1. HYMPAVZI™ reduces 93% bleeding events in hemophilia patients with inhibitors

On 26 June 2025, Pfizer announced positive results from the Phase 3 BASIS study evaluating HYMPAVZI™ (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. Both the primary endpoint and key secondary endpoints demonstrated improvement in key bleeding outcomes. Inhibitors in the patients will hinder the effectiveness of factor replacement therapies. HYMPAVZI reduced the annualised bleeding rate (ABR) by 93% in patients with inhibitors over 12 months. HYMPAVZI is a new type of drug that blocks a natural anticoagulant called the tissue factor pathway inhibitor.

Link: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-3-results

2. IMAAVY™ showed superior symptom improvement in gMG versus other FcRn blockers via indirect comparison

On 23 June 2025, Johnson & Johnson announced results from an indirect treatment comparison (ITC) comparing IMAAVY™ (nipocalimab-aahu) with other approved FcRn blockers in generalised myasthenia gravis (gMG) patients. The Phase 3 Vivacity-MG3 trial was compared to other published Phase 3 data for other FcRn blockers at several time points up to 24 weeks of treatment. In population-adjusted comparisons without a shared control group, IMAAVY showed significantly greater mean improvements in MG-ADL scores compared to one FcRn blocker between Weeks 8 and 24, and compared to another between Weeks 10 and 14. In placebo-adjusted ITCs, IMAAVY was associated with greater efficacy than one comparator at Weeks 8 and 18–24, and than another one at Weeks 10–14.

Link: https://www.jnj.com/media-center/press-releases/imaavytm-nipocalimab-aahu-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalized-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc

3. Bemarituzumab plus chemotherapy improves overall survival in FGFR2b+ gastric and GEJ cancer

On 30 June 2025, Amgen announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. The antibody targeted FGFR2b, and the trial investigated the effects in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and HER2 negative.

Link: https://www.amgen.com/newsroom/press-releases/2025/06/amgen-announces-positive-topline-phase-3-results-for-bemarituzumab-in-fibroblast-growth-factor-receptor-2b-fgfr2b-positive-firstline-gastric-cancer

4. MR-141 shows strong efficacy and patient-reported benefit in presbyopia

On 26 June 2025, Viatris announced positive results from VEGA-3, a Phase 3 trial evaluating MR-141 in treating presbyopia. Presbyopia is a condition of gradual loss of the ability to focus on nearby objects. Significantly more patients treated with VEGA-3 achieved the primary endpoint of Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) gain in binocular distance-corrected near visual acuity (DCNVA) and with less than 5 letters of loss in binocular best-corrected distance visual acuity (BCDVA) from baseline at 12 hours post-dose on Day 8, compared to placebo.

Patients treated with MR-141 also reported significantly greater satisfaction with the recovery, including upon awakening and in low-light conditions, at Days 3, 8, and Week 6 (all p<0.0001). These improvements were consistent over time, with no signs of tachyphylaxis observed during the 6-week follow-up period.

Link: https://newsroom.viatris.com/2025-06-26-Viatris-Announces-Positive-Top-Line-Results-from-Second-Pivotal-Phase-3-VEGA-3-Trial-of-MR-141-in-Presbyopia

5. FDA removes REMS and eases patients monitoring for CAR-T therapies, Breyanzi® and Abecma®

On 26 June 2025, Bristol Myers Squibb announced that the U.S. FDA has updated label to reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs for CAR-T therapy, Breyanzi® (CD19 directed for lymphoma) and Abecma^® (BCMA directed for multiple myeloma). The current pre-assessment limits patients’ access to treatment due to complex logistical and geographic barriers. However, real-world data showed that most adverse events predominantly occur early and can be managed within the existing healthcare infrastructure. The updated decision aimed to improve equitable access and simplify treatment delivery to patients.

Link: https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Streamlined-Patient-Monitoring-Requirements-and-Removal-of-REMS-Programs-within-Bristol-Myers-Squibbs-Cell-Therapy-Labels/default.aspx

6. Updates on the regulatory decisions

Link: astrazeneca.com/media-centre/press-releases/2025/datroway-approved-in-us-for-egfrm-lung-cancer.html

https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-23-05-00-00-3103085
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916358