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 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.
Krystal Biotech (NASDAQ: KRYS) announced updates to the Statistical Analysis Plan for its Phase 3 GEM-3 study of B-VEC, a treatment for dystrophic epidermolysis bullosa (DEB), following FDA guidance. The randomized trial aims to evaluate the safety and efficacy of B-VEC, with 31 enrolled patients. Adjustments made include the primary outcome measure of complete wound healing at specific weeks and the use of the McNemar test for analysis. Previous studies showed promising results with a 78.6% healing rate in B-VEC treated wounds. The trial continues to be double-blind until data lock in Q4 2021.
Krystal Biotech (NASDAQ: KRYS) announced positive results from a GLP toxicology study of its inhaled gene therapy KB407 for cystic fibrosis, showing it was well-tolerated in nonhuman primates. Key findings include a high No-Observed-Adverse-Effect Level (NOAEL) and successful distribution in lung tissues. The company is also advancing KB408 for alpha-1 antitrypsin deficiency, with promising initial preclinical results. Krystal plans to initiate a Phase 1 study of KB407 in 3Q21 and will present more detailed data for KB408 at an upcoming scientific conference.
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.
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