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NEWS #PharmaBuzz
06 Jan 2026
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2026/01/06/3213418/0/en/Biosplice-Announces-the-Submission-of-its-New-Drug-Application-NDA-to-the-FDA-for-Lorecivivint-LOR-to-Treat-Knee-Osteoarthritis.html
22 Dec 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/12/22/3209045/0/en/Biosplice-Therapeutics-Announces-First-Patient-Dosed-in-Investigator-Initiated-Phase-1-Clinical-Trial-of-Cirtuvivint-and-Olaparib-in-BRCA-HRD-Platinum-Resistant-Ovarian-Cancer.html
09 Sep 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/09/09/3146697/0/en/Biosplice-Therapeutics-Announces-First-Patient-Dosed-in-NCI-Sponsored-Clinical-Trial-of-Cirtuvivint-in-Acute-Myeloid-Leukemia-and-Myelodysplastic-Syndromes.html
01 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/01/3072165/0/en/Biosplice-Announces-First-Patient-Dosed-in-Phase-2-Trial-of-Cirtuvivint-for-Advanced-Soft-Tissue-Sarcomas.html
12 Sep 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/09/12/2945069/0/en/Biosplice-Therapeutics-Announces-Initiation-of-Acute-Myeloid-Leukemia-AML-and-Myelodysplastic-Syndromes-MDS-Trial-Sponsored-by-the-National-Cancer-Institute-NCI.html
13 Jun 2024
// CONTRACT PHARMA
https://www.contractpharma.com/contents/view_breaking-news/2024-06-13/biosplice-novo-nordisk-partner-to-develop-drug-candidates-for-treatment-of-diabetes/?widget=listSection
Drugs in Development
Details:
Cirtuvivint, a small molecule product, targets CLK/DYRK to treat BRCA-mutated Ovarian Cancer.
Lead Product(s): Cirtuvivint,Olaparib
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2025
Lead Product(s) : Cirtuvivint,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Biosplice Initiates Phase 1 Trial of Cirtuvivint and Olaparib in Ovarian Cancer
Details : Cirtuvivint, a small molecule product, targets CLK/DYRK to treat BRCA-mutated Ovarian Cancer.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 22, 2025
Details:
Cirtuvivint is a selective pan-CLK, pan-DYRK inhibitor that modulates alternative RNA splicing, including transcripts involved in oncogenic pathways, being investigated for AML.
Lead Product(s): Cirtuvivint
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Cancer Institute
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2025
Lead Product(s) : Cirtuvivint
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Cancer Institute
Deal Size : Inapplicable
Deal Type : Inapplicable
Biosplice Doses First Patient in NCI Trial of Cirtuvivint for AML and MDS
Details : Cirtuvivint is a selective pan-CLK, pan-DYRK inhibitor that modulates alternative RNA splicing, including transcripts involved in oncogenic pathways, being investigated for AML.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 09, 2025
Details:
Cirtuvivint is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Small Cell Lung Carcinoma.
Lead Product(s): Cirtuvivint,Irinotecan Hydrochloride
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Recipient: Washington University School of Medicine
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 04, 2025
Lead Product(s) : Cirtuvivint,Irinotecan Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Recipient : Washington University School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
Details : Cirtuvivint is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Small Cell Lung Carcinoma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 04, 2025
Details:
Cirtuvivint is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Sarcoma.
Lead Product(s): Cirtuvivint
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Recipient: Asociaci?n Europea y Latinoamericana SELNET para la Investigaci?n en Sarcomas
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 23, 2025
Lead Product(s) : Cirtuvivint
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Asociaci?n Europea y Latinoamericana SELNET para la Investigaci?n en Sarcomas
Deal Size : Inapplicable
Deal Type : Inapplicable
Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Details : Cirtuvivint is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Sarcoma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 23, 2025
Details:
SM08502 (cirtuvivint) is a small molecule inhibitor of CLK and DYRK kinases, being investigated for the treatement of advanced soft-tissue sarcomas.
Lead Product(s): Cirtuvivint
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 01, 2025
Lead Product(s) : Cirtuvivint
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Biosplice Doses First Patient in Phase 2 Cirtuvivint Trial for Soft-Tissue Cancer
Details : SM08502 (cirtuvivint) is a small molecule inhibitor of CLK and DYRK kinases, being investigated for the treatement of advanced soft-tissue sarcomas.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 01, 2025
Details:
The collaboration aims for Biosplice to expand its clinical candidate, SM08502 (cirtuvivint), as a standalone treatment and combination therapy in patients with AML and MDS.
Lead Product(s): Cirtuvivint
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: The Division of Cancer Treatment and Diagnosis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 12, 2024
Lead Product(s) : Cirtuvivint
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : The Division of Cancer Treatment and Diagnosis
Deal Size : Undisclosed
Deal Type : Collaboration
Biosplice Begins AML and MDS Trials Sponsored By National Cancer Institute
Details : The collaboration aims for Biosplice to expand its clinical candidate, SM08502 (cirtuvivint), as a standalone treatment and combination therapy in patients with AML and MDS.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 12, 2024
Details:
The collaboration combines Novo Nordisk’s expertise in diabetes and Biosplice’s research and development efforts focused on creating selective and potent DYRK inhibitors.
Lead Product(s): Undisclosed
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Undisclosed
Sponsor: Novo Nordisk
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 13, 2024
Lead Product(s) : Undisclosed
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Novo Nordisk
Deal Size : Undisclosed
Deal Type : Collaboration
Biosplice, Novo Nordisk Partner to Develop Drug Candidates for Treatment of Diabetes
Details : The collaboration combines Novo Nordisk’s expertise in diabetes and Biosplice’s research and development efforts focused on creating selective and potent DYRK inhibitors.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
June 13, 2024
Details:
The funding will support the clinical development of SM07883, a DYRK1A inhibitor currently in preclinical trials for treating tauopathies like Alzheimer’s Disease and Frontotemporal Dementia.
Lead Product(s): SM07883
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Miscellaneous
Sponsor: Roskamp Institute
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding March 08, 2024
Lead Product(s) : SM07883
Therapeutic Area : Neurology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Roskamp Institute
Deal Size : Undisclosed
Deal Type : Funding
Biosplice Receives DoD Award for Collaboration with The Roskamp Institute
Details : The funding will support the clinical development of SM07883, a DYRK1A inhibitor currently in preclinical trials for treating tauopathies like Alzheimer’s Disease and Frontotemporal Dementia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 08, 2024
Details:
Results from the study continue to support the potential efficacy of multiple injections of SM04690 (lorecivivint) in delaying structural progression and providing symptomatic benefic.
Lead Product(s): Lorecivivint
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 15, 2022
Lead Product(s) : Lorecivivint
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Results from the study continue to support the potential efficacy of multiple injections of SM04690 (lorecivivint) in delaying structural progression and providing symptomatic benefic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 15, 2022
Details:
SM04690 (lorecivivint), demonstrated clinical efficacy in earlier, less structurally damaged patients, although these trials fell short of reaching statistical significance in their primary endpoints of Pain NRS (daily pain score) at week 12 with all subjects.
Lead Product(s): Lorecivivint
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 11, 2022
Lead Product(s) : Lorecivivint
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SM04690 (lorecivivint), demonstrated clinical efficacy in earlier, less structurally damaged patients, although these trials fell short of reaching statistical significance in their primary endpoints of Pain NRS (daily pain score) at week 12 with all sub...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 11, 2022
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