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Krystal Biotech, Inc. - KRYS STOCK NEWS

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.

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Krystal Biotech, Inc. (KRYS) presents new preclinical data on intratumoral delivery of IL-12 and IL-2, showing enhanced local and systemic effector T-cell responses in a cold tumor preclinical model at AACR 2024 Annual Meeting.
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Krystal Biotech, Inc. (KRYS) will participate in the TD Cowen 44th Annual Health Care Conference in Boston. Chairman and CEO Krish S. Krishnan will host a fireside chat and investor meetings. A webcast of the presentation will be available on the Company's website.
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Krystal Biotech reports strong financial results with $42.1M in net product revenue in 4Q and $50.7M for the year, FDA alignment for B-VEC eyedrop formulation, and initiation of Phase 1 KB408 trial for AATD treatment.
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Krystal Biotech, Inc. (KRYS) will release its Q4 and full year 2023 financial results on February 26, 2024, followed by a webcast for financial updates. An investor webcast will also be held on the same day at 8:30 am ET.
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Krystal Biotech, Inc. receives FDA Fast Track Designation for inhaled KB707 in the treatment of solid tumors with pulmonary metastases. Phase 1 clinical trial (KYANITE-1) expected to start in 1H 2024.
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Krystal Biotech, Inc. announces positive clinical data on the compassionate use of B-VEC, an eyedrop treatment for patients with dystrophic epidermolysis bullosa (DEB) with ocular complications. The NEJM publication showed significant visual acuity improvement and full corneal healing in a patient treated with B-VEC, indicating potential benefits for DEB patients with ocular lesions.
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Krystal Biotech, Inc. (KRYS) will participate in the Guggenheim 6th Annual Biotechnology Conference in New York on February 7-8. The Chairman and CEO will host investor meetings and a webcast of the presentation will be available on the Company's website.
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Krystal Biotech, Inc. (NASDAQ: KRYS) announced that the U.S. Centers for Medicare & Medicaid Services has assigned a permanent and product-specific J-code for VYJUVEK, the first FDA-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code (J3401) became effective on January 1, 2024, ensuring efficient and accurate reimbursement for the treatment.
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Krystal Biotech, Inc. (NASDAQ: KRYS) receives Orphan Drug Designation (ODD) from Japan Ministry of Health, Labour and Welfare (MHLW) for beremagene geperpavec-svdt (B-VEC or VYJUVEK) to treat dystrophic epidermolysis bullosa (DEB)
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Krystal Biotech, Inc. (KRYS) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) to treat dystrophic epidermolysis bullosa (DEB) in the European Union. The CHMP opinion is expected in the second half of 2024. VYJUVEK has received Orphan Drug Designation, PRIME designation, and a positive opinion from the EMA Pediatric Committee, potentially leading to additional marketing exclusivity in the EU.
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FAQ

What is the current stock price of Krystal Biotech (KRYS)?

The current stock price of Krystal Biotech (KRYS) is $164.83 as of December 20, 2024.

What is the market cap of Krystal Biotech (KRYS)?

The market cap of Krystal Biotech (KRYS) is approximately 4.7B.

What does Krystal Biotech, Inc. specialize in?

Krystal Biotech, Inc. specializes in the development of gene therapies for dermatological diseases, focusing on genetic conditions caused by mutations.

What is VYJUVEK?

VYJUVEK is a topical, non-invasive, and redosable gene therapy developed by Krystal Biotech to treat dystrophic epidermolysis bullosa (DEB) by delivering the COL7A1 gene to the skin.

Where is Krystal Biotech headquartered?

Krystal Biotech is headquartered in Pittsburgh, Pennsylvania.

What are some of Krystal Biotech’s pipeline products?

Krystal Biotech's pipeline includes products like KB407 for cystic fibrosis, KB408 for alpha-1 antitrypsin deficiency, and KB707 for solid tumors.

What recent achievements has Krystal Biotech accomplished?

Recent achievements include the FDA approval of VYJUVEK, the submission of a Marketing Authorization Application to the European Medicines Agency, and receiving Orphan Drug Designation in Japan.

What is the STAR-D platform?

The STAR-D platform is Krystal Biotech's proprietary gene therapy technology used to develop treatments for rare dermatological conditions caused by genetic mutations.

How has Krystal Biotech performed financially?

In 2023, Krystal Biotech reported $50.7 million in net product revenue from VYJUVEK within six months of its approval, driven by high demand and broad access.

What is Jeune Aesthetics, Inc.?

Jeune Aesthetics, Inc. is a wholly-owned subsidiary of Krystal Biotech focused on developing gene therapies to address aging and damaged skin.

What is KB707?

KB707 is an innovative gene therapy for solid tumors that delivers genes encoding interleukin-12 (IL-12) and interleukin-2 (IL-2) to promote tumor clearance. It has received Fast Track Designation from the FDA.

How can I learn more about Krystal Biotech?

For more information, visit www.krystalbio.com and follow @KrystalBiotech on LinkedIn and Twitter.

Krystal Biotech, Inc.

Nasdaq:KRYS

KRYS Rankings

KRYS Stock Data

4.74B
24.26M
12.3%
106.91%
12.53%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
PITTSBURGH