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Lingus schreef op 23 juni 2019 13:30 :
Overigens wel interessant: de te starten trial om het booster effect van cobicistat (nota bene van Gilead) met tofacitinib te onderzoeken. Daarmee zou de dosis tofacitinib gehalveerd kunnen worden. Het zou me niet verbazen als Gilead/Galapagos binnenkort een zelfde trial starten met filgotinib.
Precies wat ik eerder al aangaf. Mijn vrouw is patiente bij Maartenskliniek, sedert begin dit jaar aan de tofacitinib en recentelijk benaderd voor dit onderzoek met Tybost. Harvester schreef in eerdere post dat ze contract hebben met AbbVie, zeker is dat Pfizer ook erg warm in bedje ligt.....
Lingus schreef op 23 juni 2019 13:22 :
Het "slimme neerzetten", daar maakt hij zich zelf schuldig aan door te focussen op effectiviteit en het wegmoffelen van het verschil in bijwerkingen tussen de JAK-remmers. Het succes van filgotinib zal gelukkig niet afhangen van de subjectieve kijk van Bart op de JAK-remmers. De wereld is groter dan de Sint Maartenskliniek.
Zeker waar en zowel chef de clinique reumatologie alsook de apotheker van den Bemt zijn enigszins gekleurd vwb. "dure"medicijnen. Biologicals moesten bij voorkeur vervangen worden door biosimilars. Wat mij wel opvalt is dat er overal in publicaties rondom Filgo maar heel weinig wordt gefocused op usp: safety
Zullen we dit draadje gebruiken voor analisten rapporten en deze discussie op inhoudelijk light voortzetten?
www.researchpool.com/provider/bryan-g... Bryan Garnier: GALAPAGOS | Buy | FV EUR140 | (MANTA) With or Without You Gilead is heading into a pre-BLA meeting to discuss data from the FINCHes trials and the filing timelines for filgotinib. The outcome of this meeting should be communicated in the coming weeks.
Morgan Stanley 2 juli 2019 MANTA Overhang Lifted; US Filgotinib Filing To Occur By YE19 Gilead announced today that an NDA for filgotinib in rheumatoid arthritis (RA) will be submitted to the FDA in 2019, based on pre-NDA discussions with U.S. regulators regarding the PhIII FINCH data in RA as well as the ongoing PhII MANTA studies evaluating the risk of testicular toxicity from filgotinib. Timing for a U.S. launch has been a key investor focus given filgotinib is likely to launch in RA after competing JAK upadacitinib (for which an NDA has been filed), and investors were uncertain how much MANTA safety data the FDA would require to accept a regulatory filing for filgotinib. As we had highlighted in our recent month ahead note (see here), we believe a 2019 filing plan is a bull case scenario and clearly indicates that the FDA is comfortable with interim safety data from the MANTA studies being included in a filing. A requirement for complete MANTA study data would have significantly delayed filing, as primary completion dates for the MANTA studies are in 2021. One lingering concern about the U.S. regulatory filing investors may have is whether a more rapid path to filing may come at the expense of a more restrictive label. While mgt. would not comment on the intended scope of the label, we expect mgt. to pursue a broad label. Overall, we believe this news is a clear positive for Gilead and Galapagos, as a 2019 NDA filing sets up filgotinib for a U.S. RA launch in 2021, one year ahead of consensus expectations. We expect GILD up 1%-2% and GLPG up 5%+.
Stifel 2 juli 2019Filgotinib NDA Submission in RA by YE19; MANTA No Longer Gating Summary Galapagos partner GILD announced that a regulatory pathway is established for an NDA submission for filgotinib in rheumatoid arthritis (RA) by YE19. The positive news came out of the recent pre-NDA meeting with FDA. GLPG investors have been concerned that the still-enrolling P2 MANTA (testicular tox) study would be a gating factor for NDA submission. Today's news largely removes this uncertainty. The press release was light on details, and in the meantime we await more clarity. It is likely that MANTA data are still required for review by FDA after NDA submission (rolling). On the competitive front, upadacitinib PDUFA is anticipated in 3Q19. We currently model for filgotinib launch in RA in FY21 (95% PoS) and unadjusted peak revenue to GLPG of $622M.
