Biotech has always been a volatile sector, and it is important for investors to recognize the phases its stocks go through. In particular, the journey through the post-bubble wilderness can be a protracted affair.

Deal Snapshot: The Danish drug maker plans to pay up to $2.7bn to Flagship Pioneering-incubated Valo Health for its AI-enabled small molecule discovery and human genetic data platform.

Sponsor’s assertion of a ‘floor effect’ cannot explain the lack of difference versus placebo on clinical endpoints, and there is no evidence that assessed biomarkers are reasonably likely to predict clinical benefit, agency says. Although advisory committee will focus primarily on efficacy, FDA also cites concerns about ‘grossly deficient’ product quality information.

Deal Snapshot: Looking to add to its neuroscience pipeline, Takeda acquires rights to the antisense candidate AS-202 from AcuraStem for development as a potential amyotrophic lateral sclerosis therapy.