Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Shots: The topline P-III (EPCORE DLBCL-4) trial results assessed epcoritamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in adults with R/R DLBCL who received ≥1L prior of therapy Trial met its 1EP, significantly improving PFS & reducing the risk of disease progression or death by 60% (US censoring) & 56% (ex-US censoring). AbbVie…

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…

Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Shots: The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I…