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FDA Decisions Expected: December 2025

Your monthly synopsis of new drugs expected to hit the market 

November 18, 2025

Drug pipeline for December 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).
Dec. 5, 2025: lisocabtagene maraleucel (Breyanzi) 
The CD19-directed chimeric antigen receptor T cell (CAR T) immunotherapy Breyanzi is undergoing an FDA Priority Review for a new indication for the treatment of relapsed or refractory marginal zone lymphoma (MZL) in patients who have received at least two prior lines of systemic therapy. The submission for MZL is supported by data from the MZL cohort in the Phase 2, open-label, single-arm TRANSCEND FL trial that reported an overall response rate (ORR) of 95.5% (p<0.0001), with a 62.1% complete response (CR) (p<0.0001) any time up to 60 months after Breyanzi treatment.¹ At 24 months, the rates for progression-free survival (PFS) and overall survival (OS) were 85.7% and 90.4%, respectively. If approved, Breyanzi will be the first CAR T-therapy in the United States indicated for MZL. 
Dec. 12, 2025: lerodalcibep 
Lerodalcibep is an adnectin-based, third-generation proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor by LIB Therapeutics. It was submitted to the FDA with a proposed indication to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) and those at least 10 years of age with homozygous familial hypercholesterolemia (HoFH). The LIBerate clinical trial program demonstrated that lerodalcibep resulted in significant reductions in LDL-C compared to placebo in patients with ASCVD or at very high or high risk for ASCVD, including HeFH, who were on stable maximally tolerated statin therapy.¹⁶ Notably, lerodalcibep also resulted in greater LDL-C reduction compared to inclisiran (Leqvio) in patients with or at very high risk for ASCVD on high intensity statin therapy (p=0.032).¹⁷ However, lerodalcibeb did not demonstrate non-inferiority compared to evolocumab based on LDL-C reduction in patients with HoFH.¹⁸ If approved, lerodalcibep could compete with existing PCSK9-targeted agents, inclisiran (Leqvio), alirocumab (Praluent) and evolocumab (Repatha) as add-on therapy to reduce LDL-C in select patients. Lerodalcibep is self-administered every four weeks via subcutaneous (SC) injection. 

For more information, see the lerodalcibep Deep Dive in the October 2025 edition of Prime’s Quarterly Drug Pipeline. 
Dec. 15, 2025: zoliflodacin 
The FDA granted a Priority Review for zoliflodacin, a first-in-class, spiropyrimidinetrione oral antibiotic by Innoviva, for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. Zoliflodacin was also granted a Qualified Infectious Disease Product (QIDP) designation. In vitro studies revealed zoliflodacin had activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. A Phase 3, open label, randomized controlled trial (NCT03959527) demonstrated that a single oral dose of zoliflodacin 3g was non-inferior to the globally recognized standard of care (SOC) regimen (a single dose of ceftriaxone 500mg intramuscular [IM] plus oral azithromycin 1g).² In the micro-intent-to-treat (micro-ITT) population (n=744), zoliflodacin achieved a 90.9% microbiological cure rate at the urogenital site (primary endpoint) compared to 96.2% with the SOC regimen (difference, 5.3%). If approved, zoliflodacin will provide a single oral dose option for patients with uncomplicated gonorrhea.  
Dec. 16, 2025: depemokimab 
GlaxoSmithKline submitted an ultra-long-acting anti-interleukin-5 (IL-5) monoclonal antibody, depemokimab, for the treatment as add-on maintenance treatment of (1) asthma with type 2 inflammation characterized by an eosinophilic phenotype in patients 12 years and older and (2) chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. Pooled data from the SWIFT-1 and SWIFT-2 trials demonstrated that depemokimab led to a 54% reduction in the annualized exacerbation rate (AER) compared to placebo in patients 12 years and older with asthma.¹⁴ In addition, pooled data from the ANCHOR-1 and ANCHOR-2 trials showed statistically significant improvements with depemokimab compared to placebo in the coprimary endpoints of total nasal polyps score at 52 weeks (treatment difference, -0.7; nominal p<0.001) and mean nasal obstruction verbal response scale (VRS) score over weeks 49–52 (treatment difference, -0.24; nominal p=0.003).¹⁵ In clinical trials depemokimab was administered SC every six months. There is potential for depemokimab to be self-administered using an auto-injector. If approved, depemokimab will compete with the current biologic agents for the treatment of severe asthma (eosinophilic phenotype) and for the treatment of CRSwNP. 

