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].

Group 1 - The Biotech Forum, led by Bret, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly market commentary [1][2] - Recent discussions in The Biotech Forum have focused on profitable buy-write or covered call strategies for selected biotech stocks [2] - Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) is highlighted as being on the verge of commercialization, with a significant inflection point expected in April of the following year [5]

Aldeyra Therapeutics, Inc. (ALDX) announced that the FDA has accepted its resubmitted new drug application (NDA) for reproxalap, a first-in-class investigational RASP modulator, for the treatment of the signs and symptoms of dry eye disease.With the FDA accepting the resubmitted NDA for review, a decision from the regulatory body is expected on April 2, 2025.Simultaneously, Aldeyra announced that it has expanded its existing option agreement with AbbVie (ABBV) .Shares of Aldeyra were up 11.6% on Nov. 18 fol ...

Financial Performance - The net loss for the three months ended September 30, 2024, was $15.11 million, compared to a net loss of $8.19 million for the same period in 2023, indicating an increase in losses of approximately 84%[6] - Net loss for the nine months ended September 30, 2024, was $40,042,677, compared to a net loss of $32,789,548 for the same period in 2023, representing a 22% increase in losses year-over-year[11] - The company reported a comprehensive loss of $15.0 million for the three months ended September 30, 2024[7] Assets and Liabilities - Total current assets decreased from $147.81 million as of December 31, 2023, to $116.72 million as of September 30, 2024, representing a decline of approximately 21%[5] - Cash and cash equivalents decreased significantly from $142.82 million as of December 31, 2023, to $28.12 million as of September 30, 2024, a reduction of about 80%[5] - Total liabilities increased from $28.53 million as of December 31, 2023, to $32.22 million as of September 30, 2024, reflecting an increase of approximately 13%[5] - The accumulated deficit grew from $394.26 million as of December 31, 2023, to $434.30 million as of September 30, 2024, an increase of about 10%[5] - The total stockholders' equity decreased from $119.80 million as of December 31, 2023, to $85.10 million as of September 30, 2024, a decline of approximately 29%[5] Research and Development - Research and development expenses for the three months ended September 30, 2024, were $12.44 million, up 79% from $6.96 million in the same period of 2023[6] - The company anticipates needing additional funding in the future to support ongoing research and development activities, as well as commercialization efforts[16] - The company’s principal activities include research and development of therapies for immune-mediated and metabolic diseases[12] Stock and Compensation - The weighted average common shares outstanding for the three months ended September 30, 2024, were 59.53 million, compared to 58.99 million for the same period in 2023[6] - Stock-based compensation for the nine months ended September 30, 2024, was $6,710,160, slightly up from $6,553,112 in the same period of 2023, reflecting a 2.4% increase[11] - Total stock-based compensation expense for the three months ended September 30, 2024, was $3,225,794, an increase from $789,217 for the same period in 2023[57] Marketable Securities and Cash Flow - The company incurred $75,351,884 in purchases of marketable securities during the nine months ended September 30, 2024, with no such purchases reported in the same period of 2023[11] - The company reported a net cash decrease of $74,702,987 for the nine months ended September 30, 2024, compared to a decrease of $1,084,476 in the same period of 2023[11] - Cash and cash equivalents at the end of the period were $68,120,029, down from $143,334,888 at the end of September 2023, indicating a decrease of approximately 52%[11] Debt and Financing - The Company has a current long-term debt obligation of $15 million under the Hercules Credit Facility as of September 30, 2024[43] - The effective interest rate on the loan was 13.3% as of September 30, 2024[42] - The Maturity Date for the Hercules Credit Facility has been extended to April 1, 2026[40] Collaboration Agreements - The Company entered into an exclusive option agreement with AbbVie, receiving a non-refundable payment of $1 million for the option to collaborate on reproxalap development[72] - AbbVie will pay the Company a $100 million upfront cash payment and up to $300 million in milestone payments related to the Collaboration Agreement[75] - The profit-sharing arrangement for the commercialization of reproxalap in the U.S. is set at 60% for AbbVie and 40% for the Company[75] Changes in Operations - As of September 30, 2024, the Company ceased development of the Helio Product Candidate, which may result in the reversion of related intellectual property rights[23] - The Company has not reported any changes to significant accounting policies during the nine months ended September 30, 2024[20] Tax and Valuation - The Company has a 100% valuation allowance against net deferred tax assets due to ongoing losses since inception[49] - The Company is subject to tax in the U.S. and is open to examination for tax years ended December 31, 2023, 2022, 2021, and 2020[50]

