Pharmaceutical Company
Appears in 4 stories
Advancing competing BBB-crossing platform for Alzheimer's disease
For decades, the blood-brain barrier has blocked nearly all large-molecule drugs from reaching the brain — a biological wall that left most neurological diseases effectively untreatable with modern biologics. On March 25, 2026, the Food and Drug Administration (FDA) approved AVLAYAH, developed by Denali Therapeutics, making it the first drug in history specifically engineered to cross that barrier and deliver a therapeutic enzyme to the central nervous system after a simple intravenous infusion.
Updated Mar 25
Running parallel Phase 3 trial of zosurabalpin for CRAB
No genuinely new class of antibiotic has reached patients since 1987. In the nearly four decades since, bacteria have steadily evolved resistance to existing drugs, and carbapenem-resistant Acinetobacter baumannii—a hospital-acquired pathogen that kills up to 60 percent of ventilated pneumonia patients—now sits atop the World Health Organization's list of critical-priority threats. On March 16, 2026, Swiss biotech BioVersys received clearance from the United States Food and Drug Administration (FDA) to begin enrolling American patients in a Phase 3 pivotal trial of BV100, a drug that cut 28-day mortality in half during earlier testing.
Updated Mar 16
Incumbent; markets Xolair (with Novartis) for food allergy
For decades, the 27 million American adults and children with food allergies had one option: avoid the allergen and carry an EpiPen. That changed in February 2024 when the FDA approved Xolair as the first drug to reduce allergic reactions—including anaphylaxis—from accidental exposure to multiple foods. Now GSK has paid $2.2 billion for RAPT Therapeutics and its experimental antibody ozureprubart, betting it can build a better version with once-quarterly dosing instead of Xolair's every-two-to-four-week schedule.
Updated Jan 20
Leading the BTK inhibitor race, awaiting final trial data
The FDA just rejected Sanofi's tolebrutinib for progressive multiple sclerosis on December 28, 2025—a crushing blow for a drug that had won Breakthrough Therapy status and became the first BTK inhibitor approved anywhere in the world. Meanwhile, Roche's rival drug fenebrutinib is racing toward approval after stunning Phase 3 victories, and Merck's evobrutinib crashed out entirely. Three pharma giants bet billions that brain-penetrating BTK inhibitors could finally slow the relentless neurodegeneration that leaves MS patients in wheelchairs. Only one looks likely to reach the finish line first.
Updated Dec 28, 2025
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