FDA Nod For BHVN’s Drug, IBIO On Watch, SGMO Soars On Biogen Deal

Today’s Daily Dose brings you news about FDA approval of Biohaven’s migraine drug, iBio’s Annual Meeting, Sangamo’s deal with Biogen, and Zogenix’s revised FDA decision date.

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The FDA has approved Biohaven Pharmaceutical Holding Company Ltd.’s (BHVN) NURTEC ODT (rimegepant) for the acute treatment of migraine in adults.

NURTEC ODT is the first FDA-approved product for Biohaven, and the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet formulation.

Aimovig, co-developed by Novartis and Amgen, Teva’s Ajovy, Eli Lilly’s Emgality and Allergan’s Ubrelvy are the other approved CGRP inhibitors for migraine – the same class of drugs to which Biohaven’s investigational Rimegepant also belongs to.

Biohaven’s NURTEC ODT could bring in $897 million in annual sales in 2024, according to EvaluatePharma.

NURTEC ODT is also being evaluated in the preventive treatment of migraine and a phase III trial in this indication is underway, with topline data expected later this quarter.

BHVN closed Thursday’s trading at $40.82, down 8.54%. In after-hours, the stock was up 7.79% at $44.00.

iBio Inc.’s (IBIO) annual meeting of stockholders is all set to be held on March 5, 2020, at 9:30 a.m. ET.

The Company focuses on developing plant-based biologics manufacturing. Its FastPharming System combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver gram quantities of high-quality monoclonal antibodies, vaccines, bioinks, and other proteins.

Early this month, iBio and Beijing CC-Pharming Ltd. entered into collaboration to develop and test a new 2019-nCoV vaccine to be manufactured using iBio’s FastPharming System.

iBio’s FastPharming Technology has been used to produce antibody candidates for Ebola and Dengue fever viruses, while human and animal studies have been completed for vaccine candidates, including yellow fever virus, human papilloma virus, seasonal influenza and avian influenza.

IBIO closed Thursday’s trading at $0.86, up 158.98%.

Shares of Sangamo Therapeutics Inc. (SGMO) jumped nearly 40 percent in extended trading on Thursday, following a global licensing collaboration agreement with Biogen Inc. (BIIB) to develop and commercialize ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets.

Sangamo’s ST-501, ST-502, and the undisclosed neuromuscular disease target are all in preclinical testing.

As part of the agreement, Biogen will pay Sangamo $350 million upfront, including a license fee and an equity investment in Sangamo stock. In addition, Sangamo is eligible to receive up to $2.37 billion in potential milestones, as well as royalties on potential net commercial sales.

SGMO closed Thursday’s trading at $6.66, down 3.27%. In after-hours, the stock was up 39.83% at $9.32.

The FDA decision date on Zogenix Inc.’s (ZGNX) New Drug Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome has been extended by three months to June 25, 2020.

The original decision date of March 25, 2020, has been extended to allow the FDA time to review additional data submitted by Zogenix in response to a recent information request from the U.S. regulatory agency.

Early this month, the Company reported top-line results from a global pivotal phase III trial of FINTEPLA for the treatment of Lennox-Gastaut syndrome.

The Lennox-Gastaut syndrome trial achieved its primary endpoint, demonstrating a statistically significant reduction in drop seizures for FINTEPLA 0.7 mg/kg/day compared to placebo. The same dose of FINTEPLA (0.7 mg/kg) also demonstrated statistically significant improvements versus placebo in key secondary efficacy measures, including the proportion of patients with a clinically meaningful reduction in drop seizure frequency.

However, for a lower dose of FINTEPLA (0.2 mg/kg/day), although there was a decrease in the frequency of drop seizures between baseline and the treatment period compared to placebo, it did not reach statistical significance.

ZGNX closed Thursday’s trading at $23.69, down 9.09%. In after-hours, the stock fell another 7.43% to $21.93.

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