MNKD Stock Eyes Best Month Since 2022 Ahead Of FDA Decision On Pediatric Diabetes Treatment

• MannKind posted Phase 3 trial results last October, comparing Afrezza in patients aged 4 to 17, with multiple daily insulin injections.
• MannKind will present additional Afrezza-related data at the American Diabetes Association Scientific Sessions next week.
• The presentations will include analysis on pediatric treatment satisfaction and A1c tests, among others.

Shares of MannKind Corp. (MNKD) were in focus on Thursday as growing investor optimism surrounded an upcoming U.S. Food and Drug Administration decision on the company’s inhaled insulin therapy for children and adolescents with type 1 or type 2 diabetes.

MNKD shares were up marginally in pre-market trading, and are on track to post their biggest monthly gains in nearly three and a half years.

All Eyes On FDA’s Decision

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29 for Afrezza. The drug is currently approved only for adults aged 18 and older and has been on the market since 2014.

A PDUFA date is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

MannKind’s filing is backed by results from the Phase 3 Inhale-1 study released last October, which evaluated Afrezza in patients aged 4 to 17. The 26-week open-label trial compared Afrezza used alongside multiple daily insulin injections combined with basal insulin.

The submission also included safety data from a 26-week extension phase where patients previously receiving injections were switched to Afrezza.

MNKD To Present Additional Data Next Week

MannKind is also preparing to present additional Afrezza-related data at the upcoming American Diabetes Association Scientific Sessions.

The presentations will include analysis on pediatric treatment satisfaction, A1c tests to measure the average amount of sugar in the blood over the past three months, inhaled insulin use with automated insulin delivery systems, and its potential use in gestational diabetes.

MNKD Bulls See Strong Upside Potential

Retail sentiment on Stocktwits turned ‘bullish’ from ‘neutral’ a day earlier, amid ‘high’ message volumes.

One user said a favorable FDA decision could leave significant upside potential for the stock after what they described as a prolonged period of undervaluation.

Another user expects the stock to “pop into the double digits immediately” if the company announces partnerships alongside FDA approval.

The stock has shed nearly 38% so far this year.

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