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

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Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808) Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…

ByRidhi RastogiDecember 18, 2025

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Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…

ByRidhi RastogiDecember 17, 2025

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InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Shots: Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg…

ByRidhi RastogiDecember 16, 2025

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)

Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

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