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Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
GlobeNewswire· 2025-04-28 11:00
VYJUVEK approved for the treatment of DEB from birth in Europe Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional PITTSBURGH, April 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) announced today that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dy ...
Krystal Biotech to Present at Upcoming Scientific Conferences
Newsfilter· 2025-04-24 12:00
Core Insights - Krystal Biotech, Inc. will present multiple programs related to lung, eye, and skin at scientific conferences in May and June 2025 [1] Conference Presentations - The company will participate in the following conferences: - American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting: Invited Oral Presentation [2] - 2025 American Society of Clinical Oncology (ASCO) Annual Meeting: Poster Presentation [2] - Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting: Poster Presentation [2] - Society for Investigative Dermatology (SID) 2025 Annual Meeting: Poster Presentation [3] Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on genetic medicines for diseases with high unmet medical needs [4] - The company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy approved by the FDA for dystrophic epidermolysis bullosa [4] - The company is advancing a pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [4]
Krystal Biotech to Report First Quarter 2025 Financial Results on May 6, 2025
GlobeNewswire· 2025-04-17 12:00
PITTSBURGH, April 17, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its first quarter 2025 financial results on Tuesday, May 6, 2025, prior to the open of U.S. markets. The Company’s management will also host a conference call and webcast at 8:30 am ET on Tuesday, May 6, 2025, to discuss the financial results and provide a business update. Investors and the general public can access the live webcas ...
Jeune Aesthetics Appoints Marc Forth as Chief Executive Officer
Newsfilter· 2025-04-07 20:30
PITTSBURGH, April 07, 2025 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. ("Jeune"), a wholly owned subsidiary of Krystal Biotech, Inc. ("Krystal") (NASDAQ:KRYS) leveraging Krystal's clinically validated gene-delivery platform to fundamentally address and reverse the biology of aging skin, announced today the appointment of Marc Forth as Chief Executive Officer (CEO), effective today. A veteran of the healthcare industry, Mr. Forth has over 30 years of commercial and executive leadership experience, with an ext ...
Krystal Biotech: Preparing To Chase Following Positive CHMP Opinion For VYJUVEK
Seeking Alpha· 2025-03-24 12:30
Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial.Krystal Biotech (NASDAQ: KRYS ) has been on the Compounding Healthcare “Bio Boom” speculative portfolio since the investing group’s inception due to their ability to develop cutting-edge “redosable” gene therapies. Although I am a big believer in cell an ...
Here's Why Krystal Biotech, Inc. (KRYS) is a Strong Momentum Stock
ZACKS· 2025-03-17 14:50
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.Featuring daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, the research service can help you become a smarter, more self-assured investor.It also includes access to the Zacks Style Scores. What are t ...
Krystal Biotech Rises 15.8% in a Month: Should You Buy Now or Wait?
ZACKS· 2025-03-08 09:35
Core Insights - Krystal Biotech (KRYS) shares have increased by 15.8% over the past month, outperforming the industry growth of 4% [1] - The company reported fourth-quarter 2024 results with earnings exceeding estimates, although sales fell short [1] - The stock's surge post-earnings is attributed to strong uptake of Vyjuvek and positive pipeline developments [1] Vyjuvek Performance - Vyjuvek, the first FDA-approved gene therapy for dystrophic epidermolysis bullosa (DEB), was launched in May 2023 [3] - Sales of Vyjuvek reached $290.5 million, a significant increase from $50.7 million in 2023 [4] - As of February 2025, Krystal secured over 510 reimbursement approvals for Vyjuvek in the U.S., with 97% of lives covered under commercial and Medicaid plans [5] Regulatory Approvals - The European Medicines Agency has recommended the approval of Vyjuvek for DEB treatment [6] - A new drug application for Vyjuvek has been filed in Japan, with a decision expected in the second half of 2025 [6] Pipeline Developments - Krystal is advancing a pipeline of genetic medicines across various fields, including respiratory and oncology [7] - KB407 is being evaluated for cystic fibrosis, with interim data expected in mid-2025 [8] - KB408 is showing promising results for alpha-1 antitrypsin deficiency, with further assessments planned [9] Financial Metrics - KRYS shares currently trade at a price/sales ratio of 10.58x forward sales, lower than its historical mean of 22.83x [13] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen to $7.07 from $5.40 over the past month [14] Cash Position - As of December 31, 2024, Krystal holds a cash balance of $749.6 million, positioning the company well for pipeline development [17] Market Position - Krystal Biotech holds a Zacks Rank 2 (Buy), indicating strong market confidence [18]
KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug
ZACKS· 2025-03-03 17:01
Krystal Biotech (KRYS) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vyjuvek (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB). The intended DEB patient population includes those who have mutations in the COL7A1 gene starting from birth.DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. I ...
Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
GlobeNewswire· 2025-02-28 12:40
EC approval decision anticipated in second quarter of 2025PITTSBURGH, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement that its Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK® (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrop ...
Krystal Biotech to Present at TD Cowen 45th Annual Health Care Conference
GlobeNewswire· 2025-02-26 13:00
Company Overview - Krystal Biotech, Inc. is a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to address diseases with high unmet medical needs [3] - The company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa [3] - Krystal Biotech is advancing a robust pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3] Upcoming Events - The company will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, in Boston [1] - Krish S. Krishnan, the Chairman and CEO, will engage in a fireside chat at 1:50 pm ET and will host investor meetings throughout the day [1] - A webcast of the presentation will be available starting at 1:50 pm ET on March 4, 2025, and will be posted on the company's website [2]