The HCPFive: Top News for Healthcare Providers from the Week of 06/22

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include data from a pair of phase 2 trials in metabolic dysfunction-associated steatohepatitis (MASH) as well as obesity/type 2 diabetes, phase 3 findings for sotatercept-csrk (Winrevair) in treating pulmonary arterial hypertension (PAH) and COMP360 for treatment-resistant depression (TRD), and a US Food and Drug Administration approval for a belimumab (Benlysta) autoinjector for active lupus nephritis (LN).

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of June 22, 2025—let’s jump in!

Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT Trial

According to positive topline results announced by Altimmune, the phase 2b IMPACT trial of pemvidutide in patients with MASH met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants and fibrosis improvement without worsening of MASH in up to 34.5% of participants in intent-to-treat analyses as well as weight loss of up to 6.2% at 24 weeks with no plateauing. According to Altimmune, the data make pemvidutide the first product candidate to demonstrate significant MASH effects and weight loss at 24 weeks.

FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, the FDA approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active LN who are receiving standard therapy. The approval of the belimumab autoinjector for this indication offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. According to GSK, it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population.

Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial Hypertension

On June 23, 2025, Merck announced positive topline results from the phase 3 HYPERION trial for sotatercept-csrk (Winrevair) in treating PAH functional class II or III at intermediate or high risk of disease progression.

“PAH is a progressive and debilitating disease with a poor prognosis that can be difficult to diagnose and treat,” said Vallerie McLaughlin, MD, Kim A. Eagle MD endowed professor of cardiovascular medicine and director, pulmonary hypertension program, University of Michigan in Ann Arbor. “The HYPERION study demonstrated that WINREVAIR on top of background therapy met its primary outcome measure of reduction in the time to clinical worsening events in adults who have been recently diagnosed with PAH.”

Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial

Compass Pathways announced positive phase 3 data from its ongoing COMP005 trial evaluating the Company’s synthetic psilocybin formulation COMP360 for TRD. A single 25-dose dose significantly reduced symptom severity on the Montgomery-Åsberg Depression Rating Scale. COMP005, the first of the 2 phase 3 trials evaluating COMP360 for TRD, met its primary endpoint: change from baseline in the MADRS scores between the active vs placebo group at week 6.

Once-Monthly Obesity Drug, MariTide, Achieves Weight Loss Up to 16% at 1 Year

New trial data presented at the 85th Scientific Sessions of the American Diabetes Association (ADA 2025) provide evidence of a once-monthly agent that could be a game-changer for management of obesity and type 2 diabetes. Results of the phase 2 trial of maridebart cafraglutide, also known as MariTide, indicate use was associated with body weight reductions ranging from 12-16% in obesity to 8.4-12% in type 2 diabetes with obesity. Additionally, secondary outcome measures revealed use could lower HbA1c by up to 1.6 percentage points.