Here are six companies awaiting regulatory decisions this month, as listed by Zacks.
- The biopharmaceutical company Alkermes seeks approval for a two-month dosing option of its schizophrenia drug Aristada. The company, which currently offers one-month and six-week dosing options, expects a decision June 5.
- Ligand Pharmaceuticals partnered with Melinta to develop Baxdela, a treatment for patients with acute bacterial skin and skin structure infections. The companies expect a response from the FDA June 19.
- Shire will learn if its new once-daily treatment for attention deficit hyperactivity disorder is approved on June 20.
- Neos Therapeutics expects to hear from the FDA June 19 regarding review of a different ADHD treatment.
- Portola Pharmaceuticals seeks approval for betrixaban, an anticoagulant used to treat acutely ill patients at risk of venous thromboembolism, a type of blood clot that forms in the vein. The drugmaker expects a decision June 24.
- Roche on June 26 will learn if the FDA approved a subcutaneous form of its best-selling cancer drug Rituxan.
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