FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFRβ inhibitors(Platelet-derived growth factor receptor beta inhibitors)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [2]

Active Indication

Ovarian CancerOsteosarcoma

Inactive Indication

Acetyl-Coa Carboxylase DeficiencyAcute Myeloid Leukemiaadenocarcinoma of biliary tract+ [41]

Originator Organization

Novartis Pharma AG

Active Organization

Oncoheroes Biosciences IncStartup

Allarity Therapeutics Europe ApS

Inactive Organization

Novartis Pharmaceuticals Corp.

Chiron Corp.

Novartis AG

+ [5]

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States), Special Review Project (China)

Structure/Sequence

Molecular FormulaC21H21FN6O

InChIKeyPIQCTGMSNWUMAF-UHFFFAOYSA-N

CAS Registry405169-16-6

Clinical Trials associated with Dovitinib

NCT05571969

/ SuspendedPhase 1

A Phase Ib, Open Label, Multicenter Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination With 2X-121 in Patients With Advanced Solid Tumors

This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.

Start Date20 Feb 2023

Sponsor / Collaborator

Allarity Therapeutics, Inc.

[+1]

NCT02268435

/ WithdrawnPhase 1IIT

A Trial of Dovitinib in Combination With Imatinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors After Failure to Imatinib and Sunitinib

The objective of this study is to determine the recommended dose of combination of dovitinib and imatinib in phase I study.

Start Date01 Mar 2015

Sponsor / Collaborator

Asan Medical Center

NCT02048943

/ WithdrawnPhase 1IIT

A Phase Ib Study of Dovitinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer

This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation are anti-cancer drugs for treating many cancer types.

Start Date01 Mar 2015

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+2]

100 Clinical Results associated with Dovitinib

100 Translational Medicine associated with Dovitinib

100 Patents (Medical) associated with Dovitinib

410

Literatures (Medical) associated with Dovitinib

24 Mar 2025·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

Identification of promising small-molecule inhibitors targeting STK17B for cancer therapeutics: molecular docking and molecular dynamics investigations

Article

Author: Oluwafemi, Oluwatosin Oluwafunmilola ; Akinboade, Modinat Wuraola ; Adekola, Adedayo Toluwanimi ; Otuomagie, Osasenaga Israel ; Ddamulira, Christopher ; Omotara, Bamidele Samson ; Ojeyemi, Toluwalase ; Ibrahim, Ismail Abiola ; Egejuru, Winner Amaka ; Egbemhenghe, Abel Ujaigbe ; Ajala, Chinedum Favour ; Aderemi, Christiana Oluwaseun ; Meejay Kanu, Ihunanya ; Abdulkareem, Teslim Oluwaseyi ; Afuape, Akinwumi Raphael ; Aderemi, Olajide Enoch

Cancer is a complex disease characterized by the uncontrolled growth of abnormal cells, leading to the formation of tumours. STK17B, a member of the DAPK family, has been implicated in various cancers and is considered a potential therapeutic target. However, no drug in the market has been approved for the treatment of STK17 B-associated cancer disease. This research aimed to identify direct inhibitors of STK17B using computational techniques. Ligand-based virtual screening and molecular docking were performed, resulting in the selection of three lead compounds (CID_135698391, CID_135453100, CID_136599608) with superior binding affinities compared to the reference compound dovitinib. While molecular docking simulation revealed specific interactions between the lead compounds and key amino acid residues at the binding pocket of STK17B, molecular dynamics simulations demonstrated that CID_135453100 and CID_136599608 exhibit stable conformations and comparable flexibility to dovitinib. However, CID_135698391 did not perform well using this metric as it displayed poor stability. Overall, small-molecule compounds CID_135453100 and CID_136599608 showed promising binding interactions and stability, suggesting their potential as direct inhibitors of STK17B. These findings could contribute to the exploration of novel therapeutic options targeting STK17B in cancer treatment.

