Ontvang nu dagelijks onze kooptips!
word abonnee
sluiten ✕
Terug naar discussie overzicht
Up Up in Mei. Kind regards, Forecast
Is er een outlook voor komende maand? 08 mei Pharming 1Q 2024 Results 21 mei Annual General Meeting (AGM) 2024 Berichtgeving vanuit EMA? Iemand aanvullingen? Dank!
Toch vind ik de koers aan de lage kant.
Melding AFM dd 25 april 2024Goldman Sachs Group Inc., The kapitaalbelang 3,39% stemrecht 3,39% (18 april 2024: kapitaalbelang 3,02% / stemrecht 3,02%)www.afm.nl/nl-nl/sector/registers/mel...
Ik weet niet of dit al geplaatst was. Advies hoe patiënten dit middel kan verkrijgen Leniolisib's EMA approval: How to prevent delays from delaying your treatment Last updated: 09 April 2024 You can legally access new medicines, even if they are not approved in your country. Learn more » (https://everyone.org/country-regulations) For patients with activated PI3K-delta syndrome (APDS) 2023 brought some long-awaited good news. The first treatment for this ultrarare condition, leniolisib, got its FDA approval in March 2023. Considered by the FDA as a first-in-class medication, Joenja (leniolisib) is a beacon of hope to patients everywhere 1. However, as of April 2024, leniolisib is still only approved in the USA. Its MHRA and EMA approvals are still pending, leaving APDS patients in Europe and the UK with more questions than answers. Here's everything you need to know about the current status of leniolisib's approval in Europe and the UK. Including all your options to safely access the medicine on your own timeline. What is leniolisib used for? Joenja (leniolisib) is indicated for adults and children with activated PI3K-delta syndrome (APDS). The medicine works by attaching to the phosphoinositide 3-kinase delta enzyme and blocking its activity. By doing so, it aims to support B and T cells in their function of fighting infections, and reduce symptoms 2. What were the results of the Joenja clinical trial? The phase 2/3 trial which informed the FDA's approval decision for Joenja had a span of 12 weeks. Some of the reported results include: • Joenja performed better than placebo in reducing lymph node size. The adjusted mean change in lymph node size was -0.30 for Joenja, compared to +37.30 for placebo; • Patients treated with Joenja had a 34.76% increase in naive B cells. For placebo patients, the number of naive B cells decreased by 5.37%; • The most common adverse effects related to Joenja were headache, atopic dermatitis, and sinusitis 6. Leniolisib's EMA approval: Delays and timelines Joenja's marketing authorization application has been under review by the EMA since 27 October 2022. Typically, the EMA's approval process takes 210 days. However, in Joenja's case, it's taken longer, as the regulator asked for additional data in November 2023 3. The current indication from the CHMP is that it will make decision on leniolisib's approval in Europe somewhere in the first half of 2024 3. If the CHMP issues a positive recommendation, the medicine's EMA approval should become official within 67 days from that date. When will leniolisib be available in Europe? To keep things interesting, an EMA approval does not mean leniolisib will be immediately available on the local markets. Every EU member state has its own local procedures to complete before that happens - including local price negotiations with the manufacturer and decisions on reimbursement. How long these processes take varies greatly from one country to another. The average time from approval to availability ranges from 102 days in Germany to 1,081 days in Estonia, with an EU average of 636 days 4. In other words, some patients in Europe may be able to access leniolisib already within 2024, while others may be left waiting for another couple of years. Leniolisib in the UK: When will it be available? Pharming, the manufacturer of Joenja, has stated its intention to apply for MHRA approval within the first half of 2024. According to current accelerated procedures, a decision on leniolisib's approval in the UK should be made within 110 days from submission. Will leniolisib be available on the NHS? This will depend on the NICE's review of the medicine. A decision on