Truist Securities on Tuesday reaffirmed its Buy rating on MannKind Corporation (NASDAQ:MNKD) and kept a $9.00 price target on the stock. That target implies substantial upside from the prevailing share price of $5.58, though it remains below the highest analyst target on the Street of $12. Analysts polled by InvestingPro continue to register a strong consensus Buy recommendation for the company.
Central to Truist’s view is a recent regulatory move by the U.S. Food and Drug Administration to approve an update to Afrezza’s prescribing label. The revision provides revised recommended starting mealtime doses for patients transitioning from subcutaneous insulin to the inhaled formulation. MannKind submitted the label change roughly one year ago after data indicated dose conversion had been off by about 50%, which had complicated patient response to therapy.
The FDA’s decision was informed by both modeling data and clinical evidence from MannKind’s Dose Optimization and INHALE-3 studies. Truist describes the label update as an "incremental positive," noting it can aid ongoing uptake in existing markets and make it easier to convert patients who require substantially higher doses when switching delivery modes.
Truist’s financial model assigns Afrezza potential peak sales of $171 million. In the firm’s valuation, Afrezza contributes approximately $2 of the $9 price target and represents about 22% of what Truist considers the company’s fair value as MannKind pursues portfolio diversification.
InvestingPro metrics cited by Truist show MannKind’s revenue expanded 17.4% over the prior twelve months, and the company’s financial health earns a "GREAT" score in that dataset. That said, the shares currently trade at a price-to-earnings ratio of 57.25, a level InvestingPro flags as high relative to near-term earnings growth expectations.
MannKind also faces a series of near-term milestones that could influence sentiment and commercial momentum. Upcoming items listed in research and company updates include a pediatric expansion with a PDUFA date of May 29, topline results from the Tyvaso TETON-1 study expected in the first half of 2026, and a Furoscix auto-injector PDUFA slated for July 26. The company’s next quarterly earnings release is scheduled for March 3, 2026, and analysts covering the name forecast adjusted earnings per share of $0.21 for fiscal 2025 alongside projected revenue growth of 19%.
Additional company disclosures and regulatory developments were noted recently. The FDA-approved Afrezza prescribing information now includes clearer starting dose guidance for clinicians moving patients from subcutaneous insulin to inhaled insulin, and it contains a conversion table to aid dose selection. MannKind has outlined two related FDA decisions that remain on the calendar for 2026 - one concerning dose conversion labeling with an expected decision by January 2026 and another concerning pediatric use of Afrezza with a May 2026 target date.
On the commercial front, MannKind closed 2025 with a reported record fourth-quarter net revenue in excess of $100 million, a performance the company attributes in part to its acquisition of scPharmaceuticals. In regulatory news beyond Afrezza, the FDA approved FUROSCIX for pediatric patients who weigh 43 kg or more, expanding the label for that product.
Truist’s note and the referenced InvestingPro analysis also point investors to additional premium research content for those seeking deeper modeling details and proprietary ProTips on MNKD. The firm’s view balances an encouraging regulatory backdrop for Afrezza with the company’s strategic initiatives for 2026 while acknowledging valuation and execution risks.
Key takeaways
- Truist reaffirmed a Buy rating and a $9.00 price target for MannKind; the target implies material upside from the current $5.58 share price.
- The FDA approved a label update for Afrezza that clarifies starting mealtime dosing for patients switching from subcutaneous insulin, supported by Dose Optimization and INHALE-3 study data and modeling.
- Near-term catalysts include a May 29 pediatric PDUFA, Tyvaso TETON-1 topline results expected in H1 2026, a July 26 Furoscix auto-injector PDUFA, and a March 3, 2026 earnings report.
Risks and uncertainties
- Regulatory timing and outcomes - Several FDA decisions remain outstanding and could materially affect commercial prospects and sentiment in the healthcare and biotech sectors.
- Valuation concerns - MannKind’s current P/E of 57.25 is high relative to anticipated near-term earnings growth, which raises valuation risk for equity investors.
- Execution and commercialization - The company’s ability to convert label changes into broader Afrezza uptake and to integrate acquisitions such as scPharmaceuticals will influence performance in pharmaceutical and medical-device markets.