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Pfizer (PFE) Gets FDA Nod for Migraine Nasal Spray Zavzpret

Pfizer PFE announced that the FDA has approved its calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant nasal spray, for the acute treatment of migraine. The nasal spray will be marketed by the trade name of Zavzpret. The product is expected to be launched in July.

The approval was based on data from two 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 migraine-associated most bothersome compared to placebo. A single intranasal dose of zavegepant led to ultra-rapid pain relief within 15 minutes and sustained efficacy through 48 hours.

In the past year, Pfizer’s stock has declined 24.6% against an increase of 3.3% for the industry.

Zacks Investment Research
Zacks Investment Research

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With the approval, Zavzpret has become the first intranasal CGRP receptor antagonist indicated for the acute treatment of migraine. The approval of Zavzpret nasal spray provides an attractive alternative to migraine patients who require ultra-rapid relief as well as for those patients who experience nausea or vomiting and need a non-oral treatment option.

Zavzpret was added to Pfizer’s migraine drugs portfolio with the 2022 acquisition of Biohaven’s CGRP programs. The acquisition closed in October 2022. Pfizer paid Biohaven $500 million, including an upfront payment of $150 million and an equity investment of $350 million. The acquisition of Biohaven’s CGRP programs, included rimegepant, zavegepant and a portfolio of five pre-clinical CGRP assets.

Rimegepant is approved and marketed as Nurtec ODT in the United States and Vydura in the European Union for both acute treatment and prevention of episodic migraine in adults. Nurtec ODT/Vydura generated sales of $211 million in the fourth quarter. Zavzpret is also in late-stage development for the prevention of acute migraine.

Prior to the closing of the acquisition by Pfizer, Biohaven completed the spin-off of Biohaven Ltd. BHVN. Biohaven is a new publicly traded company, which has retained the non-CGRP development stage pipeline compounds of legacy Biohaven.

Zacks Rank and Stocks to Consider

Pfizer currently has a Zacks Rank #5 (Strong Sell).

Some better-ranked drugmakers/biotech companies are Novo Nordisk NVO and CRISPR Therapeutics CRSP. While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), CRISPR Therapeutics has a Zacks Rank #2 (Buy).

Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.15 to $4.43. Estimates for 2024 have jumped from $4.38 per share to $5.19 in the past 60 days. Novo Nordisk’s stock has surged 38.9% in the past year.

Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 3.00%, on average.

Loss estimates for 2023 for CRISPR Therapeutics have narrowed from $8.21 per share to $7.33 per share. CRISPR Therapeutics’ stock has lost 25.6% in the past year.

CRISPR Therapeutics beat earnings expectations in two of the four trailing four quarters while missing in the other two. The company delivered a four-quarter earnings surprise of 3.19%, on average.

You can see the complete list of today’s Zacks #1 Rank stocks here.

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Pfizer Inc. (PFE) : Free Stock Analysis Report

Novo Nordisk A/S (NVO) : Free Stock Analysis Report

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Biohaven Ltd. (BHVN) : Free Stock Analysis Report

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