Founding NewLink CEO Charles Link is out; Chi-Med lines up two more drug filings
→ Four years ago NewLink’s shares were riding high on the promise of IDO in oncology, trading at more than $50 a share. But as enthusiasm for the field plummeted on the back of some key setbacks, so did the stock. And today — with the market cap sitting at $59 million and the stock opening at $1.59 — their founding CEO, Charles Link, has hit the exit. The biotech will be headed by a committee during the transition, with CFO Carl Langren joining CMO Eugene Kennedy, general counsel Brad Powers and Lori Lawley, the VP of finance.
→ Hutchison China MediTech, better known as Chi-Med, has lined up two more regulatory filings as it notes its first small amount of sales revenue for its only approved therapy — Elunate.
→ Cambridge, Massachusetts-based Momenta Pharmaceuticals has been granted Fast Track designation by the FDA for their IgG1 monoclonal antibody, M281. The antibody is designed to target FcRn, in hemolytic disease of the fetus and newborn (HDFN) — a serious blood disorder in a fetus or newborn that occurs when red cell incompatibility exists between the blood types of mother and baby.
In addition, “the United States Adopted Names Council (USAN) along with the World Health Organization (WHO) International Nonproprietary Names Expert Committee, has adopted nipocalimab as the generic drug name for M281.”