Tempus will market Personalis' NeXT Personal Dx liquid biopsy while Personalis completes its clinical validation in more indications.

The FDA cleared the firm's investigational new drug application to study its autologous cell therapy CT-0525 in patients with solid tumors overexpressing HER2.

By reducing staff and lowering its operating costs, Candel expects to fund operations into the fourth quarter of 2024.

Quest will provide RNA extraction and sequencing services for Scipher's PrismRA test, a blood-based molecular test for predicting patient response to TNF inhibitors.

The firm's supplemental biologics license application is based on encouraging data from a Phase II trial in more than 100 patients.

Vertex is also seeking to expand the Kaftrio-Kalydeco combination to cystic fibrosis patients with non-F508del Kaftrio-responsive CFTR mutations.

The firm developing several precision cancer drugs is selling 12,963,542 shares of common stock and pre-funded warrants to purchase 3,422,380 shares of common stock.

The agency will review data submitted by the firm from two trials showing pz-cel's ability to heal wounds for those with COL7A1-mutated recessive dystrophic epidermolysis bullosa.

The additional funds will allow the company to continue to study its gene therapy in Gaucher disease and GBA1-linked Parkinson's disease.

News items for the week of Nov. 20, 2023.