Enrollment Begins for Elritercept Phase 3 Trial in Lower-Risk MDS

The FDA approved 13 drugs in August 2026, including Moderna's mFLUSIVA ($149.56/dose) for influenza prevention, Takeda's Orezyful for narcolepsy, Replimune's Tudriqev ($450,000/course) for melanoma, Bristol-Myers Squibb's Zenbexus ($29,500/28-day cycle) for multiple myeloma, Lantheus' Tauklarify for Alzheimer's diagnosis, and Regeneron's Pasatru for FOP. Each drug showed positive clinical trial results.

Takeda's oveporexton (ORZEYFUL) showed significant improvements in narcolepsy type 1 (NT1) symptoms and quality of life in Phase 3 studies, according to data published in the New England Journal of Medicine. The drug, approved in the U.S., China, and Japan, is the first orexin agonist designed to treat the underlying cause of NT1. It demonstrated clinically meaningful improvements in wakefulness, sleepiness, cataplexy, and disease severity, with a generally well-tolerated safety profile. Takeda

Ionis (IONS) and Milestone (MIST) gained FDA approvals for neurology and cardiology drugs. Biogen (BIIB) and AstraZeneca (AZN) also received regulatory nods for Alzheimer's and cancer treatments. Novavax (NVAX) secured global approvals for its COVID-19 vaccine. TScan (TCRX) and Novartis (NVS) announced job cuts. Novartis (NVS) and HUTCHMED (HCM) struck deals worth up to $3.2B and $1.295B respectively.

In August 2026, the FDA approved Oveporexton (Takeda) for narcolepsy, a first-in-class drug restoring orexin signaling. It also cleared Roche's Elecsys Phospho-Tau test (with Eli Lilly) for Alzheimer's assessment and C2N Diagnostics' PrecivityAD2 for younger adults. REGENXBIO's Hunter syndrome therapy was put on hold, while Cellenkos' ALS therapy received Fast Track designation. Lantheus' Tauklarify, a tau-targeted imaging agent, was approved for AD evaluation.

The FDA approved updated 2026-2027 COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Novavax targeting the JN.1-lineage XFG variant. Approvals cover high-risk populations, including adults 65+ and those with underlying conditions. Pfizer and Moderna's mRNA vaccines and Novavax's protein-based vaccine are now authorized for distribution.

FDA approved Protagonist Therapeutics' and Takeda's drug rusfertide (Mimrylo) for polycythemia vera. Mimrylo, a weekly injection, controls red blood cell overproduction. Takeda has not disclosed the price. Analysts forecast peak sales up to $2B. Protagonist's stock has nearly tripled in a year. Mimrylo is Takeda's second of three anticipated drug launches.