including leniolisib on the NHS is expected in December 2024 5. It is of course dependent on a positive outcome of the application for MHRA approval. If NICE recommends including Joenja on the NHS, the medicine should become available to patients within 3 months from the NICE's decision. This takes us to March 2025 as the earliest date when APDS patients in the UK could access leniolisib. How to safely get leniolisib before its MHRA and EMA approvals Despite what the timelines above suggest, waiting is not the only option for APDS patients in Europe and the UK. You could immediately access the medicine by importing it for your personal use. This option is known as Named Patient Import, or expanded access. Here's how it works. Leniolisib expanded access Even if a medicine is not yet approved or available in your country, you can legally access it. A regulation known as Named Patient Import allows you to buy and import a medicine, as long as it meets these conditions: • it is approved somewhere; • it is not approved or available in your country (yet); • it has no local alternatives, and • it is for personal use. This process requires a prescription from your treating doctor. As in all other cases, the doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary. Do you want to start your treatment with leniolisib sooner, using the Named Patient Import regulation? You will first need to consult your treating doctor and get a suitable prescription (https://everyone.org/blog/an-easy-guideline-to-getting-the-right-prescription). Al ready have a prescription? Share it with our team (https://everyone.org/joenja-leniolisib?wayfinder=1&score=wayfinder_autoopen_blog) at Everyone.org. We can support you with buying leniolisib immediatel
May 3, 2024 12:45pm - 1:45pm Symposium: How to Interpret a VUS Test Report: A Step-By-Step Evaluationtwitter.com/AllaboutAPDS/status/17852... by: Pharmingwww.conferenceharvester.com/floorplan...
koers blijft goed liggen vandaag
holmes schreef op 1 mei 2024 06:38 :
Melding AFM dd 25 april 2024
Goldman Sachs Group Inc., The kapitaalbelang 3,39%
stemrecht 3,39%
(18 april 2024: kapitaalbelang 3,02% / stemrecht 3,02%)
www.afm.nl/nl-nl/sector/registers/mel... Blijkbaar zijn er naast de door alias "ffwachten" als dommerikken geprofileerde particuliere beleggers met vertrouwen in Pharming Group NV ook nog wat professionals die het wel zien zitten en er een vermeldingswaardige positie op nahouden :). Time will tell, te beginnen op 8 mei a.s. Vragen stellen op 21 mei bij twijfels...... moet je wel 1 aandeeltje in bezit hebben.
De Zwarte kat schreef op 1 mei 2024 09:40 :
koers blijft goed liggen vandaag
Ja,alles zit mee vandaag zelfs mooi zonnig weer.Morgen is nog ver weg maar de beurzen zouden vandaag half procent in de min staan dus de hoop is op vanavond dat de fed de markt niet teveel down praat.Ik ben toch bang dat de fed de markt nog een zetje naar beneden drukt.Vorige week veerde de koers van pharming bij 0,875 euro weer omhoog naar 0,922 euro misschien hebben we weer geluk.
aextracker schreef op 1 mei 2024 09:44 :
[...]
Blijkbaar zijn er naast de door alias "ffwachten" als dommerikken geprofileerde particuliere beleggers met vertrouwen in Pharming Group NV ook nog wat professionals die het wel zien zitten en er een vermeldingswaardige positie op nahouden :).
Time will tell, te beginnen op 8 mei a.s.
Vragen stellen op 21 mei bij twijfels...... moet je wel 1 aandeeltje in bezit hebben.
Voorlopig staat Pharming op €0,877. Alle overwegingen daarbij prima, maar dat is de waarde die de huidige markt toekent. En een mits-maar-markt bestaat niet.
Dat zal ook niet veranderen vandaag , morgen ??????????
G. Hendriks schreef op 1 mei 2024 10:40 :
[...]
Voorlopig staat Pharming op €0,877. Alle overwegingen daarbij prima, maar dat is de waarde die de huidige markt toekent. En een mits-maar-markt bestaat niet.
Voorlopig is euro 0.877 een moment opname ! Vond het een mooi instapmoment in aanloop naar 8 mei a.s.
Slechts een stuk of 10 postings vandaag. Is de magie van Ph. op Piet en Truus aan het oplossen?
Beur schreef op 1 mei 2024 18:48 :
Slechts een stuk of 10 postings vandaag. Is de magie van Ph. op Piet en Truus aan het oplossen?
