Final patient completes STAR-1 trial for novel once-weekly acne therapy targeting 30M+ patients annually. Topline results expected by March 2025.

Reported Wednesday, Sep 10 - 8:19am EDT (TheFly subscription required to read more.)

Reported Tuesday, Apr 15 - 9:34am EDT (TheFly subscription required to read more.)

Reported Thursday, Mar 27 - 8:05am EDT (TheFly subscription required to read more.)

Dermata Therapeutics announces groundbreaking results from its Phase 3 trial of XYNGARI™, a once-weekly treatment for moderate-to-severe acne, meeting all primary endpoints.

Dermata Therapeutics has completed patient visits in its pivotal Phase 3 trial for the groundbreaking acne treatment, XYNGARI™, aiming for FDA approval. This could reshape care standards for millions.

Dermata Therapeutics to present Phase 3 STAR-1 trial results for XYNGARI (DMT310), a novel once-weekly topical treatment for moderate-to-severe acne, at EADV Congress 2025 in Paris.

Dermata's XYNGARI achieves statistically significant results for moderate-to-severe acne in Phase 3 trial, with efficacy shown at 4 weeks. Funding secured through Q2 2026. Learn more.

Dermata Therapeutics (NASDAQ: DRMA) reported significant progress in Q1 2025, highlighted by positive topline results from its XYNGARI™ Phase 3 STAR-1 clinical trial for moderate-to-severe acne treatment. The trial achieved all three co-primary endpoints with statistical significance versus placebo, showing efficacy after just 4 weeks. The company also entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 with DAXXIFY® for axillary hyperhidrosis treatment.Financially, Dermata raised $8.8 million in gross proceeds during Q1 2025, ending the quarter with $9.7 million in cash. R&D expenses decreased to $1.3 million from $1.6 million year-over-year, while G&A expenses reduced to $1.1 million from $1.6 million. The company expects current cash resources to fund operations into Q1 2026.The company plans to initiate its second Phase 3 STAR-2 trial by end of 2025 and is in partnership discussions for XYNGARI™.

Dermata Therapeutics (NASDAQ:DRMA) has announced additional positive results from its Phase 3 STAR-1 trial for XYNGARI™, a potential first-ever once-weekly topical treatment for moderate-to-severe acne. The trial demonstrated statistically significant efficacy after just four treatments at week 4.Key results at week 4 showed:11.9% of XYNGARI™ patients achieved IGA treatment success vs 6.2% for placebo (pMean inflammatory lesion count reduction of -11.4 for XYNGARI™ vs -8.6 for placebo (pMean non-inflammatory lesion count reduction of -12.4 for XYNGARI™ vs -8.8 for placebo (pThe STAR-1 study enrolled 520 patients aged 9+ years across the US and Latin America in a 2:1 randomized, double-blind, placebo-controlled trial. This is the first of two pivotal Phase 3 studies, with successful results potentially supporting a future FDA new drug application.

Novel once-weekly XYNGARI shows significant efficacy in 520-patient Phase 3 trial for moderate-severe acne. Strong safety profile positions treatment for FDA submission.

Dermata Therapeutics (NASDAQ:DRMA) provided its year-end 2024 financial results and corporate updates. The company expects to announce topline results from its XYNGARI™ Phase 3 STAR-1 clinical trial for moderate-to-severe acne by end of March 2025.Key financial highlights include:Cash position of $3.2M as of December 31, 2024R&D expenses increased to $8.2M in 2024 from $4.1M in 2023G&A expenses rose to $4.3M from $4.0M year-over-yearRaised $7.8M in gross proceeds during 2024Notable developments include a Clinical Trial Collaboration Agreement with Revance Therapeutics to study DMT410 for axillary hyperhidrosis treatment, and a $2.55M private placement in January 2025. The company expects current cash resources to fund operations into Q3 2025.

Phase 2a trial combines Xyngari's innovative delivery system with Daxxify for treating hyperhidrosis, potentially revolutionizing treatment without needles. 48 patients to be evaluated.

- STAR-1 topline results expected by the end of March 2025 - - Over 30 million acne patients seek treatment in the U.S. each year - - XYNGARI™ Phase 3 STAR-1 trial enrolled 520 patients with moderate-to-severe acne in the U.S. and Latin America - SAN…

Dermata Therapeutics has received FDA approval for the proprietary name "Xyngari" (formerly DMT310), a significant milestone for the biotechnology company. Xyngari is a cutting-edge product currently ...