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 received a positive recommendation from the European Medicines Agency's CHMP for VYJUVEK®, a treatment for dystrophic epidermolysis bullosa (DEB). The therapy targets patients with COL7A1 gene mutations from birth.
The CHMP's recommendation supports VYJUVEK administration in clinical settings or at home, with trained patients or caregivers allowed to apply the treatment. The European Commission's final approval decision is expected in Q2 2025, covering EU member states, Iceland, Norway, and Liechtenstein.
The recommendation is based on Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, published in Nature Medicine and the New England Journal of Medicine. The company plans to launch first in Germany mid-2025, followed by France later that year.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced its participation in the TD Cowen 45th Annual Health Care Conference in Boston on March 4, 2025. Krish S. Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat at 1:50 pm ET and conduct investor meetings throughout the day.
The presentation will be accessible via webcast at the scheduled time and will subsequently be available in the Investors section of the company's website.
Krystal Biotech (NASDAQ: KRYS) reported strong financial results for Q4 and full year 2024. Q4 revenues increased 116% to $91.1 million, while full-year revenues grew 473% to $290.5 million compared to 2023. The company ended Q4 with $749.6 million in cash and investments.
VYJUVEK, their treatment for Dystrophic Epidermolysis Bullosa, achieved a 95% gross margin in Q4 and secured over 510 reimbursement approvals in the U.S., with 97% coverage under commercial and Medicaid plans. Patient compliance remained strong at 85%.
The company reported Q4 net income of $45.5 million ($1.58 per share basic) and full-year net income of $89.2 million ($3.12 per share basic). Clinical progress includes positive developments in their CF, AATD, and oncology programs, with KB707 showing a 27% objective response rate in lung cancer patients.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced it will release its fourth quarter and full year 2024 financial results on Wednesday, February 19, 2025, before U.S. markets open. The company's management will host a conference call and webcast at 8:30 am ET on the same day to discuss financial results and provide a business update.
A live webcast will be accessible to investors and the public, with a 30-day replay available on the company's investor relations website.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), has appointed Nishant Saxena as Chief Financial Officer, effective January 15, 2025. Saxena brings over 20 years of experience in finance, strategy, capital markets, M&A, and corporate development. He previously served as Managing Director at Evercore's healthcare group, where he advised on transactions exceeding $500 billion in total value.
In his 15+ years at Evercore, Saxena led numerous client engagements including mergers, IPOs, private placements, and structured financings. He holds both a B.S. in Economics and an MBA from the Wharton School. The appointment comes as Jeune prepares to advance its lead program into Phase 2 later in 2025, building on promising KB301 Phase 1 data in addressing aged skin treatments.
Krystal Biotech (NASDAQ: KRYS) reported promising preliminary results from its KYANITE-1 study evaluating inhaled KB707 in lung tumor patients. The study showed significant efficacy in non-small cell lung cancer (NSCLC) patients, with a 27% objective response rate (ORR) and 73% disease control rate (DCR).
The trial involved 37 patients, including 17 with advanced NSCLC. Among 11 evaluable NSCLC patients, who had received median 4 prior therapy lines, KB707 demonstrated notable results with 7 patients still on treatment. In lung lesions specifically, the ORR was 36% with three partial responses and one complete response.
Based on these positive results, Krystal Biotech has expanded the study to include combination therapy cohorts with anti-PD-1 therapy and chemotherapy. The treatment has been generally well-tolerated with mostly mild to moderate adverse events.
Krystal Biotech (NASDAQ: KRYS) announced clinical updates for its inhaled genetic medicine programs KB408 and KB407. The KB408 Phase 1 SERPENTINE-1 study showed successful SERPINA1 gene delivery and AAT expression in AATD patients. In two patients receiving bronchoscopies, conducting airway epithelial cells showed significant increases in AAT expression (35-39%) after KB408 dosing. One patient demonstrated an 8-fold increase in lung AAT levels and over 50% reduction in active neutrophil elastase.
The KB407 Phase 1 CORAL-1 study for cystic fibrosis received conditional sanctioning from CFF TDN. Five patients have been enrolled, with three receiving single doses and three receiving two daily doses. Both KB408 and KB407 demonstrated favorable safety profiles with only mild to moderate, transient adverse events reported. Additional data updates are expected in 2025.
Krystal Biotech (NASDAQ: KRYS) provided an update on the European Medicines Agency's (EMA) review of B-VEC for dystrophic epidermolysis bullosa (DEB). The EMA's Committee for Medicinal Products for Human Use (CHMP) cancelled the scheduled Oral Explanation and requested written responses to remaining issues. Notably, there are no Major Objections outstanding regarding B-VEC's full approval. The company now expects a CHMP opinion in 1Q 2025, while maintaining its planned commercial launch in Germany for Q2 2025.
Krystal Biotech (NASDAQ: KRYS) has announced its participation in two upcoming investor conferences. Chairman and CEO Krish S. Krishnan will participate in fireside chats at Citi's 2024 Global Healthcare Conference on December 3 at 8:45 am ET in Miami, Florida, and the 7th Annual Evercore HealthCONx Conference on December 4 at 2:10 pm ET in Coral Gables, Florida. Both presentations will be available via webcast on the company's website's Investors section, with recordings accessible for at least 30 days afterward.
Krystal Biotech (NASDAQ: KRYS) announced its participation in the Stifel 2024 Healthcare Conference on November 18, 2024, in New York. Chairman and CEO Krish S. Krishnan will participate in a fireside chat at 10:55 am ET and conduct investor meetings throughout the day. The presentation will be accessible via webcast and will be available on the company's website's Investors section.
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