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) announced that the FDA has accepted its Biologics License Application (BLA) for B-VEC, a treatment for dystrophic epidermolysis bullosa (DEB). The application has received Priority Review status with a Prescription Drug User Fee Act (PDUFA) action date set for February 17, 2023. The FDA does not plan to hold an advisory committee meeting regarding this application. B-VEC, which has also received Fast Track and RMAT designations, aims to address the underlying causes of DEB by delivering the COL7A1 gene directly to wounds.
Krystal Biotech (NASDAQ: KRYS) announced that the FDA has accepted its Investigational New Drug (IND) application for KB407, a redosable gene therapy for cystic fibrosis (CF). Designed to treat all patients regardless of genetic mutation, KB407 aims to restore normal CFTR protein function in lung cells. The Phase 1 clinical trial will assess safety and tolerability in up to 20 adults with CF, using nebulized administration of the therapy. The trial is anticipated to commence in the second half of 2022, indicating a significant milestone for the company.
Krystal Biotech announced that the FDA has accepted its IND application for KB407, an investigational gene therapy for cystic fibrosis (CF). This therapy aims to treat all CF patients, regardless of their genetic mutation, by delivering two copies of the CFTR gene to lung cells. The Phase 1 clinical trial will assess the safety and tolerability of nebulized KB407 in up to 20 adult participants, with initiation expected in the second half of 2022. The treatment addresses a significant unmet need for roughly 10-15% of CF patients who lack effective disease-modifying options.
Krystal Biotech (NASDAQ: KRYS), a leader in redosable gene therapy, will participate in the William Blair Biotech Focus Conference 2022 on July 12-13 in New York. CEO Krish Krishnan will engage in a fireside chat and lead investor meetings on July 13. A webcast of the event will be available starting 9 AM ET on July 11. The company focuses on developing innovative therapies for serious diseases, particularly rare skin and lung conditions. For more information, visit Krystal Biotech's website.
Krystal Biotech (NASDAQ: KRYS) announced the submission of a Biologics License Application (BLA) to the FDA for B-VEC, a topical gene therapy for dystrophic epidermolysis bullosa (DEB). This therapy aims to address the COL7A1 gene deficiency, crucial for skin integrity. The BLA is supported by two clinical trials, GEM-3 and GEM-1/2, demonstrating safety and efficacy with no serious adverse events. The company plans further applications in Europe and Japan, expecting EMA submission in 2H 2022.
Krystal Biotech (NASDAQ: KRYS) announced its participation in the Goldman Sachs 43rd Annual Global Healthcare Conference scheduled for June 15, 2022. The company will be represented by Chairman and CEO Krish Krishnan in a session at 10:40 am PDT. Investors can access a live webcast of the presentation on the company’s website. Krystal Biotech is focused on developing innovative redosable gene therapies for serious conditions, particularly in skin and lung diseases.
Krystal Biotech, Inc. (NASDAQ: KRYS) unveiled new data from the phase 3 GEM-3 clinical trial on the investigational gene therapy B-VEC for dystrophic epidermolysis bullosa (DEB) at the Society for Investigative Dermatology Annual Meeting. The therapy aims to treat DEB by delivering copies of the COL7A1 gene to enhance collagen production. B-VEC has received orphan drug designation and fast track status from the FDA, indicating its potential for significant market impact. The findings contribute to Krystal's ongoing efforts to innovate in gene therapy for rare skin diseases.
Krystal Biotech (NASDAQ: KRYS) reported key operational updates for Q1 2022, highlighting progress on the B-VEC application for Dystrophic Epidermolysis Bullosa, expected to be filed in the US in 2Q 2022 and in the EU in 2H 2022. The FDA has approved at-home dosing in the Open Label Extension Study of B-VEC. Positive Phase 1 results for KB301 were also reported. The company ended the quarter with a strong cash position of $468.0 million, although net losses widened to $50.0 million.
PITTSBURGH, May 3, 2022 - Krystal Biotech, Inc. (NASDAQ: KRYS), a leader in redosable gene therapy, announced that CEO Krish S. Krishnan will speak at the Bank of America Merrill Lynch Global Healthcare Conference on May 10, 2022, at 9:20 AM PDT. The event will be accessible via webcast at this link. A replay will be available on the company's website for 90 days after the event. Krystal Biotech focuses on developing gene therapies for serious conditions, particularly rare diseases.
Krystal Biotech (NASDAQ: KRYS) announced that it will allow patients with dystrophic epidermolysis bullosa (DEB) in the GEM-3 open-label extension study to receive treatment at home by a healthcare professional. This decision, based on FDA feedback, aims to ease patient burden and enhance compliance. The company plans to incorporate home dosing into its Biologics License Application (BLA) submission anticipated in Q2 2022. The GEM-3 study, which began in May 2021, aims to assess the long-term safety of the investigational gene therapy B-VEC.
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