Tags : Ozanimod

BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval as New

Shots: The approval is based on P-III SUNBEAM & RADIANCE Part B studies assessing Zeposia (0.92 mg, equivalent to 1mg) vs Avonex (interferon beta-1a, qw, IM) in 1,346 & 1,320 patients with RMS for at least 12 & 24mos. treatment period respectively Collective results: @1yr. & @2yrs.; reduction in ARR of 48% & 38% (0.18 […]Read More

Celgene Files NDA for Ozanimod to the US FDA for

Shots: The NDA filing is based on P-III SUNBEAM & RADIANCE studies assessing Ozanimod vs Avonex in 1,346 & 1,320 patients with RMS across 21 countries for 12 & 24 mos. respectively In H1’19 Celegene has also filed MAA to EMA for relapsing-remitting multiple sclerosis in adults and plans to develop new therapies for RMS […]Read More

Bristol-Myers Squibb (BMS) to Acquire Celgene for $74B

Shots: BMS acquires Celgene, in all stock transaction for $74B. Celgene to receive $50/share, 1 BMS share  and 1 Contingent Value Right (CVR) of $9 cash as regulatory milestone for each future approval of Celgene’s three drugs candidates ozanimod, liso-cel, bb2121 Celgene has received premium value of 54% on its last day closing share price […]Read More

Celgene to Present Results of Two P-III Trial SUNBEAM and

Shots: The two P-III trials SUNBEAM (N=1346) and RADIANCE (N=1320) involves assessing of two doses of ozanimod PO (0.92 & 0.46 mg, equivalent to 1 & 0.5 mg ozanimod HCI) vs 1L Avonex in RMS patients for @12 mos. & @24 mos. respectively P-III SUNBEAM & RADIANCE Part B results: early & advance RMS (1 […]Read More

FDA to Refuse Celgene for Filling Ozanimod’s NDA for the

 Shots:      •  The rejection of Ozanimod was based on unmet preclinical and clinical trials results, in patients with relapsing multiple sclerosis    •  Additionally, Celgene plans to resubmit NDA, with onset of Type A meeting with FDA regarding development of the product    •  Ozanimod is an oral sphingosine 1-phosphate 1 (S1PR1) and […]Read More