Welcome to our dedicated page for Krystal Biotech news (Ticker: KRYS), a resource for investors and traders seeking the latest updates and insights on Krystal Biotech stock.
Krystal Biotech, Inc. (KRYS) is a leader in redosable gene therapies targeting rare dermatological conditions and respiratory diseases through its proprietary HSV-1 delivery platform. This page aggregates official press releases, clinical trial updates, and regulatory developments directly from the company.
Investors and researchers can monitor progress across four key areas: dermatology (including VYJUVEK commercialization), oncology (KB707 cytokine therapy), respiratory (inhaled genetic medicines), and aesthetic medicine through subsidiary Jeune Aesthetics. All content is sourced from verified corporate communications.
Bookmark this page for real-time updates on FDA submissions, partnership announcements, and financial results. Our curation ensures you never miss critical developments in KRYS's mission to transform genetic medicine delivery.
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.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has scheduled its first quarter 2025 financial results announcement for Tuesday, May 6, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:30 am ET on the same day to discuss the results and provide a business update.
Investors and the public can access the live webcast through a dedicated link, and a replay will remain available for at least 30 days on the company's investor relations website.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), has appointed Marc Forth as Chief Executive Officer, effective April 07, 2025. Forth brings over 30 years of healthcare industry experience, notably in commercial and executive leadership.
Forth's impressive background includes serving as President and CEO of AEON Biopharma, where he managed the botulinum toxin type A complex agent ABP-450 development program. Previously, as Senior Vice President at Allergan PLC, he headed the U.S. Neurosciences, Urology and Medical Dermatology Divisions. His 16-year tenure at Allergan involved commercializing BOTOX® Therapeutic and developing marketing strategies for BOTOX® Cosmetic.
Jeune Aesthetics leverages Krystal's FDA-validated gene-delivery platform to address aging skin biology. Forth has been a board member since February 2021 and will now lead the company's expansion in rejuvenative aesthetics.
Krystal Biotech (NASDAQ: KRYS) has received a positive recommendation from the European Medicines Agency's CHMP for VYJUVEK®, a treatment for dystrophic epidermolysis bullosa (DEB). The therapy targets patients with COL7A1 gene mutations from birth.
The CHMP's recommendation supports VYJUVEK administration in clinical settings or at home, with trained patients or caregivers allowed to apply the treatment. The European Commission's final approval decision is expected in Q2 2025, covering EU member states, Iceland, Norway, and Liechtenstein.
The recommendation is based on Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, published in Nature Medicine and the New England Journal of Medicine. The company plans to launch first in Germany mid-2025, followed by France later that year.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced its participation in the TD Cowen 45th Annual Health Care Conference in Boston on March 4, 2025. Krish S. Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat at 1:50 pm ET and conduct investor meetings throughout the day.
The presentation will be accessible via webcast at the scheduled time and will subsequently be available in the Investors section of the company's website.
Krystal Biotech (NASDAQ: KRYS) reported strong financial results for Q4 and full year 2024. Q4 revenues increased 116% to $91.1 million, while full-year revenues grew 473% to $290.5 million compared to 2023. The company ended Q4 with $749.6 million in cash and investments.
VYJUVEK, their treatment for Dystrophic Epidermolysis Bullosa, achieved a 95% gross margin in Q4 and secured over 510 reimbursement approvals in the U.S., with 97% coverage under commercial and Medicaid plans. Patient compliance remained strong at 85%.
The company reported Q4 net income of $45.5 million ($1.58 per share basic) and full-year net income of $89.2 million ($3.12 per share basic). Clinical progress includes positive developments in their CF, AATD, and oncology programs, with KB707 showing a 27% objective response rate in lung cancer patients.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced it will release its fourth quarter and full year 2024 financial results on Wednesday, February 19, 2025, before U.S. markets open. The company's management will host a conference call and webcast at 8:30 am ET on the same day to discuss financial results and provide a business update.
A live webcast will be accessible to investors and the public, with a 30-day replay available on the company's investor relations website.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), has appointed Nishant Saxena as Chief Financial Officer, effective January 15, 2025. Saxena brings over 20 years of experience in finance, strategy, capital markets, M&A, and corporate development. He previously served as Managing Director at Evercore's healthcare group, where he advised on transactions exceeding $500 billion in total value.
In his 15+ years at Evercore, Saxena led numerous client engagements including mergers, IPOs, private placements, and structured financings. He holds both a B.S. in Economics and an MBA from the Wharton School. The appointment comes as Jeune prepares to advance its lead program into Phase 2 later in 2025, building on promising KB301 Phase 1 data in addressing aged skin treatments.
Krystal Biotech (NASDAQ: KRYS) reported promising preliminary results from its KYANITE-1 study evaluating inhaled KB707 in lung tumor patients. The study showed significant efficacy in non-small cell lung cancer (NSCLC) patients, with a 27% objective response rate (ORR) and 73% disease control rate (DCR).
The trial involved 37 patients, including 17 with advanced NSCLC. Among 11 evaluable NSCLC patients, who had received median 4 prior therapy lines, KB707 demonstrated notable results with 7 patients still on treatment. In lung lesions specifically, the ORR was 36% with three partial responses and one complete response.
Based on these positive results, Krystal Biotech has expanded the study to include combination therapy cohorts with anti-PD-1 therapy and chemotherapy. The treatment has been generally well-tolerated with mostly mild to moderate adverse events.
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