Which late stage bio is progressing towards fda approval in 2025
8/17/2025 10:00pm
Several late-stage biotech drugs are progressing towards FDA approval in 2025. Here are some examples:
1. **Wegovy (semaglutide)**: Novo Nordisk's Wegovy has already secured FDA approval in 2025 for treating MASH (metabolic-associated fatty liver disease), with a resolution rate of 62.9% in clinical trials. This drug is priced at $499/month with Medicare coverage, targeting a $7.38 billion MASH market.
2. **Tonmya™**: Tonix Pharmaceuticals' Tonmya™, the first fibromyalgia therapy in 15 years, has received FDA approval. The drug demonstrated a statistically significant 30% or greater reduction in pain scores at 14 weeks, with improved sleep and fatigue.
3. **Betabart (RV-01)**: Radiopharm Theranostics Limited's Betabart is targeted at B7H3 with a Phase 1 therapeutic clinical study, aiming to treat aggressive solid tumors.
4. **CagriSema**: Novo Nordisk's CagriSema is a pipeline innovation expected to commence commercial manufacturing in mid-2026, with a forecasted value of $15.2 billion by 2030.
These drugs are at various stages of clinical trials and regulatory approvals, with significant potential to impact the biotech sector and healthcare market in 2025.