Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer
Allarity Therapeutics (NASDAQ: ALLR) has received FDA Fast Track designation for stenoparib, its investigational treatment for advanced ovarian cancer. This designation enables expedited development and review process, including more frequent FDA interactions and potential eligibility for accelerated approval.
The company is currently conducting a Phase 2 clinical trial evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The trial, which began enrollment in June 2025, builds on previous Phase 2 data that demonstrated durable clinical benefit, with some patients maintaining treatment for over 22 months.
Allarity Therapeutics (NASDAQ: ALLR) ha ricevuto la designazione FDA Fast Track per stenoparib, il suo trattamento sperimentale per il carcinoma ovarico avanzato. Questa designazione consente uno sviluppo e una revisione accelerati, con interazioni pi霉 frequenti con la FDA e possibile idoneit脿 per l'approvazione accelerata.
L'azienda sta attualmente conducendo uno studio clinico di fase 2 che valuta stenoparib in pazienti con carcinoma ovarico avanzato, ricorrente, resistente al platino o non candidabile al trattamento con platino. Lo studio, che ha iniziato l'arruolamento a giugno 2025, si basa su dati di una precedente fase 2 che hanno mostrato un beneficio clinico duraturo, con alcuni pazienti in trattamento per oltre 22 mesi.
Allarity Therapeutics (NASDAQ: ALLR) ha recibido la designaci贸n Fast Track de la FDA para stenoparib, su tratamiento en investigaci贸n para el c谩ncer de ovario avanzado. Esta designaci贸n facilita un desarrollo y revisi贸n acelerados, incluyendo interacciones m谩s frecuentes con la FDA y posible elegibilidad para aprobaci贸n acelerada.
La compa帽铆a est谩 llevando a cabo actualmente un ensayo cl铆nico de fase 2 que eval煤a stenoparib en c谩ncer de ovario avanzado, recurrente, resistente al platino o no elegible para tratamiento con platino. El ensayo, que comenz贸 el reclutamiento en junio de 2025, se basa en datos previos de fase 2 que mostraron un beneficio cl铆nico duradero, con algunos pacientes mantenidos en tratamiento por m谩s de 22 meses.
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Allarity Therapeutics (NASDAQ: ALLR) a obtenu la d茅signation Fast Track de la FDA pour le stenoparib, son traitement exp茅rimental contre le cancer avanc茅 de l'ovaire. Cette d茅signation permet d'acc茅l茅rer le d茅veloppement et l'examen, avec des 茅changes plus fr茅quents avec la FDA et une possible 茅ligibilit茅 脿 l'autorisation acc茅l茅r茅e.
La soci茅t茅 m猫ne actuellement un essai clinique de phase 2 茅valuant le stenoparib chez des patientes atteintes d'un cancer de l'ovaire avanc茅, r茅cidivant, r茅sistant au platine ou non 茅ligible au traitement par platine. L'essai, dont le recrutement a d茅but茅 en juin 2025, s'appuie sur des donn茅es ant茅rieures de phase 2 ayant montr茅 un b茅n茅fice clinique durable, certaines patientes restant sous traitement pendant plus de 22 mois.
Allarity Therapeutics (NASDAQ: ALLR) hat f眉r Stenoparib, seinen Pr眉fpr盲parat zur Behandlung von fortgeschrittenem Eierstockkrebs, die FDA Fast Track-Zulassung erhalten. Diese Kennzeichnung erm枚glicht ein beschleunigtes Entwicklungs- und Pr眉fverfahren, einschlie脽lich h盲ufigerer Interaktionen mit der FDA und m枚glicher Berechtigung f眉r eine beschleunigte Zulassung.
Das Unternehmen f眉hrt derzeit eine Phase-2-Studie durch, in der Stenoparib bei fortgeschrittenem, rezidivierendem, platinresistentem oder f眉r Platin nicht in Frage kommendem Eierstockkrebs untersucht wird. Die Studie, die im Juni 2025 mit der Rekrutierung begann, baut auf fr眉heren Phase-2-Daten auf, die einen anhaltenden klinischen Nutzen zeigten, wobei einige Patientinnen die Behandlung 眉ber 22 Monate fortsetzten.
