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.
On April 23, 2023, at the ARVO Annual Meeting, Krystal Biotech (NASDAQ: KRYS) presented promising data on the compassionate use of its gene therapy B-VEC for treating dystrophic epidermolysis bullosa (DEB) patients with ocular complications. The therapy, administered to a patient with recurrent cicatrizing conjunctivitis, showed significant results: full corneal re-epithelization within three months and improved visual acuity from hand motion to 20/40 at seven months. No drug-related adverse events were reported, underscoring the safety of B-VEC. With ocular complications affecting over half of DEB patients, this innovative treatment may address an urgent need in this underserved population, prompting the company to engage with regulatory authorities for further exploration of B-VEC’s applications.
Krystal Biotech (NASDAQ: KRYS) announced the upcoming presentation of new clinical data regarding the compassionate use of B-VEC for a patient with dystrophic epidermolysis bullosa (DEB) experiencing recurrent cicatrizing conjunctivitis. This presentation will occur during the ARVO 2023 Annual Meeting from April 23-27, 2023, in New Orleans, LA. The presentation, titled 'Topical beremagene geperpavec (B-VEC) for the treatment of recurrent cicatrizing conjunctivitis in a patient with DEB', will be delivered by Alfonso L. Sabater, M.D., PhD of the University of Miami Health System on April 23 from 12:00 PM to 1:45 PM CST.
Attendees can view the poster at the conference, and additional materials will be available online at the Company's website following the event.
Krystal Biotech (NASDAQ: KRYS) appointed Catherine Mazzacco to its Board of Directors. Her extensive background in the pharmaceutical industry, including roles at LEO Pharma and GE HealthCare, is expected to enhance the company's strategic objectives. CEO Krish S. Krishnan emphasized the importance of her experience in guiding Krystal's evolution as it advances its genetic medicines pipeline for rare diseases. Mazzacco expressed enthusiasm for contributing to the company's commercialization efforts and pipeline progression, aiming to transform lives with innovative treatments.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced its participation in the 43rd Annual TD Cowen Health Care Conference in Boston from March 6-8, 2023. CEO Krish S. Krishnan will hold a fireside chat and investor meetings on March 7 at 10:30 AM ET. The presentation will be webstreamed live, with an archived version available afterward on the company’s website. Krystal Biotech focuses on developing genetic medicines for rare diseases and operates a diverse pipeline using its proprietary redosable HSV vector. Headquartered in Pittsburgh, it boasts capabilities in viral vector design and gene therapy manufacturing.
Krystal Biotech (KRYS) reported key updates and financial results for Q4 and the full year 2022 on February 27, 2023. The company has a strong cash position, ending the year with $383.8 million in cash and investments. The PDUFA date for its B-VEC treatment for Dystrophic Epidermolysis Bullosa is set for May 19, 2023. The pivotal Phase 3 trial data of B-VEC was published in the New England Journal of Medicine. Krystal plans to initiate four new clinical trials in 2023 and aims to operationalize its second manufacturing facility, ASTRA, early this year.
On January 18, 2023, Krystal Biotech (NASDAQ: KRYS) announced that the European Commission has granted orphan designation for its investigational gene therapy, KB407, targeting Cystic Fibrosis (CF). This therapy aims to directly deliver the CFTR gene to lung cells, potentially restoring normal function regardless of genetic mutations. The U.S. Food and Drug Administration has also granted orphan drug status to KB407. The designation allows for funding and regulatory incentives, including a 10-year marketing exclusivity period in the EU. CEO Suma Krishnan expressed optimism about advancing treatment options for CF patients.
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