HER2- Advanced Breast Cancer

Shots: Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…

ByRidhi RastogiMay 5, 2026

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Mirum Pharmaceuticals Reports P-IIb (VISTAS) Trial Data on Volixibat in Primary Sclerosing Cholangitis (PSC) Patients with Cholestatic Pruritus

Shots: Mirum has reported global P-IIb (VISTAS) trial data evaluating volixibat (20mg, BID) vs PBO in 158 patients with cholestatic pruritus caused by PSC, incl. 111 pts in the primary analysis cohort with mod. to sev. itch & 47 pts in the secondary cohort with mild itch In the primary cohort, volixibat met the 1EP,…

ByRidhi RastogiMay 5, 2026

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Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…

ByRidhi RastogiMay 4, 2026

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Theradaptive Receives US FDA Approval to Initiate P-III Trial of OsteoAdapt SP for Spinal Fusion Procedures

Shots: The US FDA has approved initiation of the P-III (OASIS) trial evaluating OsteoAdapt SP as an alternative to autologous & allograft bone graft in TLIF, ALIF, and LLIF procedures for symptomatic degenerative lumbosacral spine disease This approval builds on prior clinical experience in ~100 participants & expanded enrollment in Australia & Israel, while the…

ByRidhi RastogiMay 1, 2026

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Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…

ByRidhi RastogiMay 1, 2026

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InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Shots: InnoCare has dosed the first patient with orelabrutinib in the P-III trial for the treatment of systemic lupus erythematosus (SLE), assessing its efficacy & safety against PBO, with the SRI-4 response rate at Wk. 52 as the 1EP Orelabrutinib was assessed in the P-IIb trial, which met its 1EP, where orelabrutinib (75mg, QD) showed…

ByRidhi RastogiApril 29, 2026

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Boehringer Ingelheim Reports P-III (SYNCHRONIZE-1) Trial Data on Survodutide for Weight Loss

Shots: BI has reported P-III (SYNCHRONIZE-1) trial assessing survodutide (BI 456906; 3.6 or 6mg, QW) vs PBO in 725 adults living with obesity or overweight, without type 2 diabetes Trial met co-1EP, with ~85.1% achieving ≥5% weight loss vs 38.8%, & 16.6% sustained mean loss vs 3.2% after 76wks. (efficacy estimand), mainly driven by fat…

ByRidhi RastogiApril 28, 2026

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Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Shots: Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821 The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC 9MW2821, a…

ByRidhi RastogiApril 24, 2026

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Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Shots: J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

ByRidhi RastogiApril 24, 2026

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Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

Shots: Novo Nordisk has reported the P-IIIa (PIONEER TEENS) trial assessing oral semaglutide (3, 7 or 14mg, QD) vs PBO, on top of background treatment with metformin, basal insulin, or both, in 132 pts (10-17yrs.) with type 2 diabetes Trial showed superior HbA1c reduction vs PBO, lowering blood sugar by 0.83% at 26wks., with a…

ByRidhi RastogiApril 23, 2026

Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Mirum Pharmaceuticals Reports P-IIb (VISTAS) Trial Data on Volixibat in Primary Sclerosing Cholangitis (PSC) Patients with Cholestatic Pruritus

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Theradaptive Receives US FDA Approval to Initiate P-III Trial of OsteoAdapt SP for Spinal Fusion Procedures

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Boehringer Ingelheim Reports P-III (SYNCHRONIZE-1) Trial Data on Survodutide for Weight Loss

Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

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