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 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).
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.