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Krystal Is Clearer, Hits New High

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Shares of Krystal Biotech Inc. (KRYS) touched an all-time intraday high of $28.75 on Monday, a gain of 126% in six months.

We had alerted our readers to this stock on June 8, 2018, when it was trading around $12.72 (Report titled: In The Spotlight: Krystal Biotech).

Krystal is a gene therapy company focused on developing novel treatments for patients suffering from dermatological diseases through its proprietary gene therapy platform, known as Skin TARgeted Delivery platform, or STAR-D platform.

The Company's lead product candidate is KB103, a first-in-class topical gene therapy, for the treatment of dystrophic epidermolysis bullosa, or DEB, under phase I/II trial.
Interim data from the phase I/II trial of KB103, involving two adult Recessive Dystrophic Epidermolysis Bullosa ("RDEB"), NC1[+] patients aged 35 and 28 years old was reported in October of this year.

According to the Company, results on the 2 patients met all primary efficacy and safety endpoints in topically administered KB103 wounds.The phase I/II study is anticipated to be complete in the first half of 2019, and a pivotal phase III study is slated to begin in the second half of next year.

Dystrophic epidermolysis bullosa, or DEB, is an incurable, often fatal skin blistering condition caused by a lack of collagen protein in the skin. It is caused by mutations in the gene coding for type VII collagen, or COL7. The most severe form of DEB is recessive DEB, or RDEB, which is caused by null mutations in the COL7A1 gene, and the milder form of DEB occurs in the form of dominant DEB, or DDEB.

There is currently no cure for dystrophic epidermolysis bullosa, and the current standard of care for DEB patients is limited to palliative treatments. It is estimated that there may be as many as 125,000 patients worldwide who suffer from DEB.

Also in the Company's pipeline is another gene therapy candidate KB105, for the treatment of patients with TGM-1-deficient autosomal recessive congenital ichthyosis ("ARCI").

Autosomal recessive congenital ichthyosis, or ARCI, is associated with life-long pronounced scaling, where the scales are plate-like, often of a dark color, and cover the whole body surface area.

Krystal Biotech plans to file an investigational new drug application for KB105 before the end of 2018.

The Company ended October 31, 2018, with cash of about $115 million.

Krystal Biotech went public on the NASDAQ Capital Market on September 20, 2017, offering its shares at a price of $10 each. The stock has thus far hit a low of $8.03 and a high of $28.75.

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