Financial Performance - The net loss for the three months ended June 30, 2024, was $16.85 million, compared to a net loss of $8.99 million for the same period in 2023, indicating an increase in losses of approximately 87%[9] - The net loss for the six months ended June 30, 2024, was $24,929,694, compared to a net loss of $24,602,677 for the same period in 2023, indicating a slight increase in losses[20] - The company reported a net loss per share of $0.28 for the three months ended June 30, 2024, compared to a loss of $0.15 per share for the same period in 2023[9] Assets and Liabilities - Total current assets decreased from $147.81 million on December 31, 2023, to $125.65 million on June 30, 2024, representing a decline of approximately 15%[8] - Cash and cash equivalents decreased significantly from $142.82 million on December 31, 2023, to $31.03 million on June 30, 2024, a reduction of about 78%[8] - Total liabilities decreased slightly from $28.53 million on December 31, 2023, to $27.73 million on June 30, 2024, a decrease of approximately 3%[8] - Total stockholders' equity decreased from $119.80 million on December 31, 2023, to $98.31 million on June 30, 2024, a decline of approximately 18%[8] - The accumulated deficit increased from $394.26 million on December 31, 2023, to $419.19 million on June 30, 2024, an increase of approximately 6%[8] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $14.97 million, compared to $6.96 million for the same period in 2023, reflecting a year-over-year increase of approximately 115%[9] - Research and development expenses for the six months ended June 30, 2024, were $1,898,358, down 38% from $3,053,738 for the same period in 2023[65] Cash Flow and Investments - The company used $23,196,985 in operating activities during the first half of 2024, compared to $22,801,654 in the same period of 2023[20] - The company reported a net cash used in investing activities of $48,614,499 for the first half of 2024, compared to a net cash provided of $30,000,000 in the same period of 2023[20] - The company recorded a net cash decrease of $71,793,293 for the first half of 2024, contrasting with an increase of $7,256,197 in the same period of 2023[20] Stock and Equity - The company had 59,414,489 shares outstanding as of June 30, 2024, an increase from 59,195,951 shares as of December 31, 2023[8] - The company reported a total of 8,765,797 common stock equivalents as of June 30, 2024, compared to 7,775,253 as of June 30, 2023, indicating an increase of approximately 12.7%[34] - The Company has 3,542,805 shares of common stock available for grant under the 2023 Equity Plan as of June 30, 2024[60] Debt and Financing - The effective interest rate on the Company's debt was 12.6% as of June 30, 2024[50] - The company has a credit facility with Hercules Capital, Inc., providing for a term loan of up to $60 million, with the maturity date extended to October 1, 2024[48] - Future principal payments, including the Supplemental End of Term Charge, total $15,292,500 for the year ending December 31, 2024[52] Legal and Regulatory Matters - The Company is currently involved in a securities class action lawsuit alleging violations of the Securities Exchange Act, with no reasonable prediction of the outcome at this time[84] - The Company has not experienced any losses related to indemnification obligations for its officers and directors, concluding that the fair value of these obligations is negligible[79] Other Financial Metrics - Interest income for the three months ended June 30, 2024, was $1.64 million, compared to $1.88 million for the same period in 2023, a decrease of about 13%[9] - The company reported a decrease in cash paid for interest during the period, totaling $884,500 compared to $823,521 in the prior year[20] - The total grant date fair value of RSUs vested was $1.1 million for the six months ended June 30, 2024[72]