Aldeyra Therapeutics (ALDX) Leerink’s Global Healthcare Conference 2025 summary

Reproxalap and commercial strategy

• Reproxalap is under NDA review for dry eye disease, with a PDUFA date of April 2 and a co-promotion option deal with AbbVie involving $100 million upfront, $100 million at approval, and additional milestones, with a 60/40 P&L split favoring AbbVie.

• The drug is differentiated by its rapid onset, potentially working within minutes, and targets redness, a key patient concern not addressed by current chronic therapies.

• AbbVie is actively involved in FDA labeling negotiations and has observer rights in meetings, with regular communication ongoing.

• If approved, AbbVie may pay $194 million, and the launch is expected to be strategic with capped annual expenses for the smaller partner.

• Profitability for the dry eye program is anticipated in about three years, with the smaller partner's expenses capped and deferred against profit if exceeded.

Pipeline and development plans

• The pipeline includes programs in retina, skin, liver, and immunology, with a focus on RASP modulators for inflammatory and metabolic diseases.

• IND for a RASP modulator injection in dry AMD is targeted for late this year or early next year, aiming to address symptoms before geographic atrophy.

• An intravitreal methotrexate program for retinitis pigmentosa is moving forward with a pivotal phase II/III trial planned for later this year.

• A potential pivotal study in ocular lymphoma is under consideration, pending FDA guidance, due to lack of randomized controlled data.

• ADX-629, a first-generation oral RASP modulator, showed promising results in open-label trials for atopic dermatitis and psoriasis, with a second-generation molecule, ADX-248, now in phase I.

Immunology and metabolic inflammation

• RASP modulators have shown efficacy in reducing itch and improving PASI/EASI scores in atopic dermatitis and psoriasis, with minimal consistent adverse events.

• ADX-248 is a once-daily, more potent, and metabolically stable oral molecule, with phase I progressing well and target levels achieved.

• The company is exploring metabolic inflammation, observing triglyceride reductions in trials and planning further studies in obesity-related conditions, possibly in combination with GLP-1s.

• ADX-629 is also in clinical testing for alcoholic hepatitis, though enrollment is challenging.

• The company maintains flexibility with a small team and tunable programs, focusing resources on key assets as funding allows.