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On Monday, Stifel analysts reiterated their Buy rating on Palvella Therapeutics (NASDAQ:PVLA) with a steady price target of $45.00. According to InvestingPro data, analyst targets range from $30 to $50, with the stock currently trading near its 52-week high of $29.27. The company’s market capitalization stands at $319.8 million, with the stock delivering an impressive 134% return year-to-date. The firm’s positive stance comes as Palvella advances its key drug, QTORIN rapamycin, through clinical trials for rare genetic skin diseases. The company has launched Phase 3 trials for microcystic lymphatic malformations (mLMs) and Phase 2 trials for cutaneous venous malformations (cVMs). While InvestingPro analysis indicates the stock is currently trading above its Fair Value, the company maintains a GREAT financial health score, suggesting strong operational fundamentals.
The optimism from Stifel is buoyed by Palvella’s impressive Phase 2 results, where 100% of mLM patients showed ’much improvement’ or better in the Clinical Global Impression of Change (CGIC), and 83.3% in the Patient Global Impression of Change (PGI-C). These outcomes were notably achieved with limited systemic exposure to the drug.
Stifel’s endorsement of Palvella’s stock is further supported by the company’s proprietary QTORIN platform. This innovative gel-based vehicle is designed to enhance skin permeability and stabilize high molecular weight drugs like rapamycin. The platform’s versatility has been a key factor in the drug’s clinical success.
Financially, Palvella ended the fourth quarter of 2024 with $83 million in cash and equivalents, following a recent Private Investment in Public Equity (PIPE) financing. This positions the company with a cash runway extending to 2027, comfortably beyond the anticipated readouts for both the SELVA trial in the first quarter of 2026 and the TOIVA trial in the fourth quarter of 2025. The analyst’s reiteration of the Buy rating signals confidence in Palvella’s ongoing development and potential market impact. InvestingPro data reveals a healthy current ratio of 2.14 and moderate debt levels, with 10+ additional ProTips available to subscribers through the comprehensive Pro Research Report.
In other recent news, Palvella Therapeutics Inc. reported a net loss of $17.4 million for the year 2024 during its Q4 earnings call. Despite the financial loss, the company is advancing its lead product, Cutorin Rapamycin, and has secured a cash runway into the second half of 2027. Palvella plans to spend approximately $30 million in 2025, with research and development expenses projected between $18 million and $20 million. The company is preparing for key milestones, including the completion of Phase III and Phase II studies for its product, with data expected in Q1 2026 and Q4 2025, respectively. Palvella’s strategic focus on rare skin diseases positions it as a potential leader in this niche market. The company has received financial support from the FDA through a non-dilutive orphan product grant for its Phase III study. Palvella’s commercial planning is underway, with expectations to leverage its innovative product pipeline to address unmet needs in rare genetic skin diseases.
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