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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%)…
Shots:
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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Aligos has entered into an exclusive license agreement with Xiamen Amoytop Biotech, granting Amoytop rights to develop & commercialize pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection
As per the deal, Aligos will receive an $25M upfront & ~$420M in clinical, regulatory, & sales milestones along with tiered, high single-digit…
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Interna has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute Boston to evaluate its MNM technology as a delivery enhancer for targeted therapeutic modalities
As per the deal, the companies will integrate MNM molecules with targeting approaches to enhance intracellular delivery & therapeutic performance, initially focusing on preclinical…
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The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU
sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…
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CareDx has entered a definitive agreement to divest its Lab Products business, incl. PCR & NGS-based transplant diagnostics, to EuroBio Scientific for $170M in cash
Divestiture aims to streamline operations and refocus on core Precision Medicine Testing Services and digital solutions, while retaining exclusive North America rights to distribute post-transplant monitoring IVD tests, incl. AlloSeq…
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The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults
Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup
Rapiblyk…

