Avid Bioservices Inc (CDMO)

[biopharm]

Looks like Ronin Capital believes the dividend is not worth it much any more and even hints at the closing of the preferred shares as bigger news looms ahead

PS Targeting is HUG-GE and manufacturing for Halozyme seems like news can come at any moment but I am sure Ronin Capital can have Brian Weston adjust timing of MMs etc to get more CDMO just in time
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CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

Company Announcement

CHMP issued positive opinion for DARZALEX® in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant

Final decision from European Commission expected in the coming months

Opinion based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark;

December 13, 2019

Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX® (daratumumab) in the European Union. The recommendation is for the use of DARZALEX in in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

"We are very pleased with this positive opinion from the CHMP as, if approved, the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone would be the first DARZALEX containing regimen that would be a potential treatment option for newly diagnosed patients with multiple myeloma in Europe who are eligible for ASCT," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The Type II variation application was submitted to the EMA by Janssen Pharmaceutica NV in March 2019 and was based on the Phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.


https://www.sec.gov/Archives/edgar/data/1434265/000155837019011505/ex-99d1.htm