Shots:
- The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.
- Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient populations.
- Overall, July 2026 reflected the FDA’s focus on advancing targeted therapies, addressing complex and rare diseases, and introducing new treatment options that may improve clinical outcomes across multiple therapeutic areas.
Company: Vera Therapeutics
Product: Ambelvist
Active Ingredient: Gadoquatrane
Disease: Primary Immunoglobulin A Nephropathy
Date: Jul 07, 2026
Shots:
- The US FDA has granted accelerated approval to Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression
- Approval was supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in adults with IgAN, assessing eGFR-based kidney function over 2yrs., with results anticipated in Q3’26
- Trial showed a 46% reduction in proteinuria at 36wks., with a 42% decrease compared to PBO; Pts also experienced a 68% reduction in galactose-deficient IgA1
Company: Celcuity
Product: Revtorpyk
Active Ingredient: Gedatolisib
Disease: Breast Cancer
Date: Jul 14, 2026
Shots:
- FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26
- Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs 2mos.), ORR (32% vs 1%), & mDoR (17.5mos.) vs fulvestrant, while Revtorpyk + fulvestrant achieved a mPFS of 7.4 vs. 2mos., ORR of 28%, & mDoR of 12mos.
- Celcuity plans to submit an sNDA to the FDA in Q3’26 for Revtorpyk in HR+/HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer, following ≥1L of ET based on mutant cohort of VIKTORIA-1, followed by global regulatory submissions
Company: Merck
Product: Lipfendra
Active Ingredient: Enlicitide
Disease: Hypercholesterolemia
Date: Jul 15, 2026
Shots:
- The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
- At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from baseline, with a 56% PBO-adjusted reduction. Post-hoc data showed a 60% LDL-C reduction vs 3% increase after excl. LDL-C values ≤0. It also reduced non-HDL-C by 54% & ApoB by 50%
- At Wk. 24 in HeFH trial, Lipfendra reduced LDL-C by 58% from baseline vs a 3% increase, with a 59% PBO-adjusted reduction. Lipfendra also reduced non-HDL-C by 52% & ApoB by 48%, vs a 2% increase
Company: GSK
Product: Jideytro
Active Ingredient: Zidesamtinib
Disease: NSCLC
Date: Jul 15, 2026
Shots:
- The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor
- Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor
- Trial showed meaningful & durable responses, incl. in pts with brain metastases & ROS1 resistance mutations, where in the overall population, the ORR was 44%, and DoR rates were 82% & 69% at 6 & 12mos., respectively
Company: Outlook Therapeutics
Product: Lytenava
Active Ingredient: Bevacizumab-vikg
Disease: Wet AMD
Date: Jul 24, 2026
Shots:
- The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD
- Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF
- Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA
Company: Otsuka
Product: Simtriyo
Active Ingredient: Centanafadine
Disease: ADHD
Date: Jul 24, 2026
Shots:
- The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEA
- Approval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHD
- In two adult studies, both Simtriyo dose groups significantly improved AISRS total scores, with benefits emerging by Wk. 1 & sustained through 6wks. In paediatric & adolescent studies, high-dose Simtriyo significantly improved ADHD-RS-5 scores, with improvements seen as early as Wk. 1
