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 reports news on its commercial genetic-medicines business, led by VYJUVEK, a redosable gene therapy approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa. Company updates commonly cover VYJUVEK revenue and global commercialization, manufacturing and platform developments, and regulatory actions tied to its HSV-1-based gene delivery technology.
Recurring clinical and scientific updates address investigational programs including KB407 for cystic fibrosis, KB707 for advanced or metastatic non-small cell lung cancer, KB111 for Hailey-Hailey disease, KB803 for corneal abrasions in DEB patients, and additional HSV-1-based vectors. News also includes quarterly operating results, conference presentations, FDA designations, and investor-event participation.
Krystal Biotech has received approval from the Bellberry Human Research Ethics Committee in Australia for a Phase 1 clinical trial of its investigational inhaled gene therapy, KB407, aimed at treating cystic fibrosis (CF). This therapy delivers the CFTR gene to lung cells via nebulization. Enrollment for the trial is expected to start soon, following additional institutional approvals. The study will assess safety and tolerability, focusing on lung function improvements over three dosing cohorts. The company's efforts follow COVID-related delays, with plans to initiate a US trial in 2022.
Krystal Biotech (NASDAQ: KRYS) has appointed Laurent Goux as General Manager of Europe, bringing over 20 years of experience in biotechnology. Previously a key player at Galderma, Goux has successfully launched multiple dermatologic medicines and will enhance Krystal’s commercial capabilities in Europe. This leadership change comes as the company advances its lead investigational program, B-VEC for DEB, and aims to build a fully integrated biotechnology company. Goux expressed enthusiasm for contributing to Krystal's mission of developing treatments for rare diseases.
Krystal Biotech, a leader in redosable gene therapies, announced it will present data on its product candidate, beremagene geperpavec (B-VEC), for treating dystrophic epidermolysis bullosa (DEB) at the DEBRA International Conference 2021. The data includes findings from a murine model demonstrating safety and collagen VII expression after B-VEC application. The U.S. FDA approved a compassionate use request for topical B-VEC in a DEB patient's eye following surgery. DEB currently lacks approved treatments for corneal lesions.
Krystal Biotech (NASDAQ: KRYS) will present at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference, occurring from September 13-15, 2021. The company specializes in redosable gene therapies for rare diseases.
The pre-recorded presentation will be available on-demand starting September 13 at 7:00 A.M. (ET). For attendees, the presentation will be accessible for 90 days via the Krystal Biotech website. Learn more about their innovative therapies and ongoing developments at their official site.
Krystal Biotech (NASDAQ: KRYS) announced its second quarter 2021 financial results, reporting a robust cash position of $389.1 million as of June 30, 2021, up from $271.3 million at year-end 2020. The company is advancing multiple clinical programs, including the pivotal GEM-3 trial for B-VEC targeting dystrophic epidermolysis bullosa, with top-line results expected in 4Q21. Additionally, it plans to initiate a Phase 1 study for inhaled KB407 for cystic fibrosis in 3Q21 and has advanced its KB301 program for aesthetic applications.
Krystal Biotech (NASDAQ: KRYS) announced updates from its Phase 1/2 trial of KB105 for treating autosomal recessive congenital ichthyosis (ARCI). The fourth patient data shows KB105 is well tolerated, with no adverse events or immune response. Significant phenotypic improvement was noted in treated areas, particularly in high-dose sites. The next Phase 2 cohort may include pediatric patients, with discussions on optimal dosing ongoing. These promising results build on prior findings of increased TGM-1 expression from three previous patients.
Krystal Biotech (NASDAQ: KRYS) announced its participation in two virtual investor conferences. The first is the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 11:20 AM ET. A webcast link for this event is available. The second conference is the LifeSci Partners Genetic Medicines Summit 2021, scheduled for June 22, 2021. Krystal is known for its innovative gene therapy platform aimed at treating rare diseases. For further details, visit krystalbio.com.
Krystal Biotech reported financial results for Q1 2021, highlighting a strong balance sheet with cash, cash equivalents, and short-term investments totaling $403.4 million. The company completed enrollment in the pivotal GEM-3 study for B-VEC in dystrophic epidermolysis bullosa (DEB). Anticipated top-line data is expected in 4Q21. Additionally, Krystal is on track to provide updates for their KB105 and KB407 programs in 1H21 and 3Q21, respectively. Notably, R&D expenses increased to $6.2 million, and the net loss for the quarter was $15.8 million ($0.74 per share).
Krystal Biotech (NASDAQ: KRYS) has appointed Andy Orth as Chief Commercial Officer. With over 25 years of experience in biotechnology, Orth previously led U.S. operations at Alnylam Pharmaceuticals. His expertise in launching genetic medicines is seen as vital for Krystal’s growth, especially for its investigational program B-VEC aimed at treating dystrophic epidermolysis bullosa (DEB). The company aims to enhance its commercial capabilities to bring essential treatments to patients.
On April 27, 2021, Krystal Biotech (NASDAQ: KRYS) announced a digital poster presentation at the American Society of Genetic & Cell Therapy (ASGCT) Annual Meeting from May 11-14, 2021. The presentation will showcase preclinical data from its vector-encoded antibody platform, highlighting in vitro efficacy with KB501 and KB502 targeting antibodies for atopic dermatitis. The session is scheduled for May 11, 2021. Suma Krishnan, COO of Krystal, emphasized the potential of their approach for treating chronic conditions.