Pharming « Terug naar discussie overzicht

quote:

Blub schreef op 16 maart 2021 09:15:

Pharming komt in ieder geval uit de dalende trend, dat is positief. gezien de cijfers die er snel gaan komen lijkt het of er meer oprechte belangstelling is.
Ik heb iets verlies en wacht zelf ook de cijfers af. Ik heb best een enorme positie en had eerlijk is eerlijk verwacht dat PH rond 1.60-1.80 euro zou opereren. Tot nu toe komt dat erg bedrogen uit, maar met PH kan het ineens hard gaan. Dat blijft natuurlijk erg plezierig.
Risico naar beneden en minder dan omhoog. Lijkt mij een koopwaardig aandeel

Succes allemaal

quote:

De Monitor - Pharming Professor schreef op 16 maart 2021 09:21:

TAKEDA SUBMITS NEW DRUG APPLICATION FOR LANADELUMAB IN JAPAN
Takeda Pharmaceutical Company Limited has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of HAE.

In Japan, it is estimated that between 2,000 and 3,000 people are living with HAE, but only approximately 450 have been diagnosed due to low awareness of the disorder.

“Recognition of HAE remains low in Japan, meaning there are significant challenges relating to diagnosis and access to effective therapies,” says Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. “Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.

The submission of the New Drug Application in Japan is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE), in addition to interim results of a Phase 3 study evaluating the efficacy and safety of lanadelumab in Japanese subjects. Combined, these studies have demonstrated the efficacy and safety profile of lanadelumab as a preventive treatment for HAE attacks. If approved, lanadelumab will be available to patients in Japan as a pre-filled syringe presentation.

The regulatory submission in Japan will be evaluated by the Japanese Pharmaceuticals and Medical Devices Agency. Following its review, the Agency will issue a report to the Ministry of Health, Labour and Welfare of Japan for a final decision.

Lanadelumab, under the tradename Takhzyro, received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 and is now available in more than 20 countries with additional regulatory submissions ongoing worldwide.
(Source: Takeda)

haei.org/takeda-submits-new-drug-appl...

quote:

zjeeraar schreef op 16 maart 2021 09:17:

Als de koers ff oploopt wordt deze bijna gelijk weer de kop ingedrukt.

Deze move herhaald zich steeds en blijf het vreemd vinden.......

quote:

De Monitor - Pharming Professor schreef op 16 maart 2021 09:31:

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Vreemd dat jij deze persoonlijke vete mag blijven voortzetten.

quote:

Mr.Fox! schreef op 16 maart 2021 09:39:

Licht opgaande trend sinds een week of 3, keer nieuws erbij en hij knalt door richting 1.25 verwacht ik. Dieptepunt is wel achter de rug zoals ik het bekijk.

quote:

De Monitor - Pharming Professor schreef op 16 maart 2021 09:21:

TAKEDA SUBMITS NEW DRUG APPLICATION FOR LANADELUMAB IN JAPAN
Takeda Pharmaceutical Company Limited has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of HAE.

In Japan, it is estimated that between 2,000 and 3,000 people are living with HAE, but only approximately 450 have been diagnosed due to low awareness of the disorder.

“Recognition of HAE remains low in Japan, meaning there are significant challenges relating to diagnosis and access to effective therapies,” says Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. “Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.

The submission of the New Drug Application in Japan is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE), in addition to interim results of a Phase 3 study evaluating the efficacy and safety of lanadelumab in Japanese subjects. Combined, these studies have demonstrated the efficacy and safety profile of lanadelumab as a preventive treatment for HAE attacks. If approved, lanadelumab will be available to patients in Japan as a pre-filled syringe presentation.

The regulatory submission in Japan will be evaluated by the Japanese Pharmaceuticals and Medical Devices Agency. Following its review, the Agency will issue a report to the Ministry of Health, Labour and Welfare of Japan for a final decision.

Lanadelumab, under the tradename Takhzyro, received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 and is now available in more than 20 countries with additional regulatory submissions ongoing worldwide.
(Source: Takeda)

haei.org/takeda-submits-new-drug-appl...

quote:

De Monitor - Pharming Professor schreef op 16 maart 2021 09:41:

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En als Pharming moet melden dat de COVID trial niet succesvol verlopen is?

quote:

De Monitor - Pharming Professor schreef op 16 maart 2021 09:41:

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En als Pharming moet melden dat de COVID trial niet succesvol verlopen is?

quote:

Mr.Fox! schreef op 16 maart 2021 09:47:

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Gezien de K/W verhouding binnen deze industrie en het feit dat men al 13 kwartalen winst draait verwacht ik dan geen drastische daling. Uiteraard zal hier een kortstondige reactie van de markt op komen, welke snel weer gecorrigeerd zal worden door de grote jongens om bij te kopen (gezien de opnieuw verwachte omzet stijging 2021 + prima cijfers).

quote:

Potverdikkies schreef op 16 maart 2021 09:50:

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En als ze moeten melden dat het wel succesvol verlopen is?

De koersreactie van een succesvolle trial zal stukken groter zijn dan wanneer het niet niet succesvol zal zijn.

quote:

Mar-e-tak schreef op 16 maart 2021 09:11:

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Het was maar een grapje.........

quote:

Wijze man schreef op 16 maart 2021 09:24:

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Is dat nu een vetgedrukte, schreeuwerige aanhef waard?