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) reported positive interim data from the highest-dose cohort of its Phase 1 CORAL-1 study of KB407 in cystic fibrosis, confirming delivery and expression of unmodified wild-type CFTR protein in conducting airway cells. KB407 transduction was observed in all six patients with analysable bronchoscopies, with per‑patient transduction ranging 29.4%–42.1%. All biopsies from modulator‑ineligible (n=4, 23 biopsies) and modulator‑eligible (n=2, 8 biopsies) patients were positive for CFTR or viral marker. Safety through ≥28 days was generally mild/moderate; one SAE (asthma exacerbation) was judged procedure‑related and resolved. The company submitted the CORAL‑3 repeat‑dosing registrational study design to FDA in late December and expects study alignment in 1Q 2026 and enrollment start in 2Q 2026.
Krystal Biotech (NASDAQ: KRYS) announced an investor conference call and webcast on January 8, 2026 at 4:30 PM ET to present an interim clinical update from CORAL-1, its multi-center Phase 1 dose-escalation study of KB407 in patients with cystic fibrosis. The update will focus on data from the highest dose cohort and include molecular assessments of KB407 transduction and wild-type CFTR protein expression following inhaled administration.
Live webcast access is provided and an archived recording will be available on the company’s Investors website for at least 30 days.
Krystal Biotech (NASDAQ: KRYS) will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026 in San Francisco. Krish S. Krishnan, chairman and CEO, is scheduled to present at 10:30 am ET / 7:30 am PT and will host investor meetings throughout the day. A webcast of the presentation will be available beginning at 10:30 am ET / 7:30 am PT on January 12, 2026 and will be posted in the Investors section of the company website.
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.
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