New England Journal of Medicine Publishes Data from Phase 3 Studies Demonstrating Oveporexton (ORZEYFUL) Improved the Full Range of Narcolepsy Type 1 Symptoms and Quality of Life

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.

King’s College Hospital enrolled the first patient in a phase 3 trial (TAK-226-3001) comparing elritercept (TAK-226) with epoetin alfa for treating anemia in lower-risk myelodysplastic syndromes (MDS). The global study aims to enroll 300 patients, with King’s College as one of 2 UK sites. Elritercept, licensed by Takeda from Keros Therapeutics, is designed to promote red blood cell production. The trial evaluates its efficacy in reducing transfusion needs and improving patient quality of life.

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.