Krystal Biotech Inc. (KRYS) saw its stock price soar 5.06% during intraday trading on Monday.
The surge appears to be driven by news that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the company's KB707 therapy for advanced non-small cell lung cancer. This designation recognizes early clinical signals and is intended to support an expedited development and review path for the therapy.
The RMAT status for KB707 represents a significant regulatory milestone for Krystal Biotech as it seeks to expand its gene therapy platform beyond rare dermatology diseases into the competitive oncology market. This development could potentially accelerate the therapy's path to market and diversify the company's revenue streams beyond its current flagship product VYJUVEK.