AUSTIN, TX - Shattuck Labs, Inc. (NASDAQ:STTK), a biotechnology firm engaged in the development of fusion proteins for cancer and autoimmune diseases, disclosed today that the U.S. Food and Drug Administration (FDA) has awarded orphan drug designation to its lead clinical candidate, SL-172154, aimed at treating acute myeloid leukemia (AML).
This status is expected to bolster the drug's development through various incentives, including seven years of market exclusivity upon potential FDA approval.
Acute myeloid leukemia is a challenging and often fatal hematologic malignancy, with statistics from the National Cancer Institute indicating about 20,380 new cases and 11,310 deaths in the U.S. in 2023. The median diagnosis age is 68, and survival rates are particularly low for older patients, highlighting the pressing need for new therapies.
SL-172154 is designed to inhibit the CD47/SIRPα checkpoint interaction while activating the CD40 costimulatory receptor, which could enhance the immune system's response against tumors. Shattuck's CEO, Taylor Schreiber, M.D., Ph.D., underscored the FDA's recognition of the urgent need for novel AML treatments and expressed enthusiasm about progressing to later-stage clinical studies.
The company anticipates presenting additional data from the Phase 1B dose expansion clinical trial of SL-172154, combined with azacitidine, at the European Hematology Association 2024 Congress. The trial focuses on patients with higher-risk myelodysplastic syndromes and TP53 mutant AML.
Orphan drug designation by the FDA is granted to drugs that target conditions affecting fewer than 200,000 people in the United States, providing developers with incentives such as tax credits for clinical trials and waiver of application fees to encourage the creation of treatments for rare diseases.
Shattuck Labs is currently evaluating SL-172154 in multiple Phase 1 trials, including those for platinum-resistant ovarian cancer and AML. The company operates out of Austin, Texas, and Durham, North Carolina, and continues to explore its Agonist Redirected Checkpoint (ARC®) platform for developing new biologic medicines.
This announcement is based on a press release statement from Shattuck Labs, Inc.
InvestingPro Insights
As Shattuck Labs, Inc. (NASDAQ:STTK) garners FDA's orphan drug designation for SL-172154, the financial landscape of the company provides additional context for investors monitoring its journey in developing treatments for acute myeloid leukemia (AML). With a market capitalization of 333.81 million USD, the company is positioned in a competitive biotech market that demands both innovation and financial acumen.
An InvestingPro Tip highlights that Shattuck Labs holds more cash than debt on its balance sheet, a significant indicator of financial health that could support the company's clinical trials and development efforts. However, it's also noted that the company is quickly burning through cash, which underscores the importance of efficient resource management as they advance their clinical programs.
InvestingPro Data reveals a challenging profitability landscape for Shattuck Labs, with a negative P/E ratio of -3.73, which has slightly declined to -3.94 over the last twelve months as of Q1 2024. This is reflective of the company's current status of not generating profit, a common scenario for many biotech firms in the drug development stage. Additionally, the company's stock has experienced significant volatility, with a 6-month price total return of 196.2%, yet a 1-month price total return showing a decrease of -32.63%, indicating the high-risk, high-reward nature of investing in the biotech sector.
For investors seeking a deeper analysis of Shattuck Labs' financials and future prospects, InvestingPro offers additional insights. With over 12 InvestingPro Tips available at https://www.investing.com/pro/STTK, users can gain a comprehensive understanding of the company's financial health and market potential. To access these insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The company's commitment to addressing the unmet medical needs in AML treatment is clear, and the financial data available through InvestingPro can help investors make informed decisions as Shattuck Labs navigates the complex landscape of drug development and regulatory approval.
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