Amneal Pharmaceuticals, Inc. AMRX
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) is a CNS/neurology/psychiatry specialty pharmaceutical company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CREXONT | CNS (Parkinson's disease focus per 10-K) | unclear | Approved |
| BREKIYA autoinjector | not stated in extract | device-combination | Approved |
| UNITHROID | endocrine (thyroid) | unclear | Approved |
| RYTARY | CNS (Parkinson's disease focus) | unclear | Approved |
| IPX203 (Europe, licensed to Zambon) | CNS | unclear | Approved |
Recent results and decisions
- Oct 23, 2026submitted Kashiv and Amneal are developing omalizumab, a biosimilar to XOLAIR, in the United States and India, with Kashiv responsible for development, regulatory filings, and FDA approval.
The Company is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing of the product, while Amneal is responsible for marketing, selling, and pricing activities.
Filing - Oct 23, 2026submitted Intas Pharmaceuticals received exclusive rights to seek regulatory approval and commercialize Lanreotide in Europe and India under an agreement with Kashiv entered December 16, 2025.
The Company entered into an exclusive license agreement with Intas Pharmaceuticals Limited granting Intas the exclusive rights to seek regulatory approval for and commercialize Lanreotide in Europe and India.
Filing - Oct 23, 2026submitted Amneal and Kashiv entered into a license agreement for development and commercialization of Carfilzomib in May 2025.
In May 2025, Amneal and the Company entered into a separate license agreement for the development and commercialization of Carfilzomib.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other approved CNS/neurology/psychiatry companies
- Mobia Medical, Inc. MOBI
- Neuronetics, Inc. STIM
- Aytu Biopharma, Inc AYTU
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.