01 Feb 2025·MINI-REVIEWS IN MEDICINAL CHEMISTRY

Therapeutic Potental of Quinolin-2H-one Hybrids as Anticancer Agents

Article

Author: Meeramol, Chellappan ; Shivlingrao, Mamle Desai ; Soumya, Vasu ; M., Manickavasagam ; Soniya, Naik

The statistical data related to cancer in recent years has shown a great increase in the number of cases and is likely to further increase in the future. Even after seeking thorough knowledge on the aetiology of cancer and related disorders and attempting to cure it by various methods like gene therapy, T cell therapy, chemotherapy, surgery, hormone therapy, and photodynamic therapy, there has always been disappointment concerning the survival rate. Hence, there is still a great urge for the discovery of novel drugs for the treatment of cancer. Chemotherapy being one of the widely used methods, several drug entities possessing anticancer properties are already in the market but none of them is known to show good efficacy which necessitates researchers to design newer drugs for the treatment of cancer. The urge to synthesize novel anticancer entities directed researchers towards molecular hybridization as one of the novel methods for designing newer drugs. Literature reveals wide research carried out on quinolin-2-one hybrids, possessing anticancer properties through different mechanisms. Tipifarnib and Dovitinib are quinolin-2-one hybrids used to treat cancer, possessing imidazole and benzimidazole heterocyclic rings. Different heterocyclic scaffolds such as pyrone, pyrrole, pyrimidine, pyridine, thiazole, and pyrazole in combination with heterocyclic quinolin-2-one have shown high potential to become lead for newer anticancer agents with better and wider therapeutic properties and lesser side effects. The current review presents information on the different quinolin-2-one hybrids and their effect on different cancer cell lines. It also imparts knowledge of the structural requirements for designing novel anticancer agents.

01 Jan 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Identification of inhibitors targeting the FLT3-ITD mutation through 4D-QSAR, in vitro, and in silico

Article

Author: Yan, Hong ; Zhong, Qidi ; Chu, Dongchen ; Zhang, Xiaokun ; Zhang, Yu ; Ji, CuiCui ; Wei, Chaochun ; Wang, Juan

The FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation is a key target for acute myeloid leukemia (AML) treatment. The second-generation inhibitors such as Gilteritinib still present off-target effects and associated side effects. Therefore, identifying novel FLT3-ITD inhibitors has become a promising strategy for AML treatment. In this study, a 4D-QSAR model was developed based on Gilteritinib and its analogues, and it was found that introducing hydrophobic bulky groups at the piperazine or piperidine of Gilteritinib would enhance the binding affinity to FLT3-ITD. So, three series of targeted compounds (A1-A5, B1-B5 and C1-C5) were designed and synthesized. The antiproliferative activity against MOLM-13 cells was evaluated in vitro. Compound A1 (IC₅₀ = 25.65 nM), with a cubane group at the piperazine position; Compounds B2 (IC₅₀ = 63.38 nM) and C2 (IC₅₀ = 54.96 nM), with a norbornene group at the piperidine position, showed the strongest inhibition in their series. Their IC₅₀ values were comparable to that of the positive control Gilteritinib (IC₅₀ = 22.37 nM). FLT3-ITD was confirmed as the degradation target through a kinase inhibition assay, where the IC₅₀ values were 2.12 nM (Compound A1), 1.29 nM (Compound B2), and 3.06 nM (Compound C2), which were comparable to that of Gilteritinib (IC₅₀ = 0.43 nM). Additionally, molecular docking and molecular dynamics (MD) simulations showed that Compounds A1, B2, and C2 had similar binding modes to that of Gilteritinib with more stable affinities. Overall, these results demonstrated that Compounds A1, B2, and C2 were promising inhibitors for targeting AML with FLT3-ITD mutation.

