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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.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), announced positive interim safety and efficacy results from Phase 1 study PEARL-1 for KB301, an investigational aesthetic treatment. The study evaluated KB301 for improving lateral canthal lines and dynamic wrinkles of the décolleté.
Key findings include:
- 94% of décolleté subjects showed improvement in wrinkles after two months
- 75% of lateral canthal subjects showed improvement in wrinkles after two months
- Improvements were also seen in crepiness, hydration, and radiance
- The safety profile was consistent with prior clinical experience
Based on these results, Jeune will progress KB301 into Phase 2 development for treating dynamic wrinkles of the décolleté. A conference call to discuss results is scheduled for August 28, 2024.
Krystal Biotech (NASDAQ: KRYS) reported strong Q2 2024 financial results, with net product revenue of $70.3 million, up 55.3% from Q1. VYJUVEK, their treatment for Dystrophic Epidermolysis Bullosa, has generated $166.2 million since launch in August 2023. The company secured over 400 reimbursement approvals in the U.S., with 97% positive access determinations for commercial and Medicaid plans. Krystal ended Q2 with $628.9 million in cash and investments.
The company expects three clinical readouts in H2 2024, including KB301 for aesthetics, KB408 for alpha-1 antitrypsin deficiency, and KB707 for solid tumors. Krystal is advancing its pipeline across respiratory, ophthalmology, oncology, and dermatology indications. For FY2024, they anticipate $150-$175 million in non-GAAP R&D and SG&A expenses.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced it will release its second quarter 2024 financial results on August 5, 2024, 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 the results and provide a business update.
Investors and the public can access the live webcast at a provided link. For those unable to attend, a replay will be available for 30 days on the company's website. This announcement indicates Krystal Biotech's commitment to transparency and shareholder communication, as it prepares to share its latest financial performance and operational progress.
Krystal Biotech (NASDAQ: KRYS) has announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, in Miami. CEO Krish S. Krishnan will participate in a fireside chat at 10:40 am ET and host investor meetings throughout the day. A webcast of the presentation will be available on the company's website.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, announced its participation in the American Thoracic Society (ATS) 2024 International Conference from May 17-22 in San Diego, CA. The company will present new preclinical data on respiratory genetic medicine candidates KB407 and KB408. Both are modified, replication-defective, non-integrating HSV-1 vectors designed for inhaled lung delivery via nebulization. KB407 aims to treat cystic fibrosis, while KB408 targets alpha-1 antitrypsin deficiency. Data on these candidates will be shared, including insights from ongoing Phase 1 studies. Poster presentations by Dr. Sara Artusi will provide further details.
Krystal Biotech, Inc. (NASDAQ: KRYS) will participate in the BofA Securities 2024 Health Care Conference where Chairman and CEO Krish S. Krishnan will engage in a fireside chat and host investor meetings. The webcast of the presentation will be available on the Company's website.
Krystal Biotech, Inc. reported $45.3 million in net product revenue for 1Q 2024. The company is focused on delivering genetic medicines for rare diseases like Dystrophic Epidermolysis Bullosa. With a strong financial position and positive performance in clinical trials, Krystal Biotech is poised for growth. Key developments include progress with VYJUVEK, successful clinical studies in Japan, and ongoing trials for cystic fibrosis and alpha-1 antitrypsin deficiency treatments. The company also received FDA Fast Track Designation for inhaled KB707 for lung tumors. Financially, the company recorded $622.3 million in cash and investments with a net income of $0.9 million for 1Q 2024.
Krystal Biotech announced their participation in the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting where they will present new preclinical data on their HSV-1 based vector platform for back of the eye gene delivery. The poster presentation will focus on localized delivery to the posterior of the eye, with details about the presenter, date, time, and abstract number. The poster will be available both at the conference and online on the Investor section of the Company's website.
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