Drug pipeline for October 2026

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).

Q4 2026: gefurulimab 

AstraZeneca’s dual-binding complement C5 inhibitor, gefurulimab, received Orphan Drug designation from the Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG). In the double-blind, Phase 3 PREVAIL trial, gefurulimab significantly improved the primary endpoint of Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared with placebo at Week 26 (-4.2 and -2.6, respectively; P<0.0001) in adults with anti-acetylcholine receptor antibody-positive (AChR-Ab+) gMG.¹ In the trial, gefurulimab was self-administered via subcutaneous (SC) injection once weekly. Treatment-related adverse events were similar between gefurulimab and placebo. If approved, gefurulimab would expand the complement inhibitor treatment class for gMG, joining SC-administered zilucoplan (Zilbrysq; once-daily administration) and intravenously (IV) administered eculizumab (Soliris and biosimilars; administered every two weeks) and ravulizumab-cwvz (Ultomiris; administered every eight weeks). 

Q4 2026: orforglipron (Foundayo)

Eli Lilly submitted a supplemental New Drug Application (sNDA) for orforglipron (Foundayo), a once-daily oral nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist, for improving glycemic control in adults with type 2 diabetes mellitus (T2DM). Foundayo is currently indicated for chronic weight management in adults with obesity or overweight. In the Phase 3 ACHIEVE-1 trial, all three doses of Foundayo were superior to placebo in reducing hemoglobin A1c (HbA1c) from baseline to Week 40 by an estimated mean difference from placebo of -0.83, -1.06 and -1.07 percentage points for the 3 mg, 12 mg and 36 mg doses, respectively (P<0.001 for all comparisons).² In the Phase 3, open-label, comparison ACHIEVE-3 trial, Foundayo demonstrated superiority compared with oral semaglutide (Rybelsus) in adults with T2DM, with mean HbA1c reductions at Week 52 of 1.71% and 1.91% for Foundayo 12 mg and 36 mg doses versus 1.23% and 1.47% for Rybelsus 7 mg and 14 mg, respectively.³ Additional Phase 3 trials showed Foundayo was superior to dapagliflozin (Forxiga) in the ACHIEVE-2 trial and, when added to titrated insulin glargine (Lantus) in the ACHIEVE-5 trial, was superior to placebo for glycemic control in patients with T2DM.⁴ ⁵ If the FDA approves this new indication, Foundayo would provide a second oral GLP-1-targeted option for adults with T2DM. It could compete with oral semaglutide (Ozempic) 1.5 mg, 4 mg and 9 mg tablets, which are replacing Rybelsus 3 mg, 7 mg and 14 mg tablets. 

Q4 2026: pritelivir

Pritelivir, by Aicuris Anti-infective Cures, is under FDA Priority Review for the treatment of refractory herpes simplex virus (HSV) infections, with or without resistance, in immunocompromised patients. Pritelivir is a first-in-class, oral helicase-primase inhibitor that prevents HSV DNA replication and has received both Breakthrough Therapy and Fast Track designations. In the Phase 3, open-label, comparator-controlled PRIOH-1 trial, pritelivir was administered orally at a dose of 400 mg on Day 1, followed by 100 mg daily for up to 28 days, with treatment potentially extended up to an additional 14 days.⁶ At Day 28, complete lesion healing was achieved in 62.7% of pritelivir-treated patients compared with 34% of patients who received the standard-of-care therapy (investigator’s choice therapy [ICT] of foscarnet, cidofovir, compounded topical cidofovir or imiquimod); adjusted treatment difference was 28.4% (P=0.0047). Response rates increased with treatment through Day 42, with complete lesion healing observed in 82.4% of pritelivir-treated patients versus 42% of ICT-treated patients (adjusted treatment difference, 40.2%; P<0.0001). Pritelivir numerically shortened the median time to undetectable HSV DNA in mucocutaneous lesions to nine days compared with 21 days with ICT (P=0.0581). If approved, pritelivir would offer a new mechanism of action for treating HSV infection as an oral dosing regimen.

Q4 2026: pertuzumab (PERT-IJS)

Biocon is awaiting an FDA decision on PERT-IJS, its biosimilar candidate to Genentech’s pertuzumab (Perjeta). Pertuzumab is a human epidermal growth factor receptor 2 (HER2)/neu receptor antagonist approved to treat select adults with HER2-positive metastatic breast cancer. If approved, PERT-IJS will be the second pertuzumab biosimilar in the United States, following Henlius/Organon’s pertuzumab-dpzb (Poherdy), which was approved in November 2025 and is expected to be available in the United States in 2028. The anticipated launch of PERT-IJS, if approved, is yet to be determined. 

