Erytech Pharma
Erytech Pharma
Was nog geen topic over dit aandeel, dus bij deze.
ERYTECH PHARMA (Euronext Paris) ERYP
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s 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.
Sinds deze week veel grotere volumes dan gewoonlijk en prijs is reeds verdubbeld sinds eind vorige week.
Hebben enkele producten in de pijplijn, deze week zijn er nieuwe positieve resultaten vrijgegeven over de verst gevorderde.
Met marktkapitaal van 100 mln USD heeft het nog veel groeipotentieel.
Ik vind er weinig over terug op andere fora, dus hopelijk worden hier interessante visies gedeeld.
Wat is jullie gedacht ?
neku liked last!
ERYTECH PHARMA (Euronext Paris) ERYP
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s 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.
Sinds deze week veel grotere volumes dan gewoonlijk en prijs is reeds verdubbeld sinds eind vorige week.
Hebben enkele producten in de pijplijn, deze week zijn er nieuwe positieve resultaten vrijgegeven over de verst gevorderde.
Met marktkapitaal van 100 mln USD heeft het nog veel groeipotentieel.
Ik vind er weinig over terug op andere fora, dus hopelijk worden hier interessante visies gedeeld.
Wat is jullie gedacht ?
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Re: Erytech Pharma
ik ben mee voor een geweldige ritgiveme schreef: ↑29 apr 2020 12:04Was nog geen topic over dit aandeel, dus bij deze.
ERYTECH PHARMA (Euronext Paris) ERYP
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s 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.
Sinds deze week veel grotere volumes dan gewoonlijk en prijs is reeds verdubbeld sinds eind vorige week.
Hebben enkele producten in de pijplijn, deze week zijn er nieuwe positieve resultaten vrijgegeven over de verst gevorderde.
Met marktkapitaal van 100 mln USD heeft het nog veel groeipotentieel.
Ik vind er weinig over terug op andere fora, dus hopelijk worden hier interessante visies gedeeld.
Wat is jullie gedacht ?
Re: Erytech Pharma
09/06/2020 | 08:54topkoop schreef: ↑07 mei 2020 21:10ik ben mee voor een geweldige ritgiveme schreef: ↑29 apr 2020 12:04Was nog geen topic over dit aandeel, dus bij deze.
ERYTECH PHARMA (Euronext Paris) ERYP
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s 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.
Sinds deze week veel grotere volumes dan gewoonlijk en prijs is reeds verdubbeld sinds eind vorige week.
Hebben enkele producten in de pijplijn, deze week zijn er nieuwe positieve resultaten vrijgegeven over de verst gevorderde.
Met marktkapitaal van 100 mln USD heeft het nog veel groeipotentieel.
Ik vind er weinig over terug op andere fora, dus hopelijk worden hier interessante visies gedeeld.
Wat is jullie gedacht ?
Erytech fait le point sur l’étude de phase 2 menée par des chercheurs évaluant eryaspase en traitement de seconde ligne de la leucémie aiguë lymphoblastique. Cette étude, menée au travers de 22 sites cliniques dans les pays scandinaves et les pays baltes, a atteint son objectif de recrutement suite à l’inclusion du 50e patient. Les résultats préliminaires de l'étude suggèrent qu'eryaspase a atteint le niveau et la durée d'action de l'asparaginase visés chez ces patients.
En outre, l'adjonction d'eryaspase à la chimiothérapie révèle un profil de tolérance acceptable, permettant à la majorité de ces patients de recevoir les protocoles complets d'asparaginase.
Des données récentes confirment que l'interruption des traitements avec de l'asparaginase induit un taux de survie sans récidive de LAL inférieur.
La biotech francaise a indiqué que les signes encourageants d'activité mis en évidence dans le cadre de l'étude pourraient justifier l'emploi d'eryaspase en tant que traitement additionnel potentiel pour cette population de patients.
Elle a a l'intention de poursuivre le dialogue avec la FDA concernant ces données au fur et à mesure de leur analyse, afin de décider des prochaines étapes et de la poursuite éventuelle du développement d'eryaspase dans cette indication;
Re: Erytech Pharma
toch een lek
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
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
Re: Erytech Pharma
voorlopig voorbeurs 4.13
Re: Erytech Pharma
July 29 (Reuters) - Erytech Pharma SA :
* ERYTECH GRANTED U.S. FDA FAST TRACK DESIGNATION FOR
ERYASPASE IN
HYPERSENSITIVE ALL
Source text for Eikon:
Further company coverage:
(([email protected];))
* ERYTECH GRANTED U.S. FDA FAST TRACK DESIGNATION FOR
ERYASPASE IN
HYPERSENSITIVE ALL
Source text for Eikon:
Further company coverage:
(([email protected];))
