Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

Be­yond­Spring shocked in­vestors in ear­ly Au­gust af­ter its once-mar­gin­al lead drug sud­den­ly showed a lot of promise in a com­mon form of lung can­cer. With hopes high, the FDA has now slammed the door on that drug in an­oth­er in­di­ca­tion — does that spell bad news for Be­yond­Spring’s Cin­derel­la sto­ry?

The FDA is­sued Be­yond­Spring a com­plete re­sponse let­ter for its plinab­u­lin in com­bi­na­tion with gran­u­lo­cyte colony-stim­u­lat­ing fac­tor (G-CSF) for the pre­ven­tion of chemother­a­py-in­duced neu­trope­nia, ef­fec­tive­ly shut­ting down the drug’s im­me­di­ate chances at a mar­ket­ing ap­proval, the biotech said Wednes­day.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.