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380 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 ... 15 16 17 18 19 » | Laatste
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Maycon
0
quote:

Lingus schreef op 23 jun 2019 om 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.....
Maycon
0
quote:

Lingus schreef op 23 jun 2019 om 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
nmgn
5
Zullen we dit draadje gebruiken voor analisten rapporten en deze discussie op inhoudelijk light voortzetten?
Lama Daila
2
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.
avantiavanti
7
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%+.
avantiavanti
6
Stifel 2 juli 2019

Filgotinib 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.
Bijlage:
avantiavanti
9

Extract uit SVB Leerink update van vandaag.

July 2, 2019
OUTPERFORM
Reason for report:
FLASH NOTE GALAPAGOS NV

Filgotinib 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) 277-6013
pasha.sarraf@svbleerink.com
Dylan Dupuis, Ph.D.
(212) 277-6151
dylan.dupuis@svbleerink.com
Mike Kratky, CFA
(212) 277-6192
mike.kratky@svbleerink.com
avantiavanti
7
SVB Leerink 2 juli 2019

July 2, 2019
OUTPERFORM
Reason for report:
ESTIMATE CHANGE

Pasha Sarraf, M.D., Ph.D.
(212) 277-6013
pasha.sarraf@svbleerink.com
Dylan Dupuis, Ph.D.
(212) 277-6151
dylan.dupuis@svbleerink.com
Mike Kratky, CFA
(212) 277-6192
mike.kratky@svbleerink.com

GALAPAGOS NV

Raising 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.
avantiavanti
6

Cantor Fitzgerald 2 juli 2019

The ball is back in GLPG's court; FDA update lifts key overhang
Bijlage:
avantiavanti
5
Bryan, Garnier&Co 2 juli 2019

Filgo to be filed in 2019; bullish conclusions from pre-NDA meeting
Bijlage:
avantiavanti
5

H.C.Wainwright&CO 2 juli 2019

MANTA May Not Have Been the FDA Mantra After All
Bijlage:
avantiavanti
3

Jefferies 2 juli 2019

Ball's in FDA's Court with US Filgotinib Filing Now
Confirmed for 2019


*zie ook link naar notes on roadshow in dit document
Bijlage:
avantiavanti
4

Goldman Sachs 2 juli 2019

Gilead Sciences Inc. (GILD): Clarity on Filgotinib RA filing an incremental positive
Bijlage:
avantiavanti
4

Goldman Sachs 2 juli 2019

Galapagos NV (GLPG.AS): Path forward for filgotinib agreed with FDA;
NDA submission confirmed by YE19
Bijlage:
avantiavanti
9

Cowen 2 juli 2019

NDA FILING FOR FILGOTINIB IN RHEUMATOID
ARTHRITIS EXPECTED THIS YEAR
Bijlage:
Wall Street Trader
0
Jefferies Full Report as published on 29 apr 2019 om 10:29

Notes from the Road: Filgotinib in Focus (16 April 2019)

Bijlage:
Wall Street Trader
0
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
Bijlage:
maxen
0
quote:

avantiavanti schreef op 3 jul 2019 om 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

TP66
0
quote:

maxen schreef op 3 jul 2019 om 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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