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KRYS Up 4% on Initiating Dosing in Rare Eye Disease Phase III Study
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Key Takeaways
KRYS dosed the first patient in its phase III IOLITE study testing KB803 eyedrops for DEB-related eye issues.
KB803 is administered as an eye drop, aiming to treat and prevent corneal abrasions in DEB patients.
The 24-week study uses a crossover design and home dosing to ease the burden for DEB patients.
Shares of Krystal Biotech (KRYS - Free Report) gained 4.2% on Tuesday after the company announced that it has dosed the first patient in the late-stage study evaluating its investigational candidate, KB803, for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB). KB803 is administered as an eye drop.
Krystal Biotech’s only marketed product, Vyjuvek, is currently FDA-approved for treating patients aged six months or older with DEB. The drug is referred to as B-VEC outside the United States.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. More than 25% of DEB patients experience eye complications. With no corrective treatments available, care is limited to wound management and occasional surgery. An estimated 750 people in the United States and 2,000 globally are affected.
Shares of Krystal Biotech have lost 8.3% year to date compared with the industry’s 4.2% decline.
Image Source: Zacks Investment Research
More on KRYS’ Phase III DEB Study for KB803 Eyedrop
The registrational phase III IOLITE study is evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients, aged six months or older. Patients enrolled in the IOLITE study have been screened through Krystal Biotech’s ongoing natural history study to prospectively collect data on the frequency of corneal abrasions in patients with DEB.
The phase III IOLITE study looks to enroll 16 DEB patients who will receive weekly eye drops of either placebo or KB803 in both eyes for 12 weeks, then switch treatments for another 12 weeks. The IOLITE study is decentralized, with dosing done at home by a healthcare professional, which reduces the treatment burden for patients suffering from this rare disease.
The primary endpoint of the late-stage study is to measure the change in average monthly days with corneal abrasion symptoms in patients receiving KB803 compared to placebo. Statistical significance will be analyzed using intra-patient comparisons to address variability. Safety and secondary efficacy data, like weekly eye pain checks and monthly EB-EDI surveys, will be gathered throughout the 24-week study period.
KRYS’ KB803 Shows Efficacy in Earlier Compassionate Use Case
Under a compassionate use protocol, B-VEC was earlier used in a DEB patient with severe cicatrizing conjunctivitis. After eye surgery, B-VEC eye drops were added to the patient’s routine post-surgical care. The treatment was well tolerated with no drug-related side effects, leading to full corneal healing by three months as well as significant visual acuity improvement from hand motion to 20/25 by eight months. Krystal Biotech published the study results in the New England Journal of Medicine in 2024.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.57 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.80 to $1.33 during the same period. IMCR stock has gained 8.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 57.8%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has soared 82.5% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
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KRYS Up 4% on Initiating Dosing in Rare Eye Disease Phase III Study
Key Takeaways
Shares of Krystal Biotech (KRYS - Free Report) gained 4.2% on Tuesday after the company announced that it has dosed the first patient in the late-stage study evaluating its investigational candidate, KB803, for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB). KB803 is administered as an eye drop.
Krystal Biotech’s only marketed product, Vyjuvek, is currently FDA-approved for treating patients aged six months or older with DEB. The drug is referred to as B-VEC outside the United States.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. More than 25% of DEB patients experience eye complications. With no corrective treatments available, care is limited to wound management and occasional surgery. An estimated 750 people in the United States and 2,000 globally are affected.
Shares of Krystal Biotech have lost 8.3% year to date compared with the industry’s 4.2% decline.
Image Source: Zacks Investment Research
More on KRYS’ Phase III DEB Study for KB803 Eyedrop
The registrational phase III IOLITE study is evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients, aged six months or older. Patients enrolled in the IOLITE study have been screened through Krystal Biotech’s ongoing natural history study to prospectively collect data on the frequency of corneal abrasions in patients with DEB.
The phase III IOLITE study looks to enroll 16 DEB patients who will receive weekly eye drops of either placebo or KB803 in both eyes for 12 weeks, then switch treatments for another 12 weeks. The IOLITE study is decentralized, with dosing done at home by a healthcare professional, which reduces the treatment burden for patients suffering from this rare disease.
The primary endpoint of the late-stage study is to measure the change in average monthly days with corneal abrasion symptoms in patients receiving KB803 compared to placebo. Statistical significance will be analyzed using intra-patient comparisons to address variability. Safety and secondary efficacy data, like weekly eye pain checks and monthly EB-EDI surveys, will be gathered throughout the 24-week study period.
KRYS’ KB803 Shows Efficacy in Earlier Compassionate Use Case
Under a compassionate use protocol, B-VEC was earlier used in a DEB patient with severe cicatrizing conjunctivitis. After eye surgery, B-VEC eye drops were added to the patient’s routine post-surgical care. The treatment was well tolerated with no drug-related side effects, leading to full corneal healing by three months as well as significant visual acuity improvement from hand motion to 20/25 by eight months. Krystal Biotech published the study results in the New England Journal of Medicine in 2024.
Krystal Biotech, Inc. Price and Consensus
Krystal Biotech, Inc. price-consensus-chart | Krystal Biotech, Inc. Quote
KRYS’ Zacks Rank and Stocks to Consider
Krystal Biotech currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Bayer (BAYRY - Free Report) and Agenus (AGEN - Free Report) . While IMCR currently sports a Zacks Rank #1 (Strong Buy), BAYRY and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.57 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.80 to $1.33 during the same period. IMCR stock has gained 8.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 57.8%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has soared 82.5% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.