Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company (BHVN) have disclosed positive top-line results from the Phase 3 clinical trial of rimegepant in Asia-Pacific. The study included 1,431 adults for the acute treatment of migraine.
The trial, which was designed to evaluate the safety and efficacy of the orally dissolving tablet (ODT) formulation of rimegepant, met the co-primary endpoints. Remarkably, this was the fourth positive Phase 3 study of rimegepant and the first to be conducted in Asia Pacific. Rimegepant demonstrated a favorable safety and a well-tolerated profile.
Rimegepant is designed for the acute treatment of migraine attacks with or without aura and the preventive treatment of migraine in adults. It is commercialized as Nurtec ODT, the first-of-its-kind oral CGRP (calcitonin gene-related peptide) receptor antagonist, in the U.S.
As per the terms of the collaboration and license agreement between the two companies, Pfizer has the right to commercialize rimegepant outside the U.S., while globally, Biohaven continues to lead research and development and holds the U.S. market.
Other Approvals
The application for the approval of rimegepant outside the U.S. is currently being reviewed by European Medicines Agency, with the outcome expected in the first half of 2022. Positively, Kuwait and the United Arab Emirates have approved Rimegepant for the acute treatment of migraine, while Israel has approved it for both the acute and preventive treatment of migraine.
Official Comments
Biohaven CEO Vlad Coric commented, “These top-line trial results clearly show the consistent clinical profile of rimegepant to relieve migraine symptoms and return patients to normal function. Through our partnership with Pfizer, we are committed to rapidly expanding the availability of rimegepant to patients around the world, particularly in Asia Pacific where migraine is a common disease and a leading cause of disability.”
Wall Street’s Take
Recently, Morgan Stanley analyst Matthew Harrison maintained a Hold rating on Pfizer and reduced the price target to $55 (10.44% upside potential) from $60.
The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 8 Buys and 9 Holds. The average Pfizer price target of $59.80 implies 20.08% upside potential to current levels. Shares have gained 42.1% over the past year.
Risk Analysis
According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 6, 6, and 4 risks, respectively, to the total 24 risks identified for the stock.
Given a low-risk profile compared to the sector average and positive clinical development, investors might want to consider adding Pfizer to their portfolios.
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