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Allarity gets CLIA certification for its Denmark lab

Tue, 07 Jul 2026 08:03:01 -0400

Allarity Therapeutics, Inc. (NASDAQ: ALLR) announced it has obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory in Horsholm, Denmark.

The certification, administered by the U.S. Centers for Medicare & Medicaid Services, allows Allarity to perform its Drug Response Predictor (DRP®) biomarker testing internally rather than relying on external partner laboratories. The FDA requires that biomarker testing used to select patients for registration trials be conducted in a CLIA-certified laboratory environment.

According to the company's press release, the in-house capability is intended to support the development of stenoparib, its dual PARP and WNT pathway inhibitor,

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Tue, 07 Jul 2026 08:00:00 -0400

Allarity Therapeutics is now poised to run its DRP^® testing in-house in a CLIA-certified laboratory environment
The FDA requires that biomarker testing to select patients for registration trials must be performed in a CLIA-certified laboratory environment
CLIA certification for the Allarity Therapeutics Medical Laboratory is a critical strategic initiative to streamline the development of Allarity’s lead agent, stenoparib
Positions Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified partner for European companies pursuing U.S. clinical trials or commercialization

TARPON SPRINGS, Fla., July

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Tue, 07 Jul 2026 08:00:00 -0400

Allarity Therapeutics is now poised to run its DRP^® testing in-house in a CLIA-certified laboratory environment
The FDA requires that biomarker testing to select patients for registration trials must be performed in a CLIA-certified laboratory environment
CLIA certification for the Allarity Therapeutics Medical Laboratory is a critical strategic initiative to streamline the development of Allarity’s lead agent, stenoparib
Positions Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified partner for European companies pursuing U.S. clinical trials or commercialization

TARPON SPRINGS, Fla., July

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Tue, 07 Jul 2026 08:00:00 -0400

Allarity Therapeutics is now poised to run its DRP^® testing in-house in a CLIA-certified laboratory environment
The FDA requires that biomarker testing to select patients for registration trials must be performed in a CLIA-certified laboratory environment
CLIA certification for the Allarity Therapeutics Medical Laboratory is a critical strategic initiative to streamline the development of Allarity’s lead agent, stenoparib
Positions Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified partner for European companies pursuing U.S. clinical trials or commercialization

TARPON SPRINGS, Fla., July

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Tue, 07 Jul 2026 08:00:00 -0400

Allarity Therapeutics is now poised to run its DRP^® testing in-house in a CLIA-certified laboratory environment
The FDA requires that biomarker testing to select patients for registration trials must be performed in a CLIA-certified laboratory environment
CLIA certification for the Allarity Therapeutics Medical Laboratory is a critical strategic initiative to streamline the development of Allarity’s lead agent, stenoparib
Positions Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified partner for European companies pursuing U.S. clinical trials or commercialization

TARPON SPRINGS, Fla., July

Form 8-K Allarity Therapeutics, For: Jun 26

Wed, 01 Jul 2026 08:06:00 -0400

si-local-file:///var/storage/secattach/20260701/26717220.html

Form 8-K Allarity Therapeutics, For: Jun 26

Wed, 01 Jul 2026 08:06:00 -0400

si-local-file:///var/storage/secattach/20260701/26717220.html

Allarity gets U.S. patent for stenoparib companion diagnostic

Tue, 30 Jun 2026 08:01:34 -0400

Allarity Therapeutics, Inc. (NASDAQ: ALLR) announced that the U.S. Patent and Trademark Office has granted a patent covering its stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic, with protection extending through April 2042.

The patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment using the DRP® test. The grant follows a Notice of Allowance the USPTO issued in April 2026.

Allarity also holds patent protection for the stenoparib DRP® in Europe and Australia through 2039, with related applications pending in additional

Allarity Therapeutics Announces the Grant of Essential U.S. Patent for Its Stenoparib DRP® Companion Diagnostic

Tue, 30 Jun 2026 08:00:00 -0400

Key U.S. patent now protects exclusivity for developing stenoparib with the stenoparib-DRP^® until April 2042

TARPON SPRINGS, Fla., June 30, 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 granted the key U.S. patent covering its proprietary stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic. The newly granted patent has a term extending into April 2042. The patent grant follows

Allarity Therapeutics Announces the Grant of Essential U.S. Patent for Its Stenoparib DRP® Companion Diagnostic

Tue, 30 Jun 2026 08:00:00 -0400

Key U.S. patent now protects exclusivity for developing stenoparib with the stenoparib-DRP^® until April 2042

Allarity Therapeutics Announces the Grant of Essential U.S. Patent for Its Stenoparib DRP® Companion Diagnostic

Tue, 30 Jun 2026 08:00:00 -0400

Key U.S. patent now protects exclusivity for developing stenoparib with the stenoparib-DRP^® until April 2042

Allarity Therapeutics Announces the Grant of Essential U.S. Patent for Its Stenoparib DRP® Companion Diagnostic

