Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Shots: J&J has reported the P-III (Study 451) trial data, assessing Caplyta (lumateperone; 42mg, QD) vs PBO for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, at Psych Congress 2026 Trial met its 1EP, showing a 4.8-point greater reduction in YMRS total score at Wk. 3, with…

ByRidhi Rastogi12 hours ago

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Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Shots: Roche has reported the P-III (CELESTIMO) trial assessing Lunsumio (mosunetuzumab) + lenalidomide vs MabThera + lenalidomide in pts with r/r follicular lymphoma who have received ≥1L of prior systemic therapy Trial met its 1EP, showing a statistically significant & clinically meaningful improvement in PFS, while OS data remained immature at the interim analysis; the…

ByRidhi RastogiSeptember 17, 2026

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Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Shots: Arrowhead has reported P-I/IIa (ARO-DIMER-PA-1001) study data assessing the safety, tolerability, PK, PD, & effects on LDL-C and TGs of single-dose (part 1) & multiple doses (part 2) of ARO-DIMER-PA in ~78 adults with mixed hyperlipidemia ARO-DIMER-PA single doses produced dose-dependent mean maximal reductions in serum PCSK9 of 72% & APOC3 of 88%, along with…

ByRidhi RastogiSeptember 17, 2026

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Sling Therapeutics Doses First Patients in P-III (ORBIT) Trial of Linsitinib for Thyroid Eye Disease

Shots: Sling Therapeutics has dosed the first patients in the global P-III (ORBIT) trial assessing linsitinib (150mg, PO, BID) vs PBO in ~130 adults with mod. to sev. active thyroid eye disease (TED) for 24wks. The trial will assess the proportion of proptosis responders at Wk. 24, defined as a ≥2 mm reduction in the…

ByRidhi RastogiSeptember 16, 2026

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Vera Therapeutics Reports the P-III (ORIGIN 3) Trial Data on Trutakna (Atacicept-vymj) in IgA Nephropathy

Shots: Vera has reported the P-III (ORIGIN 3) trial data assessing Trutakna vs PBO in adults with primary IgAN at risk for disease progression, which met all of its prespecified endpoints. The company is planning to submit an sBLA to the FDA for full approval in Q4’26 In 428 pts, Trutakna preserved kidney function at…

ByRidhi RastogiSeptember 16, 2026

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The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Shots: The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned NDA was supported by extensive data incl. global P-III (Latitude…

ByRidhi RastogiSeptember 14, 2026

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Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs Pt-pemetrexed doublet CT + Keytruda as the 1L treatment in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Enhertu improved PFS by 37% (mPFS: 14.3 vs 8.3mos.) & showed ORR of 70%…

ByRidhi RastogiSeptember 14, 2026

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Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Shots: Resolution Therapeutics has reported that the final patient has been treated in P-I/II (EMERALD) trial assessing RTX001 in patients with end-stage liver disease (ESLD) & a history of decompensated liver cirrhosis; Interim data are expected in the Q4’26 RTX001 is engineered with IL-10 & MMP-9 to enhance anti-inflammatory & anti-fibrotic effects of RMT, delivered…

ByRidhi RastogiSeptember 11, 2026

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Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Shots: FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27 sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60,…

ByRidhi RastogiSeptember 10, 2026

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BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Shots: The P-II (QUINTESSENTIAL) trial assessed arlocabtagene autoleucel (arlo-cel) in r/r MM pts, who were previously treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy & a BCMA-targeted therapy The trial met its 1EP, showing improvement in ORR, & its key 2EP of CRR in the above-mentioned pts who had previously received ≥4L…

ByRidhi RastogiSeptember 9, 2026

Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Sling Therapeutics Doses First Patients in P-III (ORBIT) Trial of Linsitinib for Thyroid Eye Disease

Vera Therapeutics Reports the P-III (ORIGIN 3) Trial Data on Trutakna (Atacicept-vymj) in IgA Nephropathy

The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

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