Ontvang nu dagelijks onze kooptips!
word abonnee
sluiten ✕
Erytech Pharma SA (ERYP)
Volgen
Erytech Pharma SA (ERYP) Wie zit hier ook in? Interessant bedrijf volgens mij. Heeft een middel tegen alvleesklier kanker in onderzoek. Is flink gedaald in de afgelopen jaren, maar heeft vrij goede analistenbeoordeling en koersdoelen (for what it's worth). erytech.com/ En: Who Owns Most Of ERYTECH Pharma SA (EPA:ERYP)?finance.yahoo.com/news/owns-most-eryt...
Erytech Pharma S.A. Wed, July 21, 2021, 10:05 PM In this article: View my watchlists ERYTECH Confirms Plans To Submit BLA for Eryaspase in Hypersensitive ALL Patients Meeting with the U.S. FDA clarified steps and requirements for the submission of a Biologics License Application (BLA) for eryaspase for the treatment of ALL patients who developed hypersensitivity reactions to prior asparaginase therapy, supported by the NOPHO1-sponsored Phase 2 trial data, previously presented at the ASH 2020 Annual Meeting The Company expects to submit the BLA before the end of the year Cambridge, MA (U.S.) and Lyon (France), July 21, 2021 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced its intention to move forward towards the submission of a BLA to the US Food and Drug Administration (FDA) for eryaspase in hypersensitive acute lymphoblastic leukemia (ALL) patients following feedback from the agency in a pre-BLA meeting. The purpose for the meeting was to discuss clinical, non-clinical and quality content and expectations for the Company’s potential BLA submission. Based on the discussion and the totality of the available information to the Company to date, ERYTECH believes its regulatory package can potentially support an approval of eryaspase in hypersensitive ALL patients. Pending successful completion of remaining steps, the Company anticipates submitting a BLA in the fourth quarter of 2021. “We are encouraged by the interactive dialogue with the agency, and grateful for the feedback and guidance we received on a potential path to approval,” said Gil Beyen, CEO of ERYTECH. “This is an important milestone for ERYTECH as it advances our lead product candidate eryaspase as an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase, while our Phase 3 trial in second line pancreatic cancer is nearing completion. If all goes well, we could be in a position to make this product candidate available to ALL and pancreatic cancer patients in the course of next year.” In December 2020, positive Phase 2 clinical results were presented by the Nordic Society of Pediatric Hematology and Oncology, at the 2020 American Society of Hematology annual meeting. Eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions. About Acute Lymphoblastic Leukemia Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options. About ERYTECH and eryaspase ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival. The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells’ altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of triple-negative breast cancer. An investigator sponsored Phase 2 trial (IST) in acute lymphoblastic leukemia recently reported positive results, and a Phase 1 IST in 1L advanced pancreatic cancer is ongoing. Eryaspase received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced pancreatic cancer. The FDA and the European Medicines Agency have granted eryaspase orphan drug status for the treatment of pancreatic cancer and ALL. ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA. Eryaspase is not an approved medicine. ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit www.erytech.com
Laatste (22/07/21 - 09:06) 4,56 Wijziging (0,88) 23,91%
nabeurs gingen ze in de States naar Consolidated Last Sale $9.73 +5.62 (+136.74%) After-Hours Volume 1,279,519 After-Hours High $22 (04:15:06 PM) : 1.18 = 18.64 euro. ERYTECH Granted U.S. FDA Fast Track Designation for Eryaspase in Hypersensitive ALL Fast Track designation for eryaspase underscores the need for new treatment options for patients who developed hypersensitivity reactions to pegylated asparaginase Cambridge, MA (U.S.) and Lyon (France), July 29, 2021 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase). “This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a BLA for eryaspase in hypersensitive ALL patients,” said Gil Beyen, CEO of ERYTECH. “We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.” Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival, highlighting the need for additional asparaginase based treatment options. In December 2020, positive results from a Phase 2 trial evaluating the safety and enzyme activity of eryaspase in primarily pediatric ALL patients who developed hypersensitivity reactions to pegylated asparaginase were presented by the Nordic Society of Pediatric Hematology and Oncology at the 2020 American Society of Hematology annual meeting. This data demonstrated that eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions. The Company recently confirmed its intention to submit a Biologics License Application (BLA) for eryaspase in this indication in the fourth quarter of 2021 pending successful completion of remaining steps. Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. In April 2020, eryaspase was also granted Fast Track designation for the development of a second-line treatment of patients with metastatic pancreatic cancer. A Phase 3 trial in this indication completed enrollment in January 2021 and final results are expected in the fourth quarter of 2021. About Acute Lymphoblastic Leukemia Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options. About FDA Fast Track Designation Fast Track is a program designed to facilitate the expedited development and review of a new drug alone or in combination with other drugs to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions. A drug that receives Fast Track designation is eligible for some or all of the following: More frequent meetings and interactions with the review team at the FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval as well as to discuss accelerated approval, the structure and content of an NDA, and other critical issues. More frequent written communications from FDA about such things as the design of the proposed clinical trials and use of biomarkers. Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the marketing application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA. About ERYTECH and eryaspase ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival. The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells’ altered asparagine and glutamine metabolism. Eryaspase is in a Phase 3 clinical development for the treatment of second-line pancreatic cancer, which is fully enrolled and expected to read out final results in Q4 2021, and in an ongoing Phase 2 for the treatment of triple-negative breast cancer. An investigator sponsored Phase 2 trial (IST) in acute lymphoblastic leukemia recently reported positive results, and a Phase 1 IST in 1L advanced pancreatic cancer is ongoing. Eryaspase received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced pancreatic cancer and treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase). The FDA and the European Medicines Agency have granted eryaspase orphan drug status for the treatment of pancreatic cancer and ALL. ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA. Eryaspase is not an approved medicine. ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit www.erytech.com
This company has great and promising potential!
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
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
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
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)
Indices
AEX
881,78
+0,30%
EUR/USD
1,0789
0,00%
FTSE 100
7.952,62
+0,26%
Germany40^
18.505,40
+0,15%
Gold spot
2.234,24
0,00%
NY-Nasdaq Composite
16.379,46
-0,12%
Stijgers
Dalers