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The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US
Approval was based on the P-III (SERENA-6) trial assessing…
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The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU
sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…
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Dassault Systèmes has entered into a definitive agreement to acquire ArisGlobal, creating the industry’s first unified intelligence platform
As per the deal, Dassault will acquire ArisGlobal for ~$1.8B at closing in cash & ~$200M in additional payments linked to multi-year AI-related revenue milestones; closing is expected in H2’26
Acquisition will advance Dassault Systèmes’ ambition to…
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The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program
NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…
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Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27%
Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…
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Royalty Pharma will pay Neurimmune up to $425M, incl. $125M upfront, in exchange for a 3% to 4% royalty on worldwide net sales of AstraZeneca’s cliramitug
Royalty Pharma will pay Neurimmune an additional $125M in cash in Q1’27, with the remaining $175M contingent on the achievement of specified clinical & regulatory milestones
Cliramitug is…
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Repligen has entered into a definitive agreement to acquire BioLife
Repligen will acquire BioLife for an enterprise value of ~$1.5B, with BioLife stockholders receiving $11.25 per share in cash plus 0.1442 Repligen shares, representing total consideration of $31/share, comprising 64% stock & 36% cash
Acquisition is expected to fast-track Repligen’s leadership & customer solutions…
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The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor
Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor
Trial showed meaningful & durable…
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The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26
Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…
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Jupiter Neurosciences has entered into a definitive license agreement with PharmAla Biotech for perpetual exclusive US rights to ALA-002, a FDA NCE-designated, non-racemic MDMA formulation
Jupiter Neurosciences will receive perpetual exclusive US rights to ALA-002 for $3.3M upfront ($1.5M cash + $1.8M JUNS common stock), with the deal valued at up to $100M, incl.…

