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Krystal Biotech (KRYS) Earnings Call Presentation
2025-07-09 14:39
Neurotrophic Keratitis (NK) Market & KB801 Opportunity - The number of patients in the U S with at least one NK claim has increased by over 115% from 31,000 in 2020 to an estimated 68,000 in 2024[9, 10] - In 2023, U S Medicaid and Medicare spent over $540 million on Oxervate, the only FDA-approved therapy for NK[12] - An estimated over 410,000 days of Oxervate therapy were reimbursed in the U S in 2024[12] - KB801 is designed to address the shortcomings of Oxervate, aiming for superior NGF exposure with significantly reduced dosing frequency[11, 21] KB801 Preclinical Data - KB801 transduces primary human corneal epithelial cells in vitro, leading to dose-dependent expression and secretion of mature NGF[25, 26, 29] - In vitro studies confirmed functionality of secreted NGF using a growth factor starved cell proliferation assay[25, 30] - Topical administration of KB801 to wounded murine corneas was well-tolerated and resulted in localized NGF expression[25] - Head-to-head mouse PK studies demonstrated a clear durability advantage with KB801 compared to recombinant NGF, even against intensive recombinant dosing[43, 47] KB801 Clinical Development - The EMERALD-1 study is a Phase 1/2 double-masked, 2:1 randomized, placebo-controlled study in patients with moderate-to-severe NK, with the first patient dosed in July 2025[51, 53, 1] - Krystal is pursuing Platform Technology Designation with the FDA, potentially leading to expedited development of KB801[56, 57]
Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of KB801 for the Treatment of Neurotrophic Keratitis
Globenewswire· 2025-07-09 11:00
Eye drop administration of KB801 designed to enable sustained expression of NGF in the front of the eye Investor call and webcast to be held July 9 at 8:30 am ET to discuss program and trial design PITTSBURGH, July 09, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) announced today that the first patient has been dosed in its Phase 1/2 clinical trial ("EMERALD-1"), a 2:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of neuro ...
10 Under-the-Radar Healthcare Stocks With Incredible Growth Potential
The Motley Fool· 2025-06-28 13:10
There's a strong case that healthcare is the most important sector in the stock market. These companies deliver innovative therapies and medical technologies that are often life-saving.Investors stand to benefit as healthcare leaders and emerging players address the needs of an aging global population and the rising prevalence of chronic diseases.Here are 10 under-the-radar healthcare stocks that could be great buys for your portfolio. 1. CertaraCertara (CERT -0.35%) is poised to capitalize on the transform ...
3 Promising Genomics Stocks to Keep an Eye On in 2025
ZACKS· 2025-06-27 13:06
An updated edition of the May 21, 2025, article.The promising field of genomics has undergone rapid evolution over the past decade. Genomics includes the study of a complete set of genes, their work process and way of interacting with each other and the environment. The primary focus is to evaluate all the genes of an organism rather than individual genes.This genetic information is being used to evaluate individual responses to drugs, leading to the development of targeted therapies. This, in turn, has pav ...
KRYS Up 4% on Initiating Dosing in Rare Eye Disease Phase III Study
ZACKS· 2025-06-25 16:21
Key Takeaways Shares of Krystal Biotech (KRYS) gained 4.2% on Tuesday after the company announced that it has dosed the first patient in the late-stage study evaluating its investigational candidate, KB803, for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB). KB803 is administered as an eye drop. Krystal Biotech's only marketed product, Vyjuvek, is currently FDA-approved for treating patients aged six months or older with DEB. The drug is referred to as B-VEC outs ...
Strength Seen in Krystal Biotech (KRYS): Can Its 4.2% Jump Turn into More Strength?
ZACKS· 2025-06-25 14:56
Company Overview - Krystal Biotech, Inc. (KRYS) shares increased by 4.2% to close at $143.67, with trading volume significantly higher than usual, reflecting a 10.3% gain over the past four weeks [1][2] Product Development - The stock price surge followed the initiation of patient dosing in the phase III IOLITE study for KB803 eye drops, targeting DEB-related corneal damage, which is a next-generation version of the approved gene therapy Vyjuvek [2] - KB803 addresses a rare patient population lacking corrective treatments, and the decentralized, at-home study design, along with prior compassionate use data showing strong efficacy, has bolstered investor confidence [2] Financial Performance Expectations - The company is projected to report quarterly earnings of $1.31 per share, reflecting a year-over-year increase of 52.3%, with revenues expected to reach $102.5 million, up 45.9% from the previous year [3] - The consensus EPS estimate for the quarter has remained stable over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Krystal Biotech is categorized under the Zacks Medical - Biomedical and Genetics industry, where Coherus Oncology (CHRS) also operates, having closed 5.6% higher at $0.77, but with a -3.9% return over the past month [5] - Coherus Oncology's consensus EPS estimate for the upcoming report is -$0.25, representing a significant year-over-year decline of 78.6% [6]
Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of KB803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis Bullosa
Globenewswire· 2025-06-24 11:00
Intra-patient, double-blind, multicenter, placebo-controlled study with crossover design Approximately 16 subjects will be enrolled in the IOLITE study. The sample size was calculated based on the average symptomatic days per month and standard deviation data from subjects enrolled in the natural history study who would be otherwise eligible for IOLITE and provides 90% power to detect an effect size of at least 25%, allowing for a dropout rate up to 20%. Enrolled patients will initially receive either a sin ...
Krystal Biotech to Present at Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-06-03 12:00
PITTSBURGH, June 03, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, in Miami. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 2:00 pm ET and host investor meetings throughout the day. A webcast of the presentation will be available here beginning at 2:00 pm ET on Tuesday, June 10, 2025 and will ...
2024年十大畅销基因疗法,仅3款销售额超1亿美元
生物世界· 2025-05-17 06:32
撰文丨王聪 编辑丨王多鱼 排版丨水成文 " 这是最好的时代,也是最坏的时代 ",查尔斯·狄更斯在其小说《双城记》中的经典名言,用来概括当下 的 基因治疗 市场,再合适不过了。 好的一面 ——今年 ( 截至 4 月中旬) ,有 5 家基因治疗公司累计完成 5.344 亿美元的风险投资,其 中,表观基因组编辑疗法开发公司 Tune Therapeutics 在 1 月份获得了超过 1.75 亿美元的 B 轮融资,眼 科基因疗法开发公司 Atsena Therapeutics 在 4 月份完成了超额认购的 1.5 亿美元 C 轮融资。基因编辑 疗法开发公司 Arbor Biotechnologies 在 3 月份完成了 7390 万美元的 C 轮融资, 表观遗传编辑疗法开 发公司 Epicrispr Biotechnologies 在 3 月份完成了 6800 万美元 B 轮融资,心血管疾病基因治疗开发公 司 XyloCor Therapeutics 在 2 月份完成了 6750 万美元 B 轮融资。 坏的一面 ——专注于基因和细胞疗法的 CRO/CDMO 公司 AmplifyBio 在运营四年后,于今年 4 月份 ...
Pharma Fire Sale: 3 Stocks the RSI Says You Shouldn't Ignore
MarketBeat· 2025-05-14 12:30
Investors searching for high-quality opportunities in the pharmaceutical space should keep a close eye on stocks trading at extremely oversold levels. One of the most popular ways to measure this is through the Relative Strength Index (RSI), a technical momentum indicator that signals when a stock may be due for a rebound. An RSI below 30 suggests a stock is extremely oversold and could be primed for a bounce, especially if sentiment is showing signs of turning or if the stock has retained analyst support. ...