Tonix Pharmaceuticals Holding Corp. has made its first FDA‑approved fibromyalgia treatment, the cyclobenzaprine HCl sublingual tablet TONMYA, available by prescription nationwide. The launch marks the first new drug for the condition in more than 15 years and represents a significant regulatory milestone for the company.
TONMYA delivers rapid absorption through a sublingual formulation and is designed to target non‑restorative sleep, a core symptom of fibromyalgia. The drug’s mechanism and delivery platform differentiate it from existing off‑label options and provide a novel therapeutic option for the estimated 10 million U.S. adults affected by the disease.
In its most recent quarter, Tonix reported product revenue of $3.3 million, an 18% year‑over‑year increase driven largely by sales of its migraine portfolio. Net loss widened to $32 million from $14.2 million a year earlier, largely due to higher selling, general and administrative expenses associated with commercialization activities. Cash and cash equivalents stood at $190.1 million as of September 30, giving the company a runway that extends into the first quarter of 2027.
Investors responded positively to the launch, citing the revenue beat of $0.99 million against consensus estimates and the confirmation of TONMYA’s November launch. The company’s non‑GAAP loss per share of $3.59 was slightly better than the expected $3.66, reflecting disciplined cost management amid increased marketing spend.
CEO Seth Lederman said, “The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain.” He added that the launch signals the company’s transition from a research‑focused biotech to a commercial‑stage enterprise.
The commercial launch opens a new revenue stream and supports Tonix’s broader pipeline strategy, which includes immunology, infectious disease and other CNS programs. Patents covering TONMYA provide U.S. exclusivity until 2034, but the company faces headwinds such as insurance coverage uncertainty and competition from off‑label generics. Nonetheless, the first‑mover advantage and the unmet need in fibromyalgia position TONMYA as a key driver of future growth.
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