Thu, Aug. 18, 6:43 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) plummets 18% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of anticoagulant reversal agent AndexXa (andexanet alfa).
- The company says most of the requested information relates to manufacturing although the agency also wants more data to support inclusion of edoxaban [Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Savaysa] and enoxaparin [Sanofi's (NYSE:SNY) LOVENOX] in the label. It also stated that it needs more time to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.
- Andexanet alfa is a modified human Factor Xa molecule that acts as a decoy to target and sequester, with high specificity, Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to inhibit Factor Xa and normal hemostatic processes are restored.
- Management will host a conference call this morning at 8:30 am ET to discuss the situation.
- Previously: Portola down 10% ahead of FDA action on AndexXa (Aug. 17)
Sep. 30, 2013, 2:46 PM
- As expected, ArQule (ARQL -7.4%) presented MARQUEE data over the weekend at ECC and thanks (at least in part) to RBC's Adnan Butt and Reuters, investors had high hopes that new information would lead to a second chance for tivantinib in NSCLC. (see original Reuters article)
- Judging by today's market reaction, investors were underwhelmed (or just taking profits after Friday's rally).
- MARQUEE was halted last fall after it became apparent that the study was unlikely to meet the OS primary endpoint.
- However, the data presented over the weekend appears to show a PFS benefit (secondary endpoint): "In the ITT population of 1048 patients ... median PFS was 3.6 months in the treatment arm versus 1.9 months in the control arm."
- Hazard ratio was 0.74 compared to 0.98 for OS. (PR)
Sep. 27, 2013, 1:14 PM
- Today's rally in shares of ArQule (ARQL +9.7%) is likely attributable to RBC's Adnan Butt, who Reuters quotes as saying that an upcoming presentation at ESMO could mean another shot for tivantinib in lung cancer.
- The drug was effectively left for dead (at least as far as NSCLC goes) last October when ARQL and partner Daiichi Sankyo (DSKYF.PK) dropped a Phase 3 trial due to lack of efficacy.
- New data from that trial "could validate the mechanism of action for the drug and potentially allow a path forward in lung cancer as well," Butt says.
Founded on September 28, 2005 through the merger of Daiichi Pharmaceutical and Sankyo, Daiichi Sankyo delivers innovative products that enhance the lives of millions of people around the world. Our recent successes include the antihypertensive agent olmesartan (Olmetec), launched in 2002 by... More
Industry: Diversified Investments