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Tonix reports TONMYA sales of about $15M as Dr. Reddy's files generic challenge

🇺🇸 Tonix Pharmaceuticals Holding Corp. (TNXP) · Mon 09 Nov 2026

Tonix says third-quarter TONMYA net sales rose 37% on the prior quarter, while Dr. Reddy's has filed an ANDA with a Paragraph IV certification and the company plans to enforce its patents.

Tonix Pharmaceuticals reported third-quarter 2026 results on 9 November. Net sales of TONMYA, its sublingual cyclobenzaprine for adult fibromyalgia, were about $15.0 million, up 37% from the previous quarter. The company said payer coverage now reaches roughly 166 million lives in the US.

Tonix also disclosed that Dr. Reddy's has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration for a generic version of TONMYA. The filing includes a Paragraph IV certification, and Tonix said it plans to enforce its patents. As general context, a Paragraph IV certification asserts that a listed patent is invalid or will not be infringed, and it can lead to patent litigation.

On finances, Tonix ended the quarter with about $163 million in cash and reported a net loss of $53.3 million. The company projects its cash runway will extend into early the third quarter of 2027.

The pipeline update covered TNX-102 SL in major depressive disorder (MDD), TNX-4800 for Lyme disease, and TNX-1500. For TNX-4800, the company referred to FDA Type C meeting minutes. The summary available does not give further detail on these programmes.

What it means for your team

  • Market-access teams may note that TONMYA coverage of about 166 million US lives is a sign of widening payer uptake for the product.
  • Regulatory and IP teams should track the Dr. Reddy's ANDA and Tonix's stated plan to enforce its patents, as the dispute could affect the product's exclusivity outlook.
  • Tonix's cash runway guidance into early Q3 2027 sets the funding context for its pipeline work in MDD, Lyme disease and TNX-1500.

Company's press release (SEC filing): Tonix Pharmaceuticals Holding Corp. ↗

Article written by VigiEye from the official source (Tonix Pharmaceuticals Holding Corp.). Claims are the company's own. AI-assisted; check the source before acting.

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