Yep, vanaf nu stappen louter professionals in :). Particuliere Piet wordt uitgerookt door mighty Morgan....
aextracker schreef op 1 mei 2024 19:08 :
[...]
Yep, vanaf nu stappen louter professionals in :).
Particuliere Piet wordt uitgerookt door mighty Morgan....
Het 1 mei geen 1 april ;).
Beur schreef op 1 mei 2024 18:48 :
Slechts een stuk of 10 postings vandaag. Is de magie van Ph. op Piet en Truus aan het oplossen?
Mei begint zonder vuilnis. Nu nog 15-20% erbij na 8 mei.
LL schreef op 1 mei 2024 19:37 :
[...]
Het 1 mei geen 1 april ;).
Amerikaanse beurzen 1% in de plus op dit moment kan steun zijn het kan eens meezitten.
aextracker schreef op 1 mei 2024 18:34 :
[...]
Voorlopig is euro 0.877 een moment opname !
Vond het een mooi instapmoment in aanloop naar 8 mei a.s.
Welke koers op welk tijdstip dan ook is altijd een momentopname. Toen het aandeel op €1,15 stond, was het volgens sommige posters ook een mooi instapmoment. We hebben dus een nieuw begrip: de instapmomentopname.
Aantal posts per pagina:
20
50
100
Direct naar Forum
-- Selecteer een forum --
Koffiekamer
Belastingzaken
Beleggingsfondsen
Beursspel
BioPharma
Daytraders
Garantieproducten
Opties
Technische Analyse
Technische Analyse Software
Vastgoed
Warrants
10 van Tak
4Energy Invest
Aalberts
AB InBev
Abionyx Pharma
Ablynx
ABN AMRO
ABO-Group
Acacia Pharma
Accell Group
Accentis
Accsys Technologies
ACCSYS TECHNOLOGIES PLC
Ackermans & van Haaren
ADMA Biologics
Adomos
AdUX
Adyen
Aedifica
Aegon
AFC Ajax
Affimed NV
ageas
Agfa-Gevaert
Ahold
Air France - KLM
AIRBUS
Airspray
Akka Technologies
AkzoNobel
Alfen
Allfunds Group
Allfunds Group
Almunda Professionals (vh Novisource)
Alpha Pro Tech
Alphabet Inc.
Altice
Alumexx ((Voorheen Phelix (voorheen Inverko))
AM
Amarin Corporation
Amerikaanse aandelen
AMG
AMS
Amsterdam Commodities
AMT Holding
Anavex Life Sciences Corp
Antonov
Aperam
Apollo Alternative Assets
Apple
Arcadis
Arcelor Mittal
Archos
Arcona Property Fund
arGEN-X
Aroundtown SA
Arrowhead Research
Ascencio
ASIT biotech
ASMI
ASML
ASR Nederland
ATAI Life Sciences
Atenor Group
Athlon Group
Atrium European Real Estate
Auplata
Avantium
Axsome Therapeutics
Azelis Group
Azerion
B&S Group
Baan
Ballast Nedam
BALTA GROUP N.V.
BAM Groep
Banco de Sabadell
Banimmo A
Barco
Barrick Gold
BASF SE
Basic-Fit
Basilix
Batenburg Beheer
BE Semiconductor
Beaulieulaan
Befimmo
Bekaert
Belgische aandelen
Beluga
Beter Bed
Bever
Binck
Biocartis
Biophytis
Biosynex
Biotalys
Bitcoin en andere cryptocurrencies
bluebird bio
Blydenstijn-Willink
BMW
BNP Paribas S.A.
Boeing Company
Bols (Lucas Bols N.V.)
Bone Therapeutics
Borr Drilling
Boskalis
BP PLC
bpost
Brand Funding
Brederode
Brill
Bristol-Myers Squibb
Brunel
C/Tac
Campine
Canadese aandelen
Care Property Invest
Carmila
Carrefour
Cate, ten
CECONOMY
Celyad
CFD's
CFE
CGG
Chinese aandelen
Cibox Interactive
Citygroup
Claranova
CM.com
Co.Br.Ha.