For more information, see the depemokimab Deep Dive in the October 2025 edition of Prime’s Quarterly Drug Pipeline. 
Dec. 16, 2026: reproxalap 
Aldeyra is awaiting FDA decision on reproxalap, a reactive aldehyde species (RASP) modulator for the treatment of dry eye disease (DED). This is the third review of reproxalap for DED after the FDA issued Complete Response Letters (CRLs) in November 2023 and April 2025 requesting additional clinical trials to demonstrate efficacy. A double-masked, vehicle-controlled, Phase 3 trial (NCT06493604; n=116) was conducted to satisfy the latest CRL request.³ In the trial, reproxalap topical ophthalmic solution was administered six times over two consecutive days and was found to be statistically superior to vehicle based on the primary endpoint of ocular discomfort symptom score (0–100) from 80 to 100 minutes after chamber entry (least square mean [LSM] difference, 6.5; p=0.002). Reproxalap is intended for chronic use. If approved, it will be the first RASP modulator for the treatment of DED and will compete with other topical ophthalmics already on the market for this indication. 
Dec. 26, 2026: aficamten 
Aficamten is a selective cardiac myosin inhibitor (CMI) by Cytokinetics that reduces cardiac muscle contractility. It was submitted to the FDA for the treatment of obstructive hypertrophic cardiomyopathy (HCM). Aficamten received Breakthrough Therapy and Orphan Drug designations from the FDA. The 24-week, Phase 3 SEQUOIA-HCM trial demonstrated aficamten significantly improved exercise capacity compared to placebo.⁴ Aficamten increased peak oxygen uptake (pVO₂) measured by cardiopulmonary exercise testing (CPET) by 1.8 mL/kg/min compared to baseline (LSM difference from placebo, 1.74 mL/kg/min; p=0.000002) as add-on to background therapy. The double-blind, active-comparator MAPLE-HCM trial revealed aficamten monotherapy improved the primary endpoint of exercise capacity (LSM difference in pVO₂, 2.3 mL/kg/minute; p<0.001) at 24 weeks compared to metoprol and met superiority criteria.⁵ Secondary endpoints revealed aficamten decreased resting LVOT-G (-30 mm Hg), Valsalva left ventricular outflow tract gradients (LVOT-G) (-35 mm Hg) and left atrial volume index (-7 mL/m²) (all p<0.001).⁶ Long-term treatment with aficamten did not appear to increase the risk of heart failure.⁷ In clinical trials, aficamten was administered orally once daily. If approved, it will be the second CMI medication for obstructive HCM, following mavacamten (Camzyos). While Camzyos’ label includes a boxed warning regarding a risk of heart failure, it is uncertain if aficamten label will carry the same warning. 
Dec. 26, 2026: narsoplimab 
Omeros resubmitted narsoplimab to the FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).This is the second FDA review of narsoplimab after the agency issued a CRL in 2021 requiring additional efficacy data. The FDA has granted Breakthrough Therapy and Orphan Drug designations for narsoplimab. The investigational product is a human monoclonal antibody that inhibits mannan-binding lectin-associated serine protease-2 (MASP-2). The Phase 2 single-arm, dose-escalation cohort OMS721-TMA-001 trial demonstrated a statistically significant improvement in OS (secondary endpoint), in previously untreated, high-risk adults with TA-TMA (n=28) who received narsoplimab compared to those who did not receive narsoplimab in an external control registry (n=121) (hazard ratio [HR], 0.32; p<0.00001).