Krystal Biotech reports news on its commercial genetic-medicines business, led by VYJUVEK, a redosable gene therapy approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa. Company updates commonly cover VYJUVEK revenue and global commercialization, manufacturing and platform developments, and regulatory actions tied to its HSV-1-based gene delivery technology.
Recurring clinical and scientific updates address investigational programs including KB407 for cystic fibrosis, KB707 for advanced or metastatic non-small cell lung cancer, KB111 for Hailey-Hailey disease, KB803 for corneal abrasions in DEB patients, and additional HSV-1-based vectors. News also includes quarterly operating results, conference presentations, FDA designations, and investor-event participation.
Krystal Biotech (NASDAQ: KRYS) will participate in the 8th Annual Evercore Healthcare Conference on December 3, 2025 in Miami.
Krish S. Krishnan, Chairman and CEO, will appear in a fireside chat at 10:00 am ET and will host investor meetings throughout the day. A webcast of the presentation will be available beginning at 10:00 am ET on December 3, 2025 and will be posted in the Investors section of the company website.
Krystal Biotech (NASDAQ: KRYS) reported 3Q 2025 results: $97.8M VYJUVEK net product revenue in the quarter and $623.2M total since U.S. launch; quarter gross margin was 96%. Cash and investments were $864.2M as of Sept 30, 2025. The FDA approved a label update expanding VYJUVEK use from birth and enabling at-home application. VYJUVEK launched in Germany (3Q), and in France and Japan (4Q); France received an ASMR III appraisal and early reimbursed access under AP2. FDA granted platform technology designation for the KB801 vector. Clinical readouts expected: CF interim data Q4 2025, KB408 cohort data 1H 2026, KB707 interim/registrational plans 2H 2026. FY2025 non-GAAP R&D+SG&A guidance: $145–$155M.
Krystal Biotech (NASDAQ: KRYS) will report third quarter 2025 financial results on Monday, November 3, 2025, before the U.S. market open. Management will host a conference call and webcast at 8:30 am ET on November 3 to discuss results and provide a business update.
Investors can access the live webcast at https://www.webcaster5.com/Webcast/Page/3018/53113. A replay will be available for at least 30 days on the Investors section of the company website at www.krystalbio.com.
Krystal Biotech (NASDAQ: KRYS) announced on October 14, 2025 that the FDA granted platform technology designation to its genetically modified, non-replicating HSV-1 viral vector used in KB801, a redosable eye-drop gene therapy under randomized placebo-controlled study for neurotrophic keratitis (NK).
The designation may allow Krystal to leverage manufacturing and nonclinical safety data from prior FDA‑approved VYJUVEK and obtain earlier, more frequent FDA engagement, potentially creating efficiencies in development, manufacturing, and review for KB801 and other pipeline programs.
Krystal Biotech (NASDAQ: KRYS) has received FDA approval for important updates to the VYJUVEK® label, its treatment for dystrophic epidermolysis bullosa (DEB). The key changes include expanding patient eligibility to include newborns and allowing patients and caregivers to apply the treatment themselves.
The updated label also provides greater flexibility in wound dressing management, allowing dressing removal during the next change rather than waiting 24 hours. These modifications are supported by real-world data and results from an open-label extension study, demonstrating VYJUVEK's long-term safety and efficacy across all age groups.
Krystal Biotech (NASDAQ:KRYS) announced its participation in the upcoming Cantor Global Healthcare Conference 2025, taking place in New York on September 4, 2025. Chairman and CEO Krish S. Krishnan will participate in a fireside chat at 10:20 AM ET and conduct investor meetings throughout the day.
The presentation will be accessible via webcast and will be made available on the Investors section of the company's website.
Krystal Biotech (NASDAQ: KRYS) announced a strategic update for its oncology program KB707, focusing on the inhaled delivery method for treating non-small cell lung cancer (NSCLC). The company has secured an FDA End of Phase 2 meeting in October to discuss potential registration pathways for inhaled KB707.
The decision follows promising clinical results presented at ASCO 2025, showing an objective response rate of 36% in heavily pre-treated NSCLC patients. The treatment demonstrated durability with median response and progression-free survival not yet reached. Importantly, inhaled KB707 showed a favorable safety profile with no Grade 4 or 5 adverse events.
As part of this prioritization, Krystal has paused enrollment in the OPAL-1 study for intratumoral KB707 while continuing the KYANITE-1 study for inhaled KB707 in lung tumors.
Krystal Biotech (NASDAQ: KRYS) reported strong Q2 2025 financial results, highlighted by $96.0 million in VYJUVEK revenue and a robust cash position of $820.8 million. The company achieved significant milestones including VYJUVEK's approval in Japan for DEB treatment from birth, with $525.4 million in total revenue since launch in 3Q 2023.
The quarter saw impressive performance metrics including 93% gross margin and 82% patient compliance. Net income reached $38.3 million ($1.33 per share), with planned European launches in Germany (Q3) and France (Q4). The company advanced multiple clinical programs across respiratory, ophthalmology, oncology, and aesthetics divisions, with key trial progressions in CF, AATD, corneal treatments, and solid tumors.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has scheduled its second quarter 2025 financial results announcement for Monday, August 4, 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. A replay of the webcast will be available for at least 30 days on the company's investor relations website.
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).