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SAN DIEGO, CA - Dermata Therapeutics , Inc. (NASDAQ:DRMA), a pharmaceutical company specializing in dermatological treatments with a market capitalization of $4.4 million, announced the commencement of drug production for its upcoming Phase 3 STAR-2 trial for XYNGARI™. Despite seeing a strong 3.7% return over the last month, the company’s shares have declined over 76% in the past year. The trial is expected to begin in the fourth quarter of 2025, with topline results anticipated in the first half of 2027. InvestingPro analysis suggests the stock is currently fairly valued based on its proprietary Fair Value model.
The STAR-2 trial will examine the safety and efficacy of XYNGARI™, allowing patients to participate in a 9-month extension study. This additional data aims to support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Dermata anticipates the extension study’s completion by the end of the fourth quarter of 2027, with a potential NDA filing in the first half of 2028.
This announcement, disclosed in a recent 8-K filing with the Securities and Exchange Commission (SEC), reflects the company’s strategic progression in the clinical trial pathway for XYNGARI™. Dermata, incorporated in Delaware with headquarters in San Diego, CA, is recognized under the Standard Industrial Classification (SIC) code for Pharmaceutical (TADAWUL:2070) Preparations (2834).
The company’s forward-looking statements in the SEC filing include projected timelines for clinical trials and regulatory submissions. These statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
Dermata Therapeutics, committed to transparency, underscores that the information provided is based on current expectations and involves risks and uncertainties. The company’s filings with the SEC can be referenced for discussions of potential risks and other important factors.
The news of Dermata’s preparation for the Phase 3 trial of XYNGARI™ marks a significant milestone in the company’s efforts to bring new dermatological solutions to market. According to InvestingPro data, the company maintains a healthy current ratio of 3.7, with cash holdings exceeding debt levels. While analysts have set a $3 price target, they don’t expect profitability this year. As an emerging growth company, Dermata continues its pursuit of innovation in the pharmaceutical industry. Unlock 10+ additional exclusive insights and real-time alerts with InvestingPro.
In other recent news, Dermata Therapeutics announced promising results from its Phase 3 trial of XYNGARI, a once-weekly topical acne treatment. The trial, known as STAR-1, included 520 patients and demonstrated statistically significant improvements in both inflammatory and non-inflammatory acne lesions. Additionally, Dermata reported that 29.4% of patients achieved a clear or almost clear skin rating compared to 15.2% for the placebo group. These findings have set the stage for the upcoming Phase 3 STAR-2 trial, expected to begin in the latter half of 2025.
Maxim Group recently adjusted its outlook on Dermata, reducing the price target to $3.00 from $6.00 while maintaining a Buy rating. This revision follows Dermata’s first-quarter financial results, which showed operating expenses below expectations and a GAAP loss per share in line with forecasts. In another development, Dermata received a delisting notice from The Nasdaq Capital Market for not meeting the minimum stockholders’ equity requirement. The company is working on a compliance plan to address the shortfall and maintain its listing status. Dermata’s current cash reserves are projected to sustain operations into early 2026, with a potential capital raise anticipated later in 2025.
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