Insilico Medicine Advances AI-Designed IPF Drug Rentosertib into P-III Trial

Shots: Insilico has initiated a P-III trial assessing Rentosertib vs PBO in ~320 pts with idiopathic pulmonary fibrosis (IPF) over 52wks. Earlier P-IIa (GENESIS-IPF) trial data showed Rentosertib (30mg, QD or BID, & 60mg, QD) met its 1EP, plus 60mg arm demonstrated a mean FVC change of +98.4mL vs -20.3mL at 12wks. Rentosertib, an oral…

ByRidhi RastogiJuly 8, 2026

NEWS

Vera Therapeutics Reports the US FDA Accelerated Approval of Trutakna (Atacicept) to Treat IgA Nephropathy

Shots: The US FDA has granted accelerated approval to Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression Approval was supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in adults with IgAN, assessing eGFR-based kidney function over 2yrs., with…

ByRidhi RastogiJuly 8, 2026

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Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Shots: The US FDA has accepted the sNDA & granted priority review to mitapivat, under FDA’s accelerated approval pathway, for the treatment of Sickle Cell Disease (PDUFA: Nov 1, 2026) sNDA was supported by the global P-II/III (RISE UP) trial assessing mitapivat (100mg, PO, BID; n=138) vs PBO (n=69) in 207 pts with SCD (≥16yrs.)…

ByRidhi RastogiJuly 7, 2026

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Ionis Completes Patient Enrollment in Cohort 1 of P-III (REVEAL) Study of Obudanersen in Angelman syndrome (AS)

Shots: Ionis has completed enrollment in Cohort 1 (n=136; 2 to <18yrs.) of the global P-III (REVEAL) study assessing obudanersen (ION582) in pts with AS with genetic confirmation of either a UBE3A deletion or UBE3A mutation The Cohort 2 comprises adult pts (18 to ≤50yrs.) living with AS, with enrollment expected to be completed in…

ByRidhi RastogiJuly 7, 2026

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AbbVie and Genmab Report EC Approval of Tepkinly Combination to Treat R/R Follicular Lymphoma

Shots: The EC has approved Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R2) for the treatment of adults with R/R follicular lymphoma (FL) Approval was based on the P-III (EPCORE FL-1) trial assessing fixed-duration Tepkinly + R2 (n=243) vs SoC R2 (n=245) in pts with R/R FL following ≥1 prior line of treatment Trial…

ByRidhi RastogiJuly 7, 2026

NEWS

Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

Shots: The US FDA has accepted NDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks (PDUFA: Apr 23, 2027) NDA was backed by data from >1,300 HAE attacks. In P-III (RAPIDe-3) trial, deucrictibant IR met the 1EP & all eleven 2EPs, with median times to symptom relief,…

ByRidhi RastogiJuly 6, 2026

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PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Shots: The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure SkinTE is a first-in-class autologous…

ByRidhi RastogiJuly 3, 2026

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Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…

ByRidhi RastogiJuly 2, 2026

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi RastogiJuly 2, 2026

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BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

BeOne has reported topline P-III (MANGROVE) trial results on Brukinsa (Zanubrutinib; 160mg, PO, BID) + rituximab vs bendamustine + rituximab in 510 adults with previously untreated mantle cell lymphoma The trial met its 1EP of improved PFS as assessed by IRC, leading to a 43% reduction in the risk of progression or death; OS (2EP) was immature…

ByRidhi RastogiJuly 1, 2026

Insilico Medicine Advances AI-Designed IPF Drug Rentosertib into P-III Trial

Vera Therapeutics Reports the US FDA Accelerated Approval of Trutakna (Atacicept) to Treat IgA Nephropathy

Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Ionis Completes Patient Enrollment in Cohort 1 of P-III (REVEAL) Study of Obudanersen in Angelman syndrome (AS)

AbbVie and Genmab Report EC Approval of Tepkinly Combination to Treat R/R Follicular Lymphoma

Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

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