⁸ In addition, data from the narsoplimab expanded access program (EAP) reported one-year OS in pediatric (ages < 16 years) allogeneic recipients with high-risk TA-TMA was 75% among patients who received narsoplimab as first-line therapy (n=12) and 56.2% in those who received narsoplimab as second-line therapy (n = 25).⁹ The one-year OS in adult allogeneic recipients with HR TA-TMA was 58% in those who received first-line narsoplimab therapy (n=49) and 40.5% in those who received second-line narsoplimab (n=16). In clinical trials, narsoplimab was administered intravenously once weekly for up to eight weeks. Initially, the FDA decision for narsoplimab was expected by Sept. 26. 2025; however, the FDA extended the date to Dec. 26, 2025 due to a request by the agency for additional information. If approved, narsoplimab will be the first medication indicated for TA-TMA, which is currently treated with plasma exchange, dialysis and transfusion. 
Dec. 27, 2026: fibrinogen (BT-524) 
Grifols is awaiting FDA decision for their fibrinogen concentrate, BT-524, for supplementation in patients with acquired fibrinogen deficiency and for treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency. The partially blinded, Phase 3 AdFIrst trial demonstrated non-inferiority of BT-524 compared to fresh frozen plasma (FFP) or cryoprecipitate (Cryo) as first-line treatment in adults with major bleeding during major orthopedic or abdominal surgery, respectively.¹⁰ The study reported the LSM intraoperative blood loss was 1,381 mL in the BT-524 group and 1,660 mL in the FFP/Cryo group (LSM difference, -279 mL; p<0.0001). In addition, a single-arm, Phase 3 trial (NCT02065882, n=27) evaluated on-demand use of BT-524 for treatment or prophylaxis of bleeding events in patients with congenital fibrinogen deficiency.¹¹ Topline results reported the maximum clot firmness (MCF) was significantly increased one hour after the BT-524 intravenous infusion (mean change 11.1 mm; p<0.0001) in adults. Similarly, the mean MCF increase across pediatric groups ranged from 9.3 to 16.5 mm. The increase in MCF was sustained for eight hours. If approved, BT524 will compete with Fibryga (Octapharma) as the second fibrinogen concentrate for fibrinogen replacement in patients with congenital and acquired fibrinogen deficiency. 
Dec. 28, 2026: tolebrutinib 
The FDA granted a Priority Review and Breakthrough Therapy designation to tolebrutinib, by Sanofi, to treat non-relapsing secondary progressive multiple sclerosis (SPMS) and to slow disability accumulation independent of relapse activity. Tolebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor that crosses the blood-brain barrier. In the double-blind, Phase 3 HERCULES trial in patients with non-relapsing SPMS, tolebrutinib was associated with a 31% risk reduction in six-month confirmed disability progression compared to placebo (p=0.0026).¹² In the clinical trial, tolebrutinib was administered orally once daily. If approved, tolebrutinib will be the first BTK inhibitor for the treatment of MS and the first therapy specifically approved for non-relapsing SPMS. 