October 2026: aflibercept (SCD411) 

Fresenius Kabi and Sam Chun Dang Pharm are awaiting an FDA decision on SCD411, their biosimilar candidate to Regeneron’s aflibercept (Eylea). Eylea is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and retinopathy of prematurity. If approved, SCD411 will be the sixth aflibercept biosimilar FDA approved in the United States; however, only two have launched. Additional biosimilars, including SCD411, may launch in the fourth quarter of 2026. 

Oct. 10, 2026: ifinatamab deruxtecan

Daiichi Sankyo and Merck & Co.’s ifinatamab deruxtecan (I-DXd) is under Priority Review, Real-Time Oncology Review and Project Orbis review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression after platinum-based chemotherapy. Data suggest that transmembrane protein B7 homolog 3 (B7-H3) expression in small cell lung cancer is associated with larger tumor size and shorter overall survival. I-DXd is a B7-H3-directed antibody drug conjugate (ADC) that received a Breakthrough Therapy designation. The open-label, Phase 2 IDeate-Lung01 trial evaluated I-DXd, administered IV every three weeks, in adults with ES-SCLC who had received up to three prior lines of therapy, including platinum-based chemotherapy.⁷ Among patients who received I-DXd 12 mg/kg (n=137), the confirmed objective response rate (ORR) was 48.2%, the median duration of response (DOR) was 5.3 months, the median time to response was 1.4 months (range, 1–8.1), the median progression-free survival (PFS) was 4.9 months and the median overall survival (OS) was 10.3 months. If approved, I-DXd would provide an additional tool to treat patients with ES-SCLC who progress after platinum-based chemotherapy.

Oct. 26, 2026: bepirovirsen

The FDA has accepted bepirovirsen for Priority Review for the treatment of adults with chronic hepatitis B (CHB). Bepirovirsen is an antisense oligonucleotide by Ionis Pharmaceuticals and GSK designed to reduce production of hepatitis B viral RNA and hepatitis B surface antigen (HBsAg). It received Breakthrough Therapy and Fast Track designations for CHB. The replicate, double-blind, placebo-controlled, Phase 3 B-Well 1 and B-Well 2 trials evaluated bepirovirsen in adults with noncirrhotic CHB with a baseline HBsAg level of >100–3,000 IU/mL. Participants received bepirovirsen or placebo administered SC once weekly for 24 weeks, in addition to stable background nucleos(t)ide analogue (NA) therapy. NA therapy was continued for at least an additional 24 weeks.⁸ Pooled data showed that 19% of patients treated with bepirovirsen achieved a functional cure, defined as undetectable HBV DNA and undetectable HBsAg for at least 24 weeks after stopping all treatment, compared with 0% of patients who received placebo (P<0.001).⁹ The current first-line therapy for CHB consists of long-term oral NA therapy, such as entecavir (Baraclude) or tenofovir-based regimens (Vemlidy, Viread), which effectively suppress viral replication but rarely achieve functional cure and generally require indefinite treatment. If FDA approved, bepirovirsen could become the first finite-duration therapy to achieve functional cure in adults with CHB. 

Oct. 30, 2026: doruxapapogene ralaplasmid (INO-3107)

The FDA is reviewing Inovio Pharmaceutical’s INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP), a rare condition characterized by recurrent wart-like growths (papillomas) in the respiratory tract, most commonly in the larynx and vocal cords and, rarely, in the lungs. INO-3107 is a DNA immunotherapy designed to elicit human papillomavirus (HPV)-6- and HPV-11-specific T-cell responses that target and eliminate infected cells. The therapy has received Breakthrough Therapy and Orphan Drug designations for RRP. In the Phase 1/2, open-label, single-arm RRP-001 study (NCT04398433), 32 adults with HPV-6- and/or HPV-11-positive RRP and a history of at least two RRP-related surgeries in the previous year received intramuscular INO-3107 at Day 0 and Weeks 3, 6 and 9, with each dose followed by electroporation.¹⁰ At 52 weeks, 81.3% of patients achieved a clinical response, defined as at least one fewer surgical intervention in the year after treatment initiation, while 28.1% achieved a complete response, requiring no surgical procedures during the same period. Current RRP management relies primarily on repeated surgical debulking procedures (e.g., cold excision, microdebridement, pulsed dye lasers or carbon dioxide lasers) with adjuvant therapies, such as antivirals (acyclovir, ribavirin and cidofovir), bevacizumab and the Gardasil 9 HPV vaccine used off-label to delay papilloma recurrence. If approved, INO-3107 would become the second HPV-specific therapy available for RRP and the first DNA immunotherapy approved in the United States, following Precigen’s off-the-shelf, nonreplicating adenoviral vector-based immunotherapy, zopapogene imadenovec-drba (Papzimeos), which was FDA approved in August 2025. 

For more information, see Prime’s Doruxapapogene ralaplasmid (INO-3107) High-Cost Therapy Profile: February 2026. 

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