Why Is Krystal Shining?

(RTTNews) - Krystal Biotech Inc. (KRYS) has been on a tear since securing FDA approval for its first product on May 19.

Vyjuvek, a topical gel approved for the treatment of dystrophic epidermolysis bullosa, is not only the first FDA-approved product for the company but is also the first-ever redosable gene therapy and the first and only medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa, both recessive and dominant.

We featured Krystal Biotech on our site on Nov.9, 2022, when it was trading around $77.84. Yesterday, the stock touched an all-time high of $128.61 during intraday trading, before closing at $127.37. The all-time high reflects a gain of 65% in 7 months.

KB105 for the treatment of TGM1-Deficient Autosomal Recessive Congenital Ichthyosis, KB104 for the treatment of Netherton Syndrome, KB407 for the treatment of Cystic Fibrosis, KB408 for the treatment of Alpha-1 Antitrypsin Deficiency, and KB301 for the treatment of aesthetic indications are the other investigational therapies in Krystal Biotech's pipeline.

Upcoming developments

-- The company expects to make Vyjuvek available in the United States in the third quarter of 2023.

-- The official submission process of the Vyjuvek Marketing Authorization Application to the European Medicines Agency is expected to begin in the second half of 2023, and potential approval is anticipated in 2024.

-- The company is also working with the Pharmaceuticals and Medical Devices Agency in Japan to study Vyjuvek and seek approval for potential launch in 2025.

-- The phase II cohort of the phase I/II trial of KB105 in both pediatric and adult patients with TGM1 deficient autosomal recessive congenital ichthyosis is due for initiation in the first half of 2023.

-- The company is on track to make an investigational new drug (IND) filing for KB104 for the treatment of Netherton Syndrome this year.

-- A phase I study of KB407 for the treatment of Cystic Fibrosis is expected to be initiated in the U.S. in the first half of 2023.

-- A phase I trial of KB408 for the treatment of Alpha-1 Antitrypsin Deficiency is expected to be initiated in the second half of 2023.

-- KB301 for the improvement of lateral canthal lines at rest is under a phase I, Cohort 3 study, which is expected to be complete in the second half of 2023.

Cash position

Krystal ended March 31, 2023, with cash, cash equivalents, and investments of $355.5 million.

On May 22, 2023, the company entered into a securities purchase agreement for the sale of 1.725 million shares of its common stock at $92.50 per share in a private placement to certain qualified institutional buyers, raking in gross proceeds of about $160 million.

Krystal Biotech's shares made their debut on the NASDAQ Capital Market under the ticker symbol "KRYS" on September 20, 2017, priced at $10 each.

In the last 1 year, the stock has traded in a range of $49.17 to $128.61. KRYS closed Wednesday's trading at $127.37, up 1.47%.