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Krystal Biotech expects EMA opinion on DEB treatment in 1Q 2025

Published 12/09/2024, 04:21 PM
KRYS
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PITTSBURGH - Krystal Biotech , Inc. (NASDAQ: NASDAQ:KRYS), a commercial-stage biotechnology company with a market capitalization of $5.3 billion and impressive gross profit margins of 92.5%, today announced an update on the regulatory process for its gene therapy product, beremagene geperpavec-svdt (B-VEC), intended for the treatment of dystrophic epidermolysis bullosa (DEB). The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has cancelled the Oral Explanation that was scheduled for last Thursday and has instead requested written responses from the company regarding outstanding issues.

According to Krystal Biotech, there are no major objections from the EMA concerning the full approval of B-VEC. The company remains confident in its ability to address the remaining post-marketing issues and believes that this additional exchange with the EMA will benefit patients suffering from DEB. The CHMP opinion is now anticipated in the first quarter of 2025, with the company's launch timeline for Germany still on track for the second quarter of 2025.

DEB is a rare and severe genetic disorder that leads to extremely fragile skin which can blister and tear from minor friction or trauma. B-VEC is a non-invasive, redosable gene therapy designed to deliver copies of the COL7A1 gene to treat DEB at the molecular level. The therapy was approved by the U.S. Food and Drug Administration (FDA) in May 2023 and is sold in the United States under the name VYJUVEK®.

Krystal Biotech is focused on the development and commercialization of genetic medicines for diseases with high unmet medical needs. The company's first commercial product, VYJUVEK®, is the first redosable gene therapy and the first FDA-approved treatment for DEB. According to InvestingPro data, the company maintains strong financial health with a current ratio of 7.97 and has achieved remarkable revenue growth of over 2,700% in the last twelve months.

This update is based on a press release statement from Krystal Biotech, Inc. The company's forward-looking statements about the EMA's review timeline and the commercial launch in the European Union are subject to various factors, including regulatory review and marketing approvals. InvestingPro analysis shows the stock has delivered a strong year-to-date return of 49.3%, with additional insights available in the comprehensive Pro Research Report, which provides deep-dive analysis of this and 1,400+ other US stocks.

In other recent news, Krystal Biotech, a gene therapy company, reported robust results for Q3 2024. The company saw a significant increase in earnings per share, rising to $0.95 from $0.54 in Q2, and substantial revenue growth from its lead product, VYJUVEK, which generated net revenues of $83.8 million in Q3. These recent developments are due to successful commercial strategies, including a strong focus on patient and physician experience.

Krystal Biotech also provided updates on its expansion plans in Europe and Japan, and advancements in its clinical pipeline. The company is preparing for a CHMP opinion in Europe and a 2025 launch in Japan, with plans to commercially launch B-VEC in both regions in 2025. Additionally, the company expects interim data readouts by the end of 2024 from multiple products in its clinical pipeline.

In terms of finance, the company reported a strong position, with $374 million in cash and investments at the end of Q3 2024. However, it's important to note that research and development expenses have increased to $13.5 million due to heightened clinical and manufacturing costs. Despite this, the company anticipates reaching a $300 million milestone payment related to the PeriphaGen settlement in early 2025.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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