The reprioritization initiative extends Aldeyra’s cash runway into the second half of 2027.
Aldeyra Therapeutics is dropping development of its investigational RASP modulator, ADX-629, which it was studying for a host of immune-mediated diseases, such as asthma, chronic cough and atopic dermatitis.
This move comes despite what the biotech called “statistically significant” liver function improvements in a Phase II alcohol-associated hepatitis study, reporting the data in the same statement it announced the discontinuation. Relative to baseline, ADX-629 treatment improved objective markers of liver function and inflammation, according to Aldeyra, which added that the drug also had a good safety profile overall, with no serious adverse events detected.
Aldeyra did not provide a specific reason for pulling the plug on ADX-629 in its statement Tuesday, though money may have been a factor. As a result of the discontinuation, along with other changes to the company’s pipeline, Aldeyra’s cash, cash equivalents and marketable securities have extended into the second half of 2027.
On Tuesday, Aldeyra also announced that it is pushing forward two next-generation RASP modulators to replace older molecules. For instance, in metabolic inflammation, an indication that covers obesity and hypertriglyceridemia, the company will focus its efforts on ADX-248, which in a Phase I study demonstrated high levels of drug exposure with once-daily oral dosing. ADX-248 will supplant a different molecule, ADX-743.
Meanwhile, in dry age-related macular degeneration, Aldeyra will pivot to ADX-246 and decommission ADX-631. Animal model data supported this decision, the biotech said on Tuesday.
Investigational new drug applications for ADX-248 and ADX-246 are expected next year.
Aldeyra’s pipeline shuffle comes months after the FDA rejected its lead RASP modulator, reproxalap, which the biotech is proposing for dry eye disease. To explain the rebuff, the regulator said Aldeyra had “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes,” the company said at the time. There were no problems with reproxalap’s safety data.
This was the second time that reproxalap failed to secure the FDA’s blessing. The first rejection, handed down in November 2023,was likewise linked to insufficient evidence of the drug’s efficacy.
Aldeyra has since resubmitted its application, buffing it up with a “single clinical trial that achieved the primary endpoint of reducing ocular discomfort” versus a vehicle control, CEO Todd Brady said in a July 2025 company announcement. The FDA’s third decision on reproxalap is expected on Dec. 16.
