Intellitrials: Clinical Trial News 12-Feb-2026

FDA Drug Approvals

Darzalex Faspro (daratumumab and hyaluronidase-fihj): Label expansion approved 27-Jan-2026 in combination with VRd for newly diagnosed multiple myeloma patients ineligible for transplant. Johnson & Johnson. FDA Link
Zycubo (copper histidinate): Approved 12-Jan-2026 as the first treatment for Menkes disease, a rare copper metabolism disorder. FDA Link
Fibryga (fibrinogen, human): Expanded 2-gram kit approved 07-Jan-2026 for acquired fibrinogen deficiency, designed for faster administration in critical bleeding. Octapharma. FDA Link
Cablivi (caplacizumab-yhdp): Pediatric expansion approved 05-Jan-2026 for children 12 years with acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi. FDA Link
Generic Glatiramer Acetate: Approved 05-Jan-2026 as the first complex injectable generic for relapsing multiple sclerosis. ScinoPharm. FDA Link
ProlivRx: Approved Jan 2026 as the first at-home, physician-directed neuromodulation device for Major Depressive Disorder (MDD).

GSK acquires RAPT Therapeutics: $2.2 billion (Announced Jan 20, 2026). Secures RAPT’s oral small molecules for inflammation and oncology, strengthening GSK's respiratory/immunology pipeline. Source
AbbVie & RemeGen Licensing: $5.6 billion total (Jan 12, 2026). AbbVie gains rights to a bispecific antibody for oncology, continuing its aggressive expansion in targeted therapies. Source
Lilly & Seamless Therapeutics: $1.12 billion (Jan 28, 2026). A strategic collaboration focused on modular gene editing for neurological disorders. Source
AstraZeneca & SanegeneBio: $1.7 billion (Jan 30, 2026). Licensing deal for an RNAi technology platform to address metabolic and cardiovascular indications. Source
BMS & Janux Therapeutics: $1.035 billion (Jan 2026). Licensing deal for tumor-activated bispecific antibodies targeting solid tumors. Source

Bausch Health (rifaximin SSD): Phase 3 Red-C trials failed (Jan 23, 2026). The Xifaxan successor did not meet primary objectives for the prevention of hepatic encephalopathy in cirrhosis patients. Source
Milvexian (J&J/BMS): Phase 3 futility analysis (Feb 2026) led to the early termination of the ACS (Acute Coronary Syndrome) study, though other Phase 3 indications remain active. Source

NIH "Digital Twin" of the Eye: In Feb 2026, the NIH unveiled a high-resolution 3D digital replica of retinal pigment epithelial cells, providing a new AI-driven modeling platform to accelerate AMD drug discovery. Source
AI-Driven IND Streamlining: Data from Parexel in early 2026 shows AI systems are now preparing IND (Investigational New Drug) submissions 50% faster, significantly cutting the time from "ready" to "regulatory review." Source

The "Obesity Platform" Era: Experts at the 2026 J.P. Morgan Healthcare Conference noted a shift from mere GLP-1 novelty to supply chain scale and multi-modal platforms (oral, weekly, and combination therapies) to capture the projected $200B market. Source
Patent Cliff Pressure: 2026 marks the beginning of the "cliff," with over 40% of Big Pharma revenue at risk of loss of exclusivity (LoE) by 2030, driving the current 15% surge in late-stage M&A. Source

Brand Name	Active Ingredient	Company	Indication	Approval Date
Darzalex Faspro	Daratumumab	J&J	Newly Diagnosed Multiple Myeloma	27-Jan-2026
Zycubo	Copper histidinate	N/A	Menkes Disease	12-Jan-2026
Fibryga (2g)	Fibrinogen	Octapharma	Acquired Fibrinogen Deficiency	07-Jan-2026
Cablivi	Caplacizumab	Sanofi	Pediatric aTTP	05-Jan-2026
N/A (Generic)	Glatiramer Acetate	ScinoPharm	Relapsing Multiple Sclerosis	05-Jan-2026
ProlivRx	Neuromodulation	ProlivRx	MDD (At-Home Device)	Jan-2026