Shares of Aldeyra Therapeutics (NASDAQ:ALDX), a biotech firm committed to innovative treatments for immune diseases, plunged at the time of writing after it received a Complete Response Letter from the FDA regarding their new drug ADX-2191. The drug, targeted at treating a rare and fatal eye cancer (PVRL), was rejected on the grounds of insufficient evidence of effectiveness due to inadequate investigations in its application submission. However, the FDA didn’t raise any concerns related to safety or manufacturing. Despite the setback, Aldeyra is looking into alternative methods to make ADX-2191 available to patients, given the existing shortage of methotrexate – a standard treatment for PVRL – and the lack of approved therapies for this aggressive cancer.
In addition to its application for PVRL, ADX-2191 is also being developed to treat two rare eye diseases, both threatening sight: proliferative vitreoretinopathy and retinitis pigmentosa. The company is planning to release the initial results from a Phase 2 trial of ADX-2191 in retinitis pigmentosa by June 2023. Furthermore, Aldeyra is set to discuss the final stages of the clinical development of ADX-2191 for preventing proliferative vitreoretinopathy with the FDA in the second half of 2023.
A look at the past five trading days for ALDX stock highlights the level of impact today’s news had on it. Indeed, shares fell over 17% at the time of writing. As a result, investors are now down 21.16% during this timeframe.
