Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

Shots: FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26 Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…

ByRidhi RastogiJanuary 5, 2026

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HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025 Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…

ByRidhi RastogiJanuary 5, 2026

NEWS

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

Shost: Delcath Systems has reported the publication of subgroup analyses from the Phase 3 (FOCUS) study in the Journal of Cancer Research and Clinical Oncology, evaluating the efficacy and safety of the HEPZATO KIT on melphalan/hepatic delivery in pts with unresectable metastatic uveal melanoma In the subgroup analyses (n=91) of the P-III (FOCUS) Study pts,…

ByDipanshu DixitJanuary 2, 2026

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SOFIE Biosciences Reports First Patient Dosing in P-III (FAPI-GO) Trial of [18F]FAPI-74 for Diagnosis of GI Cancer

Shots: SOFIE Biosciences has dosed the first patient with [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical, in the P-III (FAPI-GO) trial for the diagnosis of GI cancers The trial will assess the clinical utility of [¹⁸F]FAPI-74 PET/CT over 24mos. in the detection of metastatic disease in 200 adults with gastroesophageal cancer across 18 sites Another P-III (FAPI-PRO)…

ByRidhi RastogiDecember 31, 2025

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Mabwell Doses First Patient in P-II Trial of 9MW3811 for Pathological Scarring

Shots: Mabwell has dosed the first patient with 9MW3811 in its P-II (CTR20254857) trial in China for pathological scarring The trial will assess safety, tolerability, PK, & preliminary efficacy of 9MW3811 in pts with pathological scarring following P-I completion in healthy subjects across Australia & China 9MW3811 has shown significant preclinical efficacy in pulmonary fibrosis…

ByRidhi RastogiDecember 31, 2025

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Mereo BioPharma Reports P-III (ORBIT & COSMIC) Trials Findings on Setrusumab in Osteogenesis Imperfecta

Shots: Mereo BioPharma has reported setrusumab (UX143) results from the global P-III (ORBIT) trial vs PBO & P-III (COSMIC) trial vs bisphosphonates (IV) in 159 pts (5-25yrs.) & 69 pts (2 to <7 yrs.), respectively, with osteogenesis imperfecta Neither study met its 1EP of reduced annualized clinical fracture rate, but both showed statistically significant improvements…

ByRidhi RastogiDecember 30, 2025

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Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

Shots: Foresee Pharmaceuticals reported its P-III (Casppian) Study data of FP-001 (leuprolide mesylate 42mg; administered every six months), a sustained-release GnRH agonist, met its 1EP in children with central precocious puberty (CPP) The study showed that 94% of pts achieved serum LH suppression to <4 mIU/mL at 60 mins. following a GnRHa stimulation test at Wk.…

ByPrince GiriDecember 25, 2025

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Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Shots: Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…

ByRidhi RastogiDecember 23, 2025

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Eli Lilly Reports Topline P-III (ATTAIN-MAINTAIN) Trial Results of Orforglipron for Weight Loss Maintenance

Shots: Lilly's P-III trial assessed orforglipron vs PBO in maintaining weight loss in 376 adults with obesity/overweight & weight-related comorbidities who previously completed the initial treatment with Wegovy/Zepbound in the SURMOUNT-5 trial; NDA was submitted to FDA & received a US FDA’s CNPV Trial met its 1EP in SURMOUNT-5 pts at a weight plateau, showing superior…

ByRidhi RastogiDecember 19, 2025

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Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

ByRidhi RastogiDecember 18, 2025

Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

SOFIE Biosciences Reports First Patient Dosing in P-III (FAPI-GO) Trial of [18F]FAPI-74 for Diagnosis of GI Cancer

Mabwell Doses First Patient in P-II Trial of 9MW3811 for Pathological Scarring

Mereo BioPharma Reports P-III (ORBIT & COSMIC) Trials Findings on Setrusumab in Osteogenesis Imperfecta

Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Eli Lilly Reports Topline P-III (ATTAIN-MAINTAIN) Trial Results of Orforglipron for Weight Loss Maintenance

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

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