Drug pipeline for December 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).

December 2026: abatacept (DRL_AB)

Dr. Reddy’s Laboratories is awaiting an FDA decision on DRL_AB as an interchangeable biosimilar to Bristol Myers Squibb’s intravenously (IV) administered abatacept (Orencia), which is indicated for use in select patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or active psoriatic arthritis, or the prophylaxis of acute graft-versus-host disease (aGVHD); however, Dr. Reddy’s is not seeking approval for the aGVHD indication. If approved, DRL_AB will become the first FDA-approved biosimilar to Orencia in the United States, with potential availability in 2026 or 2027.

December 2026: cagrilintide/semaglutide (CagriSema)

Novo Nordisk is awaiting an FDA decision for the injectable combination of the long-acting amylin analog cagrilintide and the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide for adults with obesity or overweight and at least one weight-related comorbid condition. The combination is administered as a once-weekly subcutaneous (SC) injection at a dose of 2.4 mg cagrilintide and 2.4 mg semaglutide. If approved, CagriSema will be the second GLP-1-based medicine for weight loss with dual mechanisms of action and the first to target both GLP-1 and amylin. In the Phase 3a REDEFINE-1 trial, adults with obesity or overweight without type 2 diabetes mellitus (T2DM) experienced an estimated mean change in body weight from baseline at Week 68 of -20.4% with CagriSema, compared with -14.9% with semaglutide, -11.5% with cagrilintide and -3% with placebo (P<0.001 for CagriSema versus placebo).¹ In the Phase 3a REDEFINE 2 trial, body weight reduction among patients with obesity or overweight plus T2DM was also significantly greater with CagriSema compared with placebo at Week 68 (mean change from baseline, -13.7% versus -3.4%; P<0.001).² However, the REDEFINE-4 clinical trial failed to show that CagriSema was noninferior to weekly SC tirzepatide 15 mg based on body weight reduction at Week 84 (mean change, -23% versus -25.5%).³

For more information, see the cagrilintide/semaglutide “Deep dive” in in the October 2026 edition of Prime’s Quarterly Drug Pipeline.

December 2026: golimumab (AVT05)

Alvotech resubmitted its Biologics License Application (BLA) for AVT05, a biosimilar candidate for both SC and IV formulations of Janssen Biotech’s golimumab (Simponi [SC], Simponi Aria [IV]), after the company received a Complete Response Letter (CRL) in November 2025 based on concerns related to a manufacturing facility. Golimumab is a tumor necrosis factor (TNF) blocker. Simponi is indicated for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and ulcerative colitis (UC). Simponi Aria is approved for RA, PsA, AS and polyarticular juvenile idiopathic arthritis (pJIA). If approved, AVT05 would become the second biosimilar for Simponi and Simponi Aria, following the approval of golimumab-sldi (Immgolis, Immgolis Intri) in May 2026.

Dec. 12, 2026: imsidolimab

Vanda Pharmaceuticals is awaiting an FDA decision for imsidolimab for the treatment of generalized pustular psoriasis (GPP), a rare, potentially life-threatening autoinflammatory skin disorder characterized by recurrent flares of widespread pustules and erythema, as well as systemic symptoms like fever and fatigue. Imsidolimab is a fully humanized immunoglobulin G4 (IgG4) monoclonal antibody that inhibits interleukin-36 (IL-36) receptor signaling. It was granted FDA’s Orphan Drug designation. In the Phase 3 GEMINI-1 trial, 53% of patients who received a single IV dose of imsidolimab (300 mg or 750 mg) during a GPP flare achieved clear or almost clear skin at Week 4 compared with 13% who received placebo (P=0.023).⁴ Efficacy was maintained for up to two years in the long-term extension GEMINI-2 trial (n=42), with no flares reported in the active treatment arm during monthly imsidolimab (200 mg IV) maintenance treatment. No serious adverse events leading to withdrawal from the trial were reported, and no drug reactions with eosinophilia and systemic symptoms or Guillain–Barré syndrome cases were reported in the extension study. If approved, imsidolimab could compete with the IL-36 receptor antagonist spesolimab-sbzo (Spevigo) for GPP, with dosing regimens that include IV and/or SC administration. 

