Regulus shares spike on a high success rate for RG-101 hep C combos

John Carroll Can Regulus still make a splash in the increasingly crowded hepatitis C drug market? The biotech says yes, backing up its case for RG-101 with interim Phase II data that ...

UPDATED: OncoMed hits the brakes on PhII pancreatic cancer trial, shares plummet

John Carroll OncoMed slammed the brakes on a Phase II study of the cancer stem cell drug tarextumab, citing worsening response rates in the drug arm for pancreatic cancer, with red ...

UPDATED: Sarepta shares crash on a harsh FDA review of Duchenne’s drug

John Carroll Sarepta's quest to gain an accelerated approval for eteplirsen was subjected to some harsh scrutiny by regulators at the FDA. And the insiders concluded that much of ...

Alzheimer’s player Anavex reveals SEC probe; shares dive

John Carroll Shares of Anavex took a nasty hit after the New York-based biotech issued a 10-K this morning that included news of an SEC probe, evidently focused on "unusual" ...

Chimerix shares crash as antiviral flops and deaths spike in first PhIII challenge

John Carroll High hopes for Chimerix's antiviral turned into a bad case of data shock Monday morning after the biotech revealed that brincidofovir had failed its first Phase III ...

Perrigo CEO has slammed Mylan for months–but he owns its shares

Carly Helfand Perrigo CEO Joseph Papa has cautioned investors against taking up an offer from hostile suitor Mylan. But Papa is already a Mylan shareholder himself. FiercePharma News

UPDATED: Verastem shares crater on Twitter chatter around cancer data

John Carroll Shares of Verastem cratered Wednesday morning as the Twitter crowd passed around an abstract on the company's defactinib (VS-6063), highlighting an extremely poor response ...

Glimpse of promising lymphoma responses spurs a sharp spike in Epizyme shares

John Carroll Three months after retrieving rights to the lymphoma drug EPZ-6438 from Eisai in a $ 110 million deal, Epizyme has posted a positive glimpse at the drug's efficacy ...

Threshold shares surge as PhIII cancer program enters FDA’s fast track

John Carroll Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company’s sole therapy now in ...

Battered ArQule shares bump up on badly needed positive data for tivantinib

John Carroll ArQule's badly battered shares managed a quick surge this morning on news that the biotech's lead drug tivantinib scored a positive outcome in a Phase II metastatic ...

UPDATED: Intercept shares tank as investigators question OCA’s safety/efficacy for NASH

John Carroll After crunching the data on Intercept's clinical study of OCA for nonalcoholic steatohepatitis, investigators say they tracked some distinct improvements for patients ...

Geron shares rocket up after FDA takes the cuffs off its lead drug

John Carroll After putting up evidence to show that the liver toxicity triggered by its lead drug can be reversed, the FDA has lifted the full hold placed on its lead–and only–cancer ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS