Allarity Therapeutics Advances Stenoparib with FDA Fast Track Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
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Source: Globenewswire
- Strategic Reset: Over the past two years, Allarity has focused on developing the dual-target inhibitor stenoparib, which has recently received FDA Fast Track Designation, marking a significant advancement in the treatment of ovarian cancer and expected to enhance market competitiveness.
- Clinical Outcomes: At the AACR Special Conference, Allarity presented clinical data showing that median overall survival has not yet been reached, with follow-up exceeding 22 months, indicating the durability and efficacy of stenoparib, which could attract higher investment interest.
- New Indication Expansion: Allarity has begun exploring stenoparib's application in recurrent Small Cell Lung Cancer, signing a fully funded clinical trial agreement with the US Veteran's Administration, further broadening its market potential.
- Financial Stability: The company has strengthened its financial foundation by simplifying its capital structure, ensuring continued access to public markets, which is expected to provide robust support for future clinical development.
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Analyst Views on ALLR
Wall Street analysts forecast ALLR stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ALLR is 9.50 USD with a low forecast of 9.50 USD and a high forecast of 9.50 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.090
Low
9.50
Averages
9.50
High
9.50
Current: 1.090
Low
9.50
Averages
9.50
High
9.50
About ALLR
Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. It is focused on development of stenoparib, a PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP technology to develop a companion diagnostic that can be used to select those patients expected to derive clinical benefit from stenoparib. Its therapeutic candidate, stenoparib, is a dual inhibitor of the key DNA damage repair enzyme PARP, as well as Tankyrases, critical enzymes involved in the WNT signaling pathway commonly activated in many cancers. Inhibition of key DNA damage repair enzymes, such as PARP, has clinically demonstrated to be therapeutically beneficial in the treatment of cancers (ovarian cancers). The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Allarity Therapeutics Advances Stenoparib with FDA Fast Track Designation
- Strategic Reset: Over the past two years, Allarity has focused on developing the dual-target inhibitor stenoparib, which has recently received FDA Fast Track Designation, marking a significant advancement in the treatment of ovarian cancer and expected to enhance market competitiveness.
- Clinical Outcomes: At the AACR Special Conference, Allarity presented clinical data showing that median overall survival has not yet been reached, with follow-up exceeding 22 months, indicating the durability and efficacy of stenoparib, which could attract higher investment interest.
- New Indication Expansion: Allarity has begun exploring stenoparib's application in recurrent Small Cell Lung Cancer, signing a fully funded clinical trial agreement with the US Veteran's Administration, further broadening its market potential.
- Financial Stability: The company has strengthened its financial foundation by simplifying its capital structure, ensuring continued access to public markets, which is expected to provide robust support for future clinical development.
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Allarity Therapeutics CEO Letter Highlights Progress Toward Stenoparib FDA Approval
- Strategic Reset: In 2024, Allarity undertook a strategic reset by focusing exclusively on stenoparib and shedding low-value programs, which enhanced its potential to treat complex cancers and laid a solid foundation for future clinical and regulatory success.
- Clinical Progress: In 2025, Allarity accelerated the FDA approval process for stenoparib while expanding its clinical potential into high-value indications like recurrent Small Cell Lung Cancer, further strengthening the company's financial health.
- Clinical Data: At the AACR Special Conference, Allarity presented clinical data showing that median overall survival had not been reached, with some patients on therapy for over 30 months, underscoring stenoparib's tolerability and clinical benefit, thus supporting its advantages as a next-generation PARP inhibitor.
- Future Outlook: Looking ahead to 2026, Allarity plans to expedite the approval process for stenoparib and explore its applications in other cancer indications, aiming to enhance enterprise value and address significant unmet medical needs.
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