Extract uit SVB Leerink update van vandaag. July 2, 2019 OUTPERFORM Reason for report: FLASH NOTE GALAPAGOS NVFilgotinib to File Earlier Bottom Line: An unexpected outcome during a standard pre-NDA meeting with the FDA puts filgotinib in a better competitive position in rheumatoid arthritis and possible commercial launch by 2H20. What happened. GILD (MP) and GLPG (OP) entered pre-NDA talks with the FDA following successfully completing the Phase 3 FINCH trials in 1Q19. At question was whether the FDA would remain firm in their demand that the Phase 2 MANTA/MANTA-RAy testicular toxicity studies be completed ahead of an NDA filing. Results from the three FINCH trials as well as updates from the ongoing MANTA and MANTA-RAy studies were discussed at the meetings, with GILD announcing their intention to move forward with an NDA filing at the meeting’s conclusion. We were wrong: current scenario better than our best case. This FDA meeting and GILD decision to file early clears GLPG of a near term source of uncertainty. While positive results from three separate Phase 3 trials for filgotinib left little doubt as to the efficacy of the drug in rheumatoid arthritis (RA), slow enrollment in MANTA left the timing of an NDA filing uncertain. The potential completion of testicular toxicity studies was accelerated by as much as one year with the expansion of inclusion criteria for MANTA to allow enrollment of Crohn’s disease patients and the initiation of the MANTA-RAy study in patients with RA. This decision to file by year-end places a potential launch for filgotinib as early as 3Q20, about six months ahead of our projected best case scenario. GLPG, in a pre-filing mode, is not guiding on FDA’s expectations for the MANTA studies and whether they will be a requirement prior to approval, but with the addition of MANTA-RAy and the activation of the GLPG operational machine, the recruitment in RA is likely to meet an extended deadline. Our take. We viewed the testicular toxicity signal story as a big and bounded uncertainty for filgotinib. The FDA’s guidance by no means guarantees the acceptance of an NDA application or approval, but an earlier-than-expected submission improves filgotinib’s competitive positioning. Furthermore, we note that filgotinib’s additional safety data increases the total exposed patient years to around ~4-5K, mirroring data accumulated for most, if not all Janus kinase inhibitors, while retaining the low rates of safety parameters that has us and physicians excited about its profile. The next big question for filgotinib is whether its profile can be translated into value for patients and investors. In our view the main contender to filgotinib is upadacitinib, a somewhat selective but more potent JAK-1 inhibitor that has the full might of AbbVie’s (OP) pharma commercial machine behind it. The FDA is expected to decide on its NDA application in 3Q19, and additional GLPG catalysts may reside in labeling outcomes for upadacitinib, with AbbVie twice guiding that they do not expect an advisory committee meeting for upadacitinib. We were recently at the European League against Rheumatism meeting in Madrid and were struck by one simple reality: the rheumatoid arthritis problem remains unsolved. Only less than 10% of patients achieve drug free remissions in RA despite being heavily bombarded by biologics. While the antibodies will not be disappearing anytime soon, it may be time to reconsider new modalities more broadly, increasing the opportunity for great oral drugs. Pasha Sarraf, M.D., Ph.D. (212) 277-6013pasha.sarraf@svbleerink.com Dylan Dupuis, Ph.D. (212) 277-6151dylan.dupuis@svbleerink.com Mike Kratky, CFA (212) 277-6192mike.kratky@svbleerink.com