Dec. 18, 2026: tirabrutinib

Ono Pharmaceutical is seeking Accelerated Approval for tirabrutinib for the treatment of relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL), a rare and aggressive extra-nodal form of non-Hodgkin lymphoma. Tirabrutinib is a highly selective, second-generation Bruton tyrosine kinase (BTK) inhibitor. The FDA granted it a Priority Review and an Orphan Drug designation. Top-line results from the open-label, Phase 2 PROSPECT trial showed once-daily oral tirabrutinib achieved an objective response rate (ORR) of 66.7% (primary endpoint), including a complete response (CR) rate of 43.8%, at a median follow-up of 11.5 months.⁵ The median duration of response (DOR) was 9.3 months, median progression-free survival (PFS) was 6 months, median time to response was 0.95 months (range, 0.9–3.7 months) and the median overall survival (OS) was not reached. No therapies are specifically approved for PCNSL in the United States. Recommended treatment includes high-dose methotrexate-based induction therapy, often followed by consolidation with high-dose chemotherapy and autologous stem cell rescue. If approved, tirabrutinib will be the first BTK-inhibitor therapy indicated specifically for PCNSL, providing an oral, outpatient, targeted treatment option for PCNSL and an alternative to cytotoxic chemotherapy in the salvage setting.

For more information, see the tirabrutinib “Deep dive” in the October 2026 edition of Prime’s Quarterly Drug Pipeline.

Dec. 19, 2026: imlifidase

Hansa Biopharma is seeking an Accelerated Approval for imlifidase for the desensitization of highly sensitized adults undergoing deceased-donor kidney transplantation. Highly sensitive kidney transplant candidates have limited access to compatible donor organs, and desensitization approaches may include plasmapheresis, intravenous immunoglobulin (IVIG; off-label), rituximab (off-label) and corticosteroids. Imlifidase is an immunoglobulin G (IgG)-cleaving enzyme that rapidly inactivates donor-specific antibodies and has received Fast Track and Orphan Drug FDA designations. In the Phase 3, open-label, controlled ConfideS trial, highly sensitized adults (calculated panel-reactive antibodies [cPRA] ≥99.9%) and a positive crossmatch against a deceased donor were randomized to imlifidase or institution-specific desensitization.⁶ Imlifidase was administered by IV infusion within 24 hours before transplantation, with a second dose permitted if needed. At Month 12, the mean estimated glomerular filtration rate (eGFR; primary endpoint) was 51.5 mL/min/1.73 m² with imlifidase versus 19.3 mL/min/1.73 m² with control (P<0.0001). Dialysis dependence was lower with imlifidase (16% versus 56% with control; P=0.0007) and patient survival was 97% with imlifidase and 100% with control (P=1.0). No allograft losses due to rejection were reported with imlifidase. If approved, imlifidase may provide a rapid targeted desensitization option for highly sensitized patients with limited access to compatible donor kidneys.

Dec. 22, 2026: lorundrostat

Mineralys Therapeutics is awaiting an FDA decision on lorundrostat, an oral, highly selective aldosterone synthase inhibitor that lowers aldosterone production by inhibiting the enzyme CYP11B2. The investigational medication was submitted for use with other antihypertensive drugs in adults whose blood pressure is not adequately controlled. In the double-blind, Phase 3 LAUNCH-HTN trial, once daily lorundrostat reduced automated office systolic blood pressure (primary endpoint) by 16.9 mm Hg at Week 6 compared with 7.9 mm Hg with placebo, (placebo-adjusted difference, 9.1 mm Hg; P<0.001) in adults with uncontrolled or treatment-resistant hypertension taking 2–5 antihypertensive medicines.⁷ If approved, lorundrostat would be the second aldosterone synthase inhibitor, following baxdrostat (Baxfendy), for the treatment of uncontrolled hypertension in combination with other antihypertensive drugs.

