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FDA Decisions Expected: July 2025

Your monthly synopsis of new drugs expected to hit the market 

June 18, 2025

Drug pipeline for July 2025

At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on drugs awaiting approval by the United States (U.S.) Food and Drug Administration (FDA).
July–September 2025: sodium pyruvate (N115) 
Emphycorp submitted N115 to the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). In IPF, nasal inflammation induces oxidative stress, decreases lung function and increases mucus and coughing. N115 is a nonsteroidal nasal spray that decreased coughing in patients with IPF when compared to placebo. At day 22 of a double-blind, Phase 3 trial (NCT06037408), adults with IPF who were treated with N115 experienced a 73.2% reduction in coughing episodes per 24 hours (primary endpoint) compared to 16.1% of patients who received placebo.¹ After study treatment was stopped, patients in the N115 group reported reduced coughing for a mean 38.8 days compared to 5.54 days in the placebo group. Currently available drugs indicated for IPF include the pyridine agent pirfenidone (Esbriet) and the kinase inhibitor nintedanib (Ofev); both products are administered orally. If approved, N115 will provide an additional mechanism of action to treat IPF.
July–September 2025: zongertinib 
Boehringer Ingelheim is awaiting the FDA decision for zongertinib for the treatment of patients with unresectable or metastatic, HER2 (ERBB2) gene-mutated, non-small cell lung cancer (NSCLC) after prior systemic therapy. Zongretinib is an irreversible oral tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2) while sparing EGFR, thereby limiting associated toxicities. The FDA granted the agent a Priority Review as well as Breakthrough Therapy and Fast Track designations. Results from the open-label, Phase 1b Beamion LUNG-1 trial revealed daily oral doses of zongertinib led to an objective response rate (ORR) of 71%, a complete response rate (CRR) of 7% and a disease control rate (DCR) of 96% in patients who received prior treatment for unresectable or metastatic, HER2 (ERBB2) gene-mutated NSCLC.²  Notably, the ORR was 41% and DCR was 81% among patients with brain metastases. If approved, zongertinib could compete with intravenously (IV)-administered fam-trastuzumab deruxtecan-nxk (Enhertu) in patients with advanced HER2 (ERBB2) gene-mutated NSCLC who have received prior systemic treatment.
July 7, 2025: sunvozertinib 
The FDA granted a Priority Review for sunvozertinib, by Dizal Pharmaceuticals, for the treatment of locally advanced or metastatic NSCLC in patients with EGFR exon 20 insertion mutations. Sunvozertinib is an oral irreversible EGFR inhibitor. It received a Breakthrough Therapy designation from the FDA. The Phase 2 WU-KONG1 Part B study demonstrated a best ORR of 54.3%, CRR of 2.9% and DCR of 90.8% with once daily dosing of sunvozertinib in platinum-pretreated patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations.³  If approved, sunvozertinib could compete with the current standard of care, amivantamab-vmjw (Rybrevant) in in patients who have received at least two prior systemic therapies. 
July 10, 2025: linvoseltamab 
Regeneron is awaiting FDA decision for linvoseltamab for the treatment of patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. Linvoseltamab is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. The FDA granted Fast Track designation for linvoseltamab. This is the second review of linvoseltamab by the FDA after the agency issued a complete response letter (CRL) in August 2024 citing concerns from a manufacturer facility inspection. The ongoing, open-label, LINKER-MM1 study is evaluating linvoseltamab in heavily pretreated patients with R/R MM.⁴  In Phase 2 of the trial, patients received linvoseltamab 200 mg or 50 mg IV once weekly for 14 weeks, then once every 2 weeks until week 24, after which patients on 200 mg could switch to every-4-week dosing depending on treatment response. In patients who received linvoseltamab 200 mg, at a median follow-up of 14.3 months, the ORR was 71%, with 50% of patients achieving a complete response or better and 63% achieving a very good partial response or better. The median time to response was one month and the median duration of response (DOR) was 29.4 months with linvoseltamab 200 mg. Cytokine release syndrome (CRS) occurred in 46% of patients treated with linvoseltamab 200 mg. The alternative dose of 50 mg produced lower response rates at a median follow-up of 7.4 months (ORR, 48%; CRR, 21%). If approved, linvoseltamab will compete with the subcutaneously (SC) administered bispecific antibodies talquetamab-tgvs (Talvey) and Elrexfio in the R/R MM space (after ≥ 4 prior systemic therapies). 
July 22, 2025: vusolimogene oderparepvec (RP1)
RP1 is a selectively replication-competent herpes simplex virus type 1 (HSV-1)–based oncolytic immunotherapy that expresses human granulocyte-macrophage colony-stimulating factor (GM-CSF) and the fusogenic GALV-GP-R– glycoprotein. Replimune is seeking Accelerated Approval for use of RP1 in combination with nivolumab (Opdivo) for the treatment of advanced melanoma. The FDA has granted a Priority Review and Breakthrough Therapy designation to RP1. In the ongoing, open-label, Phase 2 IGNYTE trial, 140 patients with advanced melanoma who had failed anti-programmed cell death-1 (PD-1) therapy were treated with RP1 plus nivolumab.⁵  In the trial, RP1 is administered by intratumoral injection every two weeks for eight cycles; patients are allowed to restart RP1 beyond eight cycles if they meet protocol-specific criteria. Nivolumab is administered IV for 30 cycles. At a median follow-up of 15.5 months, the ORR was 32.9% and the CRR was 15%. In addition, overall survival (OS) rates at 1, 2 and 3 years were 75.3%, 63.3% and 54.8%, respectively. Treatment options are limited in cases where melanoma progresses on or after immunotherapy. Available second-line treatments include IV-administered nivolumab (Opdivo) plus ipilimumab (Yervoy), nivolumab/relatlimab-rmbw (Opdualag), lifileucel (Amtagvi) and aldesleukin (Proleukin); however, these regimens are associated with Grade 3 or 4 adverse effects or boxed warnings. In addition, intralesional injection of the modified oncolytic HSV-1 therapy talimogene laherparepvec vaccine (Imlygic) and systemic chemotherapy are recommended in select patients but have not demonstrated improvement in overall survival. Chemotherapy via isolated limb perfusion or infusion has reported good response rates, but its use is limited due to the administration complexity. If approved, RP1 plus nivolumab provide another second-line option. 

