Allarity Therapeutics Announces Dismissal of Securities Class Action Lawsuit
Allarity Therapeutics (NASDAQ: ALLR) announced the complete dismissal of a securities class action lawsuit filed against the company in the United States District Court for the Southern District of New York. The lawsuit, originally filed on September 13, 2024, alleged false or misleading statements regarding the Dovitinib New Drug Application (NDA) regulatory prospects.
The case was dismissed with each party bearing its own legal costs, and notably, no settlement or payment was required from Allarity or its officers. The company, which is currently in Phase 2 clinical trials, is developing stenoparib—a dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary Drug Response Predictor (DRP®) technology.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato la completa archiviazione di una causa collettiva relativa ai titoli, intentata contro l'azienda presso il Tribunale Distrettuale degli Stati Uniti per il Distretto Meridionale di New York. La causa, originariamente presentata il 13 settembre 2024, accusava dichiarazioni false o fuorvianti riguardo alle prospettive regolatorie della domanda di nuovo farmaco (NDA) per il Dovitinib.
Il caso è stato archiviato con ciascuna parte che sostiene i propri costi legali, e in particolare, non è stato richiesto alcun risarcimento o pagamento da parte di Allarity o dei suoi dirigenti. L'azienda, attualmente in fase 2 di sperimentazione clinica, sta sviluppando stenoparib—un inibitore duale della via PARP/Wnt—come trattamento personalizzato per il cancro utilizzando la sua tecnologia proprietaria Drug Response Predictor (DRP®).
Allarity Therapeutics (NASDAQ: ALLR) anunció el desestimado completo de una demanda colectiva de valores presentada contra la empresa en el Tribunal de Distrito de los Estados Unidos para el Distrito Sur de Nueva York. La demanda, presentada originalmente el 13 de septiembre de 2024, alegaba declaraciones falsas o engañosas sobre las perspectivas regulatorias de la Solicitud de Nuevo Medicamento (NDA) para el Dovitinib.
El caso fue desestimado con cada parte asumiendo sus propios costos legales, y notablemente, no se requirió ningún acuerdo o pago de Allarity o sus directivos. La empresa, que actualmente se encuentra en ensayos clínicos de Fase 2, está desarrollando stenoparib—un inhibidor dual de la vía PARP/Wnt—como tratamiento personalizado para el cáncer utilizando su tecnología propietaria Drug Response Predictor (DRP®).
Allarity Therapeutics (NASDAQ: ALLR)는 미국 뉴욕 남부 지방법원에 제기된 증권 집단 소송이 완전히 기각되었다고 발표했습니다. 이 소송은 2024년 9월 13일에 제기되었으며, 도비티닙(Dovitinib) 신약 신청(NDA)의 규제 전망에 대한 허위 또는 오해의 소지가 있는 진술을 주장했습니다.
사건은 각 당사자가 자신의 법적 비용을 부담하는 것으로 기각되었으며, 특히 Allarity나 그 임원에게서 합의금이나 지급이 요구되지 않았습니다. 현재 2상 임상 시험 중인 이 회사는 개인화된 암 치료를 위해 독점 기술인 약물 반응 예측기(Drug Response Predictor, DRP®)를 사용하여 스테노파립(stenoparib)—PARP/Wnt 경로 이중 억제제를 개발하고 있습니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé le rejet complet d'un recours collectif en valeurs mobilières déposé contre la société devant le tribunal de district des États-Unis pour le district sud de New York. Le recours, initialement déposé le 13 septembre 2024, alléguait des déclarations fausses ou trompeuses concernant les perspectives réglementaires de la demande de nouveau médicament (NDA) pour le Dovitinib.
L'affaire a été rejetée, chaque partie supportant ses propres frais juridiques, et il est à noter qu'aucun règlement ou paiement n'a été exigé d'Allarity ou de ses dirigeants. L'entreprise, qui est actuellement en phase 2 d'essais cliniques, développe le stenoparib—un inhibiteur dual de la voie PARP/Wnt—comme traitement personnalisé du cancer en utilisant sa technologie propriétaire Drug Response Predictor (DRP®).
