Protocols

Tesaro gets its PD-1 registration study started, hunting accelerated OK; Ultragenyx hustles into PhIII

→ Tesaro $TSRO has launched a registration study for its PD-1 drug TSR-042, which was developed in a collaboration with AnaptysBio. The biotech — which is gunning for an accelerated approval — is planning to start a series of combo efforts that match the checkpoint with the newly approved Zejula, TSR-022, an anti-TIM-3 antibody, and TSR-033, and anti-LAG-3 antibody.

→ Novato, CA-based Ultragenyx $RARE launched a Phase III study of UX007 for the treatment of Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS) patients experiencing disabling paroxysmal movement disorders.

→ Waltham, MA-based Avedro, Inc., an ophthalmic pharma and medical device company, bagged $42 million in equity and debt financing. The equity financing was led by HealthQuest Capital, with support from OrbiMed Advisors and InterWest Partners. The debt financing is with an affiliate of OrbiMed. Avedro also announced the opening of its new, state-of-the art, manufacturing facility in Burlington with plans to continue expanding its corporate team.

→ The respiratory disease biotech Verona Pharma priced its IPO at $13.50 a share, raising $78 million after sticking with the expected price.


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RAPS Regulatory Convergence 2017