SVB Leerink 2 juli 2019 July 2, 2019 OUTPERFORM Reason for report: ESTIMATE CHANGE Pasha Sarraf, M.D., Ph.D. (212) 277-6013pasha.sarraf@svbleerink.com Dylan Dupuis, Ph.D. (212) 277-6151dylan.dupuis@svbleerink.com Mike Kratky, CFA (212) 277-6192mike.kratky@svbleerink.com GALAPAGOS NVRaising PT to $150 on Filgotinib Update Bottom Line: The decision to file an NDA for filgotinib by year-end changes our projected timeline for a U.S. commercial launch and increases our valuation for GLPG. PT raised after decision to file NDA for filgotinib by year end. We are raising our 12-month price target to $150, up from $142, after updating our model to reflect the news that GLPG’s collaborative partner GILD (MP) will be filing an NDA for filgotinib in rheumatoid arthritis (RA) by the end of the year (see LINK). We had previously projected the FDA would remain firCam in their request that an NDA filing await completion of the MANTA/MANTA-RAy testicular toxicity studies (see LINK). With this decision, we project an NDA filing in the U.S. and an MAA filing in the E.U. in 4Q19 with commercial launches in 3Q20 and 4Q20, respectively. We maintain a 90% probability of regulatory success for filgotinib in RA. Catalysts will continue to move the needle into 1H20. The most significant catalysts remaining in 2019 are topline Phase 2 proof of concept results for filgotinib in Sjogren’s disease and cutaneous lupus erythmatosus expected in 2H19 with an expected Phase 3 launch for filgotinib in psoriatic arthritis and the NDA and MAA filing for filgotinib in RA expected before the end of the year. We also expect GLPG will complete enrollment in the Phase 2 PINTA trial for GLPG1205 in idiopathic pulmonary fibrosis. GLPG is expected to round out the year by initiating a Phase 2 trial for their first generation Toledo molecule GLPG3312 in inflammatory bowel disease and initiating a Phase 1 trial for their second generation Toledo molecule GLPG3370. GLPG will kick off 2020 with topline Phase 3 results for filgotinib in ulcerative colitis and topline Phase 2 proof of concept results for GLPG1972 in osteoarthritis expected in 1H20.
Cantor Fitzgerald 2 juli 2019The ball is back in GLPG's court; FDA update lifts key overhang
Nomura 2 juli 2019FDA Meeting Sees Early NDA, More July 30
Bryan, Garnier&Co 2 juli 2019Filgo to be filed in 2019; bullish conclusions from pre-NDA meeting
H.C.Wainwright&CO 2 juli 2019MANTA May Not Have Been the FDA Mantra After All
Jefferies 2 juli 2019Ball's in FDA's Court with US Filgotinib Filing Now Confirmed for 2019 *zie ook link naar notes on roadshow in dit document
Goldman Sachs 2 juli 2019Gilead Sciences Inc. (GILD): Clarity on Filgotinib RA filing an incremental positive
Goldman Sachs 2 juli 2019Galapagos NV (GLPG.AS): Path forward for filgotinib agreed with FDA; NDA submission confirmed by YE19
Cowen 2 juli 2019NDA FILING FOR FILGOTINIB IN RHEUMATOID ARTHRITIS EXPECTED THIS YEAR
Jefferies Full Report as published on 29 apr 2019 om 10:29 Notes from the Road: Filgotinib in Focus (16 April 2019)
Cowen Report from March 29, 2019 QUICK TAKE: INDUSTRY UPDATE March 29, 2019 FILGOTINIB'S FINCH 1 AND FINCH 3 PH III DATA DEMONSTRATE A COMPETITIVE PROFILE
avantiavanti schreef op 3 juli 2019 07:53 :
Goldman Sachs 2 juli 2019
Gilead Sciences Inc. (GILD): Clarity on Filgotinib RA filing an incremental positive Grappenmakers bij GS: We are Neutral rated on Galapagos with a DCF-derived 12-month price target of €108
maxen schreef op 3 juli 2019 10:22 :
[...]
Grappenmakers bij GS:
We are Neutral rated on Galapagos with a DCF-derived 12-month price target of €108 GS is niet altijd objectief, je moet maar eens kijken waar hun belangen liggen dit geld overigens voor meerdere analisten/zakenbanken.
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