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KRYS Reports Preliminary Results for 2025, Outlines 2026 Objectives
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Key Takeaways
KRYS expects Q4 Vyjuvek revenues of $106-$107M on a preliminary basis, lifting full-year sales to $388-$389M.
KRYS benefited from strong U.S. uptake and expanded Vyjuvek approvals across Europe and Japan.
KRYS expects key 2026 catalysts, including top-line data from KB801 and KB803 registrational studies.
Krystal Biotech, Inc. (KRYS - Free Report) expects preliminary unaudited net product revenues of $106-$107 million from lead drug Vyjuvek in the fourth quarter of 2025, bringing full-year 2025 revenue forecast to $388-$389 million.
The performance reflects continued uptake in the United States and the successful launch of Vyjuvek in Europe and Japan.
Krystal ended 2025 with approximately $955 million in cash, cash equivalents and investments, providing significant financial flexibility to fund clinical programs.
For 2026, Krystal expects combined non-GAAP R&D and SG&A expenses of $175-$195 million.
KRYS’s Other Pipeline Candidates
Krystal is accelerating development of several rare disease programs built on its redosable HSV-1 gene therapy platform, designed for high-turnover tissues such as skin, lung and eye.
Key pipeline programs include KB803 for ocular complications of DEB, KB801 for neurotrophic keratitis (NK), KB407 for cystic fibrosis (CF) and KB111 for Hailey-Hailey disease (HHD).
The company increased enrollment in its registrational KB801 study to 60 patients, signaling potential for expedited development. A detailed update on the registrational study design is expected when it reports its financial results in February 2026. Top-line data from the study is expected before the end of 2026.
Krystal’s long-term strategy is to have at least four marketed rare disease therapies by 2030, treating more than 10,000 patients globally, while remaining profitable throughout the expansion phase. In parallel, the company continues to invest in earlier-stage programs addressing larger indications, including KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer, which could provide longer-term upside.
Top-line data from both KB801 and KB803 registrational studies are expected in 2026, representing important near-term catalysts.
KRYS also expects to report updates for both KB408 and KB707 before the end of the year.
Other targets for 2026 include initiating and completing enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF. KRYS also plans to dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients.
More on KRYS’ Vyjuvek
In May 2023, the FDA approved Vyjuvek, the first-ever revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
In September 2025, the regulatory body approved a label update for Vyjuvek that expanded the treatment-eligible population to include DEB patients from birth and provided patients with greater dosing flexibility, including the option for the therapy to be applied by a healthcare professional, caregiver, or directly by the patient themselves, either at home or in a healthcare setting.
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.
The therapy was also approved in Japan and Europe in 2025, making it the first and only corrective therapy approved for the treatment of DEB in each of those respective markets.
KRYS plans to expand Vyjuvek’s availability into additional European markets in 2026 and broaden its specialty distributor network to reach more than 40 countries.
KRYS’s Data on Gene Therapy
Krystal Biotech recently reported a positive interim clinical update from the highest-dose cohort of its phase I CORAL-1 study evaluating KB407 in patients with CF.
The update confirmed successful lung delivery and expression of full-length, wild-type CFTR protein following inhaled administration of KB407. Importantly, molecular confirmation of CFTR expression was observed across clinically relevant ciliated and secretory airway cells, regardless of patients’ genetic background or eligibility for existing CFTR modulator therapies.
The company submitted the proposed design for the CORAL-3 study to the FDA in late December. CORAL-3 is intended to assess the safety and efficacy of repeat dosing with KB407, including routine spirometry-based lung function evaluations, and to support a potential registration pathway. Exelixis expects to align with the FDA on the study design in the first quarter of 2026 and to begin enrolling patients in the second quarter of 2026, with additional details to be disclosed closer to study initiation.
Shares of KRYS were up 5% on Jan. 9.
Krystal Biotech stock has surged 73.9% in a year compared with the industry’s growth of 19.6%.
Image Source: Zacks Investment Research
KRYS had also reported positive interim safety results from the first two dose escalation cohorts, referred to as Cohorts 1 and 2, in the fourth quarter of 2024.
The successful development of other pipeline candidates will be a significant boost for KRYS.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $2.49 to $2.88. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Amicus Therapeutics’ 2026 EPS have decreased to 67 cents from 70 cents. Shares of FOLD have gained 54.7% in a year.
