Kaleido sets terms for $100M IPO; Mallinckrodt touts positive PhIII GVHD data, cuts trial short
→ Microbiome drug developer Kaleido Biosciences set the terms for its IPO on Tuesday, following in the footsteps of Gossamer Bio, Harpoon Therapeutics and Stealth Bio which went public this year. The Lexington, MA-based company, which plans to list under the symbol $KLDO, is offering roughly 4.8 million shares at price range of $20 – $22 to raise about $100 million, according to an SEC filing. Kaleido was launched in 2015 out of Flagship Labs with a catalogue of microbiome metabolic therapies that has since expanded to over 1,000 candidates.
→ Mallinckrodt is wrapping a Phase III study for its photopheresis therapy Therakos after an interim analysis shows it’s exceeded expectations treating 25 pediatric patients after transplants. After four weeks, 74% of these patients with steroid refractory acute graft-versus-host disease responded to the treatment. Per the protocol, which allows for study discontinuation if the overall response rate hits 48%, that means they won’t have to enroll additional patients, the company says. Researchers reported 11 serious adverse events, leading to two withdrawals and two deaths, Mallinckrodt $MNK added, while noting that none were considered related to drug.
→ Merck’s Keytruda has racked up another priority review from the FDA — its second in a little over a week. This application covers an accelerated approval for the third-line use of the PD-1 drug in advanced small cell lung cancer, marking Merck’s first venture in the indication. The pharma giant is submitting monotherapy data from the Phase II KEYNOTE-158 and Phase Ib KEYNOTE-028 trials for the sBLA. The PDUFA date is set for June 17.