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Details:
Sutro intends to use the net proceeds of this offering to fund research, clinical, and development of STRO-002 (Luveltamab Tazevibulin) with Neulasta for treating patients with FOLR1-expressed Ovarian Neoplasms.
Lead Product(s): Luveltamab Tazevibulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: STRO-002
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 02, 2024
Details:
Udenyca Onbody, the company's on-body injector (OBI) presentation of Udenyca® (pegfilgrastim-cbqv), a CSF-3R agonist. It is indicated for the treatment of decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca Onbody
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2024
Details:
Udenyca (pegfilgrastim-cbqv), is a FDA-approved biosimilar that acts as a G-CSF agonist for the treatment of patients with non-myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 26, 2023
Details:
Udenyca Onbody (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca Onbody
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2023
Details:
Udenyca Onbody (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca Onbody
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
MNPR-201 (camsirubicin) is a novel proprietary analog of widely used cancer drug doxorubicin. Doxorubicin is used to treat adult and pediatric solid and hematologic cancers including breast, gastric, ovarian and bladder cancer, soft tissue sarcomas, leukemias and lymphomas.
Lead Product(s): Camsirubicin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: MNPR-201
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Details:
Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. Doxorubicin is used to treat adult and pediatric solid and hematologic cancers including breast, gastric, ovarian and bladder cancer, soft tissue sarcomas, leukemias and lymphomas.
Lead Product(s): Camsirubicin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: MNPR-201
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2023
Details:
Udenyca (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
Udenyca (pegfilgrastim-cbqv) products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Udenyca
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2023
Details:
Camsirubicin is a novel, proprietary analog of the widely used cancer drug doxorubicin. The current Phase 1b trial is designed to test camsirubicin at progressively higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.
Lead Product(s): Camsirubicin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: MNPR-201
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
Plinabulin (BPI-2358) exerts early-onset of action in the prevention of chemotherapy-induced neutropenia (CIN) by boosting the number of hematopoietic stem/progenitor cells (HSPCs).
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Hematology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
U.S.FDA has approved its biosimilar, Stimufend® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Stimufend
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2022
Details:
FYLNETRA® (pegfilgrastim-pbbk), used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
FYLNETRA (Pegfilgrastim-pbbk) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
FYLNETRA (pegfilgrastim), is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kashiv BioSciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
Plinabulin (BPI-2358) in combination with docetaxel (DP) showed statistically significant overall survival improvements compared to docetaxel alone (D) for the ITT population (DP: n=278; D: n=281).
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Hematology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
Plinabulin is a first-in-class selective immunomodulating microtubule-binding agent (SIMBA) with potential chemotherapy-induced neutropenia (CIN) prevention and anticancer benefits.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Stimufend (pegfilgrastim) is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Stimufend
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
Company announced the positive recommendation from safety review committee to escalate to the second dose level in its camsirubicin Phase 1b trial in patients with ASTS the decision was made following a review of safety data from the patients.
Lead Product(s): Camsirubicin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2021
Details:
Under the terms of agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil. Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Oncology Product Name: Lupifil-P
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 03, 2021
Details:
Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which triggers the release of the immune defense protein, GEF-H1. The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data.
Lead Product(s): Plinabulin,Pegfilgrastim,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2021
Details:
The trial is evaluating the safety and anti-tumor activity of increasing doses of camsirubicin, an analog of doxorubicin, used in combination with growth factor support (pegfilgrastim/G-CSF) for the treatment of advanced soft tissue sarcoma (ASTS).
Lead Product(s): Camsirubicin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Camsirubicin
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers greater protection against CIN than the standard of care, G-CSF alone.
Lead Product(s): Plinabulin,Pegfilgrastim,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers greater protection against CIN than the standard of care, G-CSF alone.
Lead Product(s): Pinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
Plinabulinin combination with pegfilgrastim met the primary endpoint with statisticallysignificant improvement in the rate of prevention of Grade 4 neutropenia in Cycle1, as well as achieving statistical significancein all key secondary endpoints.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
Accord has developed an app to support cancer patients prescribed Pelgraz® PFI. The app can remind patients when and how to administer Pelgraz® PFI, helps in tracking any side effects and symptoms during active treatment, and informs about pegfilgrastim and neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Oncology Product Name: Pelgraz PFI
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
In the protocol-specified interim analysis, Plinabulin, in combination with Neulasta, was significantly better than Neulasta alone in achieving the primary endpoint, along with a well-tolerated safety profile and fewer Grade 4 adverse events, compared to Neulasta alone.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
Company presented clinical data on BeyondSpring’s first-in-class, late-stage asset, Plinabulin, showing potent CD34+ progenitor cell mobilization from bone marrow, which has broad applications for stem cell-based therapies, gene therapy and regenerative medicine.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Oncology Product Name: Nyvepria
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
PROTECTIVE-2 Phase 2 superiority trial for chemotherapy-induced neutropenia shows that the Company’s lead asset, Plinabulin, in combination with Neulasta, enables more cancer patients to receive the optimal chemotherapy dose and regimen.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Details:
BeyondSpring’s e-poster presentations are mainly focused on company's lead drug Plinabulin and the 1st poster presents a comparison between Plinabulin vs Neulasta as a monotherapy for CIN prevention.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).
Lead Product(s): Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
Details:
Fresenius Kabi’s MAA submission for pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
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