Dovitinib

NEW YORK, Nov. 10, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities between May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 17, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities bet ween May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED