Biotech Values

[DewDiligence]

PFE discontinues Lotiglipron—no_effect_on Danuglipron GLP-1-RA program:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provides-update-glp-1-ra-clinical-development

The decision to terminate the clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies…and laboratory measurements of elevated transaminases in these Phase 1 studies as well as the ongoing Phase 2 study… None of these participants reported liver related symptoms or side effects, there was no evidence of liver failure, and none needed treatment.

Such transaminase elevations have not been observed in the over 1,400 patients enrolled in the danuglipron program.

In its oral GLP-1-RA program, PFE had two shots on goal and now its has one shot on goal, Danuglipron. PFE never intended to advance both compounds into phase-3.

Danuglipron is further along in development than Lotiglipron was, but Danuglipron needs additional formulation work to make it a qD rather than BID drug. Hence, PFE may end up filing separate NDAs for BID Danuglipron and (extended release) qD Danuglipron.

The selloff in PFE shares today is happening because some investors fear that the qD formulation of Danuglipron won’t pan out.

Please see #msg-171968465 for related info.