Tonix Pharmaceuticals stock drops despite FDA approval of fibromyalgia treatment.

Tonix Pharmaceuticals' stock dropped by about 20% on Monday despite receiving US FDA approval for its fibromyalgia treatment, Tonmya. The stock had surged 19% in after-hours trading on August 15. Trading in the stock was halted.

Tonix Pharmaceuticals' stock experienced a significant drop of about 20% on Monday, despite receiving U.S. Food and Drug Administration (FDA) approval for its fibromyalgia treatment, Tonmya. The stock had surged by 19% in after-hours trading on August 15, following the FDA's approval announcement.

The FDA approval of Tonmya, a non-opioid, once-daily bedtime analgesic with a sublingual formulation, marks a significant milestone for the company. Tonmya is the first new FDA-approved therapy for fibromyalgia in over 15 years, targeting a market expected to reach $3.86 billion by 2031 [2].

The approval was based on two Phase 3 clinical trials involving nearly 1,000 patients, which demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks. The drug was generally well tolerated, with common adverse events including oral hypoesthesia, oral discomfort, abnormal product taste, and somnolence [1].

Tonix Pharmaceuticals expects commercial availability of Tonmya to begin in the fourth quarter of 2025. The company plans to host a webcast and conference call on Monday to discuss the approval further [1].

The stock's decline on Monday may be attributed to various factors, including market expectations, potential generic competition, and reimbursement challenges. Despite the FDA approval, investors are cautious about the drug's ability to capture a significant market share and the company's execution of its commercial strategy.

Tonmya's unique sublingual formulation and clinical trial results position it as a potential game-changer in the fibromyalgia treatment landscape, but the stock's performance suggests that investors are closely monitoring the drug's commercial potential and the broader market dynamics.

References:
[1] https://www.investing.com/news/stock-market-news/tonix-pharmaceuticals-stock-halted-ahead-of-fda-approval-news-93CH-4196002
[2] https://www.ainvest.com/news/tonix-pharmaceuticals-fda-approval-tonmya-strategic-implications-market-capture-fibromyalgia-2508/