ImmunoGen Antibody-Drug Conjugate Faces Delay After Study Split
Following FDA Guidance
Top-line results from the firm’s pivotal trial of pivekimab sunirine in a rare cancer indication have been delayed for two more years as the firm shifts focus to a specific subpopulation.
You may also be interested in...
Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.
The UK firm has out-licensed its NRF2 activator programme to AstraZeneca in its third major deal of the year as it works to stabilize cash flow through a broad-ranging approach to partnerships.
The controversial nasal spray has improved remission rates over an atypical antipsychotic in patients with a challenging form of depression, in Phase III data which could help boost its uninspiring market performance to date.