Tue, 30 Jun 2026 08:00:00 -0400

Key U.S. patent now protects exclusivity for developing stenoparib with the stenoparib-DRP^® until April 2042

Form 8-K Allarity Therapeutics, For: Jun 18

Mon, 22 Jun 2026 08:10:00 -0400

si-local-file:///var/storage/secattach/20260622/26670279.html

Form 8-K Allarity Therapeutics, For: Jun 18

Mon, 22 Jun 2026 08:10:00 -0400

si-local-file:///var/storage/secattach/20260622/26670279.html

Allarity to present stenoparib Phase 2 poster at ESMO congress

Thu, 18 Jun 2026 08:00:16 -0400

Allarity Therapeutics, Inc. (NASDAQ: ALLR) announced it presented a Trial-in-Progress poster at the ESMO Gynaecological Cancers Congress 2026, held June 17–19 in Copenhagen, Denmark.

The poster, titled "NCT03878849: A phase II trial of stenoparib/2X-121, a novel dual inhibitor of PARP and the WNT pathway, in platinum resistant/ineligible ovarian cancer patients," was presented by Principal Investigator Kathleen N. Moore, M.D., on June 18, 2026.

The poster outlines the scientific background, study design, and clinical rationale for Allarity's ongoing Phase 2 trial evaluating stenoparib in patients with advanced platinum-resistant or platinum-ineligible ovarian cancer. As a Trial-in-Progress presentation, it does not include new clinical data.

Stenoparib

Allarity Therapeutics to Present Trial-in-Progress Poster on Phase 2 Stenoparib Trial at ESMO Gynaecological Cancers Congress 2026

Thu, 18 Jun 2026 08:00:00 -0400

Principal Investigator Kathleen N. Moore, M.D., a leading expert in advanced ovarian cancer, will present the poster

TARPON SPRINGS, Fla., June 18, 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 it will present a Trial-in-Progress poster at the ESMO Gynaecological Cancers Congress 2026, held June 17–19 in Copenhagen, Denmark.

The poster outlines the scientific background, study design, and clinical rationale

Allarity Therapeutics to Present Trial-in-Progress Poster on Phase 2 Stenoparib Trial at ESMO Gynaecological Cancers Congress 2026

Thu, 18 Jun 2026 08:00:00 -0400

Principal Investigator Kathleen N. Moore, M.D., a leading expert in advanced ovarian cancer, will present the poster

The poster outlines the scientific background, study design, and clinical rationale

Allarity Therapeutics to Present Trial-in-Progress Poster on Phase 2 Stenoparib Trial at ESMO Gynaecological Cancers Congress 2026

Thu, 18 Jun 2026 08:00:00 -0400

Principal Investigator Kathleen N. Moore, M.D., a leading expert in advanced ovarian cancer, will present the poster

The poster outlines the scientific background, study design, and clinical rationale

Allarity Therapeutics to Present Trial-in-Progress Poster on Phase 2 Stenoparib Trial at ESMO Gynaecological Cancers Congress 2026

Thu, 18 Jun 2026 08:00:00 -0400

Principal Investigator Kathleen N. Moore, M.D., a leading expert in advanced ovarian cancer, will present the poster

The poster outlines the scientific background, study design, and clinical rationale

Form 8-K Allarity Therapeutics, For: May 27

Tue, 02 Jun 2026 17:11:00 -0400

si-local-file:///var/storage/secattach/20260602/26593100.html

Form 8-K Allarity Therapeutics, For: May 27

Tue, 02 Jun 2026 17:11:00 -0400

si-local-file:///var/storage/secattach/20260602/26593100.html

Allarity Therapeutics (ALLR) Misses Q1 EPS by 17c

Mon, 18 May 2026 06:46:54 -0400

Allarity Therapeutics (NASDAQ: ALLR) reported Q1 EPS of ($0.17).

For earnings history and earnings-related data on Allarity Therapeutics (ALLR) click here.

Allarity Therapeutics Reports First Quarter 2026 Results and Continued Stenoparib Development in Multiple Cancers

Fri, 15 May 2026 16:30:00 -0400

- Stenoparib clinical development continues in relapsed small cell lung cancer and, under FDA Fast Track designation, in advanced ovarian cancer

- Allarity has received a Notice of Allowance for new intellectual property covering its stenoparib-specific DRP^® companion diagnostic

- Strong financial position maintained with approximately $29.8 million in cash and restricted cash as of March 31, 2026

TARPON SPRINGS, Fla., MAY 15, 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 reported financial results

Allarity Therapeutics Reports First Quarter 2026 Results and Continued Stenoparib Development in Multiple Cancers

Fri, 15 May 2026 16:30:00 -0400

Allarity Therapeutics Reports First Quarter 2026 Results and Continued Stenoparib Development in Multiple Cancers

Fri, 15 May 2026 16:30:00 -0400