Allarity Therapeutics (NASDAQ: ALLR) gab die vollständige Abweisung einer Sammelklage im Wertpapierbereich bekannt, die gegen das Unternehmen beim US-Bezirksgericht für den südlichen Bezirk von New York eingereicht wurde. Die Klage, die ursprünglich am 13. September 2024 eingereicht wurde, behauptete falsche oder irreführende Aussagen zu den regulatorischen Aussichten des Dovitinib New Drug Application (NDA).
Der Fall wurde abgewiesen, wobei jede Partei ihre eigenen Rechtskosten trägt, und bemerkenswerterweise war von Allarity oder seinen Führungskräften keine Einigung oder Zahlung erforderlich. Das Unternehmen, das sich derzeit in Phase-2-Studien befindet, entwickelt Stenoparib—einen dualen PARP/Wnt-Weg-Inhibitor—als personalisierte Krebsbehandlung unter Verwendung seiner proprietären Technologie Drug Response Predictor (DRP®).
- Lawsuit dismissed without any settlement payment required
- Legal proceedings concluded allowing focus on core business
- Phase 2 clinical trials continuing as planned
- None.
Insights
The dismissal of the securities class action lawsuit marks a significant legal victory for Allarity Therapeutics, eliminating a substantial risk factor that could have threatened the company's financial resources. With a micro-cap valuation of just
Securities litigation is particularly common in the biotech sector following regulatory setbacks, and these cases typically result in one of three outcomes: dismissal, settlement (often covered partially by D&O insurance but still costly), or rarely, a full trial. The complete dismissal without any financial settlement is the best possible outcome for Allarity.
The timing is particularly advantageous as Allarity advances stenoparib into Phase 2 trials for ovarian cancer. Biotech companies in active clinical development require focus and often need to raise additional capital - both of which would have been compromised by ongoing litigation. The dismissal removes a significant overhang that likely the company's financing options and distracted management.
While this legal victory doesn't change the fundamental clinical and regulatory risks Allarity still faces with its pipeline, it does provide the company with a cleaner investment thesis focused solely on clinical outcomes rather than legal liabilities. Investors should note that while dismissed, plaintiffs in securities cases sometimes refile with amended complaints, though the complete dismissal against all defendants suggests the court found the case fundamentally lacking in merit.
Boston (February 26, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific patient selection technology—the Drug Response Predictor (DRP®)—today announced that the securities class action lawsuit in the United States District Court for the Southern District of New York referenced in the Company’s Form 10-Q filing on November 11, 2024, has been dismissed in whole against all defendants.
The lawsuit, originally filed on September 13, 2024, alleged that false or misleading statements were made regarding the regulatory prospects of the Dovitinib New Drug Application (NDA) and related matters. Allarity has consistently maintained that these claims were without merit.
The case against all defendants has been dismissed with each party bearing its own legal costs and fees. No settlement or payment of any kind was made by the Company or any of its officers in connection with this dismissal.
“We are pleased to put this matter behind us, allowing us to fully focus on advancing stenoparib and its companion diagnostic, the stenoparib-DRP, through our new Phase 2 trial protocol for the treatment of advanced ovarian cancer,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.
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/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. 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 – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, are found to 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 significantly increased. 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 in dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for more than 70 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.
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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 voluntary dismissal of the securities class action lawsuit, its impact on the Company, and Allarity’s continued focus on advancing stenoparib and its companion diagnostic, stenoparib-DRP, through its new Phase 2 trial protocol for the treatment of advanced ovarian cancer. 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 potential future litigation, regulatory scrutiny, reputational impact from legal proceedings, and the ability of the Company to focus on its core business objectives, including the continued development of stenoparib and stenoparib-DRP, without further legal distractions . 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 S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”) and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC’s website at www.sec.gov, and 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
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