Krystal Biotech, Inc. (KRYS): Price and Financial Metrics

Krystal Biotech Receives European Commission Orphan Designation for KB407 for the Treatment of Cystic Fibrosis

PITTSBURGH, Jan. 18, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced today that the European Commission has granted orphan designation for KB407 for the treatment of Cystic Fibrosis (CF). KB407 is an investigational, redosable gene therapy designed to correct the underlying cause of cystic fibrosis by delivering two copies of the CFTR gene

Yahoo | January 18, 2023

FDA extends review of Krystal's topical gene therapy for skin disorder citing manufacturing data

Krystal Biotech (NASDAQ:KRYS) said on Monday that the U.S. Food and Drug Administration (FDA) extended the review period by three months of its application seeking approval for its gene therapy B-VEC to treat patients with a type of skin disorder called dystrophic epidermolysis bullosa (DEB).

Krystal added that on Jan. 5, the FDA notified the company that based on manufacturing informatio...

Seeking Alpha | January 10, 2023

FDA extends review of Krystal''s topical gene therapy for skin disorder citing manufacturing data

Krystal Biotech (KRYS) said on Monday that the U.S. Food and Drug Administration ((FDA)) extended the review period by three months of its application seeking approval for gene…

Seeking Alpha | January 10, 2023

: Krystal Biotech’s stock is down on delayed PDUFA date

Shares of Krystal Biotech Inc. KRYS fell 9.5% in premarket trading on Monday after the company said the Food and Drug Administration moved back the decision date for its experimental treatment for a rare skin condition. The new PDUFA date for the dystrophic epidermolysis bullosa treatment candidate is May 19. The company had made a change to the hardware in the manufacturing process. “While we are disappointed that this change was viewed as a major amendment, we are committed to working with the FDA as it completes its review of the B-VEC application,” Krystal Biotech CEO Krish Krishnan said in a news release. Krystal’s stock is down 29.0% for the past year, while the S&P 500 SPX has declined 17.0%. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they mov...

MarketWatch | January 9, 2023

Krystal Biotech's decision date for experimental treatment drug receives 3-month delay from FDA

Krystal's candidate to treat dystrophic epidermolysis bullosa candidate, which is sometimes referred to as "butterfly child" due to the fragile-like conditions that become of the skin as a result of the disease, has seen a delay.

Yahoo | January 9, 2023