, leading to potential cessation of development efforts[195]. - The company acknowledges that adverse events in clinical trials could delay or prevent regulatory approval, impacting the commercialization of product candidates[200]. - Even with regulatory approval, the company may face restrictions on marketing and distribution, which could limit commercial potential[202].