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Setback For Glenmark As FDA Hands Out CRL For Ryaltris

Executive Summary

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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‘Painful’ Few Years In US For Glenmark But Rebound In Sight

With price erosion seen ‘hitting the bottom’ in the US, Glenmark expects to make a strong comeback after some tough years in that market. Much will depend on product flow, including injectables, from the new Monroe site, with investors also keeping an eye on regulatory traction for rhinitis therapy Ryaltris.

‘Painful’ Few Years In US For Glenmark But Rebound In Sight

With price erosion seen ‘hitting the bottom’ in the US, Glenmark expects to make a strong comeback after some tough years in that market. Much will depend on product flow, including injectables, from the new Monroe site, with investors also keeping an eye on regulatory traction for rhinitis therapy Ryaltris.

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