This milestone adds India to the list of countries where Afrezza is approved, joining the United States and Brazil.
Shares of MannKind Corporation climbed more than 2% in premarket trading Wednesday, on track to extend gains from the previous session.
The stock garnered significant retail attention after the company, along with its partner Cipla Ltd., announced that India’s Central Drugs Standard Control Organisation (CDSCO) had approved Afrezza (insulin human) Inhalation Powder for adult use.
This milestone adds India to the list of countries where Afrezza is approved, joining the United States and Brazil.
MannKind’s exclusive marketing and distribution agreement with Cipla, initiated in 2018, tasked Cipla with securing regulatory approvals and managing marketing and sales efforts in India.
MannKind remains responsible for supplying the product.
Retail sentiment for MNKD turned ‘bullish’ on Stocktwits from ‘neutral’ a day ago, with the ticker ranking among the top five trending symbols before the opening bell.
One user claimed they got a response from MannKind’s investor relations involving the release of pediatric data before year-end.
Another user expressed enthusiasm about the company finding a new market.
Michael Castagna, CEO of MannKind, expressed optimism about the development, stating: “Achieving approval for Afrezza in India, a country with the second-highest burden of diabetes worldwide, is an exciting milestone for MannKind and Cipla.”
“We look forward to Cipla marketing the first inhaled insulin option for adults with diabetes in India and are preparing for product export by the end of 2025,” he added.
MannKind shares have risen over 70% year-to-date.
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