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.

BOSTON – Panelists at Biopharm America debated strategies for early stage financing as they weighed the importance of a prestigious board, the wisdom of small deals by startups with pharma firms, and the likelihood (or not) that angel investors will help make the case with other backers yet to come.

BOSTON – The gut microbiome and its prospects for drug development have been matters of debate for a while, sharpened by the high-profile phase II failure of Seres Therapeutics Inc.'s candidate, SER-109, in the summer of 2016. A panel at Biopharm America surveyed the space in light of developments since the stumble with that candidate, composed of about 50 species of firmicutes spores derived from stool specimens from healthy donors, against recurrent Clostridium difficile infection.