PHARMA MAR (PHM.MC) -- ehemals Zeltia (Seite 62)
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Antwort auf Beitrag Nr.: 56.513.075 von Marenostrum am 21.12.17 09:24:57Bin nun auch gespannt wie es hier weitergeht und ob PHM hier nun schon interveniert oder erst das endgültige Urteil der Europäischen Kommission abwartet.
"After the opinion of the CHMP, the European Commission will be in charge of emitting the final verdict, which could arrive around March or April, 2018."
https://www.pharmamar.com/wp-content/uploads/2017/12/PR_Nega…
"After the opinion of the CHMP, the European Commission will be in charge of emitting the final verdict, which could arrive around March or April, 2018."
https://www.pharmamar.com/wp-content/uploads/2017/12/PR_Nega…
Antwort auf Beitrag Nr.: 56.508.899 von pischtie_hufnagel am 20.12.17 19:48:51Dieses EMA-Papier ist schon ziemlich starker Tobak angesichts der Daten und der Zusammenfassung auf der ASH-Präsentation:
CONCLUSIONS: This phase III trial on plitidepsin in combination with DXM showed prolongation of both PFS and OS, with a remarkable duration of response. These efficacy data, the reassuring safety profile and the novel mechanism of action of plitidepsin suggest that plitidepsin plus DXM can be considered as a new treatment option in patients with relapsed/refractory MM.
Entweder redet man hier aneinander vorbei oder es gibt (bewusste?) Missinterpretationen der Studienergebnisse. Man darf jetzt sehr gespannt sein auf die folgenden Schritte, die PHM einleiten wird. Ich kann mir nicht vorstellen, dass das Unternehmen diese EMA-Entscheidung so ohne Weiteres schlucken wird. Mit Yondelis haben die ja praktisch das Gleiche schon mal durchexzerzieren müssen. Interessant waren in diesem Kontext die Meldungen der spanischen Medien in der letzten Woche, dass es jetzt wohl eine Entscheidung auf der Ebene der EU-Kommission geben würde.
CONCLUSIONS: This phase III trial on plitidepsin in combination with DXM showed prolongation of both PFS and OS, with a remarkable duration of response. These efficacy data, the reassuring safety profile and the novel mechanism of action of plitidepsin suggest that plitidepsin plus DXM can be considered as a new treatment option in patients with relapsed/refractory MM.
Entweder redet man hier aneinander vorbei oder es gibt (bewusste?) Missinterpretationen der Studienergebnisse. Man darf jetzt sehr gespannt sein auf die folgenden Schritte, die PHM einleiten wird. Ich kann mir nicht vorstellen, dass das Unternehmen diese EMA-Entscheidung so ohne Weiteres schlucken wird. Mit Yondelis haben die ja praktisch das Gleiche schon mal durchexzerzieren müssen. Interessant waren in diesem Kontext die Meldungen der spanischen Medien in der letzten Woche, dass es jetzt wohl eine Entscheidung auf der Ebene der EU-Kommission geben würde.
Antwort auf Beitrag Nr.: 56.508.899 von pischtie_hufnagel am 20.12.17 19:48:51
https://ash.confex.com/ash/2017/webprogram/Paper101691.html
FINDINGS:
A total of 255 patients were randomly assigned to receive either plitidepsin plus DXM (Arm A, n=171) or DXM alone (Arm B, n=84). Thirty-seven patients (44%) from Arm B crossed over to the combination arm (Arm A). A total of 167 patients were treated in Arm A and 83 in Arm B. Median PFS with confirmation of PD by Investigator’s assessment (IA) was 3.8 months (95% CI, 2.9-5.6 months) in Arm A and 1.9 months (95% CI, 1.1-2.7 months) in Arm B (HR=0.611; p=0.0048). Median PFS with plitidepsin plus DXM without confirmation of PD according to Independent Review Committee (IRC) was 2.6 months (95% CI, 1.9-3.0 months) in Arm A and 1.7 months (95% CI, 1.1-2.0 months) in Arm B (HR=0.650; p=0.0062). A trend for longer OS was observed in Arm A, with a median of 11.6 months (95% CI, 9.2-16.1 months) and 8.9 months (95% CI, 6.0-15.4 months) in Arm B, (HR=0.797; p=0.1273). When the crossover is mitigated by a sensitivity analysis based on the two-stage method proposed by Latimer et al., a significant difference in OS was observed (median of 11.6 months in Arm A and estimated as 6.7 months in Arm B) (HR=0.667; p=0.0069). Subsequent therapies were similar in both treatment arms. Objective response rate (ORR; ≥partial response) according to the IRC in evaluable patients was 13.8% in Arm A and 1.7% in Arm B, with a median duration of response of 12.0 months in Arm A (1.8 months in the only patient with response in Arm B). Responding patients in Arm A had a median OS of 37.8 months (OS was 27.7 months in the patient with response in Arm B, who crossed over to Arm A).
