Pfizer Inc.
On Saturday, the company reported that the Phase 2b studies for berobenatide demonstrated a non-placebo-adjusted weight loss of 15.9% in participants.
The pivotal Phase 3 study is currently open for enrollment, which may further bolster Pfizer's position in the obesity treatment market.
Pfizer plans to advance 10 Phase 3 studies for berobenatide in 2026 for chronic weight management and obesity-related comorbidities, including knee osteoarthritis and obstructive sleep apnea, as part of a broader program of 20+ obesity trials.
The first clinical experience with the top weekly dose for berobenatide is were presented for the first time.
Results from a 32-week exploratory extension (Part B) of the Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9% with no plateau observed at 32 weeks on berobenatide (Week 60 of the overall study), in participants who escalated from placebo to 2.4 mg weekly berobenatide.
Phase 3 Program Expands
The VESPER-6 pivotal Phase 3 study investigating monthly maintenance dosing for berobenatide in obese adults is open for enrollment, as well as the SOLIS-1 Phase 2b study investigating weekly and monthly maintenance dosing of an ultra-long-acting amylin analog (PF'3945) as a monotherapy and in combination with berobenatide.
FDA Expands HYMPAVZI Indication
On Monday, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Pfizer's HYMPAVZI (marstacimab-hncq) to include hemophilia A or B patients 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors.
HYMPAVZI is the first subcutaneous non-factor therapy available for pediatric patients with hemophilia B aged 6 to 11 years.
PFE Stock Price Activity: Pfizer shares were down 1.3% at $25.70 at the time of publication on Monday, according to Benzinga Pro data.
