Tonix Pharmaceuticals Announces Engagement Of Rho As CRO To Support Submission Of New Drug Application To The FDA For Approval Of Tonmya For The Management Of Fibromyalgia
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Tonix Pharmaceuticals Holding Corp. (TNXP) has engaged Rho, Inc. as a Contract Research Organization (CRO) to support the submission of a New Drug Application (NDA) to the FDA for Tonmya, a non-opioid analgesic for fibromyalgia management. Tonmya has shown statistically significant results in two Phase 3 trials and aims for NDA submission in the second half of 2024. Fibromyalgia affects approximately 10 million U.S. adults, and Tonmya's approval could offer a new first-line therapy option.
February 13, 2024 | 1:12 pm
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POSITIVE IMPACT
Tonix Pharmaceuticals is advancing towards FDA submission for Tonmya, a potential fibromyalgia treatment, with Rho's support. Positive Phase 3 results could make Tonmya a first-line therapy, addressing a market of 10 million U.S. adults.
The engagement of Rho to support the NDA submission for Tonmya, combined with the positive outcomes from two Phase 3 trials, positions TNXP positively in the short term. The potential approval of Tonmya addresses a significant market need for fibromyalgia management, which could positively impact TNXP's stock price as the market anticipates a new revenue stream.
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IMPORTANCE 90
RELEVANCE 100