Tonix Pharmaceuticals Shares Rise Amid Upcoming FDA Decision on Fibromyalgia Drug Candidate

Tonix Pharmaceuticals Holding Corp (TNXP) shares are trading higher by 30% to $60.86 after the company's second-quarter financial results showed a net loss of $3.86 per share, beating the analyst consensus estimate. Sales for the quarter came in at $2.0 million, missing the forecast of $2.6 million. The stock's gain is driven by the approaching FDA decision on Tonix's lead drug candidate, TNX-102 SL, for the management of fibromyalgia, with a potential approval and launch in Q4 2023.

Tonix Pharmaceuticals Holding Corp (TNXP) shares are trading higher by 30% to $60.86 after the company's second-quarter financial results showed a net loss of $3.86 per share, beating the analyst consensus estimate of a $10.73 loss per share [1]. Sales for the quarter came in at $2.0 million, missing the forecast of $2.6 million. The stock's gain is driven by the approaching FDA decision on Tonix's lead drug candidate, TNX-102 SL, for the management of fibromyalgia, with a potential approval and launch in Q4 2023.

The company reported a net loss of $28.3 million for the quarter, which was less than the $35.4 million loss reported in the same period last year. Despite the net loss, Tonix Pharmaceuticals has a strong financial position, with $125.3 million in cash and cash equivalents as of June 30, 2025 [2]. This cash position provides a runway to fund operations until the third quarter of 2026.

The stock's performance is also buoyed by the company's recent addition to the Russell 2000 and Russell 3000 Indexes, increasing its visibility among institutional investors [1]. Additionally, the company's lead drug candidate, TNX-102 SL, has shown promising results in clinical trials, with statistically significant reductions in fibromyalgia pain [2].

Tonix Pharmaceuticals is well-positioned to capitalize on the potential approval of TNX-102 SL, which would be the first new fibromyalgia treatment in over 16 years. The company has a robust pipeline of development candidates, including TNX-1500 for organ transplant rejection and TNX-801 as a vaccine for mpox [2].

References:

[1] https://www.benzinga.com/trading-ideas/movers/25/08/47065443/tonix-pharmaceuticals-tnxp-stock-surges-on-q2-earnings-beat-and-upcoming-fda-catalyst
[2] https://www.quiverquant.com/news/Tonix+Pharmaceuticals+Reports+Financial+Results+and+Highlights+PDUFA+Goal+Date+for+TNX-102+SL+in+Fibromyalgia+Treatment