Why Cyclerion, Sol-Gel, Aldeyra, DermTech and Bionano Genomics Are Moving Today

Cyclerion Therapeutics, Inc. CYCN, Sol-Gel Technologies Ltd. SLGL, Aldeyra Therapeutics, Inc. ALDX, DermTech, Inc. DMTK and Bionano Genomics, Inc. 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.

DermTech Rallies On Possible Coverage of Skin Cancer Detection Test: DermTech, a precision dermatology company, is seeing strength on reports that health insurer Cigna Corporation CI will begin covering its melanoma detection test - the pigmented lesion assay.

DermTech shares were adding 16.79% to $48.07.

Bionano Pauses After Recent Rally: Bionano shares were on a four-session winning streak ahead of Tuesday's session in reaction to company-specific news.

The stock moved up April 21 on the news that two U.K. labs have adopted its Saphyr system for optical genome mapping.

The company also announced last week publication of a study on novel Saphyr-based method to analyze DNA replication in human genomes that could enable new level of cancer research and drug discovery.

The momentum helped the stock to move further higher and it gained a cumulative 41.6% over four sessions.

Bionano was slipping 7.88% to $7.02.

Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsPenny StocksSmall CapFDAMoversTrading IdeasGeneral
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!