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KRYS Reports Positive Early Data for KB113 in Gorlin Syndrome
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Key Takeaways
Krystal Biotech's KB113 showed clinical regression in 83.1% of assessed BCC lesions across three patients.
Responses included 85.1% regression in non-injected lesions, suggesting systemic immune-mediated activity.
KB113 was well tolerated, and Krystal Biotech has begun FDA discussions on advanced clinical development.
Krystal Biotech (KRYS - Free Report) announced positive clinical data for KB113, its investigational intratumoral immunotherapy being developed to treat basal cell carcinomas (BCCs) in patients with Gorlin syndrome. Data from a pilot study showed regression in more than 80% of assessed BCC lesions, with reductions in size across three patients treated with KB113.
KRYS’ KB113 Shows Broad Tumor Regression in Study
Per the press release, in the Gorlin Syndrome pilot study, three adult patients received six doses of KB113 over 14 weeks. At the final assessment, conducted 30 days after the last dose, 69 of 83 assessed landmark lesions (83.1%) showed some degree of clinical regression. These included 29 of 36 injected lesions (80.6%) and 40 of 47 non-injected lesions (85.1%).
More than half of the assessed lesions (50.6%) demonstrated greater than 50% clinical regression, while 9.6% showed at least 90% regression. Responses were observed as early as two weeks after treatment initiation and broadened and deepened over time.
The company also reported histologically confirmed complete responses in three injected lesions, one from each patient, that had achieved at least 90% clinical regression. Biopsies showed no evidence of residual tumor tissue. Substantial regression in lesions that were not directly injected with KB113 was consistent with an abscopal effect, suggesting potential systemic immune-mediated activity.
Treatment with KB113 was well tolerated in all three patients, consistent with prior experience in the low-dose escalation cohort of the OPAL-1 phase I/II study.
KRYS Price Performance
Year to date, shares of Krystal Biotech have rallied 33.9% compared with the industry’s rise of 3%.
Image Source: Zacks Investment Research
Krystal Biotech has initiated discussions with the FDA regarding the advanced clinical development of KB113 for Gorlin syndrome. The company plans to provide an update on its clinical development plans following alignment with the FDA.
Gorlin syndrome is a genetic disorder associated with a substantially increased risk of developing BCCs. Patients may develop multiple tumors over their lifetimes, often requiring repeated surgical procedures that can lead to scarring and permanent tissue loss. The company estimates that the number of patients with Gorlin syndrome in the United States could exceed 10,000, although prevalence data are limited.
The preliminary findings provide initial proof of concept for KB113 in this patient population. However, the study included only three patients, and further clinical development will be needed to establish the candidate's safety and efficacy.
KRYS’ Zacks Rank & Stocks to Consider
Krystal Biotech currently carries a Zacks Rank #4 (Sell).
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 57.4% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 39.6% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Halozyme’s 2026 earnings per share have risen from $8.37 to $8.80, while estimates for 2027 have increased from $9.75 to $10.29 during the same time. HALO shares have skyrocketed 80.6% year to date.
Halozyme’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average negative surprise being 19.12%.
View the Zacks #1 Rank List
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KRYS Reports Positive Early Data for KB113 in Gorlin Syndrome
Key Takeaways
Krystal Biotech (KRYS - Free Report) announced positive clinical data for KB113, its investigational intratumoral immunotherapy being developed to treat basal cell carcinomas (BCCs) in patients with Gorlin syndrome. Data from a pilot study showed regression in more than 80% of assessed BCC lesions, with reductions in size across three patients treated with KB113.
KRYS’ KB113 Shows Broad Tumor Regression in Study
Per the press release, in the Gorlin Syndrome pilot study, three adult patients received six doses of KB113 over 14 weeks. At the final assessment, conducted 30 days after the last dose, 69 of 83 assessed landmark lesions (83.1%) showed some degree of clinical regression. These included 29 of 36 injected lesions (80.6%) and 40 of 47 non-injected lesions (85.1%).
More than half of the assessed lesions (50.6%) demonstrated greater than 50% clinical regression, while 9.6% showed at least 90% regression. Responses were observed as early as two weeks after treatment initiation and broadened and deepened over time.
The company also reported histologically confirmed complete responses in three injected lesions, one from each patient, that had achieved at least 90% clinical regression. Biopsies showed no evidence of residual tumor tissue. Substantial regression in lesions that were not directly injected with KB113 was consistent with an abscopal effect, suggesting potential systemic immune-mediated activity.
Treatment with KB113 was well tolerated in all three patients, consistent with prior experience in the low-dose escalation cohort of the OPAL-1 phase I/II study.
KRYS Price Performance
Year to date, shares of Krystal Biotech have rallied 33.9% compared with the industry’s rise of 3%.
Image Source: Zacks Investment Research
Krystal Biotech has initiated discussions with the FDA regarding the advanced clinical development of KB113 for Gorlin syndrome. The company plans to provide an update on its clinical development plans following alignment with the FDA.
Gorlin syndrome is a genetic disorder associated with a substantially increased risk of developing BCCs. Patients may develop multiple tumors over their lifetimes, often requiring repeated surgical procedures that can lead to scarring and permanent tissue loss. The company estimates that the number of patients with Gorlin syndrome in the United States could exceed 10,000, although prevalence data are limited.
The preliminary findings provide initial proof of concept for KB113 in this patient population. However, the study included only three patients, and further clinical development will be needed to establish the candidate's safety and efficacy.
KRYS’ Zacks Rank & Stocks to Consider
Krystal Biotech currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Werewolf Therapeutics (HOWL - Free Report) , Arvinas (ARVN - Free Report) and Halozyme Therapeutics (HALO - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 57.4% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 39.6% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Halozyme’s 2026 earnings per share have risen from $8.37 to $8.80, while estimates for 2027 have increased from $9.75 to $10.29 during the same time. HALO shares have skyrocketed 80.6% year to date.
Halozyme’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average negative surprise being 19.12%.