USPTO allows Allarity (NASDAQ: ALLR) stenoparib DRP patent with exclusivity to 2039
Rhea-AI Filing Summary
Allarity Therapeutics, Inc. reported that the U.S. Patent and Trademark Office has issued a Notice of Allowance for its patent application covering the DRP® companion diagnostic specific to its cancer drug candidate stenoparib. The patent is expected to be formally granted within three months, subject to standard administrative procedures, and would provide exclusivity at least into 2039 for stenoparib when used together with the DRP® test.
The allowed claims cover methods for predicting clinical benefit from stenoparib using gene expression profiles and selecting patients most likely to respond. Allarity already holds European and Australian patents for the Stenoparib DRP® and 18 granted patents for other drug-specific DRPs, including eight in the United States. The company continues Phase 2 development of stenoparib in ovarian cancer and small cell lung cancer while pursuing additional DRP® patent protection globally.
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Insights
USPTO allowance extends potential U.S. exclusivity for stenoparib’s DRP-guided use into 2039.
The Notice of Allowance for Allarity’s stenoparib DRP® companion diagnostic supports its strategy to pair the drug with a predictive test. The patent is expected to be granted within three months and would provide U.S. exclusivity at least into 2039 when the drug is used with the test.
This moves stenoparib closer to a protected, personalized-therapy position, complementing existing European and Australian patents and 18 other DRP®-related patents. Actual commercial benefit still depends on successfully completing the ongoing Phase 2 trials in ovarian and small cell lung cancer and achieving regulatory approvals.
8-K Event Classification
Key Figures
Key Terms
Notice of Allowance regulatory
companion diagnostic medical
Phase 2 medical
PARP1/2 medical
WNT signaling pathway medical
platinum resistant medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Matters.
On April 27, 2026, Allarity Therapeutics, Inc. (the “Company”) announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company’s patent application covering its DRP® companion diagnostic specific to stenoparib. The Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release, dated April 27, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Allarity Therapeutics, Inc. | ||
| Date: April 28, 2026 | By: | /s/ Thomas H. Jensen |
| Thomas H. Jensen | ||
| Chief Executive Officer | ||
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Exhibit 99.1
Allarity Therapeutics Announces that the Stenoparib DRP® Test Has Received a Notice of Allowance from the US Patent and Trademark Office
- Patent expected to be formally granted within three months, subject to standard administrative procedures
- Patent would provide exclusivity at least into 2039 for stenoparib when used in concert with the stenoparib DRP test
TARPON SPRINGS, Fla., April 27, 2026 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor— today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application covering the Company’s DRP® companion diagnostic specific to stenoparib.
Importantly, this Notice of Allowance covers multiple claims and represents a major step in Allarity’s global strategy to expand and protect the commercial potential of stenoparib when selecting patients using its proprietary stenoparib DRP® test. The patent is expected to be formally granted within three months, subject to standard administrative procedures and would provide exclusivity at least into 2039 for stenoparib when used in concert with the DRP® as a companion diagnostic.
Thomas Jensen, CEO of Allarity Therapeutics, commented: “This Notice of Allowance from the USPTO represents another successful milestone in our efforts to secure intellectual property protection for our DRP® technology in the US, the world’s most important pharmaceutical market. Critically, this patent maximizes the marketing exclusivity in the US for stenoparib in patients selected using the stenoparib DRP test, which is especially important as we seek to accelerate stenoparib toward approval for Ovarian and other cancers.”
The allowed claims include methods for predicting clinical benefit based on gene expression profiles derived from tumor samples and for selecting those patients most likely to benefit from stenoparib treatment.
Allarity previously secured a European and Australian patent for the Stenoparib DRP® and holds 18 granted patents for other drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP® remain pending in Canada, Japan, China, and India.
Allarity Therapeutics, Inc. I 123 E Tarpon Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
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About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. 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. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel 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 the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.
Allarity Therapeutics, Inc. I 123 E Tarpon Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the expected grant and scope of the U.S. patent for the stenoparib DRP® companion diagnostic; the anticipated contribution of this patent to the Company’s global intellectual property strategy; and the Company’s ability to advance and commercialize stenoparib and its companion diagnostic. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the patent grant process, including potential delays or challenges; the Company’s ability to obtain, maintain, and enforce intellectual property protection; and broader risks related to the Company’s clinical development, regulatory progress, and financial resources. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2026, available at the SEC’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
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Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Allarity Therapeutics, Inc. I 123 E Tarpon Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
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