Shares of Tenax Therapeutics Inc. (NASDAQ:TENX) fell 76.4 percent to 46 cents by Tuesday's close on news that its lead candidate, levosimendan, failed to meet the co-primary endpoints of a phase III study evaluating its potential for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS), an indication for which it had been granted FDA fast track status.
Despite a 22 percent decline in Biogen Inc.’s fourth-quarter income, attributable mostly to its recent settlement with Forward Pharma A/S, company shares (NASDAQ:BIIB) climbed 2 percent to $278.89 on Thursday after the company delivered 2017 guidance largely in line with analyst expectations and news that its launch of spinal muscular atrophy (SMA) drug Spinraza (nusinersen) was progressing, though more slowly than hoped amid insurer pushback.
Seattle-based Neovia Oncology Ltd. has enrolled its first patient into a phase I dose-escalation study of intravenous NEV-801, a combination of the natural products podofilox and camptothecin that inhibits topoisomerase I and II and is intended to enhance immunotherapy response in patients with advanced drug-resistant cancers.
An adenoviral gene delivery technology developed by Genvec Inc. has drawn active synthetic biology player Intrexon Corp. to acquire the company in a stock exchange Intrexon valued at about $7 per share, or about $19.4 million. The deal gives Genvec's Adenoverse technology a new role in Intrexon's drug product manufacturing platform.
The acquisition of two partner-ready nanoparticle cancer candidates developed by Azaya Therapeutics Inc. and an associated nanotech platform could yield potential near-term revenue for Cytori Therapeutics Inc. as well as further-afield promise in the use of Azaya’s nanoparticle liposomal technology for the delivery of targeted regenerative therapies to sites of acute or chronic injury, the company said.
Takeda Pharmaceutical Co. Ltd. and Ovid Therapeutics Inc. have agreed to jointly develop and commercialize Takeda's TAK-935 in rare pediatric epilepsies, splitting costs and potential profits 50-50.
Takeda Pharmaceutical Co. Ltd. is leading a $125 million investment in Maverick Therapeutics Inc., a company founded with initial financing from MPM Capital that is working to improve the utility of T-cell redirection therapy for the treatment of cancer. The financing, encompassing both equity investment and R&D funding, provides Takeda an exclusive option to buy the company after five years for an undisclosed amount.
Concert Pharmaceuticals Inc. said in order to support dose selection for a future phase III trial of CTP-656 in cystic fibrosis (CF), the FDA will require its ongoing phase II trial to institute a washout period during which Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) treatment would be withheld – potentially a hard ask for patients meeting the study's screening criteria of having been on at least three months of stable Kalydeco therapy.
Curevac AG's mRNA-based prostate cancer vaccine CV9104, long its lead candidate, failed to meet the primary endpoint of improving overall survival during a phase IIb trial. Progression-free survival in treated patients was similar to those in the placebo arm.
