Weekly Catalyst Report
Biohaven Pharmaceuticals (NYSE: BHVN) has an estimated PDUFA date of April 14th for Nurtec ODT (rimegepant). Nurtec ODT is already FDA approved for the acute treatment of migraines in adults. The supplemental new drug application (sNDA) currently under review is for the indication of a preventative treatment of migraines. The FDA’s acceptance of the application was announced on October 14th 2020.
Nurtec ODT is Biohaven’s only approved product at this time, and was approved in February of 2020 with a commercial launch in March of 2020. On April 7th, Biohaven announced preliminary sales for the first quarter of 2021 which are estimated to be $43.8 million, bringing the cumulative net sales since launch to $107.4 million. Net sales of Nurtec ODT were $35.1 million for the fourth quarter of 2020, representing continued consecutive quarter growth.
Nurtec ODT is a CGRP receptor antagonist, which is a relatively new class of drugs used to treat migraines. There has been expansion in this class of drugs with six total drugs approved by the FDA.
Vyepti (eptinezumab): IV agent for the prevention of migraines
Aimovig (ernumab): subcutaneous injection for the prevention of migraines
Ajovy (fremanezumab): subcutaneous injection for the prevention of migraines
Emgality (galcanezumab): subcutaneous injection for the prevention of migraines (also approved for the treatment of episodic cluster headaches)
Ubrelvy (ebrogepant): oral acute treatment of migraines
As you can see, Nurtec ODT would be the first oral agent in the class approved for the prevention of migraines in adults.
Biohaven Pharmaceuticals is a large-cap company with a current market capitalization of $4,380 million. Biohaven Pharmaceuticals’s 52 week low is $31.86 and 52 week high is $100.77. Biohaven Pharmaceuticals closed trading on 04-09-21 at $69.39, which is 117.8% above the 52 week low and 31.1% below the 52 week high. The average 1-year price target for Biohaven is $102.