PITTSBURGH, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). “The FDA’s decision to grant ...

Market Overview - The AI trade has become overcrowded, with only Google and Nvidia outperforming the S&P 500 index in 2025, indicating a challenging environment for investors seeking alpha stocks in 2026 [1] - Goldman Sachs suggests that diversification may yield better risk-adjusted returns in 2026, recommending a focus on emerging markets and a mix of growth and value stocks across sectors [2] Investment Trends - Large companies, particularly AI "hyperscalers" like Meta, Amazon, Alphabet, Microsoft, and Oracle, invested over $400 billion in capital expenditures in 2025, significantly exceeding previous forecasts by nearly $150 billion [3] - These companies are expected to continue facing challenges due to the weight of their investments, which may create opportunities in other sectors [4] Stock Recommendations - SiTime Corporation (NASDAQ:SITM) has a potential upside of 5.96% with 35 hedge fund holders, and recent price target increases from UBS and Barclays suggest strong growth prospects driven by AI ventures [7][8] - Krystal Biotech, Inc. (NASDAQ:KRYS) shows a potential upside of 10.5% with 26 hedge fund holders, and multiple analysts have raised their price targets, indicating confidence in the company's growth through its registrational programs and existing product pipeline [11][13][15]

Core Insights - Krystal Biotech, Inc. (KRYS) anticipates preliminary unaudited net product revenues of $106-$107 million from its lead drug Vyjuvek in Q4 2025, raising the full-year 2025 revenue forecast to $388-$389 million, driven by strong uptake in the U.S. and successful launches in Europe and Japan [1][11] Financial Performance - At the end of 2025, Krystal reported approximately $955 million in cash, cash equivalents, and investments, providing substantial financial flexibility for clinical programs [2] - For 2026, the company expects combined non-GAAP R&D and SG&A expenses to be between $175-$195 million [2] Pipeline Development - Krystal is advancing several rare disease programs utilizing its redosable HSV-1 gene therapy platform, targeting high-turnover tissues such as skin, lung, and eye [3] - Key pipeline candidates include KB803 for ocular complications of DEB, KB801 for neurotrophic keratitis, KB407 for cystic fibrosis, and KB111 for Hailey-Hailey disease [3] Clinical Trials and Updates - Enrollment in the registrational KB801 study has increased to 60 patients, indicating potential for expedited development, with a detailed update expected in February 2026 [4] - Top-line data from the KB801 and KB803 registrational studies are anticipated in 2026, serving as important near-term catalysts [6] - Other targets for 2026 include initiating and completing enrollment in a registrational repeat dose study for KB407 and starting a double-blind, placebo-controlled study for KB111 [7] Vyjuvek Developments - Vyjuvek received FDA approval in May 2023 as the first revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB) [8] - In September 2025, a label update expanded the treatment-eligible population to include DEB patients from birth and allowed for greater dosing flexibility [9][12] Long-term Strategy - The company aims to have at least four marketed rare disease therapies by 2030, targeting over 10,000 patients globally while maintaining profitability [5] - Krystal continues to invest in earlier-stage programs for larger indications, including KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer, which could provide long-term growth potential [5] Stock Performance - Shares of KRYS increased by 5% on January 9, with a notable 73.9% rise over the past year compared to the industry growth of 19.6% [16]

Core Insights - Krystal Biotech, Inc. reported preliminary unaudited net product revenue for VYJUVEK® of $106 million to $107 million for Q4 2025, and $388 million to $389 million for the full year 2025, indicating strong financial performance [3][4] - The company aims to establish itself as a global leader in rare diseases, leveraging its HSV-1 platform to develop differentiated genetic medicines [2][5] - A robust clinical pipeline is in place, with multiple potential blockbuster launches anticipated in the next four years, positioning the company for sustained growth [2][5] Financial Performance - Preliminary net product revenue for VYJUVEK is projected to be between $106 million and $107 million for Q4 2025, and between $388 million and $389 million for the full year 2025 [3] - As of December 31, 2025, the company had approximately $955 million in cash, cash equivalents, and investments, indicating a strong balance sheet [3] Strategic Vision - The company’s strategic vision includes having at least four marketed rare disease medicines by the end of 2030, aiming to treat over 10,000 patients globally [7] - The company plans to accelerate clinical development for its rare disease pipeline, including increasing enrollment targets for ongoing studies [6][8] Corporate Objectives for 2026 - Key objectives include launching VYJUVEK in additional major European markets, expanding the specialty distributor network to over 40 countries, and reporting top-line results from various registrational studies [14] - The company expects combined non-GAAP R&D and SG&A expenses for 2026 to be between $175 million and $195 million [9]

CORAL-1 Clinical Data Update - Krystal Biotech's KB407 is a gene therapy for cystic fibrosis (CF) and has the potential to become a leadership opportunity in the treatment of CF[9] - The company plans to initiate the CORAL-3 study in the first half of 2026 to evaluate the safety and efficacy of repeat KB407 administration, which could support registration of KB407[4, 93] - The company estimates a $2 billion+ market opportunity in modulator-ineligible or refractory CF patients[12] KB407 Phase 1 CORAL-1 Highest Dose Cohort Results - In patient 03-01 with CFTR genotype 2184delA/W1282X, 42.1% of conducting airway cells expressed CFTR[55] - In patient 03-02 with CFTR genotype R553X/M1V, 29.4% of conducting airway cells expressed CFTR[68] - In patient 03-03 with CFTR genotype C1210-12T/1408A>G, 36.5% of conducting airway cells were viral marker positive[76] - In patient 03-04 with CFTR genotype R334W/R1162X, 33.8% of conducting airway cells were viral marker positive[79] - In patient 03-05 with CFTR genotype F508del/F508del, 36.8% of conducting airway cells were viral marker positive[81] - In patient 03-06 with CFTR genotype F508del/F508del, 31.4% of conducting airway cells were viral marker positive[83]

