FUM.L (Mkap 15 M€) Best in Class Erektionsmittel in P3 (Daten im 2H 2019) (Seite 39)
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ISIN: GB0033278473 · WKN: 911670 · Symbol: GYX
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Letzter Kurs 02.05.24 Frankfurt
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,2000 | +471,16 | |
| 13,110 | +38,44 | |
| 1,2100 | +21,00 | |
| 27,50 | +19,57 | |
| 4,4900 | +19,10 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 4,6300 | -11,81 | |
| 40,23 | -12,54 | |
| 4,5001 | -13,46 | |
| 0,9378 | -18,55 | |
| 36,70 | -22,87 |
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Antwort auf Beitrag Nr.: 60.875.061 von Chancen1904 am 24.06.19 10:00:04Es ist eher positiv zu werten das es nur eine Verzögerung ist denn die alternative wäre entweder eine komplette Ablehnung gewesen oder FUM müsste den Zulassungsantrag zurückziehen und nach getaner arbeit wieder einreichen was für den Kurs ähnlich schlecht wäre wie die Ablehnung . Es ist nicht ungewöhnlich das die Zulassungsbehörden in Europa während des Zulassungsverfahren zusätzliche daten oder kleine tests verlangen und dadurch zu verzögerungen kommen kann .Da die Zulassungsbehörden in der regel ein befristestes Zeitfenster vorgeben in der die daten eingereicht werden müssen scheint es keine große sache zu sein sonst wie gesagt wäre das was ich oben schon geschrieben habe passiert .
Marktkap ca £70 million (~€78 M) , eine weitere verdoppelung ist vor den Daten noch möglich aber dann muss geliefert werden , dann heißt entweder absturz auf 5p oder die MED daten sind so gut das die Aktie richtung £2.50+ wandert . TPR100 ist eher zu vernachlässigen auch wenn die Zulassung den Kurs treiben könnte so ist das Marktpotenzial nicht hoch alles hängt an MED .Viel Glück
Marktkap ca £70 million (~€78 M) , eine weitere verdoppelung ist vor den Daten noch möglich aber dann muss geliefert werden , dann heißt entweder absturz auf 5p oder die MED daten sind so gut das die Aktie richtung £2.50+ wandert . TPR100 ist eher zu vernachlässigen auch wenn die Zulassung den Kurs treiben könnte so ist das Marktpotenzial nicht hoch alles hängt an MED .Viel Glück
Antwort auf Beitrag Nr.: 60.912.291 von Stoxtrayder am 28.06.19 12:34:33Sagt er da 5 Billion Market AT THE MOMENT?
Richtung 34 Pence heute, 52-Wochen-Hoch 👌
Sehr interessanter Fund aus dem UK-Forum:
http://www.liberum.com/videos/futura-medical
Sehr interessanter Fund aus dem UK-Forum:
http://www.liberum.com/videos/futura-medical
Die Verspätung von TPR100 scheint der Markt gut aufzunehmen...Minus verkleinert sich und wieder mal hat die 30 Pence-Marke gehalten. Ich glaube nicht, daß es nochmals bis 25 Pence korrigiert. Und wie gesagt, falls Partner (Big Pharma?!) vor Bekanntgabe der PIII im Dezember beider Medis bekanntgegeben werden, gibts keine Kurse mehr unter 50 Pence...
Antwort auf Beitrag Nr.: 60.875.061 von Chancen1904 am 24.06.19 10:00:04unter 25 GBX wieder gute Gelegenheit zum Einstieg / Nachkauf
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Antwort auf Beitrag Nr.: 60.875.031 von Chancen1904 am 24.06.19 09:54:35Jetzt haben wir eine Timeline für TPR100.
Leider wird es später als ich es erwartet hatte. Ich habe ehrlich gesagt mit einer Opinion bis September gerechnet - jetzt wird es ein Quartal später. Ob der Kurs nochmal zurückkommt?
Aktuell 30 GBX (-8,5%)
Leider wird es später als ich es erwartet hatte. Ich habe ehrlich gesagt mit einer Opinion bis September gerechnet - jetzt wird es ein Quartal später. Ob der Kurs nochmal zurückkommt?
Aktuell 30 GBX (-8,5%)
AGM Statement
24 June 2019
Patient recruitment completed for MED2005 first European Phase 3 study "FM57" and on track to deliver headline data by the end of 2019
TPR100 - Thornton & Ross responding to MHRA questions
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology currently focused on sexual health and pain, is pleased to announce that John Clarke, Chairman, will provide the following update at the Company's Annual General Meeting ("AGM") which is being held at 10am BST later today in London.
MED2005 - Topical gel for erectile dysfunction ("ED")
On 19 June 2019, the Company announced the completion of patient recruitment for the first European Phase 3 study, "FM57", of MED2005. The 1,000 patient study for the treatment of mild, moderate and severe erectile dysfunction ("ED") includes approximately 60 centres across Central and Eastern Europe. Futura remains on track to deliver headline data by the end of 2019.
Planning for a second, confirmatory Phase 3 study for MED2005 has been undertaken, after extensive dialogue with regulators and KOLs in the field of ED. This study will incorporate a US patient cohort which is expected to facilitate regulatory filing in the US. This second study will be informed by the receipt and analysis of the first Phase 3 data. The Company plans to shortly commence pre-recruitment start-up activities, such as Regulatory and Ethics approvals which can take up to six months to complete to ensure recruitment is not delayed. Patient recruitment will start as soon as possible after the first Phase 3 study data analysis is complete.