For more information, see the vusolimogene oderparepvec Deep Dive in the April 2025 edition of Prime’s Quarterly Drug Pipeline.
July 23, 2025: delgocitinib
Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor by LEO Pharma that is under FDA review for the treatment of adults with moderate to severe chronic hand eczema (CHE) who have had an inadequate response to, or for whom topical corticosteroids are not advisable. CHE is considered when eczema of the hand lasts longer than three months or relapses at least twice in a year. Delgocitinib is formulated as a 2% cream and was granted Fast Track designation for CHE. Pooled data from the Phase 3, vehicle-controlled DELTA-1 and DELTA-2 trials reported a significantly greater proportion of patients treated with twice-daily delgocitinib achieved the primary endpoint of Investigator’s Global Assessment for CHE (IGA-CHE) treatment success, defined as score of 0/1 (clear/almost clear) with at least a two-step improvement from baseline, compared to patients who received vehicle cream (24.3% versus 8.4%, respectively; p<0.001) at 16 weeks.  If approved, delgocitinib could compete with non-steroid topical agents, such as roflumilast (Zoryve), ruxolitinib (Opzelura) and crisaborole (Eucrisa), for the treatment of moderate CHE; the indications for these agents include treatment of eczema beyond just the hands, but do not include treatment for severe cases. 
July 29, 2025: sepiapterin 
PTC Therapeutics is awaiting FDA decision of sepiapterin for the treatment of phenylketonuria (PKU). Orally administered sepiapterin reduces phenylalanine levels in the blood by improving phenylalanine hydroxylase activity. The ongoing, Phase 3 APHENITY study demonstrated a significant reduction in the primary endpoint of mean change from baseline in blood phenylalanine after 6 weeks with sepiapterin compared to placebo (63% versus 1%, respectively; p<0.0001) in the overall primary analysis population.⁷  In addition, an open-label, crossover, active-controlled, Phase 2 trial conducted outside the U.S. reported sepiapterin 60 mg/kg resulted in a significantly greater decrease in phenylalanine compared to saptropterin dihydrochloride (Kuvan) 20 mg/kg/day (p=0.0098); the same was not true when comparing sepiapterin 20 mg/kg to Kuvan 20 mg/kg/day. In addition, blood phenylalanine levels < 360 μmol/L were achieved in 46% of patients on sepiapterin 20 mg/kg, 50% on sepiapterin 60 mg/kg and 42% on Kuvan 20 mg/kg/day. If approved, sepiapterin will provide an additional option for patients of any age with PKU and is expected to compete with Kuvan and it’s generics.

For more information, see the sepiapterin Deep Dive in the January 2025 edition of Prime’s Quarterly Drug Pipeline.
July 30, 2025: odronextamab
Regeneron has resubmitted their fully human immunoglobulin G4 (IgG4)-based CD20 x CD3 bispecific antibody, odronextamab, to the FDA for the treatment of R/R follicular lymphoma (FL) after two or more lines of systemic therapy. This is the second review by the FDA after Regeneron resolved confirmatory trial enrollment concerns cited in the CRL issued in March 2024. The FDA has granted Fast Track and Orphan Drug designations for odronextamab for the treatment of R/R FL.⁸ The Phase 2, open-label, ELM-2 trial demonstrated that at a median follow-up of 28.3 months, odreonextamab monotherapy resulted in an ORR of 80.5% and CRR of 74.2% in heavily pretreated patients with R/R FL.  Secondary endpoints showed a median DOR of 26 months, progression-free survival (PFS) of 23 months and median OS of 54.2 months. Due to a step-up dosing regimen, most CRS events were mild in severity. If approved, odronextamab could compete with the CD20 targeting therapies including rituximab (Rituxan), obinutuuzumab (Gazyva), epcoritamab-bysp (Epkinly), mosunetuzumab-axgb (Lunsumio) and glofitamab-gxbm (Columvi) for CD20+ R/R FL. 
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