Dec. 23, 2026: anitocabtagene autoleucel (anito-cel)

Gilead is awaiting an FDA decision for anito-cel, an autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy submitted for the treatment of relapsed or refractory multiple myeloma (RRMM) after at least three prior lines of therapy. Anito-cel has received Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations and is administered as a single IV infusion after lymphodepleting chemotherapy. The ongoing, open-label, Phase 2 iMMagine-1 trial reported an ORR of 96%, including a CR or stringent complete response (CR/sCR) rate of 74%, at a median follow-up of 15.9 months.⁸ PFS rates at 12, 18 and 24 months were 82.1%, 67.4% and 61.7%, respectively, while OS rates were 94%, 88% and 83%, respectively. If approved, anito-cel would be the third BCMA-directed CAR T-cell therapy indicated for RRMM. Unlike ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma), which are approved for use in earlier lines of therapy, anito-cel was submitted for patients who had received at least three prior lines of therapy. Anito-cel utilizes a compact D-domain binder to target BCMA on the tumor cells rather than the single-chain variable fragment binders used in other BCMA-directed CAR T-cell therapies. The clinical significance relative to other BCMA-directed CAR T-cell therapies is not yet known. Anito-cel has not been evaluated against these therapies in head-to-head trials.

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

Dec. 27, 2026: relutrigine

Relutrigine is a next-generation sodium channel modulator by Praxis Precision Medicines designed to selectivity target the hyperexcitability state of sodium channels that cause seizures in SCN2A and SCN8A developmental and epileptic encephalopathy (DEE), which are rare, severe forms of epilepsy usually beginning in early childhood. Conditions associated with potential SCN2A or SCN8A gene involvement include early myoclonic encephalopathy (also known as Ohtahara syndrome), epilepsy in infancy with migrating focal seizures, and myoclonic atonic epilepsy (Doose syndrome). Anti-seizure medicines are the mainstay of pharmacologic treatment; however, treatment resistance is common. If approved, relutrigine would be the first targeted therapy for DEEs with SCN2A and SCN8A variants. It received Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations, as well as a Priority Review from the FDA. In the Phase 2/3 EMBOLD trial, patients receiving once-daily oral relutrigine 1 mg/kg experienced a 53% placebo-adjusted reduction in seizures over 16 weeks (P<0.0002) during the double-blind treatment period.⁹

For more information, see the relutrigine “Deep dive” in in the July 2026 edition of Prime’s Quarterly Drug Pipeline.

Dec. 30, 2026: sodium dichloroacetate (SL1009)

Saol Therapeutics is awaiting an FDA decision on SL1009 for the treatment of patients with pyruvate dehydrogenase complex deficiency (PDCD), an ultra-rare, life-threatening mitochondrial disease associated with neurologic manifestations (e.g., abnormal brain imaging, hypotonia, seizures, ataxia) and metabolic abnormalities (e.g., increased plasma pyruvate, lactic acidemia, metabolic acidosis). SL1009 is an oral pyruvate analog that inhibits pyruvate dehydrogenase kinase. The drug received a Priority Review, as well as Orphan Drug and Rare Pediatric Disease designations. This is the second FDA review for SL1009, following a CRL issued in August 2025 in which the FDA recommended additional survival analyses to support the NDA; no safety concerns were identified. In response to the CRL, Saol submitted additional analyses, including data on functional and survival benefits, mechanism of action and safety. Updated data from the pivotal Phase 3 trial (NCT02616484) reports that, while the primary efficacy endpoint of Observer Reported Outcome (ObsRO) survey did not demonstrate statistical significance with four months of treatment (P=0.512), longer-term treatment — including the open-label extension — resulted in a statistically significant improvement in motor function in the intent-to-treat population (P=0.002).¹⁰ In addition, SL1009 significantly decreased plasma lactate concentrations (mean change relative to placebo, -0.48 mmol/L [-20%], P=0.006). In a separate analysis, SL1009-treated patients had improved survival (log-rank P=0.027) compared with a natural-history cohort. If approved, SL1009 will be the first pharmacologic treatment for PDCD. Current therapies are supportive and include ketogenic diet and cofactor supplementation (e.g., thiamine). 

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References

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6. Montgomery, R. A., & Maldonado, A. (2026). Superior 1-year eGFR among highly sensitized patients desensitized with imlifidase compared to control. American Journal of Transplantation, 26(Suppl. 1), S268. https://doi.org/10.1016/j.ajt.2026.05.239 
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8. Gilead Sciences. (2025, December 6). Kite announces new data for pivotal iMMagine-1 study at ASH 2025, highlighting anito-cel’s opportunity in relapsed or refractory multiple myeloma. https://investors.gilead.com/news/news-details/2025/Kite-Announces-New-Data-for-Pivotal-iMMagine-1-Study-at-ASH-2025-Highlighting-Anito-cels-Opportunity-in-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx 
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