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FDA Decisions Expected: March 2026

Your monthly synopsis of new drugs expected to hit the market 

February 11, 2026

Drug pipeline for March 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 United States (U.S.) Food and Drug Administration (FDA).
1H 2026: bulevirtide 
Gilead submitted a new drug application (NDA) for bulevirtide 10 mg for the treatment of hepatitis delta virus (HDV) infection. Bulevirtide is a viral entry inhibitor. The FDA granted the agent Breakthrough Therapy and Orphan Drug designations. The Phase 3 MYR301 study evaluated bulevirtide in adults with chronic HDV. The study reported 48% of patients who received once-daily subcutaneous (SC) bulevirtide 10 mg compared to 2% of patients who received no treatment (control group) achieved the primary endpoint of a combined response at week 48 of an undetectable HDV RNA level, or a level that decreased by at least 2 log¹⁰ IU per milliliter from baseline, and normalization of the alanine aminotransferase (ALT) level.¹ Virologic suppression was maintained for nearly two years after stopping treatment in those who achieved undetectable HDV RNA.² If approved, bulevirtide will be the first medication to treat HDV infection in the United States. Of note, in 2022, the FDA issued a Complete Response Letter (CRL) for SC bulevirtide 2 mg citing concerns regarding manufacture and delivery of the product.
1H 2026: DB-OTO
DB-OTO is an investigational cell-selective, dual adeno-associated virus (AAV) vector gene therapy for the treatment of congenital hearing loss caused by variants in the otoferlin (OTOF) gene. The FDA granted DB-OTO Fast Track, Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations as well as a Commissioner’s National Priority Voucher which may shorten the FDA review timeline to about one to two months. The open-label, single-arm, Phase 1/2 CHORD trial demonstrated that nine out of 12 children with profound hearing loss due to OTOF gene variants who were treated with a single DB-OTO intracochlear infusion experienced hearing improvements at a threshold of ≤ 70 dB HL (primary endpoint) as assessed by behavioral pure tone audiometry (PTA).³ If approved, DB-OTO will be the first pharmacologic treatment for congenital hearing loss due to variants of the OTOF gene and may provide an alternative treatment to cochlear implants in patients with the condition.
 
For more information, see the DB-OTO Deep Dive in the January 2026 edition of Prime’s Quarterly Drug Pipeline.
1H 2026: tebipenem HBr
GlaxoSmithKline has resubmitted a NDA for tebipenem HBr for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. This is the second review of the product following a CRL issued by the FDA in 2022 requiring an additional clinical trial. The double-blind, Phase 3 PIVOT-PO trial demonstrated that oral tebipenem HBr (600 mg every six hours) was non-inferior to intravenous (IV) imipenem-cilastatin (500 mg every six hours), in hospitalized patients with cUTI. This was based on an overall response (composite of clinical cure plus microbiological eradication of the bacteria causing the infection) at the test of cure visit of 58.5% for tebipenem HBr compared to 60.2% for imipenem-cilastatin. Tebipenem HBr was granted Fast Track and Qualified Infectious Drug Product designations by the FDA. If approved, tebipenem HBr has the potential to be the first oral carbapenem for cUTI.  
March: insulin icodec (Awiqli)
Novo Nordisk is awaiting an FDA decision for insulin icodec for the treatment of adults with type 2 diabetes mellitus (T2DM). This is the second review of insulin icodec for T2DM after its application for type 1 and type 2 diabetes received a CRL from the FDA in July 2024. If approved, insulin icodec may be the first once-weekly basal insulin available in the United States for T2DM. In the ONWARDS clinical trial program, weekly SC administration of insulin icodec was superior to once-daily insulin glargine 100 units/mL and insulin degludec based on hemoglobin A1c (HbA1c) lowering from baseline to 26 or 52 weeks in adults with T2DM.⁵ While the incidence of significant or severe hypoglycemia was low, rates were higher with insulin icodec than its comparator insulin product in some trials. 
March 16, 2026: reproxalap
FDA extended their review timeline from December 16, 2025 to March 16, 2026 for Aldeyra’s reactive aldehyde species (RASP) modulator, reproxalap, for the treatment of dry eye disease (DED) due to the FDA requesting the Clinical Study Report (CSR) from the DED field trial. This is the third review of reproxalap for DED after the FDA issued 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. 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).⁶ 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 ophthalmic agents already available in the United States for this indication.
March 24, 2026: linerixibat
GlaxoSmithKline submitted an NDA for their ileal bile acid transporter (IBAT) linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC). Linerixibat is administered orally twice daily. It was given Orphan Drug designation by the FDA. The double-blind, Phase 3 GLISTEN trial demonstrated linerixibat significantly improved itch compared to placebo over 24 weeks, as measured on a 0-10 numerical rating scale (NRS) for the worst itch (WI-NRS) (least squares mean difference, -0.72; p=0.001). Significant improvement was seen as early as week 2.⁷ If approved, linerixibat could compete with the oral peroxisome proliferator-activated receptor (PPAR) agonists elafibranor (Iqirvo) and seladelpar (Livdelzi) as second-line therapy for cholestatic pruritus associated with PBC. 
March 28, 2026: marnetegragene autotemcel (Kresladi)
Kresladi, by Rocket Pharmaceuticals, is undergoing it’s second review by the FDA for the treatment of severe leukocyte adhesion deficiency type 1 (LAD-1). In June 2024, the FDA issued a CRL for Kresladi requesting additional Chemistry Manufacturing and Controls (CMC) information. Kresladi is a lentiviral vector (LVV) gene therapy that delivers a functional copy of the integrin subunit beta 2 (ITGB2) gene into a patient's own hematopoietic stem cells. It’s administered as a one-time IV infusion. In a global Phase 1/2 study, Kresladi demonstrated a 100% survival rate in the absence of allogeneic HSCT at least 18 months post-infusion.⁸ A significant reduction incidences of significant infections requiring hospitalization or intravenous antimicrobials was also observed. Kresladi was given Fast Track, Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations. If approved, Kresladi will be the first agent indicated for patients with LAD-1. It has the potential to be a curative option, particularly for patients without a human leukocyte antigen (HLA)-matched sibling donor. 

