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The Genentech's P-III (METEOROID) trial data assessed Enspryng (60, 120 or 180mg based on body weight; SC) vs PBO, administered at 0, 2 & 4wks., then Q4W thereafter in pts (≥12yrs.) with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)
Trial met its 1EP with 87% vs 67% relapse-free pts at 48wks., & response onset as…
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The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D
Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…
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The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance
Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…
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Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab)
Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacy
Bosaya & Vevzuo are anti-RANKL monoclonal…
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Monopar has highlighted P-III (FoCus) trial data assessing ALXN1840 (tiomolibdate choline, TMC; n=77) vs SoC (n=35) in Wilson disease pts with neurologic symptoms at baseline, at AAN’26
Trial showed better outcomes with ALXN1840, with lower neurologic worsening (9% vs 25%) & higher improvement (45% vs 32%) vs SoC, plus greater CGI-S (61% vs 17%)…
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Akeso has reported the P-II (COMPASSION-26) trial results assessing cadonilimab + CT as the 1L treatment of advanced pancreatic ductal adenocarcinoma (PDAC)
As of Oct 20, 2025 (mFU of >2yrs.), trial showed robust & durable survival benefits, with mPFS of 11.1mos. & mOS of >23mos., showing 12 & 24mos. OS rate of 91.7% &…
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The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026)
sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…
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TJ Bio has granted Biogen exclusive rights to felzartamab in Greater China, giving Biogen full global ownership as the drug advances through P-III trials across multiple immune-mediated diseases
As per the deal, TJ Bio will receive $100M upfront, with ~$750M in commercial & sales milestones, plus mid-single to low-double-digit % of royalties on Greater…
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Eli Lilly has entered into a definitive agreement to acquire Kelonia Therapeutics, expanding Lilly’s genetic medicine capabilities
As per the deal, Lilly will acquire Kelonia for ~$7B in cash, incl. $3.25B upfront, & additional clinical, regulatory & commercial milestone payments; closing expected in H2’26
Acquisition will add Kelonia’s in vivo gene placement system (iGPS0) & its lead asset, KLN-1010, a one-time IV…
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Pheast Therapeutics presented initial P-Ia data for PHST001 at AACR Annual Meeting 2026, demonstrating target engagement, innate immune activation, and early clinical activity
PHST001 (anti-CD24 macrophage checkpoint inhibitor) was generally well tolerated, across dose-escalation cohorts and early signals of clinical activity were observed incl. tumor shrinkage and disease stabilization
Preclinical data showed enhanced tumor…

