Expedited Review Pathways: 82 Drugs Designated in February 2026

Updated on March 20,2026|Written by Patsnap Team

In February 2026, 82 drugs received expedited review designations across the US, EU, China, Japan, and South Korea. These designations — spanning Orphan Drug, Breakthrough Therapy, Priority Review, Fast Track, Accelerated Approval, and others — provide a forward-looking window into which programs regulators expect to have the greatest impact on unmet clinical need in the near term.

All data is sourced from Patsnap Synapse, which tracks ERP designations across all major regulatory agencies in real time.

February 2026 ERP Summary

Orphan Drug designations alone accounted for 57% of all February ERP grants. This proportion is consistent with recent historical patterns: rare disease programs have dominated expedited designation volume since the 2012 expansion of the Orphan Drug Act’s financial incentives, and AAV-based gene therapies — of which at least five received ODD in February — have added a new wave of rare disease submissions.

For an explanation of each pathway, see FDA expedited pathways explained.

Breakthrough Therapy Designations: February 2026

Breakthrough Therapy designation (BTD) is granted when preliminary clinical evidence indicates a drug may demonstrate substantial improvement over existing therapies on a clinically significant endpoint. It comes with intensive FDA guidance and rolling review — the most valuable regulatory benefit package outside Accelerated Approval.

12 drugs received BTD in February 2026. Seven were in oncology.

Notable patterns:
– China accounted for 6 of 12 BTDs — reflecting the NMPA’s maturing Breakthrough Therapy program, introduced in 2020 and rapidly adopted by domestic developers.
– KRAS mutations drove 3 designations — Calderasib (G12C), GFH-375 (G12D), and pembrolizumab in KRAS G12C+ NSCLC — making KRAS the single most active target in February’s BTD cohort.
– ADCs appeared twice — MHB088C (CD276) and Zocilurtatug pelitecan (DLL3) — confirming the ADC modality’s expansion into previously underserved targets.

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Priority Review: February 2026

Priority Review is granted when a drug addresses an unmet medical need for a serious condition. It shortens the FDA standard review timeline from 12 to 6 months following NDA/BLA submission.

The Priority Review cohort is notable for its rare disease and pediatric focus: Glycogen Storage Disease I, Niemann-Pick Type C, and Pulmonary Alveolar Proteinosis are all ultra-rare conditions.

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Fast Track Designations: February 2026

Fast Track is granted earlier in development than Breakthrough Therapy — typically based on preclinical data or early Phase 1 results — and primarily provides increased FDA interaction opportunities and rolling review eligibility.

Radiopharmaceuticals featured prominently — both a therapeutic ([²²⁵Ac]Ac-AKY-1189) and a diagnostic (99mTc-maraciclatide) received Fast Track, reflecting FDA’s growing comfort with this modality class.

Orphan Drug Designations: Themes and Highlights

The 47 Orphan Drug designations spanned a wide range of rare conditions. Key themes:

AAV gene therapies dominated rare neurological and muscular disease: NGN-401 (Rett), AAV-SGCG (Limb-Girdle MD 2C/R5), AAV-GUCY2D (retinal dystrophies), GS1191-0445 (Hemophilia A), SRN-101 (high-grade glioma) — at least 5 AAV programs received ODD.

Oncology rare cancers: Multiple ADCs, bispecific antibodies, and small molecules targeting rare or refractory cancers including SCLC (DM-005, Zocilurtatug), follicular lymphoma (BMS-986458, Surovatamig), soft tissue sarcoma (CAN-1012, Epsametostat), and pancreatic cancer (DM-002).

Autoimmune and immunological rare disease: Povetacicept (myasthenia gravis), VIS-954 (ANCA-associated vasculitis), Deupirfenidone (idiopathic pulmonary fibrosis), Rilzabrutinib (IgG4-related disease, Japan ODD).

Metabolic and enzymatic rare disease: Pariglasgene brecaparvovec (GSD I), Adrabetadex (Niemann-Pick C), Tebapivat (sickle cell anemia), Desidustat (sickle cell anemia), Nesuparib (SCLC).

Accelerated Approval and RMAT

Navepegritide received Accelerated Approval for achondroplasia — validated by surrogate endpoint (annualized height velocity) with confirmatory trials ongoing.

Pegzilarginase received Accelerated Approval for hyperargininemia — a rare urea cycle disorder caused by arginase I deficiency, with no previously approved treatment.

KB-707 (IL-12/IL-2 cytokines, Krystal Biotech) received RMAT designation for advanced NSCLC — only the second RMAT granted for a non-gene therapy advanced therapeutic product in the lung cancer space.

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Patsnap Synapse tracks every ERP designation across FDA, NMPA, EMA, PMDA, and MFDS — connected to clinical trial data, patent estates, and competitive landscapes for each drug. Explore ERP intelligence on Synapse →

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Further Reading

• Global drug approvals roundup — February 2026
• Breakthrough Therapy designations in depth — February 2026
• ADC pipeline analysis — February 2026
• FDA expedited pathways explained
• Rilzabrutinib: BTK inhibition in warm autoimmune hemolytic anemia

Data sourced from Patsnap Synapse. This post is for informational purposes only.