Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) saw a volatile trading session on Tuesday, initially surging before reversing to trade significantly lower. This came on the heels of a major announcement that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid treatment. Here’s a breakdown of the key developments:
FDA Acceptance of TNX-102 SL NDA
The FDA’s acceptance of the NDA sets the stage for an in-depth review of TNX-102 SL. As part of the process, the agency will assign a Prescription Drug User Fee Act (PDUFA) target action date and determine if the application qualifies for priority review. This information will be detailed in the FDA’s Day 74 Letter. Notably, TNX-102 SL was granted Fast Track designation by the FDA in July 2024, underscoring its potential significance in addressing unmet medical needs.
The Potential Impact of TNX-102 SL
Fibromyalgia, a chronic condition that affects over 10 million adults in the United States—predominantly women—has not seen the approval of a new treatment in more than 15 years. TNX-102 SL, if approved, would represent a groundbreaking development as the first new class of analgesic drugs for fibromyalgia.
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The drug’s NDA submission is supported by two Phase 3 clinical trials:
- RELIEF Study (Completed December 2020): This trial demonstrated statistically significant results in reducing daily pain compared to a placebo, achieving a p-value of 0.010.
- RESILIENT Study (Completed December 2023): The confirmatory trial also met its primary endpoints, with a highly significant p-value of 0.00005.
Both studies showed that TNX-102 SL was generally well tolerated, with the most common side effect being temporary numbness of the tongue or mouth at the administration site. This side effect did not lead to significant discontinuations.
CEO Highlights Importance of TNX-102 SL
Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the importance of this milestone, noting that the fibromyalgia community has long awaited a new treatment option. He also highlighted the concerning trend of fibromyalgia patients being more likely to receive opioid prescriptions than the three currently FDA-approved drugs combined within 18 months of diagnosis.
Tonix’s Preparation for Approval
Tonix is gearing up for potential approval in 2025, with a commercial leadership team already in place to support the launch of TNX-102 SL. The company also markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for the acute treatment of migraines, showcasing its established presence in the pharmaceutical market.
TNXP Stock Performance
Despite the initial positive momentum, Tonix shares experienced a sharp reversal. At the time of writing, Tonix shares were up by approximately 25% during the session but later declined to trade down 7.11%, sitting at $0.49 per share, according to Benzinga Pro.Source: Benzinga Pro
Trusted Sources Link- Source: FDA Fast Track Designation Announcement
Conclusion
Tonix Pharmaceuticals’ TNX-102 SL represents a potentially transformative development for fibromyalgia treatment, marking a significant step forward for the company and the medical community. However, the market’s reaction underscores the inherent volatility and uncertainty associated with biotech stocks. Investors will likely keep a close eye on upcoming milestones, including the PDUFA target action date and any further communications from the FDA.
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