FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024
Details : Dasynoc (dasatinib) is an amorphous solid dispersion form & innovative protein kinase inhibitor, small molecule drug. It is being developed for the treatment of chronic myeloid leukemia.
Product Name : Dasynoc
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 02, 2024
Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission
Details : Xspray Pharma's lead product XS004 (dasatinib) is being evaluated in the late-stage clinical trial studies for treating patients suffering from chronic myeloid leukemia.
Product Name : Dasynoc
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2024
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Final Data From The AGENT Study Confirms Topline Results
Details : In AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the stand...
Product Name : Modufolin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 25, 2022
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Isofol Reports Data from the AGENT Study
Details : Progression-free survival (PFS) was approximately 12.8 months for the arfolitixorin arm and 11.6 months for the control arm, with a P-value of 0.76. Data for this endpoint is not final but it is not deemed to change significantly moving forward.
Product Name : Modufolin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 09, 2022
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.
Product Name : Modufolin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2022
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Oncopeptides Phase 3 Ocean Study Published in the Lancet Haematology
Details : The OCEAN Phase 3 results demonstrate that melflufen (Melphalan Flufenamide) improves PFS for lenalidomide refractory RRMM patients who have received two to four prior lines of therapy with significant statistical interactions between the OS HR result.
Product Name : Pepaxti
Product Type : Peptide
Upfront Cash : Inapplicable
January 13, 2022
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study used for treatment of patients with metastatic colorectal cancer (mCRC).
Product Name : Modufolin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 23, 2021
Lead Product(s) : Arfolitixorin,Fluorouracil,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Melphalan Flufenamide
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Jakob Lindberg Appointed CEO of Oncopeptides
Details : Melphalan flufenamide (melflufen, Pepaxto®) is a peptide conjugated alkylating drug used in combination with dexamethasone for the treatment of multiple myeloma.
Product Name : Pepaxti
Product Type : Peptide
Upfront Cash : Inapplicable
November 15, 2021
Lead Product(s) : Melphalan Flufenamide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Oncopeptides Presents Phase 3 OCEAN Study Results at the IMW Meeting
Details : Melflufen met the primary endpoint of superior Progression Free Survival (PFS) as assessed by the Independent Review Committee (IRC), with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide.
Product Name : Pepaxti
Product Type : Peptide
Upfront Cash : Inapplicable
November 09, 2021
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Oncopeptides Presents New Melflufen Data at The Annual American Society of Hematology Meeting ASH
Details : Melflufen (melphalan flufenamide) a novel class of peptidase-enhanced compounds that elicit increased cytotoxicity in target multiple myeloma cells and substantially reduced off-target cell toxicity.
Product Name : Pepaxti
Product Type : Peptide
Upfront Cash : Inapplicable
October 12, 2021
Lead Product(s) : Melphalan Flufenamide,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable