AstraZeneca PLCAstraZeneca's Phase 3 SERENA-4 trial of camizestrant plus palbociclib failed to meet its primary endpoint of improved progression-free survival.
Olema Pharmaceuticals shares fell 15.1% in pre-market trading to $8.68 after AstraZeneca reported that its Phase 3 SERENA-4 trial of camizestrant did not meet its primary endpoint. AstraZeneca said on Friday that camizestrant, in combination with palbociclib, did not demonstrate a statistically significant improvement in progression-free survival as a first-line treatment for patients with ER-positive, HER2-negative advanced breast cancer. Investors were assessing the result in relation to Olema's lead candidate, palazestrant, also known as OP-1250, which is being evaluated in the pivotal Phase 3 OPERA-01 trial; palazestrant is an oral selective estrogen receptor degrader and complete estrogen receptor antagonist, or SERD/CERAN, giving it mechanistic similarities to camizestrant, although AstraZeneca's trial outcome does not determine the results of Olema's separate clinical programme. Following the AstraZeneca results, Stifel reduced its price target for Olema to $30 from $48 while maintaining a Buy rating. Olema shares were trading above their 52-week low of $6.65 following Monday's decline, compared with a 52-week high of $36.26, as the broader US market also moved lower, with the Nasdaq falling 1.7% and the S&P 500 declining 0.7%.
AstraZeneca PLCAstraZeneca's Phase 3 SERENA-4 trial of camizestrant plus palbociclib failed to meet its primary endpoint of improved progression-free survival.
Olema Pharmaceuticals IncAstraZeneca's SERENA-4 miss for camizestrant, mechanistically similar to Olema's palazestrant, raises doubts about Olema's Phase 3 OPERA-01 readout.
Roche Holding AG
Stifel Financial Corporation