Reproxalap

Aldeyra Therapeutics announces achievement of primary endpoint in Phase 3 dry eye disease trial for reproxalap, showing statistical superiority over vehicle for ocular discomfort (P=0.004).

Aldeyra Therapeutics completed enrolment for its Phase III trial of 0.25% reproxalap for dry eye disease, aiming for NDA resubmission in 2024. Previous trials showed significant ocular discomfort reduction. The FDA requested more efficacy data last year. Aldeyra plans to highlight symptom improvement and redness reduction in the NDA.

Aldeyra Therapeutics' lead candidate, reproxalap, is in phase III for dry eye disease and allergic conjunctivitis. Following FDA feedback, a new study is planned for 2024 to address efficacy concerns, aiming for NDA resubmission. Shares surged 43.3% after the development plan announcement. Aldeyra also has ADX-629 in phase II for other conditions.

Aldeyra Therapeutics plans to resubmit a New Drug Application for reproxalap, a RASP modulator for dry eye disease, with a dry eye chamber trial in H1 2024, aiming for NDA resubmission in H2 2024, contingent on trial success.

Ligand Pharmaceuticals reported Q4 2023 adjusted earnings of $1.05 per share, surpassing estimates, with revenues at $28.1M, down 44% due to no COVID-19 Captisol sales. Shares rose 19.9%. Royalty revenues increased to $22.5M, driven by key products. 2024 revenue guidance is $130-$142M, with adjusted EPS expected at $4.25-$4.75. FDA approved Zelsuvmi for molluscum contagiosum, set for 2024 launch.

Aldeyra's shares fell after FDA identified issues with its NDA for reproxalap, requiring additional studies. Annovis Bio's Alzheimer’s study on buntanetap showed positive interim results. Scholar Rock plans to expand into cardiometabolic disorders with SRK-439. Evelo's psoriasis study failed, halting EDP2939 development. Amylyx faces EU setback for ALS treatment AMX0035, focusing on phase III study results.

Aldeyra Therapeutics reported 2022 financial results, highlighting FDA acceptance of two new drug applications: Reproxalap for dry eye disease and ADX-2191 for primary vitreoretinal lymphoma. The company is advancing its RASP modulation platform, with ADX-629 in Phase 2 trials for various conditions. ADX-2191, targeting ocular lymphoma, has a PDUFA date of June 21, 2023. Aldeyra's cash position supports operations into late 2024, with a net loss of $62.0 million in 2022.

Reproxalap, a novel small molecule drug, inhibits RASP to reduce ocular inflammation in dry eye disease. Clinical trials show significant activity, with potential for early, broad efficacy and a unique product profile. Studied in over 1,800 patients, it's safe, with mild, transient discomfort reported. Aldeyra plans to advance 0.25% topical ocular reproxalap for treatment.