In August 2025, BioWorld logged 95 clinical trial updates across phases I to III, compared to 140 tracked in July and 254 in June. Among them, 15 phase III studies delivered positive results, while one trial each reported a failure and mixed outcome.

Amyotrophic lateral sclerosis (ALS), formerly known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder with no known cure. While three therapies have gained U.S. FDA approvals to date, including Rilutek (riluzole), Radicava/Radicava ORS (edaravone) and tofersen (BIIB-067, the lack of a disease-modifying drug has spurred the continual search for novel therapies.

While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.

The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159.

As Wall Street awaits phase IIb data from Kala Bio Inc. with KPI-012 in persistent corneal epithelial defect, odds are being weighed for that candidate – and others in development – against the lone approved treatment used in a market already worth more than $1 billion.