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 Food and Drug Administration (FDA). 

 

Q3 2026: brepocitinib  

Brepocitinib, a first-in-class dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor from Priovant Therapeutics, is undergoing a Priority Review for the treatment of dermatomyositis, a rare autoimmune disorder characterized by inflammation and progressive damage to the muscles, skin, lungs, joints, heart and gastrointestinal tract. Granted Orphan Drug designation for dermatomyositis by the FDA, brepocitinib was evaluated in the Phase 3, double-blind, placebo-controlled VALOR trial in 241 adults with dermatomyositis who had an inadequate response to at least one prior traditional therapy, including systemic glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs) or intravenous immune globulin (IVIG).¹ Standard therapies were continued and glucocorticoids were tapered. The primary efficacy endpoint was the mean Total Improvement Score (TIS; range, 0–100; higher score indicates greater improvement). At 52 weeks, 30 mg of brepocitinib once daily resulted in a significant least-squares mean difference in the TIS versus placebo of 15.3 points (p<0.001). In addition, 62% of patients who received 30 mg of brepocitinib reduced their corticosteroid dose (prednisolone equivalent) to ≤2.5 mg/day. If approved, brepocitinib would be the first TYK2/JAK1 inhibitor to treat dermatomyositis and would expand the treatment options beyond other therapies, such as corticosteroids, DMARDs (off-label use) and IVIG (e.g., Octagam).  

Q3 2026: denecimig 

Novo Nordisk is awaiting an FDA decision for denecimig as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A, with or without inhibitors. Denecimig is a next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic that mimics the role of FVIIIa by bridging factor IXa and factor X. Denecimig has received Orphan Drug designation by the FDA. The FRONTIER clinical program evaluated denecimig in patients with hemophilia A, including pediatrics, with or without inhibitors.²˒³˒⁴˒⁵ Subcutaneous (SC) dosing regimens administered once monthly, every two weeks and once weekly were assessed. Across the studies, denecimig significantly reduced the estimated mean annualized rate of treated bleeding events compared with on-demand therapy or clotting factor prophylaxis. The safety of switching from emicizumab-kxwh (Hemlibra) prophylaxis to denecimig prophylaxis was also demonstrated. If approved, denecimig would be the first FVIIIa mimetic to offer flexible dosing delivered via a prefilled, single-use pen for individuals living with hemophilia A, with or without inhibitors.  

For more information, see the denecimig Deep dive in the April 2026 edition of Prime’s Quarterly Drug Pipeline.  

Q3 2026: insulin efsitora alfa 

Eli Lilly is awaiting an FDA decision on its long-acting injectable insulin, insulin efsitora alfa, for the treatment of type 2 diabetes mellitus (T2DM). The once-weekly insulin was studied in the Phase 3 QWINT global development program, which included four parallel-design, open-label trials. In QWINT-1 (insulin-naïve patients), insulin efsitora alfa reduced hemoglobin A1c (HbA1c) by 1.31%, compared with 1.27% for once-daily insulin glargine, at Week 52 for the efficacy estimand.⁶ In QWINT-2 (insulin-naïve patients), insulin efsitora alfa reduced HbA1c by 1.34%, versus 1.26% for once-daily insulin degludec, at Week 52 for the efficacy estimand.⁷ In QWINT-3 (insulin-experienced patients), insulin efsitora alfa reduced HbA1c by 0.86%, compared with 0.75% for once-daily insulin degludec, at Week 26 for the efficacy estimand. In QWINT-4, insulin efsitora alfa and once-daily insulin glargine each reduced HbA1c by 1.07% at Week 26 for the efficacy estimand. If approved, insulin efsitora alfa would compete directly with Novo Nordisk’s once-weekly insulin icodec (Awiqli) for the management of T2DM. 