Coca-Cola European Partners
Cofinimmo
Cognosec
Colruyt
Commerzbank
Compagnie des Alpes
Compagnie du Bois Sauvage
Connect Group
Continental AG
Corbion
Core Labs
Corporate Express
Corus
Crescent (voorheen Option)
Crown van Gelder
Crucell
CTP
Curetis
CV-meter
CVC Capital Partners
Cyber Security 1 AB
Cybergun
D'Ieteren
D.E Master Blenders 1753
Deceuninck
Delta Lloyd
DEME
Deutsche Cannabis
DEUTSCHE POST AG
Dexia
DGB Group
DIA
Diegem Kennedy
Distri-Land Certificate
DNC
Dockwise
DPA Flex Group
Draka Holding
DSC2
DSM
Duitse aandelen
Dutch Star Companies ONE
Duurzaam Beleggen
DVRG
Ease2pay
Ebusco
Eckert-Ziegler
Econocom Group
Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
Energie
Energiekontor
Engie
Envipco
Erasmus Beursspel
Eriks
Esperite (voorheen Cryo Save)
EUR/USD
Eurobio
Eurocastle
Eurocommercial Properties
Euronav
Euronext
Euronext
Euronext.liffe Optiecompetitie
Europcar Mobility Group
Europlasma
EVC
EVS Broadcast Equipment
Exact
Exmar
Exor
Facebook
Fagron
Fastned
Fingerprint Cards AB
First Solar Inc
FlatexDeGiro
Floridienne
Flow Traders
Fluxys Belgium D
FNG (voorheen DICO International)
Fondsmanager Gezocht
ForFarmers
Fountain
Frans Maas
Franse aandelen
FuelCell Energy
Fugro
Futures
FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
Gemalto
General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
Hypotheken
IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
Ierse aandelen
IEX Group
IEX.nl Sparen
IMCD
Immo Moury
Immobel
Imtech
ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
Intervest Offices & Warehouses
Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
Kas Bank
KBC Ancora
KBC Groep
Kendrion
Keyware Technologies
Kiadis Pharma
Kinepolis Group
KKO International
Klépierre
KPN
KPNQwest
KUKA AG
La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
LBI International
Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
MDxHealth
Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
Mopoli
Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
Nationale Nederlanden
NBZ
Nedap
Nedfield
Nedschroef
Nedsense Enterpr
Nel ASA
Neoen SA
Neopost
Neovacs
NEPI Rockcastle
Netflix
New Sources Energy
Neways Electronics
NewTree
NexTech AR Solutions
Nextensa
NIBC
Nieuwe Steen Investments
Nintendo
Nokia
Nokia Oyj
Nokia OYJ
Novacyt
NOVO-NORDISK AS
NPEX
NR21
Numico
Nutreco
Nvidia
NWE Nederlandse AM Hypotheek Bank
NX Filtration
NXP Semiconductors NV
Nyrstar
Nyxoah
Océ
OCI
Octoplus
Oil States International
Onconova Therapeutics
Ontex
Onward Medical
Onxeo SA
OpenTV
OpGen
Opinies - Tilburg Trading Club
Opportunty Investment Management
Orange Belgium
Oranjewoud
Ordina Beheer
Oud ForFarmers
Oxurion (vh ThromboGenics)
P&O Nedlloyd
PAVmed
Payton Planar Magnetics
Perpetuals, Steepeners
Pershing Square Holdings Ltd
Personalized Nursing Services
Pfizer
Pharco
Pharming
Pharnext
Philips
Picanol
Pieris Pharmaceuticals
Plug Power
Politiek
Porceleyne Fles
Portugese aandelen
PostNL
Priority Telecom
Prologis Euro Prop
ProQR Therapeutics
PROSIEBENSAT.1 MEDIA SE
Prosus
Proximus
Qrf
Qualcomm
Quest For Growth
Rabobank Certificaat
Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
Resilux
Retail Estates
RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)