Grandbrothers/iStock Editorial via Getty Images Shares of Tonix Pharmaceuticals ( NASDAQ: TNXP ) gained in the premarket Thursday after the commercial-stage biopharma announced that the U.S. Food and Drug Administration (FDA) issued its fast-track designation for the company's non-opioid pain therapy Tonmya.
The FDA has issued the fast-track tag for Tonmya's use in the management of fibromyalgia, a chronic pain disorder affecting mainly females. Fast-track designation allows a faster timeline for the development and review of drugs targeted at serious conditions with unmet medical needs. It enables developers to communicate frequently with the regulator on plans for clinical studies.
Subject to certain conditions, companies with fast-track designations can secure the FDA's accelerated approval and priority review to bring their products to market sooner. "The designation validates that fibromyalgia is a serious condition and that Tonmya has the potential to address this unmet medical need," the company said, reforming its plans to submit a marketing application for the drug in H2 2024. More on Tonix Pharmaceuticals Tonix Pharmaceuticals secures $34M DoD contract for antiviral program Tonix Pharma prices $4M public offering Seeking Alpha’s Quant Rating on Tonix Pharmaceuticals Historical earnings data for Tonix Pharmaceuticals Financial information for Tonix Pharmaceuticals.
