Eledon Pharma Stock Jumps Despite FDA Asking For Additional Preclinical Study In Non-Primate Animal Models
- As part of ongoing discussions with the FDA regarding Eledon Pharmaceuticals Inc's (NASDAQ: ELDN) AT-1501 renal transplant program, the agency has requested AT-1501 specific renal transplant data in non-human primates before starting a Phase 2 trial in renal transplantation in the U.S.
- Hence, Eledon plans to initiate an evaluation of AT-1501 in a standard non-human primate model of renal transplantation, which is expected to be completed by late 2022.
- No significant drug-related safety signals with AT-1501 have been identified to date. This change in development strategy is not due to any specific event or data, the company said.
- AT-1501, the company's lead candidate, is an anti-CD40L antibody with a high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential.
- AT-1501 is a humanized IgG1 antibody engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches.
- SVB Leerink analyst Thomas Smith maintains Eledon's Outperform rating and lowers the price target from $34 to $33.
- Price Action: ELDN shares are up 7.1% at $11.48 in the premarket trading on the last check Tuesday.
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