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Biotech Stocks Facing FDA Decision In September 2021

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Impel NeuroPharma
Impel NeuroPharma

The FDA decision on Impel NeuroPharma Inc.’s (IMPL) intranasal migraine candidate, Trudhesa, is slated for September 6.

Trudhesa, formerly known as INP104, is proposed for the acute treatment of migraine headaches with or without aura in adults.

Trudhesa uses a proprietary Precision Olfactory Delivery (POD) technology to deliver a lower dose (1.45mg) of dihydroergotamine mesylate (DHE) to the upper nasal space. An intranasal formulation of DHE that delivers a higher dose is already approved by the FDA under the brand name Migranal (4mg/mL), sold by Bausch Health in the US.

Impel has partnered with Veeva Systems (VEEV) on important pre-launch preparations for Trudhesa to accelerate its market preparation.

IMPL closed Friday’s trading at $17.09, up 4.72%.