The most common grade 3-4 treatment-related adverse events (% of patients in Arm A/Arm B) were fatigue (10.8%/1.2%), myalgia (5.4%/0%) and nausea (3.6%/1.2%). The most common grade 3-4 hematological/non-hematological laboratory abnormalities regardless of relationship (% of patients in Arm A/Arm B) were anemia (31.3%/35.4%), thrombocytopenia (21.9%/27.9%), neutropenia (15.7%/5.1%), CPK increase (20%/0%), ALT increase (14.5%/0%) and AST increase (8.9%/0%). Most of these events were transient and reversible. Fifteen patients (9%) discontinued treatment due to treatment-related adverse events in Arm A; 3 (6.5%) in Arm B, and 5 in crossover patients (13.5%). One treatment-related adverse event lead to death in Arm A (0.6%) and one in Arm B (1.2%).
ASH - Randomized Phase III Study (ADMYRE)
hier nochmal die auf der ASH vorgestellten zahlen der studiehttps://ash.confex.com/ash/2017/webprogram/Paper101691.html
FINDINGS:
A total of 255 patients were randomly assigned to receive either plitidepsin plus DXM (Arm A, n=171) or DXM alone (Arm B, n=84). Thirty-seven patients (44%) from Arm B crossed over to the combination arm (Arm A). A total of 167 patients were treated in Arm A and 83 in Arm B. Median PFS with confirmation of PD by Investigator’s assessment (IA) was 3.8 months (95% CI, 2.9-5.6 months) in Arm A and 1.9 months (95% CI, 1.1-2.7 months) in Arm B (HR=0.611; p=0.0048). Median PFS with plitidepsin plus DXM without confirmation of PD according to Independent Review Committee (IRC) was 2.6 months (95% CI, 1.9-3.0 months) in Arm A and 1.7 months (95% CI, 1.1-2.0 months) in Arm B (HR=0.650; p=0.0062). A trend for longer OS was observed in Arm A, with a median of 11.6 months (95% CI, 9.2-16.1 months) and 8.9 months (95% CI, 6.0-15.4 months) in Arm B, (HR=0.797; p=0.1273). When the crossover is mitigated by a sensitivity analysis based on the two-stage method proposed by Latimer et al., a significant difference in OS was observed (median of 11.6 months in Arm A and estimated as 6.7 months in Arm B) (HR=0.667; p=0.0069). Subsequent therapies were similar in both treatment arms. Objective response rate (ORR; ≥partial response) according to the IRC in evaluable patients was 13.8% in Arm A and 1.7% in Arm B, with a median duration of response of 12.0 months in Arm A (1.8 months in the only patient with response in Arm B). Responding patients in Arm A had a median OS of 37.8 months (OS was 27.7 months in the patient with response in Arm B, who crossed over to Arm A).
The most common grade 3-4 treatment-related adverse events (% of patients in Arm A/Arm B) were fatigue (10.8%/1.2%), myalgia (5.4%/0%) and nausea (3.6%/1.2%). The most common grade 3-4 hematological/non-hematological laboratory abnormalities regardless of relationship (% of patients in Arm A/Arm B) were anemia (31.3%/35.4%), thrombocytopenia (21.9%/27.9%), neutropenia (15.7%/5.1%), CPK increase (20%/0%), ALT increase (14.5%/0%) and AST increase (8.9%/0%). Most of these events were transient and reversible. Fifteen patients (9%) discontinued treatment due to treatment-related adverse events in Arm A; 3 (6.5%) in Arm B, and 5 in crossover patients (13.5%). One treatment-related adverse event lead to death in Arm A (0.6%) and one in Arm B (1.2%).
EMA Refusal of the marketing authorisation for Aplidin (plitidepsin)
The CHMP was concerned that the data from the main study showed only a modest increase of around one month in the time patients given Aplidin lived without their disease getting worse, compared with those treated with dexamethasone alone. In addition, improvement in overall survival (how long
patients lived overall) was not sufficiently demonstrated.
