$MNKD currently has 2 products with excellent chances of FDA approval in May & July this year
1. FUROSCIX ReadyFlow Autoinjector PDUFA: July 26, 2026
2. Afrezza Pediatric Indication PDUFA: May 29, 2026
The stock took a major drop in February when it's partner United Therapeutics announced it was developing it's own competitor drug for Mannkind's bestseller Tyvaso, but this product won't be ready for a market launch until 2028 (and that's only if everything goes smoothly) so the drop was premature and overdone considering Mannkind's other market opportunities, for instance Mannkind has been busy co-developing ralinepag DPI (MNKD-1501) with United Therapeutics, MKND has been paid $5m already & is eligible for another $35 million in milestone payments plus a lucrative 10% royalty on net sales
Apart from that $MKND is due FDA decision on 2 extremely promising products in May & July this year:
The decision for Afrezza Pediatric Indication is due around 29th May, Afrezza will be the **only needle-free mealtime insulin** for children, there is nothing else like it on the market & FDA places a heavy emphasis on Unmet Need Factor & patient preference in chronic pediatric conditions
FUROSCIX ReadyFlow Autoinjector is a Supplemental New Drug Application (sNDA) for a drug that is already FDA-approved, FDA has already signed off on the drug and the formulation; it is merely evaluating the new delivery device which reduces therapeutic dose delivery from 5 hours down to an incredible under 10 seconds, the FDA decision is due around end of July 2026
Major investment banks Wells Fargo and H.C. Wainwright recently upgraded their long-term price targets on MannKind to $10.00