Tonix Pharmaceuticals

The 2022 #mpox (formerly monkeypox) outbreak threatened thousands globally, and experts warn that not enough has been done to prevent its spread since then. Now, a new lethal variant of mpox is spreading unchecked in several African countries. In a recent interview with James Reynolds at the Daily Mail News, Zeil Rosenberg, M.D., Executive Vice President, Medical at Tonix Pharmaceuticals, discussed the severity of mpox and explained the two clades currently in circulation. To stop the spread of diseases, Tonix is developing TNX-801, a #mpox and smallpox preventing #vaccine candidate. Tonix remains committed to improving population health worldwide. Read now: https://bit.ly/3yFCAKB

Today, Tonix Pharmaceuticals announced the publication of a research paper in Microorganisms (MDPI), which highlights proprietary imaging technology to screen convalescent sera for generating neutralizing, fully-human mAbs against SARS-CoV-2 variants & other potential pathogens. https://bit.ly/3SCUEfa  

This week, Tonix Pharmaceuticals announced the potential positive impact of The National Academies of Sciences, Engineering, and Medicine (NASEM) new definition of #LongCOVID on the size of the #fibromyalgia market for TNX-102 SL. NASEM cites FM as a “diagnosable condition” in people suffering from Long COVID. Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for TNX-102 SL relative to pre-COVID-19 pandemic estimates. https://bit.ly/3SyzgIa

Today, Tonix Pharmaceuticals announced a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, on August 7th in Amsterdam, Netherlands. The presentation will highlight statistically significant Phase 3 results of Tonmya™ for the management of #fibromyalgia, including improvement in pain and sleep quality. Tonix was recently granted FDA Fast Track Designation for Tonmya™ and plans to submit a NDA in 2H’24. https://bit.ly/3SwRfia  

Yesterday, Tonix Pharmaceuticals announced that the FDA has granted Fast Track designation to Tonmya™ for the management of #fibromyalgia. The designation validates that FM is a serious condition and that Tonmya has the potential to address this unmet medical need. https://bit.ly/46jTR8A

Last week, Tonix Pharmaceuticals announced it is filing an NDA submission in 2H’24 and laying plans for the commercial launch of Tonmya™ for the management of fibromyalgia, assuming approval by the FDA in 2H’25. A new FM drug has not been approved since 2009. Yet, despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5B each (both are now generic). Tonmya is a new therapeutic class unlike the currently approved FM drugs. Tonix will be competing for a slice of a global market that was valued at over $3B in 2023 and is expected to grow. https://bit.ly/3LtNoyo

Last week on July 10, Tonix Pharmaceuticals announced the closing of its public offering. The gross proceeds are $4.0M before deducting placement agent fees and other estimated offering expenses payable by the Company. More here: https://bit.ly/4eWQlVA

Last week, Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-NDA meeting with the FDA for Tonmya™ for the management of #fibromyalgia during which Tonix & FDA agreed that the proposed data package is sufficient to support the NDA submission. Tonix remains on track to submit the NDA for Tonmya 2H’24 which would allow for a potential FDA approval in 2H’25. https://bit.ly/45TfAUN

Last week on June 28th, Tonix Pharmaceuticals announced the closing of its public offering. The gross proceeds are $4.0M before deducting placement agent fees and other estimated offering expenses payable by the Company. More here: https://bit.ly/3xF8xSS

Last week on June 26th, Tonix Pharmaceuticals announced that it regained compliance with the Nasdaq minimum bid price requirement. https://bit.ly/3RRYHDU