Which biotech companies are expected to have FDA approvals in the next year?

Several biotech companies are expected to have FDA approvals in the next year. Here are some of the key players: 1. **Abeona Therapeutics (ABEO)**: The company has already received FDA approval for its gene therapy ZEVASKYN™ for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). However, the approval was based on a Phase 3 trial, and the company is likely to seek additional indications for its AAV-based gene therapies in the coming year. 2. **Agios Pharmaceuticals (AGIO)**: Agios has a drug called PYRUKYND® (mitapivat) that has been approved in Saudi Arabia for the treatment of adults with thalassemia. The company is currently awaiting FDA approval in the United States, with a PDUFA date of September 7, 2025. 3. **Fortress Biotech (FBIO)**: Fortress Biotech has a drug called CUTX-101 for the treatment of Menkes disease, which has a PDUFA date of September 30, 2025. The company has also recently announced a strategic monetization of its SG&A and commercial infrastructure, which could pave the way for additional FDA approvals. 4. **Xspray Pharma (XSPRAY)**: Xspray has a drug called Dasynoc® that is currently under FDA review with a PDUFA date of October 7, 2025. The company has also submitted a New Drug Application for its second product candidate, XS003, which is being reviewed by the FDA with a strong clinical potential. 5. **NRx Pharmaceuticals (NRXP)**: NRx has a drug called NRX-100 that is being reviewed by the FDA for the treatment of suicidal ideation in depression, including bipolar depression. The company has recently received Fast Track designation for this drug and is seeking accelerated approval. These companies are likely to be at the forefront of FDA approvals in the coming year, given the strength of their clinical trials and partnerships. However, it's important to note that FDA approvals are subject to various factors, including clinical trial results, regulatory agency feedback, and manufacturing and quality control considerations.