Galapagos NV

Reg european commission grants marketing authorization for jyseleca ( filgotinib) for the treatment of adults with moderate to severe active rheumathoid arthritis. jyseleca( ) demonstrated durable efficacy combined with a consistent safety profile in rheumatoid arthritis through 52 weeks in phase 3 CLI NIC al development program. under agreement, galapagos will receive a milestone payment of 75 million in recognition of approval of jyseleca by european commission.

Galapagos announces that gilead received a complete response letter for filgotinib for treatment of moderately to severely active rheumatoid arthritis. fda has requested data from manta and manta ray studies before completing its review of nda. fda also has expressed concerns regarding overall benefit risk profile of filgotinib 200 mg dose. following this crl, galapagos revises its full year 2020 operational cash burn guidance to between eur 490 and eur 520 million.

Reported on thursday h1 group revenues and other income of eur 224.6 million. h1 operating loss of eur 130.8 million. h1 net loss of eur 165.6 million. cash and current financial investments on 30 june 2020 of eur 5.6 billion. r& d expenditure in h1 amounted to eur 265.9 million, compared to eur 177.6 million for h1 2019 . this planned increase was mainly due to an increase in subcontracting costs primarily related to our filgotinib program, our toledo program and other CLI NIC al programs. retains 2020 operational cash burn guidance of 400 430 million, which includes 205 million in potential milestone payments subject to regulatory approvals of filgotinib. anticipates the potential approval of filgotinib by the european commission in 2020. expects to report topline results from three PAT ient trials later in 2020. with regard to toledo, novel program in inflammation, expects to launch several proof of concept PAT ient trials with glpg3970 in h2, with topline data expected in the h1 2021.

Gilead and galapagos announce positive european chmp opinion for jyseleca ( filgotinib) for the treatment of adults with moderate to severe rheumatoid arthritis. gilead sciences filgotinib' s CLI NIC al development program showed durable efficacy with consistent safety profile in rheumatoid arthritis through 52 weeks. gilead sciences chmp positive opinion supported by data from phase 3 finch & phase 2 darwin programs. gilead sciences european commission DEC ision for jyseleca expected in q3 of 2020.

Announced on thursday share capital increase through subscription right exercises. issued 435,540 new ordinary shares for a total capital increase ( including issuance premium) of eur 17,914,162.40. ceo onno van de stolpe exercised 40,000 subscription rights. four other management board members exercised an aggregate number of 345,000 subscription rights. notes that its total share capital currently amounts to eur 352,968,964.92, the total number of securities conferring voting rights amounts to 65,254,562. two warrants issued to gilead therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of gilead gild. o and its affiliates to 25.1% and 29.9%, respectively.

Gilead and galapagos announce positive topline results of phase 2 b 3 trial of filgotinib in moderately to severely active ulcerative colitis. galapagos nv filgotinib 200 mg demonstrated greater efficacy compared with placebo in induction and maintenance of remission in selection trial. galapagos nv rates of adverse events were low and comparable across treatment groups. galapagos nv estimated 40% of PAT ients with ulcerative colitis experience a relapse annually and do not achieve sustained remission. galapagos nv filgotinib 100 mg did not achieve statistically significant CLI NIC al remission at week 10.

Announced on thursday first three month 2020 financial results. q1 group revenues and other income of 106.9 million. q1 operating loss of 44.6 million. q1 net loss of 50.6 million vs net loss of 48.7 million yr ago. on track to report on a number of later stage CLI NIC al trials throughout 2020. cash and current financial investments on 31 march 2020 of 5.7 billion. a total net DEC rease of 58.4 mln in cash and cash equivalents and current financial investments was recorded during the first three months of 2020, compared to a net DEC rease of 67.9 mln during the first three months of 2019. outlook due to the impact of covid 19 on the recruitment rate and trial starts, our cash burn guidance has been revised down and is now expected to be in the range of 400 and 430 mln, compared to 420 and 450 mln previously guided." from a financial perspective, we ended the first quarter of 2020 with a strong cash balance, positioning us well to grow our pipeline further and deliver on operational excellence for the anticipated commercial launch of filgotinib" cfo.

Galapagos and ryvu announce research collaboration. today announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. ryvu will receive an upfront payment and will be eligible for further option, milestone, and royalty payments. this is a joint research collaboration in which ryvu is responsible for early drug discovery. under terms of agreement, galapagos will have an exclusive option to license IP developed by ryvu and to continue to develop this during collaboration. pending achievement of pre agreed criteria and utilizing its option, galapagos will be responsible for all further development of program.

Galapagos nv fy group revenues & other income of eur 896 million, compared to eur 318 million in 2018. galapagos nv fy net profit of eur 150 million, compared to a net loss of eur 29 million in 2018. galapagos nv fy diluted income per share 2.49 euros. galapagos in 2020, expect an operational cash burn between 420 and 450 million. galapagos co, gilead expect approval of our first product candidate, filgotinib, in ra in the u. s., europe, and japan.

Reg orphan drug DES ignation for glpg1690 in systemic sclerosis. us food & drug administration ( fda) and european commission ( ec) have granted investigational autotaxin inhibitor glpg1690 ' orphan drug DES ignation' for treatment of systemic sclerosis ( ssc). with the novesa phase 2 trial in ssc fully recruited, we expect to see topline data in the second half of the year cmo. incentives include amongst others 7 to 10 years of market exclusivity once medicine is on market, regulatory fee reductions and fee waivers and access to centralized procedure for marketing authorization in europe.