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.

The Cushing's syndrome market is heating up with three second-generation drugs in late-stage development to join the two approved medications, Signifor (pasireotide, Recordati SpA) and Korlym (mifepristone, Corcept Therapeutics Inc.), as well as a couple of off-label options.

Abbott Laboratories had a busy Transcatheter Cardiovascular Therapeutics (TCT) 2019 conference. Among the news it generated was the unveiling of new analyses of the COAPT trial on the cost-effectiveness of Mitraclip vs. guideline-directed medical therapy (GDMT) alone in heart failure patients with secondary mitral regurgitation (MR).

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.

Shares of Seattle Genetics Inc. (NASDAQ:SGEN) rose 12.4% to $85.40 on news that an antibody-drug conjugate (ADC) it is developing with Tokyo-based Astellas Pharma Inc., when combined with Keytruda (pembrolizumab, Merck & Co. Inc.), shrank tumors in the majority of people participating in a phase I first-line bladder cancer study.

SAN FRANCISCO – Abbott Laboratories expects that its self-expanding transcatheter aortic valve replacement (TAVR) system Portico will be able to become a top competitive product. A pivotal trial of Portico has found that the implant is noninferior to current FDA-approved TAVR systems that are marketed in the U.S. The results from the 750-patient, randomized trial were presented here last week at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.