Replies to post #135276 on Biotech Values

[DewDiligence]

Bayer submits NDA for regorafenib in second-line CRC:

http://finance.yahoo.com/news/bayer-submits-drug-application-regorafenib-160000393.html

The PR says the regorafenib MAA for the EU has also been submitted, but it doesn’t say exactly when.

[DewDiligence]

Bayer reports (but ONXX issued this PR) positive phase-3 PFS data for Regorafenib in third-line GIST:

http://finance.yahoo.com/news/phase-3-data-regorafenib-met-041700269.html

Onyx Pharmaceuticals (ONXX) today announced data from the Phase 3 GRID (GIST – Regorafenib In Progressive Disease) trial evaluating the investigational drug regorafenib, a Bayer compound, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib. The GRID study met its primary endpoint of progression-free survival (PFS) (HR=0.27, p<0.0001).

In keeping with this board’s new policy, I am deliberately not citing the median PFS values of the trial arms :- )

[DewDiligence]

FDA grants priority review for Bayer's Regorafenib in CRC:

http://finance.yahoo.com/news/u-fda-grants-priority-review-063000304.html

This PR doesn’t disclose the exact PDUFA date, but we now know it’s in late October insofar as the PR states that the submission was made in late April. (Bayer did not disclose the submission until 5/23/12—see #msg-75907495.)