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CLAIM #48387 · Pfizer Inc (PFE) · 2024Q2 earnings call · Jul 30, 2024 · due Dec 31, 2024

We plan to conduct dose optimization studies in the second half of the year that are intended to inform our registration enabling studies.

Albert Bourla · CEO

CANNOT_DETERMINE
resolved by a revision, graded at the moved level · official band 5 percent
Committed
We plan to conduct dose optimization studies in the second half of the year that are intended to inform our registration enabling studies.
Reported
we're now targeting first quarter to have data from the ongoing dose optimization and formulation study, the PK study, and we're on track to deliver that in Q1.

In context

preclinical obesity pipeline. In previously reported results from the Phase 2b study in obesity, danuglipron demonstrated what we believe is good efficacy in its twice-daily formulation. For tolerability, we previously reported the maximum rate of GI adverse events across all doses investigated. Looking at individual dose levels in our Phase 2b study, however, we observed tolerability profiles that are competitive for the class. Our efforts are now focused on developing the once-daily formulation essential to delivering a competitive oral product. We were encouraged by a pharmacokinetic study evaluating multiple modified release technologies and formulations. This strengthened our confidence in potentially delivering a competitive once-daily pill at dose levels expected to be efficacious. We plan to conduct dose optimization studies in the second half of the year that are intended to inform our registration enabling studies. Obesity represents a growing area of patient need and it’s a key area of focus for Pfizer's R&D programs. We believe these study results, along with learnings from our previous Phase 2 studies and data that we have accumulated from 1,400 participating patients, leave us well positioned to execute on a registration-enabling study as we work to deliver a competitive product in a rapidly growing market. When we hosted our Oncology Innovation Day in February, we shared the pipeline milestones that would mark our success over the next year and we are already demonstrating progress. A highlight was our strong presence at the American Society of Clinical Oncology Annual Meeting last month, which was anchored by three positive Phase 3 readouts. Follow-up data from the Phase 3 CROWN study of Lorbr

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SEC filings for PFE · Claim quote is verbatim from the 2024Q2 earnings call.