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Investing.com -- Shares of Supernus Pharmaceuticals (NASDAQ:SUPN) climbed 5.5% Tuesday as the U.S. Food and Drug Administration approved ONAPGO for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. The wearable subcutaneous infusion device, which is set to be available in the U.S. in the second quarter of 2025, is the first of its kind approved by the FDA.
The company’s announcement on February 4, 2025, highlighted the device’s role in providing consistent control of OFF time without the need for invasive surgery. The approval was based on a Phase 3 study showing significant reductions in daily OFF time and increases in GOOD ON time. Supernus CEO Jack Khattar expressed the company’s commitment to developing novel alternatives for managing neurological conditions.
In response to the approval, TD Cowen analyst Stacy Ku, Ph.D. raised the price target on Supernus Pharmaceuticals to $44.00 from $43.00 while maintaining a Buy rating. "The FDA has approved Onapgo (SC apomorphine pump), to treat OFF episodes in Parkinson’s disease. Onapgo should be a nice addition to Supernus’ PD franchise, with launch in Q2:2025 and potential peak sales of $200MM," the analyst stated.
The device’s continuous infusion mechanism directly stimulates dopamine receptors, offering a new approach for Parkinson’s patients experiencing motor fluctuations. This method bypasses the gastrointestinal tract, potentially leading to more predictable symptom improvement.
The approval of ONAPGO aligns with Supernus’ history of success in the CNS therapeutic category, and the company plans to support the launch with a comprehensive nurse education program and access support. The Parkinson & Movement Disorder Alliance CEO Andrea Merriam emphasized the importance of consistent daily control of OFF time, noting that ONAPGO could help make days with Parkinson’s more predictable for many patients.
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