BioCentury | Apr 2, 2020
Product Development

April 1 Quick Takes: Gedeon gets Europe rights to Myovant’s uterine fibroid therapy following MAA submission; plus Orion-Bayer, BMS-bluebird, Mesoblast and more

Myovant licenses relugolix rights to Gideon for $40M  Myovant Sciences GmbH (NYSE:MYOV) licensed rights of relugolix combination tablets to Gedeon Richter plc (Budapest:RICHTER) in Europe, Russia, Latin America, Australia and New Zealand. Myovant, which retains...
BioCentury | Feb 28, 2020
Product Development

Feb. 27 Quick Takes: FDA approves Biohaven’s migraine therapy, plus Acacia, Zogenix, Ultragenyx-Kyowa, GSK, Illumina-BGI

Migraine drug marks Biohaven’s first FDA approval Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN) announced after market close that FDA approved NURTEC ODT rimegepant as an acute treatment for migraine, marking the company’s first U.S. approval....
BioCentury | Feb 8, 2020
Product Development

Zogenix’s Fintepla underwhelms in Phase III for rare epilepsy as data fall short of GW’s Epidiolex

Zogenix lost over $900 million in market cap on Friday after Phase III data for Fintepla to treat Lennox-Gastaut syndrome left investors questioning how well the therapy will compete against GW’s Epidiolex for the rare...
BC Extra | Sep 25, 2019
Company News

Sept. 24 Company Quick Takes: FDA approves smallpox vaccine; plus Epidyolex, Vitrakvi, Oral semaglutide, Takeda-Evotec, Guerbet-IBM Watson

FDA approves Bavarian Nordic’s smallpox/monkeypox vaccine  FDA approved Jynneos MVA-BN from Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) to prevent smallpox and monkeypox, making the vaccine the only approved non-replicating smallpox vaccine in the U.S. and the...
BC Extra | Aug 23, 2019
Company News

Aug. 22 Company Quick Takes: Innovent, Lilly in biologics deal; plus Sobi, Gilead, Themis-Merck, Iconic-Novartis, GW, BeiGene, Clearside, Inex Innovations

Innovent, Lilly in third biologics deal  Innovent Biologics Inc. (HKEX:1801) in-licensed Chinese rights to OXM3 from Eli Lilly and Co. (NYSE:LLY) to treat diabetes. The oxyntomodulin analog -- a dual agonist of GLP-1R and GCGR...
BC Extra | Aug 19, 2019
Clinical News

Aug. 19 Clinical Quick Takes: Kalytera's cannabidiol shows promise for transplant, plus Abbisko and Brigham and Women's

Kalytera's CBD prevents graft-vs-host disease  Kalytera Therapeutics Inc. (TSX-V:KLY; OTCQB:KALTF) announced plans to start a Phase III registrational trial of cannabidiol after low and medium doses reduced the incidence of Grade 2-4 acute graft-versus-host disease...
BC Extra | Aug 6, 2019
Company News

Aug. 6 Company Quick Takes: Sales updates from Alnylam, Sage, Regeneron and GW; plus regulatory updates from MorphoSys and more

Alnylam's Onpattro bests consensus  Sales of amyloidosis therapy Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) reached $38.2 million in 2Q19, the drug's third full quarter on the market. The figure beat analysts' consensus of $32...
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BioCentury | Jun 29, 2019

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BC Extra | May 6, 2019
Company News

May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx

FDA accepts Esperion NDAs for LDL-C-lowering indications  Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe...
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