By Denny Jacob
Context Therapeutics Inc. shares shot up 58% to $1.08 each after the company said its clinical trial collaborator Stemline Therapeutics Inc. received approval from the Food and Drug Administration for orserdu.
The clinical-stage biopharmaceutical company said the FDA approval for orserdu was for the treatment of postmenopausal women or adult men with estrogen receptor positive, HER2-negative, estrogen receptor 1 gene-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
"Our collaboration with Menarini in the ongoing Phase 1b/2 ELONA trial is evaluating the potential of Context's oral progesterone receptor antagonist onapristone extended release, to enhance [orserdu]'s activity in both ESR1-mutated and wild type metastatic breast cancer," said Chief Executive Martin Lehr.
The stock's trading surge would put it on pace for its largest percent increase on record and its highest close since Dec. 7.
Trading was paused for volatility twice Tuesday and most recently resumed at 9:43 a.m. ET. Roughly 65.9 million shares had traded as of 12:35 p.m. ET, compared with its 65-day average volume of roughly 668,599 shares.
Shares are down 47% over the last 12 months.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
01-31-23 1309ET
