Shots:
Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precisionÂ
Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
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The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026
Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…
Novo Nordisk Enters ~$2.1B Deal with Omeros to Advance Zaltenibart for Rare Blood & Kidney Disorders
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Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains certain rights to other preclinical MASP-3 programs, incl. small-molecule MASP-3 inhibitors for select indications
As per the deal, Novo will receive exclusive global rights to develop…
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Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included
EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…
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The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25
The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

