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. (NASDAQ: KRYS) is a commercial-stage biotechnology company headquartered in Pittsburgh, Pennsylvania, focused on genetic medicines for diseases with high unmet medical needs. Its news flow reflects the evolution of a gene therapy business built around VYJUVEK, the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa, and a growing pipeline across respiratory, ophthalmology, dermatology, oncology, and aesthetics.
On this page, readers can follow KRYS news related to commercial performance and global launches of VYJUVEK, including label updates, reimbursement milestones, and market expansions in regions such as Europe and Japan. Company updates also cover strategic objectives for building a rare disease franchise, including plans to increase the number of marketed rare disease medicines and to reach more patients worldwide through direct launches and specialty distributor networks.
Investors and observers will find frequent clinical and regulatory news on Krystal Biotech’s pipeline programs. This includes interim data from studies such as CORAL‑1 for KB407 in cystic fibrosis, SERPENTINE‑1 for KB408 in alpha‑1 antitrypsin deficiency lung disease, IOLITE for KB803 in ocular complications of DEB, EMERALD‑1 for KB801 in neurotrophic keratitis, and oncology trials of KB707 in non‑small cell lung cancer. Updates often detail safety and molecular findings, study design progress, and interactions with regulators, such as FDA platform technology designation for the HSV‑1 vector used in KB801.
Krystal Biotech also regularly announces participation in major healthcare and investor conferences, quarterly financial results, and corporate guidance through press releases and SEC filings. This news page aggregates those disclosures so that users tracking KRYS stock can review earnings announcements, business updates, and key clinical milestones in one place.
Krystal Biotech (NASDAQ: KRYS) will present at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 in Boston. Company executives will participate in a fireside chat at 3:10 pm ET and hold investor meetings that day. A webcast will be available beginning at 3:10 pm ET and posted on the Investors section of the company website.
Krystal Biotech (NASDAQ: KRYS) reported strong 4Q and FY2025 results highlighted by $107.1M in 4Q VYJUVEK revenue and $389.1M for full-year product revenue, with a 94% gross margin. The company ended 2025 with $955.9M in cash and investments and provided FY2026 non-GAAP R&D+SG&A guidance of $175–$195M. Regulatory milestones include FDA RMAT for KB707 (advanced NSCLC) and Fast Track for KB111 (Hailey-Hailey disease). Positive clinical readouts were reported for inhaled KB407 (CF airway transduction 29.4%–42.1%) and multiple registrational study timelines target 2026–2027.
Krystal Biotech (NASDAQ: KRYS) will report fourth quarter and full year 2025 financial results on Tuesday, February 17, 2026, before the U.S. market opens. Management will host a conference call and live webcast at 8:30 am ET that day to discuss results and provide a business update.
According to the company, the live webcast is available at the provided webcast link and a replay will be accessible for at least 30 days on the Investors section of the company website.
Krystal Biotech (NASDAQ: KRYS) announced on February 9, 2026 that the FDA granted RMAT designation to KB707 for treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The designation recognizes preliminary clinical activity from the ongoing KYANITE-1 trial and offers expedited development benefits such as rolling review and intensive FDA interaction. Enrollment in KYANITE-1 continues; additional data will be presented at upcoming scientific conferences and the trial is listed as NCT06228326.
Krystal Biotech (NASDAQ: KRYS) provided a business update ahead of its J.P. Morgan Healthcare Conference presentation on Jan 12, 2026, reporting preliminary unaudited Q4 2025 VYJUVEK net revenue of $106M–$107M and full‑year 2025 revenue of $388M–$389M. Cash, cash equivalents, and investments were approximately $955M as of Dec 31, 2025. The company raised enrollment for a registrational NK study from 27 to 60 patients, expects top‑line NK data before end of 2026, and plans multiple registrational readouts in 2026. 2026 objectives include additional European launches, expanding distribution to >40 countries, and advancing a pipeline aimed at four marketed rare‑disease medicines by 2030. 2026 non‑GAAP R&D+SG&A guidance: $175M–$195M.
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.