Core Insights - Krystal Biotech (KRYS) shares have increased by 57.2% over the past year, significantly outperforming the biotech industry growth of 17.1% [1][9] - The stock's strong performance is attributed to the successful uptake of Vyjuvek and positive developments in its pipeline [1][9] Vyjuvek Performance - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in May 2023 [4] - In September 2025, the FDA updated Vyjuvek's label to expand the treatment-eligible population to include DEB patients from birth and allowed for greater dosing flexibility [5] - As of November 3, 2025, Krystal secured over 615 reimbursement approvals for Vyjuvek in the U.S., ensuring strong nationwide access [6][9] - The therapy has also been approved in Japan and Europe, making it the first corrective therapy for DEB in those markets [6] Pipeline Progress - Krystal Biotech is advancing a diverse pipeline, including candidates for respiratory, ophthalmology, oncology, dermatology, and aesthetics [9] - KB407 is being evaluated for cystic fibrosis, with ongoing enrollment in a multi-center trial [10] - KB408 targets alpha-1 antitrypsin deficiency lung disease, with interim results expected in the first half of 2026 [10] - In ophthalmology, KB803 is in a phase III study for corneal abrasions in DEB patients, with enrollment expected to complete soon [11] - KB801 is under evaluation for neurotrophic keratitis, with a phase II trial currently enrolling [12] - KB707 is being developed for non-small cell lung cancer (NSCLC), with plans for a phase III trial based on FDA feedback [13][14][15] - The aesthetics division is developing KB304 for wrinkles, with a phase II study set to begin in the first half of 2026 [16] Financial Outlook - KRYS shares currently trade at a price/earnings ratio of 29.39x forward earnings, higher than its historical mean but lower than the biotech industry average [18] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen to $6.45 from $6.18 over the past 60 days, indicating positive earnings momentum [20] - The company had a cash balance of $864.2 million as of September 30, 2025, positioning it well for pipeline development [22] Investment Recommendation - Given the strong performance of Vyjuvek and the promising pipeline, Krystal Biotech is viewed as having significant growth potential, making it an attractive investment opportunity [1][22]
KRYS Stock Surges 57% in a Year: More Upside Potential in 2026?