Aldeyra Therapeutics Inc. (ALDX) shares plummeted 36.33% in after-hours on Monday, December 20, 2021, and closed the daily trading at $4.54. However, in the regular trading session of Monday, ALDX’s stock gained 1.28%. ALDX shares have fallen 5.31% over the last 12 months, and they have moved up 1.71% in the past week. Over the past three months, the stock has lost 10.20%, while over the past six months, it has declined 36.96%.
Let’s see what’s going on recently with the company?
ALDX Phase 3 TRANQUILITY Trial results
On December 20, 2021, Aldeyra Therapeutics, Inc. (ALDX) announced top-line results from the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational product candidate for the treatment of dry eye disease.
The company was unable to achieve the primary endpoint but the secondary endpoint, which is statistical significance was achieved for dry eye disease. The company also increased enrollment from 300 to up to 400 patients in TRANQUILITY-2 and expects top-line results in mid-2022.
ALDX Phase 2 TRANQUILITY Trial results
On November 02, 2021, ALDX achieved the primary endpoint of ocular redness in a randomized, double-masked, vehicle-controlled Phase 2 clinical trial in patients with dry eye disease.
A total of 158 individuals were included in phase 2 clinical study, with 80 receiving 0.25 percent reproxalap ophthalmic solution and 78 receiving vehicle ophthalmic solution.
The Phase 2 trial exceeded 90% power to detect statistical significance in the primary endpoint of ocular redness over all time points in aggregate in the dry eye chamber.
ALDX latest financial results
On October 28, 2021, Aldeyra Therapeutics, Inc. (ALDX) reported financial results for the quarter ended September 30, 2021.
Q3 2021 financial highlights
- ALDX reported zero revenue in Q3 2021 and Q3 2020.
- Research and development expenses were $12.9 million in Q3 2021, compared with $6.1 million for the same period in 2020.
- General and administrative expenses were $2.5 million in Q3 2021 compared to 2.3 million in Q3 2020.
- It suffered a net loss of $15.8 million or net loss per share of $0.27 in Q3 2021, compared with a net loss of $8.9 million or net loss per share of $0.23 for the quarter ended September 30, 2020.
- The company ended the quarter with cash and cash equivalents of $241.4 million.
The Aldeyra stock faced significant loss after the company reported that it was unable to achieve the primary endpoint in the phase three trial which we have discussed above. Its stock price can further go down in the coming trading sessions.