Urovant Sciences Ltd., an offshoot of Roivant Sciences Ltd., has kicked off a global phase III trial to evaluate vibegron, an oral beta 3-adrenergic agonist, in adults with symptoms of overactive bladder (OAB). Top-line data from the trial, called Empowur, are expected in 2019. The drug could potentially help millions of people for whom first-line behavioral therapies have fallen short. However, it is likely to face considerable headwinds, too.
Despite positive new pivotal data supporting its migraine treatment candidate, rimegepant, Biohaven Pharmaceutical Holding Co. Ltd. saw its shares (NYSE:BHVN) touch an all-time low Monday as investors fretted over the program's competitive stance in the crowded class of calcitonin gene-related peptide (CGRP) receptor antagonism. By day's end, the candidate's success in meeting the trials' co-primary endpoints appeared to soften the blow, leaving shares just 7.3 percent lower at $22.96.
NMD Pharma A/S, a Danish biotech developing therapies for severe neuromuscular disorders, has landed a €38 million (US$46.9 million) series A financing. Proceeds from the round are expected to back proof-of-concept studies for an oral therapy targeting the orphan neuromuscular disorder myasthenia gravis and, in the critical care setting, an I.V. therapy for the reversal of muscular blockade in connection with surgery. The studies are expected to take three to five years to complete.
TOKYO – Japan's new accelerated regulatory framework for regenerative medicines has made the time right for U.S. cell therapy specialist Athersys Inc. and its Tokyo-based partner, Healios K.K., "to run a little bit faster," Athersys CEO Gil Van Bokkelen told BioWorld Asia during the 15th BIO Asia International Conference. Jumpstarting the race, Healios is making a $21.1 million equity investment in Athersys and is expected to soon license Multistem, Athersys' allogeneic stem cell product, for multiple indications in Japan.
TOKYO - Following more than a decade of mostly steady progress on Japan's drug regulation and business development fronts, dangers to well-compensated therapeutic innovation are creeping ever-forward in the important Asian market, industry representatives warned.
TOKYO – Japan's new accelerated regulatory framework for regenerative medicines has made the time right for U.S. cell therapy specialist Athersys Inc. and its Tokyo-based partner, Healios K.K., "to run a little bit faster," Athersys CEO Gil Van Bokkelen told BioWorld during the 15th BIO Asia International Conference. Jumpstarting the race, Healios is making a $21.1 million equity investment in Athersys and is expected to soon license Multistem, Athersys' allogeneic stem cell product, for multiple indications in Japan.
TOKYO - Following more than a decade of mostly steady progress on Japan's drug regulation and business development fronts, dangers to well-compensated therapeutic innovation are creeping ever-forward in the important Asian market, industry representatives warned.
A partial restriction on tests of an experimental and well-financed gene therapy for Duchenne muscular dystrophy (DMD) gave way to a full FDA clinical hold following a serious adverse reaction in the first patient dosed. The boy has since recovered. But shares of Solid Biosciences Inc. (NASDAQ:SLDB), which raised $133.7 million in a January IPO despite a then-partial hold on the candidate, SGT-001, fell 64.6 percent to $9.32 by Thursday's close.
Foghorn Therapeutics Inc., a Cambridge, Mass.-based startup devoted to developing new cancer drugs that exploit the chromatin regulatory system to direct gene expression, has launched with an initial capital commitment of $50 million from Flagship Pioneering, the 17-year-old venture firm previously known as Flagship Ventures.
A new joint development program testing Eisai Co. Ltd.'s Lenvima (lenvatinib mesylate), an oral tyrosine kinase inhibitor, both alone and together with Merck & Co. Inc.'s anti-PD-1 therapy, Keytruda (pembrolizumab), across a dozen cancers could yield a multibillion-dollar payout for the Tokyo-based company while opening up new markets for both partners. The far-reaching deal completes a triplet of immuno-oncology-focused bets by Merck following earlier tie-ups with Astrazeneca plc last year and Ablynx NV in 2015.
