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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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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Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC at WCLC’26

Shots: The global P-III (REZILIENT3) trial data assessed zipalertinib + CT vs CT in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations After a 6-patient safety lead-in, 279 pts were randomized to zipalertinib (100mg, BID) + CT (n=140) or CT alone (n=139); as previously reported, the trial met…

ByRidhi RastogiSeptember 14, 2026

NEWS

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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Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has approved Joenja (leniolisib; 40 & 50mg, BID, PO) for the treatment of children (4-11yrs.; ≥27kg) with activated phosphoinositide 3-kinase delta (APKD) syndrome Approval was backed by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced lymphadenopathy & increased naïve B cells over 12wks. with a favorable safety profile…

ByRidhi RastogiSeptember 14, 2026

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Scholar Rock Reports the US FDA Approval of Isembyld (Apitegromab-mstn) to Treat Spinal Muscular Atrophy

Shots: The US FDA has approved Isembyld for the treatment of spinal muscular atrophy (SMA) in pts (≥2yrs.) who are currently receiving a SMN2-targeted treatment Approval was backed by the P-III (SAPPHIRE), which met its 1EP of 2.2-point improvement in HFMSE with Isembyld + SMN2-targeted therapy vs PBO at 1yr. in main efficacy population (n=103);…

ByRidhi RastogiSeptember 14, 2026

NEWS

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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Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

Shots: The US FDA has accepted BLA of Mogenry (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration for pts with retinitis pigmentosa (RP) having severe vision loss BLA was supported by the P-I/IIa trial, & the P-IIb/III (RESTORE) trial, where RESTORE met its 1 & 2EPs, showing improvements in visual acuity at…

ByRidhi RastogiSeptember 9, 2026

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

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

Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC at WCLC’26

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

Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Scholar Rock Reports the US FDA Approval of Isembyld (Apitegromab-mstn) to Treat Spinal Muscular Atrophy

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

Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

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