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, confirmed alignment on key Chemistry, Manufacturing, and Controls (CMC) topics necessary for the NDA.

The company says this latest announcement confirms agreement on nonclinical, clinical pharmacology and clinical aspects.

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Is TNXP A Good Stock To Buy?

An investor can make a few decisions when deciding whether a stock is a good buy. In addition to valuation metrics and price action which you can find on Benzinga's quote pages – like Tonix Pharmaceuticals‘s page for example – there are factors like whether or not a company pays a dividend or buys a large portion of its stock each quarter.

These are known as capital allocation programs. Tonix Pharmaceuticals does not pay a dividend, but obviously has a few ways it can return value to shareholders. Feel free to search Benzinga's dividend calendar for the next company that is due to pay a dividend and determine what kind of yield you can earn for holding a share of the company.

For example, if you're looking to earn an annualized return of 12.91%, you'll need to buy a share of Highland Glb Allocation by the Sep. 23, 2024. Once done, you can expect to receive a nominal payout of $0.08 on Sep. 30, 2024.

According to data from Benzinga Pro, TNXP has a 52-week high of $60.16 and a 52-week low of $0.60.