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The NMPA has approved iza-bren (izalontamab brengitecan) for the treatment of adult pts with recurrent or metastatic ESCC whose disease has progressed following prior Pt-based CT & PD-1/PD-L1 inhibitor therapy
Approval was based on the P-III (PANKU-Esophagus01) trial assessing iza-bren vs CT in the above-mentioned pts (n=497) across China, which met its dual 1EP…
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Samsung Biologics has launched an all-cash public tender offer to acquire 100% of the fully diluted share capital of PolyPeptide, expanding its capabilities beyond antibodies & ADCs to include peptide therapeutics
As per the deal, PolyPeptide will receive CHF 44.31 (~$54.8) in cash per share, representing an implied equity value of ~CHF 1.46B (~$1.8B);…
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Aqemia has expanded its multi-year research collaboration with Sanofi, marked by the nomination of a new therapeutic target & an additional payment
The collaboration, initially announced in Dec 2023, makes Aqemia eligible to receive up to a total of $140M in upfront & milestone payments across programs
Aqemia uses its physics-based generative AI platform,…
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Mission Therapeutics has reported the divestment of its P-II-ready asset MTX652, to Dimerix for initial development in Acute Kidney Injury (AKI)
As per the deal, Mission will receive ~$292M in upfront, development & commercial milestones, plus up to double-digit tiered royalties on global net sales
The divestment aligns with Mission’s strategy to maximize its…
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The EC has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) & adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER) program, comprising the FIBRONEER-IPF & FIBRONEER-ILD trials. Both met their 1EP, demonstrating that Jascayd slowed lung function decline, measured by the change in FVC…
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The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression
Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…
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Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks.
Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…
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The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…
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Eli Lilly has entered into a definitive agreement to acquire AtaiBeckley, incl. its asset, BPL-003 (mebufotenin benzoate) & VLS-01 (buccal film formulation of DMT) to treat treatment-resistant depression; closing expected in Q3’26
Lilly will acquire AtaiBeckley for $6.75/share, plus a CVR of ~$2.5/share tied to development & regulatory milestones for BPL-003 & VLS-01. The…
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Diagonal has dosed the first patient with DIAG723, a clustering agonist antibody, in P-I/II (DIAMOND) trial (n=~93) for people living with hereditary hemorrhagic telangiectasia (HHT)
Trial will evaluate DIAG723 (SC) vs PBO in 3 parts: Part A (P-I) will assess single ascending doses; Part B (P-II) will evaluate multiple doses over 14wks. for safety…

