PITTSBURGH - Krystal Biotech , Inc. (NASDAQ:KRYS), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to their inhaled KB707 treatment for patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard care. This development aims to address the lack of immunotherapy options for many cancers that predominantly metastasize to the lungs.
KB707 is a genetically modified HSV-1 vector that delivers genes for human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the tumor environment, potentially promoting systemic immune-mediated tumor clearance. The FDA also cleared an amendment to the company's Investigational New Drug application in January 2024, allowing the evaluation of inhaled KB707 in a Phase 1 clinical trial for patients with advanced lung tumors.
The trial, known as KYANITE-1, is set to begin in the first half of 2024, with the first patient expected to be dosed during this period. The study is an open-label, multicenter, monotherapy dose escalation and expansion trial.
This is the second Fast Track Designation for KB707; the first was granted in July 2023 for the treatment of locally advanced or metastatic melanoma that is relapsed or refractory to anti-programmed cell death protein-1 therapy.
Krystal Biotech, headquartered in Pittsburgh, Pennsylvania, focuses on genetic medicines for diseases with significant unmet medical needs. Their first commercial product, VYJUVEK®, is the first redosable gene therapy approved by the FDA for dystrophic epidermolysis bullosa.
The information in this article is based on a press release statement from Krystal Biotech, Inc.
InvestingPro Insights
As Krystal Biotech, Inc. (NASDAQ:KRYS) continues to make strides in the biotechnology sector with recent FDA designations, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Krystal Biotech holds a market capitalization of $3.27 billion USD, showcasing its substantial size within the biotech industry. Despite not being profitable over the last twelve months, with a P/E ratio (adjusted) of -31.03, the company's strong cash position is reflected in its balance sheet, holding more cash than debt, which provides financial flexibility for ongoing research and development activities.
An InvestingPro Tip highlights that Krystal Biotech's liquid assets exceed its short-term obligations, indicating a robust liquidity position that can support the company through its clinical trials and potential market expansions. Additionally, the company has experienced a significant 3-month price total return of 16.25%, reflecting investor confidence in its growth prospects and recent clinical advancements. Moreover, with 3 analysts having revised their earnings upwards for the upcoming period, there's an optimistic outlook for the company's financial future.
For those considering an investment in Krystal Biotech, it's worth noting that the company does not pay dividends to shareholders, as it reinvests earnings back into its core business operations. To explore more insights and get a deeper analysis of Krystal Biotech, including additional InvestingPro Tips, visit https://www.investing.com/pro/KRYS. There are 9 more tips available on InvestingPro that could provide further guidance on investment decisions. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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