Krystal Biotech Stock Price, News & Analysis

Krystal Biotech (NASDAQ: KRYS) has received marketing authorization from Japan's Ministry of Health, Labour and Welfare for VYJUVEK®, marking a significant milestone as the first genetic medicine approved in Japan for treating dystrophic epidermolysis bullosa (DEB).

The approval allows for flexible administration options, including home dosing and administration by patients or family members. VYJUVEK works by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression. The company expects to launch in Japan by the end of 2025, pending completion of reimbursement procedures.

Clinical data supporting the approval included results from a Japanese open label extension study, where all four patients achieved full wound closure at six months, consistent with previous U.S. Phase 3 study results. The treatment has already received approvals in the United States (May 2023) and Europe (April 2025).

Jeune Aesthetics (NASDAQ: KRYS) announced positive Phase 1 results from the PEARL-2 study evaluating KB304 for treating décolleté wrinkles. The randomized, double-blind, placebo-controlled trial demonstrated significant aesthetic improvements in 19 subjects, with 100% of KB304-treated patients showing improvement at three months according to investigator assessments.

The study showed substantial benefits across multiple skin attributes, including elasticity, crepiness, hydration, and radiance. 81.8% of KB304-treated subjects reported improved satisfaction with wrinkle appearance versus 14.3% for placebo. The safety profile was consistent with prior clinical experience, showing only mild-to-moderate adverse events.

Following these positive results, Jeune plans to advance KB304 to Phase 2 development, targeting initiation in the first half of 2026 after FDA consultation.

Krystal Biotech (NASDAQ: KRYS) has initiated its Phase 1/2 clinical trial EMERALD-1 with the first patient dosed using KB801, an innovative eye drop gene therapy for treating neurotrophic keratitis (NK). The trial is a randomized, double-masked, multicenter, placebo-controlled study that will enroll up to 27 adults with Stage 2 or Stage 3 NK.

The study will evaluate KB801's safety and efficacy, administered twice weekly for 8 weeks. NK is a degenerative corneal disease affecting an estimated 68,000 patients in the United States as of 2024, marking a significant 115% increase from 31,000 patients in 2020. The therapy aims to overcome current limitations in treating corneal epithelial defects through sustained protein expression via simple eye drop application.

Krystal Biotech (NASDAQ: KRYS) has initiated dosing in the Phase 3 IOLITE clinical trial of KB803, evaluating its effectiveness in treating and preventing corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. The trial is designed as an intra-patient, double-blind, multicenter, placebo-controlled study with crossover design.

The study will enroll approximately 16 subjects, targeting DEB patients aged 6 months or older. Previous compassionate use of the treatment showed promising results, with one patient achieving full corneal healing at 3 months and improved visual acuity from hand motion to 20/25 at 8 months. The condition affects over 750 patients in the United States and 2,000 worldwide, with no current corrective therapies available.

The trial's primary endpoint will measure the change in average days per month with corneal abrasion symptoms while receiving KB803 versus placebo. The treatment is administered as a weekly eye drop at a concentration of 109 PFU/mL.

Krystal Biotech (NASDAQ: KRYS) has announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference, taking place in Miami on June 10, 2025. Chairman and CEO Krish S. Krishnan will engage in a fireside chat at 2:00 pm ET and conduct investor meetings throughout the day. The presentation will be accessible via webcast starting at 2:00 pm ET and will be available on the company's Investors section of their website.

Krystal Biotech (NASDAQ: KRYS) has announced its participation in the BofA Securities 2025 Health Care Conference in Las Vegas on May 14, 2025. The company's Chairman and CEO, Krish S. Krishnan, will participate in a fireside chat at 11:20 am PT and conduct investor meetings throughout the day. The presentation will be accessible via webcast and will be available on the company's website in the Investors section.

Krystal Biotech reported strong Q1 2025 financial results, highlighted by VYJUVEK achieving $88.2 million in quarterly revenue and $429.4 million since its Q3 2023 launch. The company secured European Commission approval for VYJUVEK to treat DEB patients from birth, with German launch planned for mid-2025. Key financial metrics include a robust cash position of $765.3 million and quarterly net income of $35.7 million ($1.24 per share). The company maintains strong market access with 97% coverage under commercial and Medicaid plans, and 540+ reimbursement approvals. Pipeline developments include KB801 for neurotrophic keratitis entering clinical trials, and upcoming 2025 readouts for cystic fibrosis, AATD, DEB ocular complications, and aesthetics programs. VYJUVEK demonstrated 94% gross margin and 83% patient compliance.

Krystal Biotech (NASDAQ: KRYS) has received European Commission approval for VYJUVEK® (beremagene geperpavec-svdt), marking it as the first corrective medicine approved in Europe for treating dystrophic epidermolysis bullosa (DEB). The approval, granted on April 23, 2025, allows for treating DEB patients from birth who have COL7A1 gene mutations.

The treatment can be administered either at home or in healthcare settings, with the option for patient or caregiver administration when deemed appropriate by healthcare professionals. The approval covers all European Union member states, Iceland, Norway, and Liechtenstein, with Germany targeted for the first launch in mid-2025.

The approval was based on clinical evidence from Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, demonstrating successful COL7A1 gene delivery and durable wound closure. With approximately 1,000 DEB patients identified in France and Germany alone, Krystal Biotech aims to ensure widespread access to VYJUVEK across Europe.

Krystal Biotech (NASDAQ: KRYS) has announced its participation in multiple scientific conferences during May and June 2025, showcasing developments across lung, eye, and skin programs.

Key presentations include:

• An oral presentation on HSV-1 vector systems for respiratory tissues at the ASGCT 28th Annual Meeting on May 17
• A poster presentation on KB707 immunotherapy for lung tumors at ASCO Annual Meeting on June 2
• Research on KB801 gene therapy for corneal wounds at ARVO 2025 on May 5
• Findings on HSV-1-based gene therapy for Hailey-Hailey and Darier diseases at SID 2025 on May 9

All presentation materials will be made available on the company's investor relations website after the conferences.