It is usual for two Phase 3 studies to be required for regulatory filing. However, depending on data from the first European Phase 3 study, Futura may explore filing MED2005 with regulatory bodies in Europe with one Phase 3 study which could occur during 2020. The US FDA has been clear that two studies are required, and filing will await results from the second Phase 3 study.
TPR100 - Topical gel for pain relief
The Company's novel topical pain relief gel TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA AG. In response to Thornton & Ross's marketing authorisation application filed in July 2018, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has raised a number of questions requiring additional lab work to be conducted. This work is well advanced, and we expect Thornton & Ross to respond to the MHRA in September with regulatory opinion before the end of the year.
The Company has received expressions of interest from a number of parties to enable Futura to expand the geographical reach of TPR100. Futura is awaiting regulatory authorisation in the UK before progressing further.
Futura's Chairman, John Clarke, commented: "We continue to make good progress in the development and commercialisation of our pipeline of product opportunities. We are pleased to have completed recruitment for the first European Phase 3 study of MED2005 and eagerly await the Phase 3 data read-out at the end of the year. We look forward to updating the market on Futura's developments during 2019, which I expect to be a year of very significant progress for the Company."
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 203 100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
Notes to editors:
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.
The first European Phase 3 study for MED2005, referred to as "FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2005 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment of erectile dysfunction with an open label extension. FM57 is progressing on track, with headline data expected by the end of 2019.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com
24 June 2019
Patient recruitment completed for MED2005 first European Phase 3 study "FM57" and on track to deliver headline data by the end of 2019
TPR100 - Thornton & Ross responding to MHRA questions
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology currently focused on sexual health and pain, is pleased to announce that John Clarke, Chairman, will provide the following update at the Company's Annual General Meeting ("AGM") which is being held at 10am BST later today in London.
MED2005 - Topical gel for erectile dysfunction ("ED")
On 19 June 2019, the Company announced the completion of patient recruitment for the first European Phase 3 study, "FM57", of MED2005. The 1,000 patient study for the treatment of mild, moderate and severe erectile dysfunction ("ED") includes approximately 60 centres across Central and Eastern Europe. Futura remains on track to deliver headline data by the end of 2019.
Planning for a second, confirmatory Phase 3 study for MED2005 has been undertaken, after extensive dialogue with regulators and KOLs in the field of ED. This study will incorporate a US patient cohort which is expected to facilitate regulatory filing in the US. This second study will be informed by the receipt and analysis of the first Phase 3 data. The Company plans to shortly commence pre-recruitment start-up activities, such as Regulatory and Ethics approvals which can take up to six months to complete to ensure recruitment is not delayed. Patient recruitment will start as soon as possible after the first Phase 3 study data analysis is complete.
It is usual for two Phase 3 studies to be required for regulatory filing. However, depending on data from the first European Phase 3 study, Futura may explore filing MED2005 with regulatory bodies in Europe with one Phase 3 study which could occur during 2020. The US FDA has been clear that two studies are required, and filing will await results from the second Phase 3 study.
TPR100 - Topical gel for pain relief
The Company's novel topical pain relief gel TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA AG. In response to Thornton & Ross's marketing authorisation application filed in July 2018, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has raised a number of questions requiring additional lab work to be conducted. This work is well advanced, and we expect Thornton & Ross to respond to the MHRA in September with regulatory opinion before the end of the year.
The Company has received expressions of interest from a number of parties to enable Futura to expand the geographical reach of TPR100. Futura is awaiting regulatory authorisation in the UK before progressing further.
Futura's Chairman, John Clarke, commented: "We continue to make good progress in the development and commercialisation of our pipeline of product opportunities. We are pleased to have completed recruitment for the first European Phase 3 study of MED2005 and eagerly await the Phase 3 data read-out at the end of the year. We look forward to updating the market on Futura's developments during 2019, which I expect to be a year of very significant progress for the Company."
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 203 100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
Notes to editors:
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.
The first European Phase 3 study for MED2005, referred to as "FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2005 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment of erectile dysfunction with an open label extension. FM57 is progressing on track, with headline data expected by the end of 2019.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com
Nö, bin weder in RavenQuest noch in CytoDyn investiert. CytoDyn steht momentan ziemlich hoch auf meiner Watchlist...😉
Antwort auf Beitrag Nr.: 60.840.952 von Stoxtrayder am 19.06.19 12:34:51
Willst noch ---->nööööööööö<----n WEITEREN Bio, 2 look(---->@@@@@<----)??
RavenQuest, bist Du Da aktiv geworden?
Zitat von Stoxtrayder: Yep, ohne Biohero wären wir hier wohl nie auf die Aktie aufmerksam geworden...😯
Schade, daß er nicht mehr hier aktiv ist. 😕
Habe einen Durchschnitts-EK von 0,16 Euro. Das 1. Mal im Januar gekauft und noch 2x aufgestockt. Sechst größte Position (nach Clinuvel, AEterna, Sirona, Evotec & Intertainment) mittlerweile im Depot. 😉
Willst noch ---->nööööööööö<----n WEITEREN Bio, 2 look(---->@@@@@<----)??
RavenQuest, bist Du Da aktiv geworden?
Schönes Intraday-Reversal gestern 💪
Ich denke unter 30 Pence wird es schwer, nochmals zum Zug zu kommen...
Ich denke unter 30 Pence wird es schwer, nochmals zum Zug zu kommen...
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