MannKind Receives FDA Approval for Afrezza Label Update
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3d ago
0mins
Source: NASDAQ.COM
- FDA Approval Update: MannKind Corporation announced that the FDA has approved an update to the Afrezza prescribing information, adding guidance for transitioning patients from multiple daily injections or insulin pump therapy, aimed at providing clearer, evidence-based dosing directions for healthcare providers.
- Clinical Data Support: The update includes a conversion table and dosing recommendations supported by clinical data from the Dose Optimization and INHALE-3 studies, ensuring that healthcare teams can make more precise decisions when initiating Afrezza for patients.
- Market Uniqueness: Afrezza remains the only inhaled mealtime insulin available in the U.S. market, and MannKind is advancing additional clinical initiatives to expand its use across broader patient populations, further solidifying its market position.
- Future Outlook: The FDA has accepted a supplemental Biologics License Application (sBLA) for Afrezza to expand its use to children and adolescents aged 4-17, with a target action date of May 29, 2026, indicating the company's strategic focus on pediatric diabetes treatment.
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Analyst Views on MNKD
Wall Street analysts forecast MNKD stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MNKD is 9.25 USD with a low forecast of 7.50 USD and a high forecast of 11.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.640
Low
7.50
Averages
9.25
High
11.00
Current: 5.640
Low
7.50
Averages
9.25
High
11.00
About MNKD
MannKind Corporation is a biopharmaceutical company engaged in transforming chronic disease care through patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, it develops and commercializes treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. Its commercial assets include Afrezza, FUROSCIX and V-Go along with Tyvaso DPI. Its commercializing Afrezza (insulin human) Inhalation Powder, an ultra-rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Its orphan lung disease product, Tyvaso DPI (treprostinil) inhalation powder, is used in the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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