Yesterday, United Therapeutics (UTHR), MannKind’s (MNKD) partner for Technosphere treprostinil (TreT), hosted its Science Day 2018. MannKind’s dry powder inhalable treprostinil formulation for pulmonary arterial hypertension (PAH) was prominently featured in United’s “Next Generation Delivery Systems” presentation and in the overall strategic vision, which includes potential inhalable treprostinil in to more PH indications.
H.C. Wainwright analyst Oren Livnat commented, “Yesterday, for the first time, we got a peek at some of the TreT Phase 1 PK data, which was only press-released in June as “positive.” TreT data appear to show two things: (1) linear Cmax and AUC dose progression to tolerable doses well above Tyvaso’s recommended and maximum tolerable doses (potentially allowing higher efficacy); and (2) PK parameters that appear to closely track Tyvaso at similar doses, which is crucial for the planned bioequivalence development pathway. Interestingly, at the peril of making cross-trial comparisons, TreT appears to much better match Tyvaso’s PK profile than does the potential competitor from recently-IPO’d Liquidia (LQDA; not rated), which also plans a bioequivalence path. United is keeping the specific TreT development pathway close to the vest for now, but MannKind’s prior standalone guidance was to conduct a small Tyvaso “switch study,” and a pivotal bioequivalence PK study with a potential 505(b)2 NDA filing in 2H2020. We suspect United wants to take the most expedited pathway, but we await confirmation of further studies next year which will give us a better sense of both timing and potential labeling and dosing differentiation from Tyvaso.”
Net net, Livnat reiterates a Buy rating on MannKind, with a $4.00 price target, which implies an upside of 111% from current levels.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Oren Livnat has a yearly average return of 2.9% and a 53% success rate. Livnat has a -8.4% average return when recommending MNKD, and is ranked #2149 out of 4877 analysts.