Drug Development

Protocols: Tricida bags $55M round for CKD drug; $MRK gets a ‘breakthrough’;

South San Francisco-based Tricida has brought its total fundraising to $95 million, with a new $55 million C round earmarked to fund its work on an experimental therapy for chronic kidney disease. Company CEO Gerrit Klaerner says the biotech is “on track to complete a first-in-human 100 patient phase 1/2 study of its lead compound, TRC101, in 2016, and is preparing to discuss the safety and efficacy results from the study with the FDA in a Type B meeting later this year.” Longitude Capital led the round with participation by new investor Vivo Capital and existing investors OrbiMed, Sibling Capital Ventures and Limulus Venture Partners.

Regulators on both sides of the Atlantic have put Merck’s ebola vaccine on their inside track, with a breakthrough designation from the FDA and PRIME status in Europe.

Germany’s Morphochem has won fast track status at the FDA for MCB3837, its antibacterial for Clostridium difficile infection.

San Diego-based Halozyme Therapeutics says it has resumed the enrollment and dosing of patients in its ongoing Phase Ib trial of PEGPH20 in combination with Merck’s Keytruda (pembrolizumab) in patients with advanced non-small cell lung and gastric cancers under a revised clinical protocol.

It’s Monday and we’re off and running on what looks to be a busy news week. Tips and embargoes? Send them my way ASAP. — John Carroll

 


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RAPS Regulatory Convergence 2017