For more information, see the tolebrutinib Deep Dive in the July 2025 edition of Prime’s Quarterly Drug Pipeline. 
Dec. 30, 2026: relacorilant 
Corcept is awaiting FDA decision for their selective glucocorticoid receptor (GR) modulator relacorilant. The orphan drug was evaluated in the two-part, Phase 3 GRACE trial in adults with endogenous Cushing syndrome and uncontrolled hypertension and/or hyperglycemia. At 22 weeks, once-daily oral relacorilant led to significant improvements in systolic and diastolic blood pressure (LSM change in SBP and DBP, -7.9 and -5.1 mm Hg, respectively; p<0.0001 for both) in patients with hypertension and significant improvement from baseline in glucose metabolism (LSM change in glucose area under the curve, -2.7 h*mmol/L, p<0.0001) in patients with hyperglycemia. If approved, relacorilant may be an alternative to once-daily mifepristone to normalize cortisol action in patients with Cushing syndrome. Relacorilant differentiates itself from mifepristone, particularly in females, as it has no affinity for the progesterone receptor; therefore, it does not cause antiprogesterone side effects including endometrial hypertrophy, irregular vaginal bleeding and risk of pregnancy termination. 

For more information, see the relacorilant Deep Dive in the July 2025 edition of Prime’s Quarterly Drug Pipeline. 
Dec. 30, 2026: tradipitant 
Vanda’s neurokinin receptor 1 (NK-1R) antagonist tradipitant was submitted to the FDA for treatment of motion sickness. Oral doses of tradipitant 85 mg and 170 mg were evaluated in two randomized, placebo-controlled, Phase 3 trials (NCT04327661, NCT05903924) in patients with a history of motion sickness. Study doses were administered one hour prior to departure on multiple four-hour coastal water boat trips.¹³ Both studies reported significantly lower incidence of vomiting with tradipitant 85 mg (19.5%; 18.3%) and tradipitant 170 mg (18.3%; 10.4%) compared to placebo (44.3%; 37.7%). If approved, tradipitant will compete with currently available agents for motion sickness, including scopolamine and first-generation antihistamines. Of note, Vanda submitted a separate application for tradipitant to the FDA in 2023 seeking an indication for the treatment of gastroparesis symptoms; however, the FDA issued a CRL requesting additional gastroparesis studies. 

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References  
  1. Press release: https://www.businesswire.com/news/home/20250613870408/en/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel 
  2. Press release: https://www.businesswire.com/news/home/20240424323555/en/Innoviva-Specialty-Therapeutics-Positive-Phase-3-Oral-Zoliflodacin-Data-for-the-Treatment-of-Uncomplicated-Gonorrhea-Announced-at-ESCMID-Global-2024 
  3. Press release: https://www.businesswire.com/news/home/20250506374075/en/Aldeyra-Therapeutics-Achieves-Primary-Endpoint-in-Phase-3-Dry-Eye-Disease-Chamber-Trial-of-Reproxalap-and-Plans-NDA-Resubmission 
  4. Press release: https://www.globenewswire.com/news-release/2024/12/02/2989688/35409/en/Cytokinetics-Announces-FDA-Acceptance-of-New-Drug-Application-for-Aficamten-for-the-Treatment-of-Obstructive-Hypertrophic-Cardiomyopathy.html 
  5. MAPLE-HCM trial: https://www.nejm.org/doi/full/10.1056/NEJMoa2504654 
  6. MAPLE-HCM trial: https://pubmed.ncbi.nlm.nih.gov/40932433/ 
  7. Press release: https://www.globenewswire.com/news-release/2025/08/31/3141927/35409/en/Cytokinetics-Presents-New-Data-Related-to-Aficamten-at-the-European-Society-of-Cardiology-Congress-2025.html 
  8. Press release: https://www.businesswire.com/news/home/20250220420439/en/Omeros-Announces-Robust-Results-for-Narsoplimab-Expanded-Access-Program-in-TA-TMA 
  9. Journal abstract: https://onlinelibrary.wiley.com/doi/10.1002/ajh.70044 
  10. AdFIrst trial: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00196-8/fulltext 
  11. American Society of Hematology abstract 1221: https://ash.confex.com/ash/2024/webprogram/Paper198116.html 
  12. HERCULES trial: https://www.nejm.org/doi/full/10.1056/NEJMoa2415988 
  13. Investor presentation: https://www.vandapharma.com/pdfs/vanda_corporate_presentation_sept_25.pdf 
  14. SWIFT-1 and SWIFT-2: https://www.nejm.org/doi/full/10.1056/NEJMoa2406673 
  15. ANCHOR-1 and ANCHOR-2: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00197-7/abstract 
  16. Press release: https://www.businesswire.com/news/home/20250506664509/en/LIB-Therapeutics-Announces-Key-Results-from-Presentations-at-2025-European-Atherosclerosis-Society-Meeting-in-Glasgow-May-5-6 
  17. Press release: https://www.businesswire.com/news/home/20240529904905/en/LIB-Therapeutics-Announces-Positive-Lerodalcibep-Results-from-Two-Phase-3-LIBerate-Studies-at-the-92nd-European-Atherosclerosis-Society-Congress 
  18. LIBerate-HoFH: https://pubmed.ncbi.nlm.nih.gov/39870096/ 
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