Amneal Pharmaceuticals, Inc. (AMRX) Files BLA for XOLAIR® Biosimilar, Targets Multi-Billion-Dollar Market

We recently compiled a list of the 12 Healthcare Stocks with Insider Buying in 2025. Amneal Pharmaceuticals, Inc. is one of them.

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) continues to strengthen its position in generic, branded, and specialty medicines, marking September 2025 with key regulatory milestones and financial progress.

On September 26, AMRX submitted a Biologics License Application (BLA) for a biosimilar to XOLAIR® (omalizumab), targeting a multi-billion-dollar market that includes asthma, chronic rhinosinusitis, food allergies, and chronic urticaria. This marks a significant step in expanding into the U.S. biosimilars market.

Earlier in the month, Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) secured multiple FDA approvals. On September 23, Amneal received clearance for Bimatoprost Ophthalmic Solution 0.01%, a treatment for open-angle glaucoma and ocular hypertension with a reference market of about $685 million annually. On September 4, the FDA approved Risperidone Extended-Release Injectable Suspension, a therapy for schizophrenia and Bipolar I disorder maintenance. This complex injectable, which carries 180-day exclusivity under the Competitive Generic Therapy designation, is expected to launch in Q4 2025. Amneal also gained approval for Sodium Oxybate Oral Solution, further broadening its specialty portfolio.

Financial results have reinforced this momentum. In Q2 2025, the corporation reported revenue of $725 million, up 3% year-over-year, with net income of $22 million and a 13% rise in adjusted EBITDA to $184 million. These results prompted an upgraded full-year outlook, with projected adjusted EBITDA of $665–$685 million and EPS of $0.70–$0.75.

Strategically, Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) completed a $2.7 billion debt refinancing, extending maturities to 2032 and lowering interest costs, bolstering financial flexibility to support its growth trajectory. Together, these regulatory wins and financial moves underline AMRX’s focus on scaling complex generics and specialty medicines while positioning for long-term expansion.

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