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Johnson& Johnson

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots:  J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

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PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:   Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN  Read More: Apellis Pharmaceuticals and Sobi  Daiichi Sankyo Reports First Patient…

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Novartis

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots: Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab) Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…

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Apellis and Sobi

Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN

Shots: Apellis & Sobi have reported data from the open-label period of P-III (VALIANT) trial of Empaveli for the treatment of C3G & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN); regulatory review is ongoing in the US & EU The P-III (VALIANT) trial assessed Empaveli (Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124)…

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Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapy Trial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…

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