Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Wednesday, Citizens JMP analyst David Turkaly maintained a Market Outperform rating and a $26.00 price target on AxoGen, Inc. (NASDAQ:AXGN), representing a 40% upside from the current price of $18.62. The stock has already demonstrated strong momentum, delivering a remarkable 107% return over the past year. Turkaly’s outlook is notably influenced by the potential commercial coverage tailwind expected to begin after the Avance Nerve Graft receives Biologics License Application (BLA) approval in September. According to InvestingPro data, analysts expect the company to turn profitable this year, with several more insights available to subscribers.
The analyst emphasized the significant competitive advantage BLA approval would confer upon AxoGen’s Avance Nerve Graft, granting it 12+ years of market exclusivity from the date of approval. This exclusivity is critical as it would officially classify Avance as a reference product for biosimilars, providing a substantial period of protection in the marketplace. The company’s strong financial position, with a healthy current ratio of 3.24 and impressive gross margin of 75.79%, suggests it’s well-positioned to capitalize on this opportunity.
Turkaly also pointed out that the BLA approval would play a crucial role in changing the current perception of AxoGen’s product. At present, the Avance Nerve Graft is hindered by an "experimental or investigational" designation, which limits its coverage from certain commercial insurers. Despite having excellent coverage from the Centers for Medicare & Medicaid Services (CMS), only about 50% of commercial lives are currently covered.
The approval in September could, therefore, be a transformative event for AxoGen. It is expected to pave the way for Avance to become the standard of care in its target markets and to secure broader coverage across its algorithm. Turkaly’s comments reflect a positive outlook on the company’s prospects, contingent on the anticipated regulatory milestone later this year.
In other recent news, AxoGen, Inc. reported fourth-quarter revenue of $49.4 million, reflecting a 15.1% increase year-over-year and surpassing various analysts’ expectations. JMP Securities, Canaccord Genuity, Raymond (NSE:RYMD) James, Leerink Partners, and Cantor Fitzgerald all raised their price targets for AxoGen, indicating strong confidence in the company’s financial performance and growth prospects. JMP Securities increased its price target to $26, noting the company’s positive net income and guidance for cash flow positivity by 2025. Canaccord Genuity also set a $26 target, maintaining a Buy rating, and highlighted AxoGen’s enhanced commercial execution and strategic plans for market expansion.
Raymond James raised its target to $25, citing the company’s strong gross margin and strategic initiatives under new CEO Mike Dale. Leerink Partners set a $25 target, emphasizing AxoGen’s fiscal year 2025 sales growth guidance, which exceeded consensus estimates. Cantor Fitzgerald increased its target to $24, acknowledging AxoGen’s robust fourth-quarter results and optimistic revenue outlook for 2025. These developments reflect a positive sentiment among analysts regarding AxoGen’s potential for sustained growth and profitability in the coming years.
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