Aldeyra Therapeutics Inc. (ALDX) stock fell by 36.33% in the after-hours following the announcement of results from its TRANQUILITY trial. On December 20, ALDX shared top-line results from its Phase 3 TRANQUILITY trial in dry eye disease. The company failed to meet the primary endpoint of the trial, hence causing the stock to plunge.
During the regular session, the stock traded in the green with a gain of 1.28% at its close of $7.13. Following the results, the stock took a big hit in the after-hours, diving down to $4.54 at 1.3 million shares.
Aldeyra Therapeutics Inc. has a market capitalization of $408.97 million for its 58.09 million outstanding shares.
ADLX’s Top-line Results
ALDX has been conducting the phase 3 trial of its TRANQUILITY study for 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Reproxalap is the company’s investigational product candidate for dry eye disease and allergic conjunctivitis. Moreover, dry eye disease is an inflammatory disease that leads to dryness, pain, discomfort, irritation, and permanent vision impairment. An estimated 34 million people are affected by dry eye disease in the U.S. alone.
On Monday, the company announced the top-line results from the phase 3 trial. According to this, ALDX was unable to meet the primary endpoint of ocular redness. Moreover, the study did achieve a secondary endpoint of statistical significance (p=0.0001) for the Schirmer test. Moreover, the Schirmer test is an accepted part of the basis approval of dry eye disease products by the FDA.
Hence, the company modified the primary endpoint of the study to achieve statistical significance in ocular redness or the Schirmer test. Furthermore, ALDX also increased TRANQUILITY-2 target enrollment to 400 patients from 300. In addition, the company expects the top-line results from TRANQUILITY-2 in mid-2022.
Q3 2021 Financial Results
On October 28, ALDX reported its financial results for the third quarter of 2021, which ended on September 30, 2021. In the third quarter of 2021, the net loss was $15.8 million against $8.9 million in the year-ago quarter. Subsequently, the net loss per share for the third quarter of 2021, was $0.27, against $0.23 in Q3 of 2020.
Moreover, ALDX ended the third quarter of 2021, with cash and cash equivalents of $241.4 million. According to the current operating plan of the company, ALDX expects this to be enough cash flow through the end of 2023.
