π Which late-stage biotech companies have multiple drugs in various stages of FDA approval?
8/17/2025 10:00pm
Several late-stage biotech companies have multiple drugs in various stages of FDA approval. Here are some examples:
1. **Novo Nordisk**: Novo Nordisk has multiple drugs, including Wegovy (semaglutide) and CagriSema, in various stages of FDA approval. Wegovy has already secured FDA approval in 2025 for treating MASH, while CagriSema is a pipeline innovation expected to commence commercial manufacturing in mid-2026.
2. **Radiopharm Theranostics Limited**: Radiopharm Theranostics Limited has received IND approval from the FDA to initiate a Phase 1 therapeutic clinical study targeting B7H3 with Betabart (RV-01). The company is also awaiting FDA approval for its drug targeting prostate cancer.
3. **Karyopharm Therapeutics**: Karyopharm Therapeutics has multiple drugs in late-stage trials, with the most significant being the anticipated release of pivotal data from its Phase III SENTRY study in myelofibrosis, initially expected in late 2025 or early 2026.
4. **Shattuck Labs**: Shattuck Labs has secured $103 million in private funding, extending its financial runway to 2029, and has submitted an IND application for SL-325, a DR3-blocking antibody targeting IBD, with FDA clearance expected in Q3 2025.
These companies are at various stages of clinical trials and regulatory approvals, with multiple drugs showing promise in treating various diseases and conditions.