MannKind shares rise after FDA clears Afrezza label update
New dose conversion guidance for switching from injectable insulin could simplify prescribing and boost adoption of inhaled therapy
MannKind Corporation gained ground in Tuesday trading after the U.S. Food and Drug Administration approved updated prescribing information for its Afrezza inhaled insulin, providing healthcare providers with clearer guidance on transitioning patients from injectable insulin therapies.
The revised labeling, announced by the company on January 26, establishes a conversion matrix for adult patients switching from multiple daily injections or insulin pump mealtime therapy. Patients currently taking up to 3 units of subcutaneous mealtime insulin should start with 4 units of Afrezza, while those on 4 to 5 units should begin at 8 units. The dosing escalates to 12 units for patients on 6 to 7 units, and 16 units for those requiring 8 or more units.
"We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps," said Dr. Kevin Kaiserman, Senior Vice President and Therapeutic Area Head, Diabetes at MannKind. The company noted the new guidance is supported by modeling data and clinical results from the Dose Optimization study and INHALE-3 trial, which demonstrated improved postprandial glucose outcomes.
The regulatory approval arrives after MannKind's stock fell 7.6% on January 23, declining from $5.88 to $5.46, as investors positioned themselves around the FDA decision. Shares of the Westlake Village, California-based biopharmaceutical company currently trade at approximately $5.46, giving it a market capitalization of $1.56 billion.
Despite the recent volatility, analyst sentiment remains largely positive. A consensus of six analysts rates MannKind as a "Buy," with an average 12-month price target of $10.06, according to MarketBeat data. The company's latest market data shows one Strong Buy rating and eight Buy ratings from covering analysts, with zero Hold or Sell ratings.
The bullish outlook reflects expectations that simplified dosing guidance could accelerate adoption of Afrezza, which MannKind has positioned as a rapid-acting insulin alternative that addresses limitations of conventional injectable therapies. The company reported $313.8 million in trailing twelve-month revenue as of its most recent quarter.
Institutional investors maintain significant confidence in the company, with 55.1% of shares held by institutions. Zacks Research upgraded MannKind to a "Strong Buy" rating on January 13, citing the pending regulatory decision as a potential catalyst.
Looking ahead, MannKind faces another regulatory milestone in May 2026, when the FDA is expected to rule on a supplemental Biologics License Application seeking approval of Afrezza for children and adolescents aged 4 to 17 with type 1 or type 2 diabetes. The agency accepted the application for review in October 2025.
The label update represents a significant commercial development for Afrezza, which was initially approved by the FDA for adults in June 2014. By reducing complexity around dosing conversions, the company aims to lower barriers to prescribing and support appropriate initiation of therapy for patients seeking an alternative to multiple daily injections or insulin pumps.