Krystal Biotech Inc. (NASDAQ: KRYS) stocks soared more than 115%. It was trading at $88.02 at 11:02 a.m. ET, up by 121.02%. The stocks had earlier touched it All-Time-High at $102.99 todsy. With this achievement it came closer to its 1-year target of $103.
Also, its shares had surged past 133% in the early trading hours. The spike has been a breather as Krystal Biotech’s stocks had witnessed a significant decline last week. It closed at $39.81 on Friday, down by 3.77% from its opening price of $41.37.
The current market capitalization stands at $1.9 billion.
Reason for the sudden surge
Krystal Biotech’s stocks surged in response to topline results for GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEK™, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).
The Key highlights ofnthe announcement include:
- 31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis
- 67% of wounds treated with VYJUVEK™ achieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)
- 71% of wounds treated with VYJUVEK™ achieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)
- In an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)
- VYJUVEK™ was well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.
- The immunogenicity profile of VYJUVEK™ (as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies
“Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTM which showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds. With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”– said Suma Krishnan, Founder and Chief Operating Officer of Krystal Biotech.