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KRYS Reports Preliminary Results for 2025, Outlines 2026 Objectives
Key Takeaways
Krystal Biotech, Inc. (KRYS - Free Report) expects preliminary unaudited net product revenues of $106-$107 million from lead drug Vyjuvek in the fourth quarter of 2025, bringing full-year 2025 revenue forecast to $388-$389 million.
The performance reflects continued uptake in the United States and the successful launch of Vyjuvek in Europe and Japan.
Krystal ended 2025 with approximately $955 million in cash, cash equivalents and investments, providing significant financial flexibility to fund clinical programs.
For 2026, Krystal expects combined non-GAAP R&D and SG&A expenses of $175-$195 million.
KRYS’s Other Pipeline Candidates
Krystal is accelerating development of several rare disease programs built on its redosable HSV-1 gene therapy platform, designed for high-turnover tissues such as skin, lung and eye.
Key pipeline programs include KB803 for ocular complications of DEB, KB801 for neurotrophic keratitis (NK), KB407 for cystic fibrosis (CF) and KB111 for Hailey-Hailey disease (HHD).
The company increased enrollment in its registrational KB801 study to 60 patients, signaling potential for expedited development. A detailed update on the registrational study design is expected when it reports its financial results in February 2026. Top-line data from the study is expected before the end of 2026.
Krystal’s long-term strategy is to have at least four marketed rare disease therapies by 2030, treating more than 10,000 patients globally, while remaining profitable throughout the expansion phase. In parallel, the company continues to invest in earlier-stage programs addressing larger indications, including KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer, which could provide longer-term upside.
Top-line data from both KB801 and KB803 registrational studies are expected in 2026, representing important near-term catalysts.
KRYS also expects to report updates for both KB408 and KB707 before the end of the year.
Other targets for 2026 include initiating and completing enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF. KRYS also plans to dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients.
More on KRYS’ Vyjuvek
In May 2023, the FDA approved Vyjuvek, the first-ever revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
In September 2025, the regulatory body approved a label update for Vyjuvek that expanded the treatment-eligible population to include DEB patients from birth and provided patients with greater dosing flexibility, including the option for the therapy to be applied by a healthcare professional, caregiver, or directly by the patient themselves, either at home or in a healthcare setting.
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.
The therapy was also approved in Japan and Europe in 2025, making it the first and only corrective therapy approved for the treatment of DEB in each of those respective markets.
KRYS plans to expand Vyjuvek’s availability into additional European markets in 2026 and broaden its specialty distributor network to reach more than 40 countries.
KRYS’s Data on Gene Therapy
Krystal Biotech recently reported a positive interim clinical update from the highest-dose cohort of its phase I CORAL-1 study evaluating KB407 in patients with CF.
The update confirmed successful lung delivery and expression of full-length, wild-type CFTR protein following inhaled administration of KB407.
Importantly, molecular confirmation of CFTR expression was observed across clinically relevant ciliated and secretory airway cells, regardless of patients’ genetic background or eligibility for existing CFTR modulator therapies.
The company submitted the proposed design for the CORAL-3 study to the FDA in late December. CORAL-3 is intended to assess the safety and efficacy of repeat dosing with KB407, including routine spirometry-based lung function evaluations, and to support a potential registration pathway. Exelixis expects to align with the FDA on the study design in the first quarter of 2026 and to begin enrolling patients in the second quarter of 2026, with additional details to be disclosed closer to study initiation.
Shares of KRYS were up 5% on Jan. 9.
Krystal Biotech stock has surged 73.9% in a year compared with the industry’s growth of 19.6%.
Image Source: Zacks Investment Research
KRYS had also reported positive interim safety results from the first two dose escalation cohorts, referred to as Cohorts 1 and 2, in the fourth quarter of 2024.
The successful development of other pipeline candidates will be a significant boost for KRYS.
Krystal’s Zacks Rank & Other Stocks to Consider
Krystal sports a Zacks Rank #1 (Strong Buy) at present. A couple of other top-ranked stocks in the pharma/biotech sector are CorMedix (CRMD - Free Report) and Amicus Therapeutics (FOLD - Free Report) , each carrying a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $2.49 to $2.88. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Amicus Therapeutics’ 2026 EPS have decreased to 67 cents from 70 cents. Shares of FOLD have gained 54.7% in a year.