Swiss women's health specialist ObsEva SA had been preparing for the near-term launch of its first commercial product – the GnRH antagonist linzagolix for bleeding associated with uterine fibroids – but after hitting a regulatory roadblock the company is now restructuring and returning rights to the drug to its partner Kissei Pharmaceutical Co., Ltd instead.
ObsEva Ends Linzagolix Launch Plans, Casting Another Shadow Over Women's Health
The Swiss drug maker will initiate a "mass dismissal" and return rights to its lead drug candidate after the US FDA alerted the company to NDA deficiencies.

More from Immunological
The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
Obefazimod has been heralded as a potential blockbuster for ulcerative colitis and there will be great interest in the readout of Phase III induction trials in the third quarter of this year.
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
More from Therapy Areas
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.