Iroko withdraws IPO

Iroko Pharmaceuticals LLC (Philadelphia, Pa.) withdrew its planned IPO, which the company first proposed in June. Iroko said it received "significant interest from the investment community" but said the timing of the IPO "may not be optimal and in the best interest of the company." Earlier this month, Iroko had amended its IPO and said it planned to sell 6.5 million shares at $14-$17. At the $15.50 midpoint, the company would have raised $100.8 million and been valued at $492.2 million.

FDA is reviewing NDAs from Iroko for Tiforbex submicron indomethacin to treat acute pain in adults and Zorvolex submicron diclofenac to treat mild to moderate acute pain in adults. Zorvolex is a submicron formulation of the NSAID diclofenac, and Tiforbex is a submicron formulation of the NSAID indomethacin. Both use SoluMatrix nanoformulation technology from iCeutica Inc. (Philadelphia, Pa.). Iroko is seeking approval of the products under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. The PDUFA dates are not disclosed. ...