Shots:
The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform
Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…
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…
Shots:
The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies
Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…
Shots:
CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks.
Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…
Shots:
Ipsen has entered into a definitive share purchase agreement to acquire all issued & outstanding shares of Memo Therapeutics, with closing expected in Q3’26
As per the deal, Memo shareholders will receive €200M upfront at closing, with total consideration exceeding €700M upon achieving development, regulatory, & sales milestones. Assets & employees unrelated to potravitug…
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…
Shots:
METiS TechBio has granted Boulevard worldwide development, manufacturing, and commercialization rights to MTS-128, a trispecific T-cell engager (TCE) program
As per the deal, METiS TechBio will receive a $20M upfront payment & ~$1.6B in development, regulatory, & commercial milestone payments, in addition to tiered royalties on product sales
MTS-128 is a trispecific T-cell engager…
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.…
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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…
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…

