Key Takeaways Krystal Biotech gained FDA approval to expand Vyjuvek's label to DEB patients from birth.The update allows at-home administration and flexibility in managing wound dressings.Approvals in Europe and Japan, plus U.S. growth, are expected to boost Vyjuvek sales.Krystal Biotech (KRYS) announced that the FDA has approved a label update of its marketed product, Vyjuvek (beremagene geperpavec-svdt), to include dystrophic epidermolysis bullosa ("DEB") patients from birth.Shares of Krystal Biotech were ...

The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s KRYS label update for Vyjuvek (beremagene geperpavec-svdt).The update expands the Vyjuvek eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek application and managing wound dressings.Epidermolysis bullosa (EB) is a group of rare, inherited genetic conditions that cause the skin and mucous membranes to be fragile, l ...

Krystal Biotech (NASDAQ:KRYS) announced that the FDA has approved an updated label for its gene therapy, Vyjuvek (beremagene geperpavec). The new approval broadens the patient eligibility for Vyjuvek to include individuals with dystrophic epidermolysis bullosa from birth. It also allows patients ...

Revised label allows treatment of DEB patients from birth VYJUVEK can now be applied by patients and caregivers PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibili ...

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Summary of Conference Call Company and Industry - **Company**: Crystal Biotech - **Industry**: Biotechnology, specifically focusing on gene therapy and dermatological treatments Key Points and Arguments Launch and Adoption of Vajjvek - The launch of Vajjvek in the U.S. has been ongoing for approximately 18-20 months, with positive healing outcomes observed in patients starting treatment in 2023 [2] - The healing process is chronic, with patients expected to return to treatment as their wounds blister due to the nature of collagen half-life and skin cell turnover [2] Patient Dynamics and Revenue Expectations - The launch experience is characterized by "waviness," indicating fluctuating patient enrollment and treatment pauses, leading to variable quarterly performance [3] - Despite a strong Q2 performance with revenues of $96 million, a sequential decline in Q3 is anticipated, but no significant drop in U.S. revenue is expected [5][6] Patient Segmentation and Market Potential - The current patient base is split 70-30 between DDEB and RDEB, with an estimated 1,200 identified DEP patients, indicating potential for additional RDEB patients [8][9] - The company is actively increasing its sales force to improve patient outreach and prescription rates, with a target of 24-25 sales representatives [11][13] Regulatory Developments - A PDUFA date for at-home administration is set for September 13, with expectations for positive discussions with regulatory agencies [16] - The potential for self-administration could enhance patient compliance and convenience, particularly for adult patients with mild to moderate symptoms [15] Global Expansion and Market Strategy - Crystal Biotech is launching in Germany and France, with plans to expand into the UK, Spain, and Italy, and has received approval to launch in Japan in Q4 [34] - Pricing strategies in international markets are still being negotiated, with expectations for German pricing to be around 50-60% of U.S. prices [36] Pipeline Developments - The company is optimistic about the ocular VIGEVEC program, targeting neurotrophic keratitis, with a market opportunity estimated to exceed $1 billion in the U.S. [39][40] - The dosing frequency for the new treatment is expected to be biweekly, which is more convenient compared to existing treatments that require six doses a day [41] Clinical Trials and Future Outlook - Enrollment for the Phase I study is expected to complete by year-end, with Phase III data anticipated in the first half of the following year [49] - The company is also advancing its AATD and inhaled oncology HSV programs, with ongoing discussions with the FDA regarding regulatory pathways [57][59] Additional Important Content - The company emphasizes the importance of patient compliance and the logistical challenges of transitioning from nurse-administered to self-administration of treatments [19] - There is a focus on the safety and efficacy of treatments, with ongoing monitoring of patient experiences and outcomes in clinical trials [22][23]

Core Viewpoint - Krystal Biotech, Inc. has shown a positive performance with an 8.5% increase in shares since the last earnings report, outperforming the S&P 500, but faces concerns regarding future revenue guidance [1][2]. Financial Performance - The company reported Q2 2025 earnings per share (EPS) of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [3]. - Revenues reached $96 million, a 36.6% year-over-year increase, surpassing the Zacks Consensus Estimate of $91 million, with all revenues derived from Vyjuvek sales [3]. - Despite strong quarterly results, shares fell by 14% due to soft guidance for third-quarter revenues [4]. Product Developments - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has secured over 575 reimbursement approvals in the U.S. as of July [5]. - The European Commission approved Vyjuvek for treating DEB-related wounds, with launches planned in Germany and France in Q3 and Q4 respectively [7]. - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [7]. Research and Development - Research and development expenses were $14.4 million, down 7.5% year-over-year, while selling, general, and administrative expenses rose to $35.2 million, a 27.2% increase from the previous year [6]. - The company is evaluating KB407 for cystic fibrosis, with four patients enrolled in a study, and expects interim data before year-end [8]. - KB408 is being assessed for alpha-1 antitrypsin deficiency, with positive results reported in a patient from a dose escalation study [9]. Pipeline Progress - Krystal Biotech is advancing multiple candidates, including KB801 for neurotrophic keratitis and KB707 for solid tumors, with ongoing enrollment in various studies [11][12]. - Jeune Aesthetics, a subsidiary, reported positive results for KB304 in treating décolleté wrinkles, leading to its progression into phase II studies [13][14]. Market Outlook - Since the earnings release, there has been a downward trend in estimates, with a consensus estimate shift of -16.13% [15]. - The stock has an average Growth Score of C, a Momentum Score of F, and a Value Score of D, resulting in an aggregate VGM Score of F [16]. - Krystal Biotech holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [17][18].

Company Participation - Krystal Biotech, Inc. will participate in the Cantor Global Healthcare Conference 2025 on September 4, 2025, in New York [1] - Krish S. Krishnan, Chairman and CEO, will engage in a fireside chat at 10:20 am ET and host investor meetings throughout the day [1] Webcast Information - A webcast of the presentation will be available starting at 10:20 am ET on September 4, 2025, and will be posted on the Company's website [2] Company Overview - Krystal Biotech, Inc. is a fully integrated, commercial-stage global biotechnology company focused on 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 genetic medicine approved in the US, Europe, and Japan for dystrophic epidermolysis bullosa [3] - The Company is advancing a robust pipeline of investigational genetic medicines in various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3]

"I was not afraid to hire young scientists with no experience, but mentoring them."Suma Krishnan, chairman and CEO of Krystal Biotech, spoke about the growth of her company from $50 million to $4.4 billion. #ForbesOver50https://t.co/utEODMUAoB https://t.co/wOnhOSzwW6 ...

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