News (Medical) associated with Dovitinib

14 Mar 2025

·endpts.com

Altimmune to put its incretin into addiction trials; Tarsus aims to raise $125M

Plus, news about Heidelberg, Accropeutics, Allarity Therapeutics, Cadrenal and Inovio: Altimmune to test its incretin in addiction : Following the path set by Novo Nordisk last week , Altimmune said Thursday at its R&D Day that it plans to begin trials of its injectable GLP-1/glucagon agonist pemvidutide in alcohol use disorder as well as alcoholic liver disease. Stifel analysts wrote in a note on Thursday that Altimmune has animal data that suggest pemvidutide could reduce daily alcohol intake by around half. They also cautioned that additional data would be needed to validate the hypothesis. — Elizabeth Cairns Tarsus Pharmaceuticals’ expected $125 million stock sale: The drugmaker said the funds from the public offering will be used to support the US commercialization of Xdemvy, eye drops for irritation caused by tiny mites. Tarsus also said the funds will be used to advance its experimental ocular rosacea and lyme disease drugs. — Lei Lei Wu Heidelberg amends royalty deal: The company signed an agreement with HealthCare Royalty a year ago to provide royalties to Zircaix, or TLX250-CDx, an imaging agent for some kidney cancers. While the total value of the milestones remains the same at $90 million, the companies changed the deal so that Heidelberg will receive $20 million immediately rather than get $15 million as a sales milestone. They also reduced the FDA approval milestone to $70 million from $75 million. (That milestone will be further reduced if approval comes after 2025.) Heidelberg licensed the drug to Telix in 2017, and a rolling FDA submission was initiated in 2023. — Max Gelman Accropeutics raises $12M to fund IBD asset : The Series B-plus round was led by Shenzhen Capital Group and is set to extend the biotech’s cash runway into the second half of next year. The proceeds will be used for the ongoing Phase 1b trial of Accropeutics’ RIPK2 inhibitor, known as AC-101, in ulcerative colitis. Accropeutics also has a mid-stage TYK2/JAK1 inhibitor in development for psoriasis and a RIPK1 inhibitor for graft-versus-host disease. — Elizabeth Cairns Allarity Therapeutics settles with SEC: The company will pay $2.5 million to the Securities and Exchange Commission after the regulator alleged Allarity executives concealed from investors that the FDA had recommended against approving dovitinib, an experimental cancer therapy. The company did not admit or deny the allegations. — Jaimy Lee Cadrenal is still seeking a partner for tecarfarin: It wants help advancing the oral vitamin K antagonist into a pivotal trial for patients with left ventricular assist devices and other rare cardiovascular conditions. — Jaimy Lee Inovio’s DNA therapy is durable in early trial : The company said Thursday that a Phase 1 trial proves the concept of its so-called DMAbs. The DNA plasmids encoding antibodies derived from Evusheld, AstraZeneca’s Covid-19 prophylactic, were given to patients and were translated into the proteins by the patient’s own cells. All subjects who reached week 72 had biologically relevant levels of the antibodies, according to Inovio, and the expressed DMAbs bound to the SARS-CoV-2 spike protein confirmed functional activity. However, the company did not say whether the approach prevented infections . — Elizabeth Cairns

Phase 1Clinical Result

10 Nov 2024

·www.prnewswire.com

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Allarity Therapeutics, Inc. Inc. of Class Action Lawsuit and Upcoming Deadlines - ALLR

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

Executive ChangeNDA

17 Oct 2024

·www.prnewswire.com

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Allarity Therapeutics, Inc. Inc. of Class Action Lawsuit and Upcoming Deadlines - ALLR

