Sigilon’s SIG-007 Granted Orphan Drug Designation By FDA; Shares Pop 6%


Sigilon Therapeutics received orphan drug designation for SIG-007 by the US Food and Drug Administration (FDA) for the treatment of Fabry disease, a progressive, life-threatening lysosomal disease. Shares of the biotechnology company jumped 6% to close at $23.18 on March 5.

SIG-007 is formed of cells, which are genetically modified with a non-viral vector to express human alpha-galactosidase A, or AGAL. AGAL deficiency and the accumulation of certain substrates within a patient’s cells cause Fabry disease, leading to multi-organ failures including kidney, gastrointestinal symptoms, strokes, and heart disease at a young age.

The designation granted by the US regulator makes Sigilon (SGTX) eligible for various development incentives for SIG-007, which include tax credits for qualified clinical trials and market exclusivity in the US for seven years, following commercial approval by the FDA.

Sigilon CEO Rogerio Vivaldi commented, “This marks our third orphan drug designation, and further highlights our commitment to bringing potential functional cures to patients who suffer from chronic, rare diseases.” (See Sigilon stock analysis on TipRanks)

Notably, several investigational new drug (IND) enabling studies have been initiated by Sigilon, with a target to file four INDs within the next 12-24 months including SIG-007.

On Feb. 16, Canaccord Genuity analyst Michelle Gilson reiterated a Buy rating on the stock with a price target of $62 (167.5% upside potential). The analyst continues to view “Sigilon’s SLTx platform as highly differentiated and uniquely positioned within the cell and gene therapy space, mitigating key safety concerns emerging as gen1 technologies mature, while still offering exposure to the growing space.”

The consensus rating among analysts is a Strong Buy based on 3 Buys versus 1 Hold. The average analyst price target stands at $53.75 and implies upside potential of almost 132% to current levels over the next 12 months.

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