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J&J
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Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…
January 7, 2026

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Hutchmed
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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…
January 5, 2026

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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,…
January 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)…
December 31, 2025

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NEWS

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…
December 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…
December 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.…
December 25, 2025

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