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

Executive ChangeNDA

100 Deals associated with Dovitinib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05928

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	Denmark	Novartis Pharmaceuticals Corp.	28 May 2014
Metastatic Renal Cell Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Japan	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	Colombia	Novartis Pharmaceuticals Corp.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01223027 (ESMO2021)	Phase 3	Solid tumor	570	Dovitinib	jwvwjalkbw(ogmhqetomd) = hksyhwyput focgjhwmcc (axafquxzlh, 9.53 - 35.58) View more	-	16 Sep 2021
NCT01223027 (ESMO2021)	Phase 3	Solid tumor	570	Sorafenib	-	-	16 Sep 2021
NCT01831726 (SIGNATURE, Pubmed) Manual	Phase 2	Neoplasms	80	dovitinib	jexbgucyzn(gxenpquqdu) = ndijueuuea pivghrjqpf (pqtckefuhq ) View more	Negative	07 Apr 2020
NCT01753713 (Pubmed) Manual	Phase 2	Recurrent Glioblastoma	33	Dovitinib (included patients with recurrent GBM)	bahoeotmro(kquvznuecq) = qvhfqvkbws bzdjzasyaa (vceebukumn ) View more	Negative	01 Sep 2019
NCT01753713 (Pubmed) Manual	Phase 2	Recurrent Glioblastoma	33	Dovitinib (anti-angiogenic naïve patients with recurrent GBM that had progressed on prior anti-angiogenic therapy.)	bahoeotmro(kquvznuecq) = mafplrocjp bzdjzasyaa (vceebukumn ) View more	Negative	01 Sep 2019
NCT01994590 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer \| Metastatic castration-resistant prostate cancer	4	prednisone+abiraterone+Dovitinib	iurgvwavni = dzcxsvyjgk ovizxbklfx (situoamecg, ugxxplqzzu - xzgnevhftk) View more	-	19 Mar 2019
NCT01732107 (GU12-157, CTgov)	Phase 2	Bladder Cancer \| Transitional Cell Carcinoma	13	Dovitinib	shflvrcvfl = lahipdzdrz hfidizknev (tolggonvzx, quqmdzfgpu - kcbxpjkxxp) View more	-	22 Aug 2018
NCT02116803 (CTgov)	Phase 2/3	Solid tumor	12	dovitinib (Dovitinib)	wrviguudve = qzmuiquhkz jlqptmgwya (ydmwgzdubi, vdlyrezsoq - utiqoakxae) View more	-	01 Feb 2018
NCT02116803 (CTgov)	Phase 2/3	Solid tumor	12	Fulvestrant+dovitinib (Dovitinib + Fulvestrant)	wrviguudve = bfrjpclnib jlqptmgwya (ydmwgzdubi, nmbinfjxim - ycnsdgfbpv) View more	-	01 Feb 2018
NCT01478373 (Pubmed \| Med J Aust) Manual	Phase 2	Gastrointestinal Stromal Tumors Second line	38	Dovitinib	ywahirebxi(zhbwyphefu) = ogmsorpupe aupjdoqtcu (txmdoueyrs, 38.2 - 66.7) View more	Positive	24 Oct 2017
NCT01753713 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	33	laboratory biomarker analysis+dovitinib (Anti-angiogenic Therapy Naive Patients)	xiubbhmlnx = jrnhjnbkkd udbapyirpo (fpegrtfgug, ixxgybvbfi - eaxeprffac) View more	-	08 Aug 2017
NCT01753713 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	33	laboratory biomarker analysis+dovitinib (Anti-angiogenic Therapy Patients)	xiubbhmlnx = vfutqlvazh udbapyirpo (fpegrtfgug, nhjydtpdrk - fficaqjqkp) View more	-	08 Aug 2017
NCT01676714 (CTgov)	Phase 2	Advanced Colorectal Adenocarcinoma \| Colorectal Cancer \| Advanced Lung Non-Small Cell Carcinoma	10	Dovitinib	vebydwdjlg = wppjsfdqkp ycgyeyenzi (immqhpgaky, bwbwhoiycp - gxvdhxivez) View more	-	15 May 2017
NCT01831726 (SIGNATURE, CTgov)	Phase 2	Acute Myeloid Leukemia \| Solid tumor \| Neoplasms ... View more	80	Dovitinib (TKI258)	tejahxpvnj = kpmnwippku wstwhjhjnw (goatokqtls, iujpzttanq - udtradugvd) View more	-	20 Mar 2017

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