Regarding safety, severe side effects were reported more frequently with the combination of Aplidin and dexamethasone than with dexamethasone alone.
Based on the above, the CHMP was of the opinion that the benefits of Aplidin did not outweigh its risks and recommended that it be refused marketing authorisation.
http://www.ema.europa.eu/docs/en_GB/document_library/Summary…
The CHMP was concerned that the data from the main study showed only a modest increase of around one month in the time patients given Aplidin lived without their disease getting worse, compared with those treated with dexamethasone alone. In addition, improvement in overall survival (how long
patients lived overall) was not sufficiently demonstrated.
Regarding safety, severe side effects were reported more frequently with the combination of Aplidin and dexamethasone than with dexamethasone alone.
Based on the above, the CHMP was of the opinion that the benefits of Aplidin did not outweigh its risks and recommended that it be refused marketing authorisation.
http://www.ema.europa.eu/docs/en_GB/document_library/Summary…
Antwort auf Beitrag Nr.: 56.460.536 von pischtie_hufnagel am 15.12.17 15:09:50Hab's trotzdem nochmal mit einer kleinen Abstauberorder probiert. Vielleicht klappt es ja zum Handelsende heute...
Trading Spotlight
Antwort auf Beitrag Nr.: 56.460.227 von Marenostrum am 15.12.17 14:37:05...das Gute ist: Das untere gap konnte geschlossen werden.
Wer verkaufen wollte, dürfte bereits verkauft haben, insofern gute Bedingungen für Bodenbildung und Anstieg.
Wer verkaufen wollte, dürfte bereits verkauft haben, insofern gute Bedingungen für Bodenbildung und Anstieg.
Antwort auf Beitrag Nr.: 56.459.534 von pischtie_hufnagel am 15.12.17 13:37:51Ja, mit dieser hier bereits vorab kommentierten Negativ-Entscheidung musste man leider rechnen. In den spanischen Online-Medien ist die Meldung auch schon durch. Der Kurs schmiert ab, scheint sich aber von den heutigen Tiefstständen bereits wieder etwas zu erholen. M.E. sind das aktuell sagenhafte Kaufkurse (Buy the Dip). Wenn ich nur nicht schon wieder so cash-klamm wäre. Mal sehen, ob sich noch was machen lässt.
The CHMP confirms its earlier trend towards a negative vote for the commercialization of plitidepsin in Europe
As expected after the Company announcement of the 8th of November, the Committee for Medicinal Products for Human Use (CHMP), belonging to the EMA, has emitted an opinion against the approval of Aplidin®for the treatment of multiple myeloma.
As expected in the announcement made by PharmaMar on November 8th, the Committee for Medicinal Products for Human Use (CHMP) has finally emitted its opinion against the approval of the Marketing Authorization Application (MAA) of Aplidin® (plitidepsin), for the treatment of patients with relapsed multiple myeloma, in combination with dexamethasone.
After the opinion of the CHMP, the European Commission will be in charge of emitting the final verdict, which could arrive around March or April, 2018.
https://www.pharmamar.com/wp-content/uploads/2017/12/PR_Nega…
As expected after the Company announcement of the 8th of November, the Committee for Medicinal Products for Human Use (CHMP), belonging to the EMA, has emitted an opinion against the approval of Aplidin®for the treatment of multiple myeloma.
As expected in the announcement made by PharmaMar on November 8th, the Committee for Medicinal Products for Human Use (CHMP) has finally emitted its opinion against the approval of the Marketing Authorization Application (MAA) of Aplidin® (plitidepsin), for the treatment of patients with relapsed multiple myeloma, in combination with dexamethasone.
After the opinion of the CHMP, the European Commission will be in charge of emitting the final verdict, which could arrive around March or April, 2018.
https://www.pharmamar.com/wp-content/uploads/2017/12/PR_Nega…
Antwort auf Beitrag Nr.: 56.443.634 von bonDiacomova am 14.12.17 06:02:03ok, Danke, ...also "Familienunternehmen", free float entsprechend geschmälert, gefällt mir 
Antwort auf Beitrag Nr.: 56.443.616 von bonDiacomova am 14.12.17 05:44:26Wow, sehr interessantes Statement. Kann ich nur voll unterschreiben...
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