Company: PCRX
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001396814-25-000061
Chunk: 180

Company: Pacira BioSciences, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 8
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 FDA granted PCRX-201 a Regenerative Medicine Advanced Therapy, or RMAT, designation. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising therapies, including genetic therapies, that are intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and for which preliminary clinical evidence indicates that the drug or therapy has the potential to address an unmet medical need. RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application and other opportunities to expedite development and review. PCRX-201 is the first gene therapy product candidate to receive RMAT designation for OA. PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023.

External Innovation

In parallel to our internal clinical programs, we are pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today. We are using a combination of strategic investments, in-licensing and acquisition transactions to buildout a pipeline of innovation to improve patients’ journeys along the neural pain pathway. The strategic investments we have made to support promising early-stage platforms are summarized below:

CompanyDevelopment StageDescription of Platform TechnologyPotential Therapeutic AreasCarthroniX, Inc.Phase 1-ReadyCX-011, a small molecule modulator of gp130 formulated as an IA injection designed to slow joint degeneration by mediating IL-6 cytokinesKnee OAGenascence CorporationPhase 1bAdeno-associated virus (AAV) based gene therapy engineered to deliver Interleukin-1 Receptor Antagonist (IL-1Ra) to target cells in joint(s)Knee OASpine BioPharma, LLCPhase 3SB-01, a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1)Degenerative disc disease (DDD)

Pacira BioSciences, Inc.  |  Q1 2025 Form 10-Q  |  Page 40

Product Portfolio and Internal Pipeline

Our current product portfolio and internal product candidate