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The HCPFive: Top News for Healthcare Providers from the Week of 03/09
Our top 5 headlines featured an oral drug delivering 16% weight loss, notable blood pressure reductions from a hypertension treatment, and 3 key FDA decisions.
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 focused on an oral weight loss drug achieving nearly 16% weight loss, an oral inhibitor for lowering blood pressure in uncontrolled hypertension, and 3 key decisions from the US Food and Drug Administration (FDA), including a new target goal date for ketamine, a new designation for ophthalmic gene therapy, and the approval of the first interchangeable biosimilar for omalizumab.
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 March 09, 2025—let’s jump in!
Interested in oncology news? Check out The OncFive, from our sister publication OncLive.
CagriSema Yields Nearly 16% Weight Loss in Phase 3 REDEFINE 2 Trial
A fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, CagriSema was superior to placebo in adults with obesity or overweight and type 2 diabetes (T2D) but fell short of Novo Nordisk’s expected ≥25% weight loss. In the Phase 3 REDEFINE 2 trial, CagriSema achieved a weight reduction of nearly 16%, compared with 3% for placebo, if all individuals adhered to treatment.
Lorundrostat Significantly Lowers Blood Pressure in Key Hypertension Trials
Efficacy and safety results from the pivotal Phase 3 Launch-HTN and Phase 2 Advance-HTN trials demonstrated the promise of lorundrostat treatment for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Both trials showed that Mineralys Therapeutics’ oral aldosterone synthase inhibitor achieved statistically significant reductions in systolic blood pressure while maintaining favorable safety and tolerability.
PharmaTher Receives New Early June FDA Goal Date for Ketamine
In a release, PharmaTher announced the receipt of a new FDA target goal date for ketamine to treat anesthesia, sedation, pain, mental health, and neurological indications. In the Amendment Acknowledgment Letter (AAL), the FDA acknowledged that the drug met the criteria for Priority Review and set a new goal date of June 4, 2025.
FDA Awards Fast Track Designation to ATSN-201 Gene Therapy for XLRS
The FDA granted Fast Track designation to ATSN–201 for the treatment of X-linked retinoschisis (XLRS), following Orphan Drug and Rare Pediatric Disease designations. With this new designation, Atsena Therapeutics can receive the agency’s Priority Review for their novel gene therapy if relevant criteria are met.
FDA Approves First Interchangeable Biosimilar for Omalizumab
The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar for reference omalizumab (Xolair), marking the first respiratory biosimilar, for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). The biosimilar was approved for subcutaneous injection doses of 75 mg/0.5 mL and 150 mg/mL.
