Phase I
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Navitor Pharmaceuticals, headquartered in Cambridge, Massachusetts, announced that Thomas E. Hughes will be the company’s new chief executive officer.
Cellectis announced it had appointed Stefan Scherer to the role of senior vice president Clinical Development and deputy chief medical officer.
Impact Therapeutics, headquartered in Nanjing, China, completed a Series C financing round worth $30 million. The round was led by Decheng Capital with participating from Lilly Asian Ventures (LAV).
Denali Therapeutics stock climbed 11 percent after the release of positive data from its Phase I clinical trial of DNL201 in Parkinson’s disease.
Boston-based biotech company Karuna Pharmaceuticals completed a $42 million Series A financing. The round included the issuance of $22 million in shares upon conversion of debt into equity.
Although Pfizer’s second-quarter financials exceeded expectations, with its adjusted earnings per share coming in at $0.81 compared to a forecast of $0.74, in its reporting there were a few changes to its pipeline.
Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical, indicated their guadecitabine (SGI-110) missed its co-primary endpoints in acute myeloid leukemia (AML).
Liquidia Technologiesnlaunched a successful initial public offering on July 25, raising $50 million. Neal Fowler, the company’s chief executive officer, and Kevin Gordon, Liquidia’s president and chief financial officer, took time out to talk with BioSpace about the company and where it’s headed.
MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced that dosing has commenced in a Phase 1b single-ascending dose patient study of its investigational drug candidate MYK-491.
PRESS RELEASES