Q3 2026: oveporexton 

Oveporexton, an orexin receptor 2 (OX2R)-selective agonist from Takeda, is undergoing FDA Priority Review for the treatment of narcolepsy type 1 (NT1). The oral agent was also granted Breakthrough Therapy and Orphan Drug designations. Data from the FirstLight and RadiantLight clinical trials, presented at World Sleep 2025, revealed that 1 mg and 2 mg twice-daily doses of oveporexton resulted in statistically significant improvement in the primary efficacy endpoint of change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) compared to placebo at 12 weeks. Most patients treated with 2 mg twice daily achieved wakefulness within the normal range (≥20 min) on the MWT, and nearly 85% achieved Epworth Sleepiness Scale (ESS) scores consistent with healthy individuals (≤10).⁸ If approved, oveporexton could provide an alternative to current treatments for NT1, such as sodium oxybate (Xyrem, Xywav, Lumryz), pitolisant (Wakix), armodafinil (Nuvigil) and modafinil (Provigil). 

Q3 2026: rusfertide 

Rusfertide, Takeda’s hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV), was granted a Priority Review — as well as Breakthrough Therapy, Fast Track and Orphan Drug designations — by the FDA. Rusfertide is a self-administered, weekly SC injection. The Phase 3, placebo-controlled VERIFY trial evaluated rusfertide in patients with PV who had uncontrolled hematocrit and were phlebotomy-dependent despite receiving current standard-of-care (SOC) treatment, such as hydroxyurea, interferon and/or ruxolitinib (Jakafi). In Part 1a of the study, 27% of patients treated with rusfertide plus SOC required phlebotomy between Weeks 0 and 32, the primary endpoint, compared with 78% of patients who received placebo plus SOC.⁹ In addition, 84.1% of patients who experienced a clinical response with rusfertide in Part 1a maintained their response at Week 52.¹⁰ If approved, rusfertide will be a first-in-class erythrocytosis-specific therapy for PV. Rusfertide may compete with existing PV therapies, including ruxolitinib (Jakafi) and ropeginterferon alfa-2b-njft (Besremi), for the treatment of PV. 

July 6, 2026: allogeneic T-cell immunotherapy (Orca-T) 

Orca-T is an allogeneic T-cell immunotherapy by Orca Bio under FDA Priority Review for the treatment of hematological malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS). The FDA also granted the cellular therapy Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations. Orca-T differs from conventional allogeneic hematopoietic stem cell transplant (allo-HSCT) by incorporating highly purified, polyclonal donor regulatory T cells, which are intended to reduce graft-versus-host disease (GVHD) while requiring less immunosuppression. Orca-T is administered via intravenous (IV) infusion after myeloablative conditioning. In the Phase 3 Precision-T trial, a regimen of Orca-T with tacrolimus led to significantly fewer cases of chronic GVHD at 12 months compared with a regimen of allo-HSCT with tacrolimus and methotrexate in patients with AML, ALL or MDS (78% versus 38.4%, respectively).¹¹ 

For more information, see the Orca-T Deep dive in the January 2026 edition of Prime’s Quarterly Drug Pipeline. 

July 7, 2026: atacicept 

Vera Therapeutics and Bristol Myers Squibb are seeking Accelerated Approval for atacicept for the treatment of immunoglobulin A nephropathy (IgAN), also known as Berger's disease. Atacicept is a recombinant Fc fusion protein that contains a transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor, which binds to and inhibits two key cytokines — B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) — that play a significant role in IgAN pathogenesis. The FDA granted atacicept a Priority Review, as well as Breakthrough Therapy and Orphan Drug designations, for the treatment of IgAN. Interim data from the double-blind, placebo-controlled, Phase 3 ORIGIN-3 trial showed that atacicept, when added to SOC, resulted in a significantly greater reduction in the primary endpoint of percentage reduction from baseline on the 24-hour or urine protein-to-creatinine ratio (UPCR) compared with SOC alone (45.7% versus 6.8%, respectively; p<0.001) at 36 weeks.¹² In the clinical trial, atacicept was self-administered as a 150 mg SC injection once weekly. Vera Therapeutics plans to submit a supplemental biologic license application (sBLA) for full approval in Q4 2026, pending estimated glomerular filtration rate (eGFR) results anticipated in Q3 2026. 

For more information, see the atacicept Deep dive in the April 2026 edition of Prime’s Quarterly Drug Pipeline.  

