Thanks to Myovant Sciences GmbH’s potential $4.2 billion deal with Pfizer Inc. for recently approved Orgovyx (relugolix) in prostate cancer (PC), more physicians are going to be learning about [the compound] faster,” said chief commercial officer Adele Gulfo. “This is going to create huge demand.”
Following a priority review of Orgovyx (relugolix), an oral hormone therapy developed by Myovant Sciences GmbH, the FDA has approved the medicine for the treatment of adults with advanced prostate cancer. The first success among three indications for which Myovant has developed the gonadotropin-releasing hormone (GnRH) receptor agonist, the green light marks Myovant’s transformation into a commercial-stage company, SVB Leerink analyst Ami Fadia noted. Company shares (NYSE:MYOV) fell 4.5% to $23.61 following the Dec. 18 approval.
With a Dec. 20 PDUFA date bearing down on relugolix from Myovant Sciences GmbH, of Basel, Switzerland, freshly released and slightly downbeat secondary endpoint phase III data created a rift with management and analysts on one side and investors on the other.
With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication.
An FDA review of Enzyvant Inc.'s RVT-802, a tissue-based therapy for children born without a thymus, has drawn a complete response letter (CRL) from the agency over concerns about chemistry, manufacturing and controls, scuttling hopes it would become the first FDA-designated regenerative medicine advanced therapy (RMAT) to win approval from the agency.
Myovant Sciences Ltd. reported that its lead candidate, relugolix, met its primary efficacy endpoint and all six secondary endpoints in a phase III study of men with advanced prostate cancer, adding new strength to the asset's story, analysts said.