Renewed excitement over signs that RG-101, a microRNA-122 antagonist from Regulus Therapeutics Inc., could shorten the duration of several direct-acting antiviral (DAA) treatment regimens for hepatitis C virus (HCV) to as little as four weeks boosted company shares (NASDAQ:RGLS) briefly on Friday before giving way to concerns about whether the cure it delivers will persist over time, sending shares down 11 percent to close at $7.23.
Venture-backed orphan drug accelerator Cydan Development Inc. is taking on sickle cell disease (SCD) through the launch of its second new company, Imara Inc. Financed with a $31 million series A round from Cydan's syndicate, Imara will soon file an investigational new drug application for its phosphodiesterase 9 (PDE9) inhibitor, IMR-687.
Noveome Biotherapeutics Inc., of Pittsburgh, shared positive top-line safety results from three phase I trials of its multifaceted lead candidate, ST266, ahead of plans to move the cell-derived therapy into a phase II study in periodontitis this quarter.
Intellia Therapeutics Inc., a gene-editing start-up that filed for a proposed $120 million IPO on Monday, added a new partnership with Regeneron Pharmaceuticals Inc. The six-year deal, focused on discovery and development of CRISPR/Cas9-based products, carries a $75 million up-front fee for Cambridge, Mass.-based Intellia, plus a promised $50 million equity investment, potential milestone payments of up to $320 million per target and possible royalties.
STOCKHOLM – Speaking at the BIO-Europe Spring meeting in the heart of mobile communications giant Ericsson AB's Swedish headquarters complex, representatives of Merck KGaA, Abbvie Inc. and others suggested that while the platform for digital health technologies is strong in Sweden, much work remains left to be done to sort out how best to manage its technical complexities and assess its value.
STOCKHOLM – With pressures to provide ever greater value for money spilling out of Europe and into the U.S., interest in leveraging open innovation to access fresh ideas at the earliest possible moment is gaining increasing traction in all quarters of the industry, delegates at BIO-Europe said Monday.
With an FDA complete response letter in hand, Italy’s Newron Pharmaceuticals SpA is on the hook for providing the agency with a clinical evaluation of the potential abuse liability and dependence or withdrawal effects of its Parkinson’s disease (PD) candidate, Xadago (safinamide).
Top-line data showing that ferric citrate, an iron-based drug sold by Keryx Biopharmaceuticals Inc., can help certain patients with chronic kidney disease (CKD) better deal with a common complication, iron deficiency anemia (IDA), positioned the company to seek an expanded label for the drug later this year. An approval in the indication could significantly boost revenue by expanding the market for the drug, analysts said.
Positive top-line efficacy data for migraine prevention drug ALD403 pushed Alder Biopharmaceuticals Inc. shares (NASDAQ:ALDR) 50 percent higher to $25.70 by Monday market close, bolstering the company's standing in a race to bring the first calcitonin gene-related peptide (CGRP) receptor antagonist to what's expected to be a multibillion-dollar market.
