Tenaya Therapeutics Inc. CEO Faraz Ali told BioWorld that the company, which raised $92 million in a series B round, has programs from three cardiac platforms "stacked on top of each other" and wants to enter the clinic by the end of 2021 "with at least one of the multiple projects we're advancing." The South San Francisco-based firm wanted not to "let resources be the barrier" as to which goes first, he said. "We wanted the science to dictate that."
Elicio Therapeutics Inc. CEO Robert Connelly acknowledged "a general malaise about cancer vaccines," but described the strategy of his firm to BioWorld as "very different. None of these other approaches [has] delivered the goods to the lymph nodes, where the immune response is orchestrated."
Minerva Neurosciences Inc. CEO Rémy Luthringer said his firm knew about the cyberattack on a contractor helping with the roluperidone phase III trial in schizophrenia "toward the end of the summer," when "the provider was trying to solve the problem" and ultimately did. But the attack still meant an enrollment delay, and Wall Street reacted accordingly. Despite imminent, possibly transforming data in major depressive disorder (MDD), investors pushed Minerva shares (NASDAQ:NERV) down $2.04, or 26.3%, Tuesday to close at $5.71.
Wall Street will have to wait until the American Heart Association (AHA) meeting next month in Philadelphia for full data from Resverlogix Inc.'s phase III BETonMACE trial with apabetalone, but disclosure of the endpoint miss was enough to send investors fleeing.
Aravive Inc.'s chief medical officer, Gail McIntyre, told BioWorld that a "very clever mechanism" designed by researchers at Stanford University helped lead to positive data from the first 12 patients of the ongoing phase Ib part of the phase Ib/II experiment with AVB-500 against notoriously hard-to-beat ovarian cancer.
Proteon Therapeutics Inc.'s inventorying of options after the phase III failure with vonapanitase in chronic kidney disease (CKD) ended in a merger deal with Artara Therapeutics Inc., a startup that has hung its main hat on TARA-002, a therapy for lymphatic malformations (also called lymphangiomas) that has already gained validation by way of a similar product in Japan.
Investor-pleasing news from the FDA regarding Dublin-based Avadel Pharmaceuticals plc's pivotal phase III trial testing once-nightly sodium oxybate (FT-218) for narcolepsy sparked Wall Street speculation regarding what the update might mean for Jazz Pharmaceuticals plc, also of Dublin, which markets twice-nightly Xyrem (sodium oxybate) in the space.
Bagsvaerd, Denmark-based Novo Nordisk A/S' chief medical officer, Todd Hobbs, told BioWorld it "won't be too much longer" – probably a week or so – before the firm sets pricing of oral once-daily Rybelsus (semaglutide) in type 2 diabetes, approved Friday thanks to a priority review voucher that guaranteed a greased path for the first non-injected glucagon-like peptide (GLP-1) receptor protein therapy.
During its second-quarter earnings report, Cambridge, Mass.-based TCR2 Therapeutics Inc. touted the start of a phase I/II trial with TC-210 to treat patients with mesothelin-positive tumors of various types, and interest continues to grow in the company's approach.
With the NDA target date of October approaching for roxadustat, Fibrogen Inc.'s hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for anemia in chronic kidney disease (CKD), watchers of the space are handicapping the prospects for competitor Akebia Therapeutics Inc., developing vadadustat in the same class.