- FDA Fast Track designation received for stenoparib in advanced ovarian cancer
- Potential eligibility for accelerated approval, priority review, and rolling review
- Prior Phase 2 data showed durable clinical benefit lasting over 22 months
- Active patient enrollment in new Phase 2 trial since June 2025
- None.
Insights
FDA Fast Track designation for stenoparib significantly accelerates Allarity's ovarian cancer treatment timeline, boosting development prospects.
The FDA's Fast Track designation for stenoparib represents a significant regulatory milestone for Allarity Therapeutics. This designation isn't granted lightly鈥攊t acknowledges both the serious nature of advanced ovarian cancer and the agency's assessment that stenoparib shows potential to address unmet needs in this patient population.
The designation offers Allarity substantial regulatory advantages, including more frequent FDA interactions, potential eligibility for accelerated approval, priority review, and rolling review processes. These benefits can meaningfully compress development timelines, potentially bringing stenoparib to market faster if clinical data supports approval.
Mechanistically, stenoparib's dual PARP and WNT pathway inhibition represents a differentiated approach. Standard PARP inhibitors have shown efficacy in ovarian cancer, but resistance remains a significant challenge. The addition of WNT pathway inhibition could potentially overcome resistance mechanisms and expand the drug's efficacy profile.
The ongoing Phase 2 trial in platinum-resistant or platinum-ineligible ovarian cancer targets a particularly difficult-to-treat patient population. The mention of patients remaining on treatment for over 22 months in prior Phase 2 data is clinically meaningful, as durable responses in this setting are uncommon. This suggests stenoparib may offer sustained disease control for some patients.
The integration of their DRP庐 companion diagnostic in the trial design represents a precision medicine approach that could potentially identify patients most likely to respond to treatment, increasing the probability of clinical success and eventual regulatory approval.
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TARPON SPRINGS, Fla., August 26, 2025 -- Allarity Therapeutics, Inc. (鈥淎llarity鈥� or the 鈥淐ompany鈥�) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib鈥攁 differentiated, dual PARP and WNT pathway inhibitor鈥攖oday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer.
The FDA鈥檚 Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. This designation enables more frequent interactions with the FDA throughout the drug development process and potentially provides eligibility for accelerated approval, priority review, and rolling review if relevant criteria are met.
鈥淲e are very pleased that the FDA has granted Fast Track designation to stenoparib,鈥� said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. 鈥淭his recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes. We look forward to engaging closely with the FDA as we advance this program.鈥�
Allarity recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The first patient was enrolled in early June 2025, and several patients have already been dosed. The trial is designed to accelerate clinical development of stenoparib and its DRP庐 companion diagnostic and builds on prior encouraging Phase 2 data showing durable clinical benefit, including patients who remain on treatment now for over 22 months.
About Stenoparib
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/尾-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib鈥檚 unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian 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.
About the Drug Response Predictor 鈥� DRP庐 Companion Diagnostic
Allarity uses its drug-specific DRP庐聽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庐聽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庐聽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 .
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Forward-Looking Statements
This press release contains 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company鈥檚 current expectations or forecasts of future events. The words 鈥渁nticipates,鈥� 鈥渂elieve,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減ossible,鈥� 鈥減otential,鈥� 鈥減redicts,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渨ould鈥� 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 regulatory advancement of stenoparib; anticipated interactions with the FDA under Fast Track designation; expected timelines and outcomes of the ongoing Phase 2 trial in advanced ovarian cancer; and the potential impact of the DRP庐 companion diagnostic on patient selection and treatment outcomes. Any forward-looking statements in this press release are based on management鈥檚 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 future development and regulatory approval of stenoparib; the outcome of FDA interactions and potential reliance on Fast Track-related incentives; uncertainties in clinical trial enrollment, execution, and data interpretation; and the Company鈥檚 ability to successfully validate and deploy its DRP庐 companion diagnostic. 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 鈥淩isk Factors鈥� in our Form 10-K annual report filed with the Securities and Exchange Commission (the 鈥淪EC鈥�) on March 31, 2025, available at the SEC鈥檚 website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company鈥檚 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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FAQ
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