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PITTSBURGH - The U.S. Food and Drug Administration has approved a label update for Krystal Biotech’s (NASDAQ:KRYS) VYJUVEK that expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth, the company announced Monday. The biotech company, currently valued at $4.16 billion, has demonstrated impressive financial performance with a 116% revenue growth over the last twelve months. According to InvestingPro analysis, the stock appears to be trading below its Fair Value, suggesting potential upside opportunity.
The updated label also allows patients and caregivers to apply the treatment themselves and provides greater flexibility in managing wound dressings, which can now be removed during the next dressing change rather than waiting 24 hours.
VYJUVEK is a topical gene therapy designed to deliver copies of the COL7A1 gene directly to DEB wounds, addressing the fundamental disease-causing mechanism by providing skin cells with the template to produce normal COL7 protein.
"By providing patients and their caregivers the ability to apply VYJUVEK themselves, we have made it easier for patients to integrate VYJUVEK into their daily routines and lifestyle," said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. The company maintains exceptional gross profit margins of 93.37% and has received a "GREAT" financial health score from InvestingPro, which offers comprehensive analysis and 10+ additional ProTips for this promising biotech player.
Brett Kopelan, Executive Director of debra of America, called the label update "a significant and impactful step forward for all those living with DEB," noting that it allows for "increased convenience without sacrificing safety."
The label update is based on real-world data collected since VYJUVEK’s launch in the United States, as well as results from an open label extension study published earlier this year, which demonstrated long-term safety and efficacy across patients of all ages, including cases where patients or caregivers applied the treatment.
VYJUVEK is currently approved in the United States, Europe, and Japan. The most common adverse reactions reported include itching, chills, redness, rash, cough, and runny nose, according to the press release statement.
In other recent news, Krystal Biotech reported impressive earnings for the second quarter of 2025, with earnings per share (EPS) reaching $1.29, surpassing the forecast of $1.22. The company also reported revenue of $96.04 million, exceeding expectations of $92.24 million. Despite these strong results, management indicated that third-quarter revenue might be lower due to patient pausing trends, prompting BofA Securities to lower its price target to $182, although it maintained a Buy rating. Meanwhile, Krystal Biotech is advancing its inhaled KB707 immunotherapy treatment for non-small cell lung cancer and has been granted an End of Phase 2 meeting with the FDA to discuss potential registration pathways. Chardan Capital Markets adjusted its price target to $216, maintaining a Buy rating, following the company’s strategic shift to prioritize the inhaled delivery of KB707. H.C. Wainwright also maintained its Buy rating with a price target of $240, supporting the company’s focus on the inhaled KB707 for treating advanced non-small cell lung cancer. These developments highlight Krystal Biotech’s ongoing efforts to innovate and adjust its strategies in response to market and clinical trial signals.
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