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Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: 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 to Acquire ArisGlobal for ~$2B

Shots: 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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Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: 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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Royalty Pharma Inks ~$425M Deal with Neurimmune to Acquire Royalty Interest in AstraZeneca’s Cliramitug

Shots: 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 to Acquire BioLife for ~$1.5B

Shots: 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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GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Shots: 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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Jupiter Neurosciences Inks ~$100M Deal with PharmAla Biotech for Exclusive US Rights to ALA-002

Shots: 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.…

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