Benefit for patients with disease that has spread to the brain put a special shine on top-line data rolled out by Seattle Genetics Inc. (Seagen) from the HER2Climb study, an experiment to test the oral small-molecule tyrosine kinase inhibitor (TKI) tucatinib, designed as highly selective for HER2 without significantly knocking down EGFR.
PARIS – Clinatec Research Center, of Grenoble, France, is heralding the publication of results from its Brain Computer Interface (BCI) Exoskeleton clinical trial in the journal Lancet Neurology. Its semi-invasive medical device, Wimagine, has enabled a quadriplegic patient to move by transmitting signals emitted by his brain to an exoskeleton. This is the first proof of concept for control of a four-limb exoskeleton by a neuroprosthesis.
The pipeline shift made public Thursday by Syros Pharmaceuticals Inc. may have been presaged by analysts, who in August sounded lukewarm about the Cambridge, Mass.-based firm's prospects as they stood then.
Israel's Protalix Biotherapeutics Inc., the first company to gain FDA approval for a protein therapy produced by plant cell cultures in 2012, has moved one step closer to seeking FDA approval for a second such product with new phase III data supporting its experimental therapy for Fabry disease.
Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia.
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma.
HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN). But, while the Seoul-based company, formerly known as Viromed, said VM-202 met the primary safety and secondary efficacy endpoints for a DPN therapy at 12 months, investors are doubting that the results are trustworthy.
Top-line data from Relmada Therapeutics Inc.'s phase II study of REL-1017 (dextromethadone) in patients with treatment-resistant depression caused the stock to more than double Tuesday, a great day on the market.
Reata Pharmaceuticals Inc.'s surprise victory in the pivotal, second part of the phase II study called Moxie with Nrf2 activator omaveloxolone in patients with Friedreich's ataxia (FA) energized Wall Street and sharpened appetites for data due shortly with another candidate in the class, bardoxolone methyl, in the works for Alport syndrome (AS).