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 pioneering commercial-stage biotechnology company specializing in the development of innovative gene therapies for skin diseases. Headquartered in Pittsburgh, Pennsylvania, the company leverages its proprietary gene therapy platform, known as STAR-D, to create revolutionary treatments for rare and orphan dermatological conditions caused by genetic mutations.
Krystal Biotech's flagship product, VYJUVEK, is a topical, non-invasive, and redosable gene therapy designed to treat dystrophic epidermolysis bullosa (DEB), a debilitating skin disease characterized by fragile, blistering skin. VYJUVEK delivers the COL7A1 gene directly to the skin, providing the cells with the template to produce normal collagen type VII, thereby addressing the root cause of the disease. This groundbreaking therapy is the first-ever redosable gene therapy approved by the FDA for DEB, marking a significant milestone in genetic medicine.
The company's robust pipeline includes several promising candidates such as KB407 for cystic fibrosis, KB408 for alpha-1 antitrypsin deficiency, and KB707, an innovative gene therapy for solid tumors. KB707 is notable for its dual-action mechanism, delivering genes encoding interleukin-12 (IL-12) and interleukin-2 (IL-2) to promote tumor clearance. This treatment has received Fast Track Designation from the FDA, reflecting its potential to meet critical unmet medical needs.
Krystal Biotech's commitment to scientific innovation and operational excellence extends to its aesthetic subsidiary, Jeune Aesthetics, Inc., which focuses on reversing the biology of aging and damaged skin.
Recent developments highlight Krystal Biotech's ongoing efforts to expand its global footprint. The company has submitted a Marketing Authorization Application for VYJUVEK to the European Medicines Agency, with a CHMP opinion anticipated in the second half of 2024. Additionally, VYJUVEK has been granted Orphan Drug Designation in Japan, underscoring its potential to address significant unmet medical needs in international markets.
Financial Performance: In 2023, Krystal Biotech reported significant financial growth, driven by the successful launch and robust demand for VYJUVEK in the U.S. market. The company achieved $50.7 million in net product revenue within six months of VYJUVEK's approval, supported by high patient and physician demand, broad access, and compliance.
Krystal Biotech continues to advance its clinical and preclinical pipeline, striving to deliver next-generation genetic medicines across various therapeutic areas, including respiratory, oncology, dermatology, ophthalmology, and aesthetics.
For more information, visit www.krystalbio.com and follow @KrystalBiotech on LinkedIn and Twitter.
Krystal Biotech (NASDAQ: KRYS) has completed enrollment for the pivotal GEM-3 study of B-VEC, a treatment for dystrophic epidermolysis bullosa (DEB). The study enrolled 31 patients, with 61% being pediatric. The company plans to report top-line results in Q4 2021, marking a significant milestone for potential treatment options for DEB. B-VEC is designed to address the root cause of DEB through a topical application in a double-blind, placebo-controlled setting.
Krystal Biotech (NASDAQ: KRYS) has announced its participation in two virtual conferences. The first is the Guggenheim Healthcare Talks: 2021 Genomic Medicines & Rare Disease on April 1, where Krystal's leadership will join a panel discussion at 4:00 PM ET. The second event is the 2021 Virtual Cell & Gene Meeting on the Mediterranean from April 6-9, featuring on-demand presentations. Krystal focuses on redosable gene therapies for rare diseases and is committed to developing innovative treatments.
Krystal Biotech Inc. (NASDAQ: KRYS) launched a new subsidiary, Jeune, Inc., focusing on aesthetic gene therapies. Initial data from the Phase 1 PEARL-1 study for their lead candidate, KB301, indicates safety and tolerability following repeat injections. Results from seven healthy subjects showed no safety signals, with mild, transient adverse events. KB301 effectively expressed COL3A1 collagen gene, crucial for skin health. Jeune plans to advance KB301 and other products targeting aging skin, with detailed data to be presented at the SID Annual Meeting in May.
Krystal Biotech reported key operational updates and financial results for Q4 2020. The company anticipates completing enrollment in the pivotal B-VEC GEM-3 study in Q1 2021, with topline data expected in Q4 2021. The European Medicines Agency granted orphan drug designation for KB407, aimed at treating cystic fibrosis. As of December 31, 2020, the company had a strong balance sheet with $271.3 million in cash and equivalents. Net losses for 2020 totaled $32.2 million, with a loss per share of $(1.71). A public offering in February raised $135 million in net proceeds.
Krystal Biotech Inc. (NASDAQ: KRYS) announced that Krish S. Krishnan, CEO, will participate in a fireside chat at the 41st Annual Cowen Health Care Conference from March 1-4, 2021. The presentation is scheduled for March 4, 2021, at 9:50 AM EST. Interested individuals can access the webcast via this link. A recording will be available for 90 days on the company’s website. Krystal Biotech focuses on developing therapies for rare diseases through its innovative gene therapy platform.
Krystal Biotech (NASDAQ: KRYS) announced a public offering of 1,923,077 shares at $65.00 per share, aiming to raise approximately $125 million. Underwriters have a 30-day option for an additional 288,461 shares. The funds will support pivotal trials for B-VEC, advance clinical development of KB105 and KB104, and bolster the respiratory pipeline. The offering is set to close around February 5, 2021, following customary conditions. Goldman Sachs, Cowen, and Evercore act as joint book-running managers.
Krystal Biotech Inc. (NASDAQ: KRYS) announced a $100 million underwritten public offering of its common stock, with a potential 15% increase in shares for underwriters. The funds will support ongoing clinical trials, including pivotal testing of B-VEC for DEB, and advance the development of therapies for cystic fibrosis and other rare diseases. The offering is contingent on market conditions and is conducted under a previously effective shelf registration statement.
Krystal Biotech (NASDAQ: KRYS) has appointed Dr. Chris Mason and Dr. Jing L. Marantz to its board of directors, enhancing its expertise in gene therapy and rare diseases. Dr. Mason, with over 25 years in cell and gene therapy, brings substantial R&D experience, while Dr. Marantz contributes over 20 years in the biopharmaceutical sector, specializing in medical affairs and commercial strategy. Their appointments are expected to bolster Krystal's efforts to advance its proprietary gene therapy technologies and tackle significant unmet medical needs.
Krystal Biotech Inc. (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx virtual conference, scheduled for December 1-3, 2020. The presentation will take place on December 1 at 1:50 p.m. ET. Interested parties can access the webcast via this link. A recording of the presentation will be available for 90 days on Krystal's website.
Krystal specializes in innovative gene therapies targeting rare skin and lung diseases.
Krystal Biotech (Nasdaq:KRYS) announces the departure of Chief Commercial Officer Jennifer Chien, effective immediately, as she pursues another opportunity. The company’s senior commercial team will report directly to CEO Krish Krishnan during the search for her replacement. Despite the leadership change, Krishnan expresses confidence in the continuity of pre-launch activities and states that the GEM-3 clinical trial is progressing as planned with early enrollment completion expected next year. Challenges from the COVID-19 environment have been managed effectively, maintaining patient enrollment across U.S. sites.
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