Aldeyra Therapeutics (ALDX) Jefferies London Healthcare Conference 2024 summary

Pipeline and recent progress

• Lead asset Reproxalap targets dry eye disease and is under NDA review with a PDUFA date set for April 2, 2025, following a successful additional clinical trial addressing FDA requirements.

• AbbVie holds an option to co-promote Reproxalap, with a potential $194 million in milestones and a 60/40 profit split post-approval.

• Reproxalap also completed phase 3 trials for allergic conjunctivitis, addressing a significant patient overlap with dry eye disease.

• Additional pipeline assets include ADX-629 for alcoholic hepatitis (phase 2 data expected later this year), ADX-248 for atopic dermatitis (phase 1 starting soon), and ADX-2191 for retinitis pigmentosa (phase 2/3 planned).

• The RASP platform underpins multiple programs in immunology, skin, liver, and retina, with future data and program updates anticipated in 2025.

Regulatory and commercial outlook

• The FDA requested an additional trial for Reproxalap, which showed highly significant results and led to a straightforward NDA resubmission.

• Draft label for Reproxalap includes two signs and two symptoms, with ocular redness as a key differentiator for chronic use.

• AbbVie is expected to lead commercialization efforts if the option is exercised, leveraging its expertise in eye care.

• Market opportunity for dry eye disease is substantial, with increasing prevalence due to aging and screen use; Reproxalap is positioned as the first drug to show rapid symptom relief.

• Approval of Reproxalap could trigger significant milestone payments and support further development across the pipeline.

Strategic vision and future catalysts

• The RASP platform is being leveraged to develop oral and injectable therapies for a range of inflammatory and metabolic diseases.

• ADX-248 aims to address unmet needs in atopic dermatitis with an oral therapy, with phase 2A data expected next year.

• Retina programs target dry AMD and retinitis pigmentosa, with novel endpoints and delivery methods under development.

• Key 2025 catalysts include the PDUFA decision for Reproxalap, potential AbbVie option exercise, and data readouts from ongoing trials.

• Current cash position of $113 million is expected to fund ongoing and planned programs.