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References  
  1. MYR301 trial: https://www.nejm.org/doi/full/10.1056/NEJMoa2213429.
  2. Press release: https://www.businesswire.com/news/home/20250506030074/en/Final-Data-From-the-Phase-3-MYR301-Study-Demonstrated-Longer-Treatment-With-Bulevirtide-Was-Associated-With-Sustaining-Undetectability-After-Stopping-Treatment 
  3. CHORD trial: https://www.nejm.org/doi/full/10.1056/NEJMoa2400521 
  4. Press release: https://www.globenewswire.com/news-release/2025/10/21/3169930/0/en/PIVOT-PO-Phase-3-Data-Show-Tebipenem-HBr-s-Potential-as-the-First-Oral-Carbapenem-Antibiotic-for-Patients-with-Complicated-Urinary-Tract-Infections-cUTIs.html 
  5. Novo Nordisk presentation: https://cdn.ipaper.io/iPaper/Files/19499566-ce83-4ba8-9aa1-ceee7ae59206.pdf?Policy=eyJTdGF0ZW1lbnQiOlt7IlJlc291cmNlIjoiaHR0cHM6Ly9jZG4uaXBhcGVyLmlvL2lQYXBlci9GaWxlcy8qIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6eyJBV1M6RXBvY2hUaW1lIjoxODAwMTE0NjYwfX19XX0_&Signature=REbRI6iClkTBhyOi-ZJjdXZnWqknAaIIbbEuVDIUzFrfYhbSEL2OTLjQaveq8SqJIpQi0DIcXYrc2QOt32s9rANSZ4O8YSU5adJOEFpGmCBJqgAI9t4eKXZAqDD0Hwn2bKc0c58t1wvfTRLKOgTrzQSY6piJttwTIGF5FdwrU6A_&Key-Pair-Id=APKAIPGQN6BDBMBZ2LCA 
  6. 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 
  7. Press release: https://www.gsk.com/en-gb/media/press-releases/glisten-phase-iii-trial-results-show-linerixibat-significantly-improves-cholestatic-pruritus/ 
  8. Press release: https://www.businesswire.com/news/home/20240510805823/en/Rocket-Pharmaceuticals-Presents-Positive-Data-from-LV-Hematology-Portfolio-at-the-27th-Annual-Meeting-of-the-American-Society-of-Gene-and-Cell-Therapy-ASGCT