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 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.
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.