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Biohaven Pharmaceuticals said Monday its new migraine drug rimegepant met all major goals in two recent studies, allowing the company to file for FDA approval next year.
But the New Haven drug-maker’s stock plunged 23 percent Monday morning, as analysts questioned whether the results were good enough to compete with the many competitors working on similar drugs, according to MarketWatch and other reports. The stock opened at $23.30 Tuesday morning.
Biohaven said 19.2 and 19.6 percent of patients administered rimegepant in two phase 3 clinical trials were free from pain after two hours, compared to 14 and 12 percent in the placebo group.
In addition, rimegepant outperformed a placebo when it came to relief from other symptoms accompanying migraines, like nausea or sensitivity to light or sound, Biohaven said.
“The topline data from our two pivotal trials show that a single oral dose of rimegepant has the potential to be an effective and safe acute treatment for migraine, addressing both pain and most bothersome symptoms without the need for repeat dosing or rescue medicines,” Biohaven CEO Dr. Vlad Coric said in a statement.
The treatment is part of a potential new class of drugs known as CGRP receptor antagonists, which work by blocking a brain chemical that transmits pain.
Biohaven says rimegepant, which aims to stop migraines when they happen, is a potential alternative for people with heart disease, who can't take popular migraine drugs like Imitrex because they constrict blood vessels.
Rival drugmaker Allergan plans to seek FDA approval on a similar drug next year, MarketWatch said. Others are working on new drugs that would prevent attacks.
Also Monday, specialty diagnostics company Precipio Inc. said it has struck a deal with India-based Core Diagnostics to offer its ICE COLD-PCR (ICP) liquid biopsy testing services in India, Nepal, Bangladesh, Sri Lanka, Oman and Dubai. Terms were not disclosed.
New Haven-based Precipio, which specializes in technology aimed at reducing disease misdiagnosis, bills the liquid biopsy as a less invasive way to diagnose cancer.
Core Diagnostics is described as one of the premier laboratories in India, providing diagnostic technology to major hospital networks throughout that country and the region.
Natalie Missakian can be reached at news@newhavenbiz.com
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