Aldeyra Therapeutics, INC 8-K filings

Aldeyra Therapeutics has entered into a lease agreement for approximately 4,067 square feet of office space in Concord, Massachusetts, to serve as its new corporate headquarters.

Aldeyra Therapeutics received FDA minutes regarding reproxalap NDA resubmission for dry eye disease and plans further FDA engagement.

Aldeyra Therapeutics director Martin J. Joyce has announced he will not stand for re-election at the 2026 annual meeting.

Aldeyra Therapeutics, Inc. announced the full repayment and termination of its $15 million Hercules Credit Facility.

Aldeyra Therapeutics received a Complete Response Letter from the FDA for its dry eye disease drug reproxalap, citing insufficient efficacy evidence.

Aldeyra Therapeutics' Chief Development Officer, Stephen G. Machatha, Ph.D., has voluntarily resigned to pursue other opportunities, with a transition plan in place until March 31, 2026.

Aldeyra Therapeutics announced the FDA extended the PDUFA target action date for its dry eye disease drug, reproxalap, to March 16, 2026, following a request for additional clinical data.

Aldeyra Therapeutics announced the expansion of its RASP platform into central nervous system diseases and provided positive manufacturing updates for reproxalap.

Aldeyra Therapeutics announced positive Phase 2 results for ADX-629 in alcohol-associated hepatitis, refined its RASP modulator pipeline, and extended its cash runway into the second half of 2027.

Aldeyra Therapeutics announced that the FDA granted Fast Track Designation for ADX-2191 for the treatment of retinitis pigmentosa, a rare genetic eye disease with no approved treatments for most forms.

The U.S. Food and Drug Administration has accepted for review a resubmitted New Drug Application for a first-in-class investigational drug for dry eye disease, setting a target action date for approval.

Aldeyra Therapeutics announced it has received a Special Protocol Assessment Agreement Letter from the FDA for its investigational drug ADX-2191 for the treatment of primary vitreoretinal lymphoma, a rare and fatal cancer.

Aldeyra Therapeutics has resubmitted its New Drug Application for topical ocular reproxalap for dry eye disease to the FDA, incorporating new clinical data that met its primary endpoint and addressed previous methodological issues.

Aldeyra Therapeutics, Inc. announced the successful election of three Class II directors, the ratification of BDO USA, P.C. as its independent auditor, and the advisory approval of executive compensation at its 2025 annual meeting of stockholders.

Aldeyra Therapeutics reports successful Phase 3 trial results for reproxalap in treating dry eye disease and intends to resubmit its New Drug Application (NDA) to the FDA.

Aldeyra Therapeutics appoints Chip Clark to its Board of Directors, expanding the board to eight members.

Aldeyra Therapeutics received a Complete Response Letter from the FDA regarding its resubmitted New Drug Application for reproxalap for dry eye disease, citing the need for additional efficacy data.

Aldeyra Therapeutics announced the FDA has accepted its resubmitted New Drug Application for reproxalap to treat dry eye disease and has expanded its option agreement with AbbVie.

Aldeyra Therapeutics has resubmitted its New Drug Application to the FDA for reproxalap, a potential treatment for dry eye disease, incorporating positive results from a recent clinical trial.

Aldeyra Therapeutics has amended its loan agreement, extending the interest-only payment period and the term loan maturity date to April 1, 2026, while also adjusting the interest rate and adding a supplemental end of term charge.

Aldeyra Therapeutics has appointed Michael Alfieri as its new principal financial officer and principal accounting officer, effective August 31, 2024, while also entering into separation and consulting agreements with former officer Bruce Greenberg.

Aldeyra Therapeutics announced that its Phase 3 clinical trial for reproxalap in dry eye disease met its primary endpoint, showing a statistically significant reduction in ocular discomfort.

Aldeyra Therapeutics has entered into a new agreement to sell up to $75 million of its common stock through Jefferies LLC, replacing a previous expired agreement.

Aldeyra Therapeutics announced the advancement of new RASP modulators and shared recent preclinical data in obesity during an Investor Roundtable.

Aldeyra Therapeutics has completed enrollment in its Phase 3 clinical trial for reproxalap in dry eye disease, with results and a potential NDA resubmission expected in the second half of 2024.

Aldeyra Therapeutics held its 2024 annual meeting, electing two directors and ratifying BDO USA, P.C. as its independent auditor.

Aldeyra Therapeutics presented new preclinical data for its RASP modulators and announced a planned Phase 2/3 clinical trial for ADX-2191 in retinitis pigmentosa at its 2024 Research & Development Day.

Aldeyra Therapeutics plans to resubmit its New Drug Application for reproxalap in dry eye disease following discussions with the FDA, contingent on positive results from a new clinical trial.

Aldeyra Therapeutics presented an update on its clinical and regulatory progress, including its lead drug candidate reproxalap, at the Oppenheimer 34th Annual Healthcare Life Sciences Conference.