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]

VYJUVEK Launch and Revenue - Since launch, VYJUVEK has generated over $623 million in net revenue[10] - Q3 2025 VYJUVEK product revenue reached $97.8 million, compared to $83.8 million in Q3 2024[35] - The company has secured over 615 reimbursement approvals for VYJUVEK in the U S[14] European and Japanese Expansion - VYJUVEK launched in Germany in late August, with over 10 prescribing centers and prescriptions for an estimated 20 DEB patients[15] - VYJUVEK launched in Japan in October, targeting over 500 estimated DEB patients[17, 18] - The company is building a specialty distributor partner network to reach thousands of potential DEB patients in rest-of-world markets[20] Pipeline Development - The FDA granted Platform Technology Designation for KB801, potentially accelerating its path to market[21] - The company expects to report molecular data from the KB407 Phase 1 trial for Cystic Fibrosis by year-end[28] - KB111 is entering clinical trials for the treatment of Hailey-Hailey disease, targeting an estimated 10,000-15,000 patients in the U S and Europe[34] Financial Performance - The company's cash and investments totaled $864.2 million as of September 30, 2025[35] - Net income for Q3 2025 was $79.4 million, compared to $27.2 million in Q3 2024[35] - Non-GAAP R&D and SG&A expense guidance for full year 2025 is updated to $145 million to $155 million[36]

Core Insights - Krystal Biotech's lead drug Vyjuvek is a non-invasive, topical gene therapy approved for treating dystrophic epidermolysis bullosa (DEB) in the U.S., Europe, and Japan [1][3] - The FDA recently expanded Vyjuvek's label to include DEB patients from birth, allowing for home administration and greater flexibility in wound management [2][10] - Vyjuvek generated sales of $184.2 million in the first half of 2025, with expectations for further growth due to recent label updates and approvals in multiple regions [4][10] Company Developments - Krystal Biotech is currently focused on developing other candidates, including KB707, an immunotherapy for solid tumors, with an FDA end-of-phase II meeting scheduled for October [7][8][10] - The company has paused enrollment in the OPAL-1 study for intratumoral KB707 to prioritize inhaled KB707 [9][10] - Krystal Biotech is also exploring treatments for cystic fibrosis (KB407) and alpha-1 antitrypsin deficiency (KB408) [11] Competitive Landscape - The DEB treatment space is becoming competitive, with Abeona Therapeutics' Zevaskyn recently approved as the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) [5][6] - In oncology, Krystal Biotech faces competition from major players like Merck and Bristol Myers, which have established portfolios of oncology drugs [11]

Core Viewpoint - Krystal Biotech, Inc. has shown a positive performance with an 8.5% increase in shares since the last earnings report, outperforming the S&P 500, but faces concerns regarding future revenue guidance [1][2]. Financial Performance - The company reported Q2 2025 earnings per share (EPS) of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [3]. - Revenues reached $96 million, a 36.6% year-over-year increase, surpassing the Zacks Consensus Estimate of $91 million, with all revenues derived from Vyjuvek sales [3]. - Despite strong quarterly results, shares fell by 14% due to soft guidance for third-quarter revenues [4]. Product Developments - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has secured over 575 reimbursement approvals in the U.S. as of July [5]. - The European Commission approved Vyjuvek for treating DEB-related wounds, with launches planned in Germany and France in Q3 and Q4 respectively [7]. - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [7]. Research and Development - Research and development expenses were $14.4 million, down 7.5% year-over-year, while selling, general, and administrative expenses rose to $35.2 million, a 27.2% increase from the previous year [6]. - The company is evaluating KB407 for cystic fibrosis, with four patients enrolled in a study, and expects interim data before year-end [8]. - KB408 is being assessed for alpha-1 antitrypsin deficiency, with positive results reported in a patient from a dose escalation study [9]. Pipeline Progress - Krystal Biotech is advancing multiple candidates, including KB801 for neurotrophic keratitis and KB707 for solid tumors, with ongoing enrollment in various studies [11][12]. - Jeune Aesthetics, a subsidiary, reported positive results for KB304 in treating décolleté wrinkles, leading to its progression into phase II studies [13][14]. Market Outlook - Since the earnings release, there has been a downward trend in estimates, with a consensus estimate shift of -16.13% [15]. - The stock has an average Growth Score of C, a Momentum Score of F, and a Value Score of D, resulting in an aggregate VGM Score of F [16]. - Krystal Biotech holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [17][18].

Core Viewpoint - The article maintains a "Strong Buy" rating on Krystal Biotech (NASDAQ: KRYS) despite recent updates regarding its immunotherapy candidate KB707, which the company has decided to pause [2]. Company Analysis - Krystal Biotech is currently focusing on its immunotherapy candidate KB707, which has faced a pause in development [2]. - The company is part of a broader analysis service that provides insights into various pharmaceutical companies, including a model portfolio of small and mid-cap stocks [2]. Investment Insights - The Biotech Analysis Central service offers a comprehensive library of over 600 biotech investing articles, aimed at helping healthcare investors make informed decisions [2].