DeZwarteRidder schreef op 21 mei 2019 om 18:36:
Zo zal het ook vergaan met Probio:
BioCryst down 49% premarket on underwhelming Phase 3 results for BCX7353
May 21, 2019 7:25 AM ET|About: BioCryst Pharmaceutica... (BCRX)|By: Douglas W. House, SA News Editor
BioCryst Pharmaceuticals (NASDAQ:BCRX) announces positive results from a Phase 3 clinical trial, APeX-2, evaluating plasma killikrein inhibitor BCX7353 for the prevention of hereditary angioedema (HAE) attacks.
The study met the primary endpoint for both doses (110 mg and 150 mg), reducing the rate of HAE attacks by 44% compared to placebo. Patients in the 150 mg arm with a baseline attack rate of <2/month experienced a 66% reduction versus control. Patients with an attack rate of 2 or more per month experienced a 40% reduction compared to control.
Investors are heading for the exits because the treatment benefit appears less than Takeda's (NYSE:TAK) TAKHZYRO (lanadelumab), approved in the U.S. in August 2018 and in Europe three months later. Patients receiving 150 mg - 300 mg experienced reductions in HAE attack rates of 76 - 87%.
Undeterred, BCRX plans to file a U.S. marketing application in Q4 followed by an application in Europe in Q1 2020.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
Shares are down 49% premarket on increased volume.