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Biohaven's (BHVN) Zavegepant NDA for Migraine Accepted by FDA
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Biohaven Pharmaceutical (BHVN - Free Report) announced that the FDA accepted its new drug application (NDA) for review. The NDA is seeking approval for its intranasal formulation of the small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant nasal spray, in its pipeline as an acute treatment of migraine.
The company included data from two successfully completed pivotal studies that evaluated zavegepant nasal spray in migraine patients. Data from the studies demonstrated the superiority of zavegepant in achieving pain freedom and freedom from the migraine-associated most bothersome symptom in migraine patients compared to placebo. A single intranasal dose of zavegepant led to ultra-rapid pain relief within 15 minutes and sustained efficacy through 48 hours.
The FDA is expected to provide its decision related to zavegepant NDA in the first quarter of 2023.
A potential approval to zavegepant nasal spray will provide an attractive alternative to migraine patients who require ultra-rapid relief, in as early as 15 minutes, as well as for those patients who experience nausea or vomiting and need a non-oral treatment option. The candidate also has the potential to provide longer relief that lasts through 48 hours after a single dose.
Per the company, if approved, zavegepant will become the first intranasal CGRP receptor antagonist indicated for the acute treatment of migraine.
Biohaven is also investigating zavegepant for other indications. The company is evaluating an oral formulation of zavegepant in a phase III study as a preventive treatment of migraine. The company is also evaluating the candidate in a phase II study as a potential treatment for pulmonary complications of the COVID-19 disease. The company plans to initiate clinical studies on the candidate to evaluate it in non-migraine indications.
Shares of Biohaven have gained 3.7% so far this year against the industry’s decline of 23.8%.
Image Source: Zacks Investment Research
Please note that Pfizer (PFE - Free Report) has agreed to acquire Biohaven for $148.50 per share or an aggregate equity value of $11.6 billion earlier this month. Pfizer has already acquired the commercial rights to Biohaven’s sole marketed drug — Nurtec ODT — and CGRP pipeline candidates in ex-U.S. markets. These rights were acquired by PFE last November when it entered into a strategic collaboration agreement with BHVN.
However, the company will continue to operate under Biohaven’s name after the acquisition. PFE will also pay off BHVN’s third-party dues as well as redeem the latter’s outstanding preferred stock.
The acquisition deal, unanimously approved by the boards of directors of Pfizer and Biohaven, is subject to customary closing conditions, including approval from Biohaven’s shareholders and regulatory authorities. The transaction is expected to be completed by early 2023.
Biohaven Pharmaceutical Holding Company Ltd. Price
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 13 cents to 3 cents in the past 30 days. Shares of ALKS have risen 26% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.9% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
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Biohaven's (BHVN) Zavegepant NDA for Migraine Accepted by FDA
Biohaven Pharmaceutical (BHVN - Free Report) announced that the FDA accepted its new drug application (NDA) for review. The NDA is seeking approval for its intranasal formulation of the small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant nasal spray, in its pipeline as an acute treatment of migraine.
The company included data from two successfully completed pivotal studies that evaluated zavegepant nasal spray in migraine patients. Data from the studies demonstrated the superiority of zavegepant in achieving pain freedom and freedom from the migraine-associated most bothersome symptom in migraine patients compared to placebo. A single intranasal dose of zavegepant led to ultra-rapid pain relief within 15 minutes and sustained efficacy through 48 hours.
The FDA is expected to provide its decision related to zavegepant NDA in the first quarter of 2023.
A potential approval to zavegepant nasal spray will provide an attractive alternative to migraine patients who require ultra-rapid relief, in as early as 15 minutes, as well as for those patients who experience nausea or vomiting and need a non-oral treatment option. The candidate also has the potential to provide longer relief that lasts through 48 hours after a single dose.
Per the company, if approved, zavegepant will become the first intranasal CGRP receptor antagonist indicated for the acute treatment of migraine.
Biohaven is also investigating zavegepant for other indications. The company is evaluating an oral formulation of zavegepant in a phase III study as a preventive treatment of migraine. The company is also evaluating the candidate in a phase II study as a potential treatment for pulmonary complications of the COVID-19 disease. The company plans to initiate clinical studies on the candidate to evaluate it in non-migraine indications.
Shares of Biohaven have gained 3.7% so far this year against the industry’s decline of 23.8%.
Image Source: Zacks Investment Research
Please note that Pfizer (PFE - Free Report) has agreed to acquire Biohaven for $148.50 per share or an aggregate equity value of $11.6 billion earlier this month. Pfizer has already acquired the commercial rights to Biohaven’s sole marketed drug — Nurtec ODT — and CGRP pipeline candidates in ex-U.S. markets. These rights were acquired by PFE last November when it entered into a strategic collaboration agreement with BHVN.
However, the company will continue to operate under Biohaven’s name after the acquisition. PFE will also pay off BHVN’s third-party dues as well as redeem the latter’s outstanding preferred stock.
The acquisition deal, unanimously approved by the boards of directors of Pfizer and Biohaven, is subject to customary closing conditions, including approval from Biohaven’s shareholders and regulatory authorities. The transaction is expected to be completed by early 2023.
Biohaven Pharmaceutical Holding Company Ltd. Price
Biohaven Pharmaceutical Holding Company Ltd. price | Biohaven Pharmaceutical Holding Company Ltd. Quote
Zacks Rank & Stocks to Consider
Biohaven currently carries a Zacks Rank #3 (Hold).
Some better-ranked biotech stocks are Alkermes (ALKS - Free Report) and Sesen Bio . While Sesen Bio sports a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 13 cents to 3 cents in the past 30 days. Shares of ALKS have risen 26% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.9% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.