Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) shares are trading lower by 11.3% to $0.71 during Monday’s session after the company announced receipt of the formal minutes from a recent pre-New Drug Application meeting with the FDA for Tonmya for the management of fibromyalgia.
What Happened?
Tonix Pharmaceuticals earlier Monday announced that it received formal minutes from a recent pre-New Drug Application (NDA) meeting with the FDA regarding Tonmya™ (cyclobenzaprine HCl sublingual tablets) for fibromyalgia management. Both parties agreed that the data package is sufficient for NDA submission, which Tonix plans to submit in the second half of 2024, aiming for potential FDA approval in the second half of 2025.
CEO Seth Lederman highlighted the potential benefits of Tonmya for fibromyalgia patients, particularly as an alternative to opioids. Additionally, a prior meeting on June 20, ...
TNXP) Stock Is Falling>Full story available on Benzinga.com