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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, &…
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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…
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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…
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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…
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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
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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…
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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…
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Orion Pharma has entered into an agreement with Shilpa Biologicals to commercialize IV nivolumab biosimilar that is currently under development, across Europe
As per the deal, Orion will gain exclusive right to distribute, market & sell the biosimilar in the EU, while Shilpa will supply the product & receive certain development & regulatory milestone…
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Enhertu approval for previously treated adults with unresectable or metastatic HER2+ (IHC 3+) solid tumors & no satisfactory treatment option, was based on subgroup data from P-II trials, incl. DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.
In DESTINY-PanTumor02, Enhertu achieved a cORR of 52.3% & mDOR of 21.1mos. in previously treated HER2+ solid tumors (n=111), while DESTINY-Lung01 reported a cORR of…

