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CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company with a market capitalization of $148.2 million, has announced a significant step forward in the regulatory review process for its investigational drug TNX-102 SL, which is being developed for the management of fibromyalgia. The U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the New Drug Application (NDA) for TNX-102 SL, potentially speeding up the review process. According to InvestingPro data, the company maintains a healthy current ratio of 6.5, indicating strong short-term financial stability.
If approved, TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, would become the first new treatment option for fibromyalgia in over a decade. This comes as a relief to the more than 10 million adults in the U.S. suffering from this chronic pain disorder, which causes widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction, among other symptoms.
The FDA granted TNX-102 SL Fast Track designation in 2024, recognizing the need for new therapies to treat serious conditions with unmet medical needs. The Prescription Drug User Fee Act (PDUFA) goal date for a decision on marketing authorization is set for August 15, 2025. InvestingPro analysis shows the company holds more cash than debt on its balance sheet, though it’s currently burning through cash rapidly - crucial factors for investors monitoring the path to potential commercialization.
Tonix’s CEO, Seth Lederman, M.D., expressed optimism about the drug’s potential and the company’s readiness for commercial launch in the fourth quarter of 2025, pending FDA approval. TNX-102 SL is a non-opioid analgesic that targets four neuroreceptor subtypes, which are believed to play a role in the non-restorative sleep characteristic of fibromyalgia.
The company’s development pipeline also includes other central nervous system (CNS) disorders and immunology and infectious disease products. TNX-102 SL’s approval would not only provide a new treatment option for patients but also strengthen Tonix’s position as a company focused on innovative therapies for pain management and public health challenges.
This update is based on a press release statement from Tonix Pharmaceuticals Holding Corp. and reflects the company’s current progress towards bringing TNX-102 SL to market. The stock has shown significant volatility, with a notable 77% return over the past six months, though it remains below its 52-week high of $1,146.01. Investors and patients alike are watching closely as the PDUFA goal date approaches, marking a potential milestone in the management of fibromyalgia. The company’s next earnings report is scheduled for May 12, 2025, which could provide additional insights into its commercialization readiness. Subscribers to InvestingPro can access 12 additional exclusive tips and comprehensive financial metrics to better evaluate the company’s potential.
In other recent news, Tonix Pharmaceuticals reported fourth-quarter earnings and revenue that did not meet analyst expectations. The company posted a loss of $9.77 per share, which was considerably wider than the anticipated loss of $3.91 per share. Revenue for the quarter was $2.58 million, falling short of the consensus estimate of $3.2 million. Net product revenue decreased to $2.6 million from $3.8 million in the same period last year, primarily from sales of its migraine treatments, Zembrace SymTouch and Tosymra. Research and development expenses were reduced to $8.3 million from $17.1 million a year ago, attributed to fewer clinical trials and pipeline prioritization. CEO Seth Lederman mentioned that the company is preparing for the potential launch of TNX-102 SL for fibromyalgia management, pending FDA approval. Tonix Pharmaceuticals also reported having $98.8 million in cash as of December 31, 2024, which is expected to fund operations beyond the August 2025 PDUFA date for TNX-102 SL.
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