Cyclerion Therapeutics, Inc. (NASDAQ:CYCN), Sol-Gel Technologies Ltd. (NASDAQ:SLGL), Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), DermTech, Inc. (NASDAQ:DMTK) and Bionano Genomics, Inc. (NASDAQ:BNGO) are among the biggest health care movers Tuesday.
Cyclerion Slips On Study Delay: Cyclerion, a clinical-stage biopharma developing treatments for restoring cognitive functions, provided a clinical pipeline update.
The company delved on the development strategy and execution for its lead asset CY6463, which is being evaluated in Alzheimer’s disease with vascular pathology as well as mitochondrial encephalomyopathy lactic acidosis and stroke-like episodes, or MELAS. The MELAS study is enrolling more slowly than initially projected, primarily due to COVID-19, the company said. It now expects to report data from the Phase 2a pilot study by year-end 2021.
Cyclerion shares were slipping 16.39% to $2.60.
Sol-Gel Down On Potential Delay In FDA Decision: Sol-Gel’s new drug application for Epsolay in the treatment of inflammatory lesions of rosacea had a PDUFA goal date of Monday. This would mean the FDA is mandated to communicate its verdict latest by this date.
With neither the FDA nor the company issuing an update on the regulatory decision, investors who may have bought the shares in the run up to the binary event are likely liquidating their holdings.
Sol-Gel was slipping 15.87% to $11.56.
Related Link: The Week Ahead In Biotech (April 25-May 1): FDA Decisions For Sol-Gel, Protalix Bio, Ardelyx
Aldeyra Gains On Positive Late-stage Readout: Gene therapy company Aldeyra announced positive top-line results from the Phase 3 INVIGORATE study of 0.25% reproxalap ophthalmic solution, an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.
“The statistically significant superiority of reproxalap over vehicle across all allergic conjunctivitis symptoms and signs assessed in INVIGORATE is remarkable, and suggests utility in one of the world’s most common ocular surface diseases,” stated Todd Brady, CEO of Aldeyra.
Aldeyra said it plans to meet with the FDA in the second half of 2021 to discuss the results and the potential submission of a new drug application.
Aldeyra shares were jumping 29.61% to $14.40.