Setback For Glenmark As FDA Hands Out CRL For Ryaltris
India's Glenmark gets US Complete Response Letter for Ryaltris but emphasizes the FDA hasn’t faulted the clinical data for the product, and that the action won’t impact recent alliances for the rhinitis asset.
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Glenmark reports challenging first quarter across key markets amid the pandemic, with US momentum impacted in part by pricing pressure in the dermatology segment. New product flows could restore uptick in that market, though US approval for rhinitis therapy Ryaltris is anticipated only in the second half of 2021.
Glenmark’s innovation spin-out initiates efforts to raise capital in the US, unfazed by mixed top-line results for its investigational atopic dermatitis treatment. Its parent firm has underscored the value proposition of the oncology franchise and proprietary bispecific antibody technology platform.
Glenmark ended 2019 on a buoyant note, with its rhinitis therapy getting the go-ahead in Australia. Though not seen as a huge commercial opportunity in the island continent, the clearance augurs well for the product’s overall trajectory.