Aldeyra (ALDX) Up On Positive Data From Conjunctivitis Study
Aldeyra Therapeutics ALDX announced that the phase III INVIGORATE-2 study of reproxalap ophthalmic solution (reproxalap) to treat patients with allergic conjunctivitis has successfully achieved its primary and secondary endpoints. Shares of the company were up almost 4% on Jun 15, following the news.
In the late-stage study, 131 patients were enrolled and divided into two groups. While one received 0.25% reproxalap, the other was a placebo.
The primary endpoint of the study was to see the extent of improvement in the patients' eye itching (at different times) after being exposed to allergens. The key secondary endpoint was to measure any changes in their eyes’ redness for the time spent in the allergen chamber.
The results showed that the group treated with reproxalap experienced significant reduction in eye itchiness compared to the placebo group. This improvement was observed consistently across all 11 primary endpoint comparisons, measured between 110 and 210 minutes after exposure to the allergen chamber.
The study also achieved statistical significance for two additional secondary endpoints — the change in patient-reported ocular tearing score and the change in the total ocular severity score.
Shares of Aldeyra have risen 56.2% year to date against the industry’s 1.4% decline.
Image Source: Zacks Investment Research
Allergic conjunctivitis often coexists with dry eye disease, making it challenging for patients and healthcare providers to diagnose and treat both conditions simultaneously.
The study did not observe safety or tolerability concerns. The most common adverse event observed was mild and transient instillation site irritation.
Currently, a new drug application (NDA) for reproxalap as a treatment for dry eye disease is under review by the FDA. The Prescription Drug User Fee Act (PDUFA) date for reproxalap is set for Nov 23, 2023.
Aldeyra’s NDA for ADX-2191 was also accepted for priority review by the FDA in March 2023. The candidate is being developed to treat primary vitreoretinal lymphoma. The regulatory body has assigned a PDUFA date of Jun 21, 2023, for the application.
Successful development and subsequent commercialization of these candidates would be a huge boost for the company.
Aldeyra Therapeutics, Inc. Price and Consensus
Aldeyra Therapeutics, Inc. price-consensus-chart | Aldeyra Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Aldeyra currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics AKRO, ADMA Biologics, Inc. ADMA and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimate for Akero Therapeutics has narrowed from $3.46 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have risen 0.7% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 2.9% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
Loss per share estimate for Omega Therapeutics has narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 39.2% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
ADMA Biologics Inc (ADMA) : Free Stock Analysis Report
Aldeyra Therapeutics, Inc. (ALDX) : Free Stock Analysis Report
Akero Therapeutics, Inc. (AKRO) : Free Stock Analysis Report
Omega Therapeutics, Inc. (OMGA) : Free Stock Analysis Report