July 17, 2026: gedatolisib 

Gedatolisib, developed by Celcuity and Pfizer, is under FDA Priority Review and Real-Time Oncology Review for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) and PIK3CA (phosphatidylinositol-3-kinase catalytic subunit alpha) wild-type advanced breast cancer (ABC). The breakthrough therapy broadly inhibits the PAM pathway — comprising PI3K (phosphoinositide 3-kinase), AKT (protein kinase B) and mTOR (mammalian target of rapamycin) — distinguishing it from currently available therapies. The open-label Phase 3 VIKTORIA-1 trial demonstrated a significant improvement in progression-free survival (PFS) when gedatolisib (with or without palbociclib) was added to fulvestrant in patients with HR+/HER2- ABC, following progression on or after cyclin-dependent kinases 4 and 6 (CDK4/6) and aromatase inhibitor therapy.¹³ In the trial, gedatolisib was administered via IV once weekly for three weeks (on Days 1, 8 and 15), followed by one week off. If approved, gedatolisib could become an option in the second-line treatment of HR+/HER2- PIK3CA wild-type ABC.  

July 23, 2026: rivoceranib + camrelizumab 

Elevar Therapeutics is awaiting an FDA decision for rivoceranib, in combination with camrelizumab (developed by Jiangsu Hengrui), for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Rivoceranib is an oral tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptor 2 (VEGFR-2), and camrelizumab is an IV-administered, programmed cell death-1 (PD-1)-directed humanized monoclonal antibody. Both products received FDA Orphan Drug designation for HCC. In the open-label Phase 3 CARES-310 trial, the combination significantly improved the primary endpoints of PFS and overall survival (OS) compared with sorafenib (400 mg, orally, twice daily).¹⁴ At the data cutoff for the final analysis, median follow-up was 22.1 months in the rivoceranib plus camrelizumab group and 14.9 months in the sorafenib group. The median PFS was 5.6 months with rivoceranib plus camrelizumab and 3.7 months with sorafenib (p<0.0001). The median OS was significantly prolonged with rivoceranib plus camrelizumab compared with sorafenib (23.8 months vs. 15.2 months, respectively; hazard ratio, 0.64; p<0.0001). This is the third review for rivoceranib plus camrelizumab, following Complete Response Letters issued by the FDA in May 2024 and March 2025 citing deficiencies related to a manufacturing-site inspection. If approved, the combination of oral rivoceranib plus IV camrelizumab may compete with the SOC all-IV regimens: atezolizumab (Tecentriq) plus IV bevacizumab (Avastin), nivolumab (Opdivo) plus ipilimumab (Yervoy) and the recently approved durvalumab (Imfinzi) plus tremelimumab-actl (Imjudo).  

July 24, 2026: isatuximab-irfc (Sarclisa) SC 

The FDA has extended its review of Sanofi’s supplemental Biologics License Application for SC isatuximab-irfc administered via an on-body delivery system for the treatment of multiple myeloma. Isatuximab-irfc is a CD38-directed cytolytic antibody that is currently available under the brand name Sarclisa for IV use in combination with a proteasome inhibitor and/or a thalidomide analog in patients with multiple myeloma. The open-label Phase 3 IRAKLIA trial showed that SC isatuximab-irfc (1,400 mg), administered via a single-use, on-body delivery system, was noninferior to IV-administered isatuximab-irfc (10 mg/kg) in patients with relapsed or refractory multiple myeloma, when combined with pomalidomide and dexamethasone. Grade 3 or higher treatment-emergent adverse events occurred in 81.7% of patients in the SC group and 76.1% in the IV group. Systemic infusion reactions occurred in 1.5% of patients receiving the SC formulation, versus 25% with IV administration. The incidence of local injection-site reactions associated with SC administration was 0.4%. If approved, SC isatuximab-irfc delivered via an on-body delivery system could offer a shorter administration time — about 10 minutes versus 30–60 minutes for an IV infusion — as well as improved patient comfort due to fewer systemic infusion reactions. The SC formulation may also enable at-home administration by a healthcare professional. 

July 24, 2026: centanafadine 

Centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) by Otsuka, is undergoing FDA Priority Review for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Clinical and preclinical data suggest that it has a low potential for abuse. Across four double-blind Phase 3 trials, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo. Efficacy was measured using the ADHD Rating Scale-5 (ADHD-RS-5) in adolescents and children and the ADHD Investigator Symptom Rating Scale (AISRS) in adults.¹⁵˒¹⁶ If approved, centanafadine will provide an alternative nonstimulant treatment option for patients with ADHD. 

All brand names are the property of their respective owners.