Every material Form 8-K Aldeyra Therapeutics, Inc. has filed with the SEC since July 15, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Aldeyra asked the FDA's Division of Ophthalmology to request that review of the ADX-2191 IND for primary vitreoretinal lymphoma move to the Division of Hematologic Malignancies 2, and it withdrew the Special Protocol Assessment for the planned trial. The company said the regulatory path is now uncertain and may be significantly delayed, and that the planned trial will need to be redesigned, which could raise costs and shorten its cash runway.
Aldeyra requested a review jurisdiction transfer to the FDA's Division of Hematologic Malignancies 2 (DHM2), announced November 9, 2026
The company withdrew the SPA protocol for ADX-2191 in PVRL, which the Division of Ophthalmology had previously agreed to
Aldeyra does not expect to start the planned trial while the request is pending; the FDA may deny the request or transfer the IND to another division
The filing warns of higher costs, a shorter cash runway and possible need for earlier capital raising
Aldeyra Therapeutics said it intends to submit a Formal Dispute Resolution Request to the FDA, appealing the March 16, 2026 Complete Response Letter that denied approval of reproxalap for dry eye disease. The company also extended its projected operational cash runway into 2029, based on $45.1 million in cash and cash equivalents as of June 30, 2026. The appeal's outcome and timing remain uncertain, and the filing states that the FDRR submission and meeting with the Office of New Drugs are expected in the fourth quarter of 2026.
Intends to submit an FDRR to the FDA's Office of New Drugs, appealing the March 16, 2026 Complete Response Letter for reproxalap
FDRR submission and a meeting with the Office of New Drugs are expected in the fourth quarter of 2026
Cash and cash equivalents were $45.1 million as of June 30, 2026; operational cash runway extended into 2029
Aldeyra Therapeutics executed a lease on July 28, 2026 for about 4,067 square feet of office space at 23 Bradford Street in Concord, Massachusetts, to serve as its corporate headquarters. The lease starts September 1, 2026 and runs through September 30, 2029, with monthly base rent of $12,201.00 plus operating expenses and taxes. This is a routine administrative agreement with limited direct financial effect on shareholders.
Lease covers about 4,067 square feet at 23 Bradford Street, Concord, Massachusetts, with Bradford Street, L.L.C.
Term begins September 1, 2026 and ends September 30, 2029; base rent is $12,201.00 per month and increases annually.
Company will post an initial security deposit of $50,000.00 and pay additional operating expenses, taxes and fees.
Aldeyra received minutes from a June 10, 2026 Type A meeting with the FDA about potential resubmission of the New Drug Application for reproxalap, a treatment for dry eye disease. The company has asked the FDA for a clarification of the minutes and plans to request a Type D meeting to discuss resubmission, which is expected by the end of the third quarter of 2026.
Type A meeting with the FDA held June 10, 2026; minutes received July 14, 2026
Clarification of the minutes requested from the FDA on July 15, 2026
Type D meeting on NDA resubmission expected by end of third quarter 2026
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
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