Core Viewpoint - Krystal Biotech, Inc. (KRYS) has experienced a significant stock surge of 21.9% year-to-date, outperforming the industry growth of 7.8%, the Medical sector, and the S&P 500 Index, primarily due to the strong uptake of its newly approved drug Vyjuvek and positive pipeline developments [1][2][3]. Company Performance - The company reported better-than-expected second-quarter results, with both earnings and sales exceeding estimates [2]. - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), was approved by the FDA in May 2023 and launched in Q2 2023, generating sales of $70.3 million in Q2 2024, reflecting a 55.3% sequential increase [3][4]. Drug Development and Pipeline - Krystal has secured over 400 reimbursement approvals for Vyjuvek in the U.S. and achieved positive access for 97% of lives covered under commercial and Medicaid plans as of July 2024 [4][5]. - The company is progressing with its marketing authorization application for Vyjuvek in Europe, with a decision expected in the second half of 2024 [6]. - Plans are in place to submit an application for approval in Japan in the second half of 2025 [7]. - A study was initiated in August to collect data on corneal abrasions in DEB patients, serving as a precursor for a registrational study on B-VEC eyedrops, expected to commence in Q4 2024 [8]. Research and Development - Krystal is advancing a robust pipeline of investigational genetic medicines across various fields, including respiratory, oncology, dermatology, ophthalmology, and aesthetics [9]. - The company is evaluating KB407 for cystic fibrosis and has completed dosing in cohort 2 of the phase I CORAL-1 study, with plans to initiate further cohorts [9]. - KB408 is being assessed for alpha-1 antitrypsin deficiency, with interim data expected in Q4 2024 [10]. - The company is also progressing with KB707 for injectable solid tumors and KB301 for aesthetic indications [11]. - Development of KB105 for lamellar ichthyosis has resumed, with phase II trials expected to start in the first half of 2025 [12]. Financial Position - As of June 30, 2024, Krystal holds a cash balance of $628.9 million, positioning the company well for the development of its pipeline candidates [13].

Krystal Biotech, Inc. (KRYS) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. Since a c ...

Net product revenue of $70.3 million in 2Q and $166.2 million since launch in August 2023 On track to deliver three clinical readouts in 2H 2024 Jeune Aesthetics' KB301 Phase 1 PEARL-1 study (Cohorts 3 and 4) in 3Q 2024; KB408 Phase 1 SERPENTINE-1 study for the treatment of AATD in 4Q 2024; and KB707 Phase 1 OPAL-1 study for the treatment of injectable solid tumors in 4Q 2024 Strong balance sheet, ending the quarter with $628.9 million in cash and investments PITTSBURGH, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Kr ...

Company Overview - Krystal Biotech, Inc. is a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines for diseases with high unmet medical needs [3] - The company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa [3] - Krystal Biotech is advancing a robust pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3] Upcoming Financial Results - The company will report its second quarter 2024 financial results on August 5, 2024, prior to the opening of U.S. markets [1] - A conference call and webcast will be hosted by the company's management at 8:30 am ET on the same day to discuss the financial results and provide a business update [1] Access to Information - Investors and the general public can access the live webcast through a provided link [2] - A replay of the webcast will be available for 30 days on the company's website for those unable to listen live [2]

A solid price increase over a period of 12 weeks reflects investors' continued willingness to pay more for the potential upside in a stock. KRYS is quite a good fit in this regard, gaining 30.3% over this period. Moreover, KRYS is currently trading at 93.7% of its 52-week High-Low Range, hinting that it can be on the verge of a breakout. The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Za ...

Krystal Biotech, Inc. (KRYS) appears an attractive pick given a noticeable improvement in the company's earnings outlook. The stock has been a strong performer lately, and the momentum might continue with analysts still raising their earnings estimates for the company. Analysts' growing optimism on the earnings prospects of this company is driving estimates higher, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revi ...

Shares of the commercial-stage biotechnology company, Krystal Biotech, Inc. (KRYS) , surged 36.5% year to date against the industry's decline of 4.3%. This was due to the strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress. Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). Krystal dosed the first patient in phase I SERPENTINE-1 study in adult patients with AATD. Recruitment is ongoing and the company remains on track to re ...

Core Insights - Krystal Biotech, Inc. will present new preclinical data on respiratory genetic medicine candidates KB407 and KB408 at the ATS 2024 International Conference from May 17-22, 2024 [1] Group 1: Product Information - KB407 is designed for the treatment of cystic fibrosis and encodes two full-length copies of CFTR, while KB408 targets alpha-1 antitrypsin deficiency (AATD) and encodes two full-length copies of alpha-1 antitrypsin [2] - Both KB407 and KB408 are currently undergoing Phase 1 studies [3] Group 2: Presentation Details - The poster presentation for KB408 will cover a murine toxicology study and is scheduled for May 20, 2024, from 11:30 AM to 1:15 PM PT [3] - The poster presentation for KB407 will evaluate its efficacy in healthy and patient-derived airway cells and is set for May 21, 2024, from 11:30 AM to 1:15 PM PT [3] Group 3: Company Overview - Krystal Biotech is a commercial-stage biotechnology company focused on genetic medicines for diseases with high unmet medical needs, with its first product VYJUVEK® being the first FDA-approved redosable gene therapy for dystrophic epidermolysis bullosa [4] - The company is advancing a diverse pipeline of investigational genetic medicines across various therapeutic areas including respiratory, oncology, dermatology, ophthalmology, and aesthetics [4]

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.20 per share. This compares to loss of $1.76 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -85%. A quarter ago, it was expected that this company would post a loss of $0.52 per share when it actually produced earnings of $0.30, delivering a surprise of 157.69%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ FORM 10-Q _____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) _____________________________________________________ For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECU ...