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) 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.
Krystal Biotech (Nasdaq:KRYS) has announced positive preclinical results for KB301, a novel gene therapy aimed at reversing collagen decline in aging skin. Findings will be presented at the ASDS 2020 Virtual Meeting on October 9-11, 2020. The study showed that KB301 effectively transduced human dermal fibroblasts, inducing full-length COL3 expression. In vivo results indicated dose-dependent COL3 expression in mice, with no toxicity or systemic distribution observed. This research is critical as Krystal prepares to advance KB301 through clinical trials.
Krystal Biotech (NASDAQ: KRYS) announces its participation in significant healthcare conferences. CEO Krish S. Krishnan will present at the HC Wainwright 22nd Annual Global Investments Conference on September 15, 2020, at 4:30 PM ET and will also participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on September 16, 2020, at 5:00 PM ET. Both events will provide insights into Krystal’s innovative gene therapy developments. Webcasts of the presentations will be accessible for 30 days post-event on the company’s website.
Krystal Biotech (NASDAQ: KRYS) announced that the FDA has granted Orphan Drug Designation for its preclinical gene therapy product, KB407, targeting cystic fibrosis (CF). This designation supports the development of treatments for rare diseases affecting fewer than 200,000 individuals in the U.S. KB407 aims to provide non-invasive inhaled gene therapy, successfully delivering functional CFTR in cell studies. The company plans to file an IND in 2021, with marketing exclusivity and tax incentives available upon FDA approval.
Krystal Biotech (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will participate in a fireside chat at the William Blair BioTech Conference from August 4-6, 2020. The specific presentation is scheduled for August 6, 2020, at 11:00 a.m. ET. A webcast will be available for 30 days post-event on the company’s website. Krystal Biotech is focused on developing gene therapies for dermatological conditions, utilizing its proprietary HSV-1 platform. For more details, visit www.krystalbio.com.
Krystal Biotech has initiated the GEM-3 trial, a pivotal Phase 3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) patients. The trial is randomized and double-blind, involving around 30 patients for six months. B-VEC, a topical gene therapy, has shown positive results in earlier studies and is granted orphan drug and fast track designations by the FDA and EMA. The company expects to submit a Biologics License Application (BLA) in 2021, with a Marketing Authorization Application (MAA) soon after. Krystal's GMP facility is equipped to support the therapy's launch in the U.S.
Krystal Biotech (NASDAQ: KRYS) announced the appointment of Whitney Ijem as the Senior Vice President of Strategy and Business Development. Joining from Guggenheim Securities, Ijem brings extensive experience in genetic medicine. Her role aims to advance Krystal's efforts in treating rare skin and lung diseases using their proprietary HSV-1 platform. CEO Krish S. Krishnan expressed enthusiasm for Ijem’s addition, highlighting her strong industry connections and expertise.
Krystal Biotech (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast on June 10, 2020, at 1:20 p.m. ET. The presentation will highlight the company's transformative gene therapy developments aimed at treating protein or gene dysfunction-related diseases. A webcast will be accessible for 90 days post-event. For more details on Krystal's presentations, visit Krystal Biotech Website.
Krystal Biotech, Inc. (Nasdaq: KRYS) has announced the pricing of an underwritten public offering of 2,275,000 shares at $55.00 each, with gross proceeds expected to be about $125.1 million. The offering is set to close around May 21, 2020, and includes a 30-day option for underwriters to purchase an additional 341,250 shares. Proceeds will be used for advancing clinical trials and developing a manufacturing facility. Leading firms managing the offering include Cowen, Evercore ISI, and others.
Krystal Biotech (Nasdaq: KRYS) has announced an underwritten public offering of its common stock, granting underwriters a 30-day option for an additional 15% of shares. The offering is subject to market conditions and lacks definitive terms. Proceeds will fund the Phase 3 trial of KB103, advance KB105 development, and support clinical efforts for multiple other compounds. The company seeks to establish a certified manufacturing facility for its products and cover working capital needs. This offering is part of a shelf registration effective since May 4, 2020.
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