Krystal Biotech shares are up 140% on Monday: here’s the catalyst

Shares of Krystal Biotech Inc (NASDAQ: KRYS) more than doubled on Monday after the gene therapy company said its pivotal GEM-3 trial for VYJUVEK reported positive topline results.

GEM-3 trial met its primary and secondary endpoint

According to Krystal Biotech, the study involving its topical treatment for Dystrophic Epidermolysis Bullosa (Dystrophic EB) achieved the primary and secondary endpoint. In the press release, COO Suma Krishnan said:

VYJUVEK is different from the current standard of care as it treats Dystrophic EB at the molecular level. The topical gene therapy did not present any serious adverse effects during the trial.

The sharp increase in the stock price today added millions to Krystal Biotech’s market cap that now stands at $1.92 billion.

BLA to be submitted to the FDA next year

Krystal Biotech expects biologics license application (BLA) for the treatment to be submitted to the U.S. FDA by mid-2022. Shortly after, it added, it will apply for marketing authorisation in Europe.

Krystal Biotech is a Pittsburgh-headquartered pivotal-stage gene therapy company focused on treatments for rare diseases. Including a nearly 150% surge on Monday, the stock is now up 60% year-to-date.