MannKind's Afrezza Receives FDA Label Update Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3d ago
0mins
Source: stocktwits
- FDA Approval Update: MannKind Corporation announced that the FDA approved an update to the prescribing information for its inhaled mealtime insulin Afrezza, leading to a more than 7% increase in pre-market trading, indicating positive market reception.
- Dose Guidance Optimization: The revised label offers clearer starting-dose guidance for adult patients transitioning from multiple daily injections or insulin pump therapy, aiming to improve glycemic control and enhance the product's competitive positioning in the diabetes treatment market.
- Clinical Study Support: This update is backed by clinical results from the Dose Optimization study and the INHALE-3 trial, which demonstrated significantly improved post-meal glucose control after switching to Afrezza, reinforcing the product's established clinical profile.
- Enhanced Healthcare Support: MannKind executives stated that this label update will assist healthcare providers by offering clearer starting dose guidance when transitioning patients to inhaled insulin, thereby promoting appropriate therapy initiation and improving patient treatment experiences.
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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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