Archive for February, 2017
Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)
Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for the phase 3 ADAPT trial of its cancer vaccine AGS-003 in combination with Sutent in metastatic renal cell carcinoma recommended that the trial should be discontinued. Following an interim analysis, the DMC concluded that […]
Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)
Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been raised due to some postings on message boards. Negative blogs have contended that NWBO has included the clinical data from 32 pseudo-progressors in the clinical data base of 331 patients enrolled in the phase […]
Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)
Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18 months. We may see topline data on the phase 3 trial by mid-summer or possibly in a late breaker paper at ASCO in May. Linda Liau, principal investigator on the phase 3 trial, is encouraged […]
AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)
Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]
Cytokinetics: Discussion of Financing Deal with Royalty Partners (CYTK, Buy, $11)
Terms and Implications of This Deal Cytokinetics announced that it had concluded a deal to sell a portion of the future royalty stream on omecamtiv to Royalty Partners, perhaps the leading purveyor of this type of financial instrument. Omecamtiv is partnered with Amgen and recently entered the phase 3 GALACTIC HF trial which will enroll […]