New Hope for Nerve Damage Patients as AstraZeneca/Ionis' Eplontersen Receives FDA Nod for Hereditary Amyloidosis Treatment
Portfolio Pulse from Vandana Singh
The FDA has approved AstraZeneca and Ionis Pharmaceuticals' Wainua (eplontersen) for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Wainua is unique as it can be self-administered via an auto-injector. The approval is based on positive results from the NEURO-TTRansform Phase 3 trial. The companies plan to commercialize Wainua in the U.S. and seek approval in other regions. Analysts estimate peak sales could reach $3.5 to $7 billion with expanded approval. IONS shares rose 7% and AZN shares increased 0.47% in premarket trading.
December 22, 2023 | 12:49 pm
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AstraZeneca's Wainua, developed with Ionis, received FDA approval for treating hereditary amyloidosis, with plans for global commercialization.
The FDA approval of Wainua is a significant milestone for AstraZeneca, likely to have a positive impact on the stock in the short term due to the potential for new revenue streams and market expansion. The positive premarket price action reflects investor optimism.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
Ionis Pharmaceuticals' collaboration with AstraZeneca on Wainua has led to FDA approval, with shares rising 7% in premarket trading.
Ionis Pharmaceuticals is directly involved in the development of Wainua, and the FDA approval is a significant positive catalyst for the company's stock. The 7% premarket increase indicates strong investor confidence, suggesting a likely continued positive impact in the short term.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90