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. It is caused by one or more mutations in a gene called COL7A1. Vyjuvek is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds.

The CHMP’s favorable opinion supports the administration of Vyjuvek in a healthcare setting (such as a clinic) or at home. If considered suitable by a healthcare professional, trained patients or caregivers may also apply Vyjuvek themselves. A final decision from the regulatory body is expected in the second quarter of 2025. The decision will apply to all EU member states, as well as Iceland, Norway and Liechtenstein.

In the past three months, shares of Krystal Biotech have plunged 18.3% compared with the industry’s 0.6% decline.

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More on CHMP’s Positive Opinion on Vyjuvek’s EU Approval

The positive CHMP opinion recommending the approval of Vyjuvek for the DEB indication in the EU is based on the results of Krystal Biotech’s phase I/II GEM-1 and phase III GEM-3 studies. Data from these studies collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration. 

KRYS also reported additional data from its completed open-label extension study in the United States as well as real-world experience with Vyjuvek, which supports the long-term safety and efficacy of the drug.

Krystal Biotech is currently gearing up to launch Vyjuvek for the DEB indication in Germany around mid-2025, subject to approval, which will be the first of many launches in the EU, including a launch in France planned for later in 2025.

US Approval of KRYS’ Vyjuvek for DEB

In 2023, Krystal Biotech received FDA approval for Vyjuvek as the first-ever revocable gene therapy for treating patients aged six months or older with DEB.

In the fourth quarter of 2024, the company recorded total revenues of $91.1 million, up 116% year over year, which came solely from the sales of Vyjuvek.

As of February 2025, KRYS has secured more than 510 reimbursement approvals for Vyjuvek in the United States. It also achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans. The gross margin in the fourth quarter of 2024 was 95%. Additionally, patient adherence to weekly treatment while on the drug remained high at 85% as of the end of 2024.

Krystal Biotech, Inc. Price and Consensus

Krystal Biotech, Inc. price-consensus-chart | Krystal Biotech, Inc. Quote

KRYS’ Zacks Rank and Other Stocks to Consider

Apellis currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the sector are Gilead Sciences GILD, BioMarin Pharmaceutical BMRN and Amicus Therapeutics FOLD, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, Gilead Sciences’ earnings estimates for 2025 have improved from $7.56 to $7.85 per share. During the same timeframe, the earnings per share for 2026 have improved from $7.82 to $8.17. In the past three months, shares of Gilead Sciences have gained 24.8%.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 earnings per share have increased from $4.01 to $4.21. Estimates for 2026 earnings per share have decreased from $5.21 to $5.17 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 7%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

In the past 30 days, the estimate for Amicus Therapeutics’ 2025 earnings per share has remained constant at 43 cents. The estimate for 2026 earnings per share has deteriorated from 72 cents to 71 cents. In the past three months, shares of Amicus Therapeutics have lost 3.8%.

FOLD’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 45.42%.

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