RBC Sees 33% of Zafgen (ZFGN) Death Happening in Placebo Arm; Reiterates 'Outperform' Rating
RBC Capital is positive on news from Zafgen (Nasdaq: ZFGN) following news of a death with the company's Phase 3 bestPWS study of beloranib in Prader-Willi Syndrome.
Analyst Simos Simeonidis said the firm spok with Zafgen managmenet and there may be a 33 percent chance that the patient death was on the placebo arm.
What now? Simeonidis said, The company has been working with FDA to figure out next steps, but there is currently no interruption in dosing in the two ongoing trials, which are close to being completed, anyway. It is not clear at this point, whether the company will disclose whether the patient death occurred while on drug or placebo, when they find out. The decision will depend on how this may affect trial data integrity.
Obviously, it is very important to know if the patient was on placebo or drug and if on drug, whether the death was drug-related ... It is however worth remembering that this patient population has a ~3% annual death rate. The patients in the trial were treated for six months, so one death in ~108 patients treated for six months is definitely within the expected range for this patient population, the analyst noted.
RBC rates Zafgen at Outperform, Speculative Risk, $58 price target.
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