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193,518 Results for "krystal biotech".
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FDA
Krystal Biotech’s FDA Platform Designation Pushes Limits of the Award
The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.
October 21, 2025
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2 min read
·
Dan Samorodnitsky
Press Releases
Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference
January 5, 2026
·
1 min read
Gene therapy
FDA’s Second Platform Designation Goes to Krystal After Sarepta Withdrawal
After the FDA revoked Sarepta Therapeutics’ platform designation in July, Krystal Biotech is “poised to be the first major beneficiary” of this program, according to analysts at William Blair.
October 15, 2025
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2 min read
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Tristan Manalac
Press Releases
Krystal Biotech Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference
January 12, 2026
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7 min read
Regulatory
Krystal Cuts Melanoma Study of Viral Immunotherapy as FDA ‘Uncertainty’ Muddies Approval Pathway
Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.
August 22, 2025
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2 min read
·
Tristan Manalac
Press Releases
Krystal Biotech to Present at 8th Annual Evercore Healthcare Conference
November 27, 2025
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1 min read
Press Releases
Krystal Biotech to Announce Interim Clinical Update from Highest Dose Cohort of Phase 1 CORAL-1 Study Evaluating KB407 in Patients with Cystic Fibrosis
January 8, 2026
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1 min read
Regulatory
6 Biotechs With a Shot at the FDA’s Platform Technology Designation
After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.
November 21, 2025
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9 min read
·
Tristan Manalac
Press Releases
Krystal Biotech Announces Third Quarter 2025 Financial and Operating Results
November 4, 2025
·
20 min read
Press Releases
Krystal Biotech to Report Third Quarter 2025 Financial Results on November 3, 2025
October 22, 2025
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1 min read
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