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Pharming april 2019

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BassieNL 8 april 2019 19:16

quote:
De Monitor schreef op 8 april 2019 19:11:
[...]

Inderdaad, ben ook maar een gewone man.

Op beleggingsplatform IEX.nl is hij moderator van fora over bedrijven als Galapagos, ING, TomTom en Pharming. Volgens hem moeten we ook het sociale aspect van beleggen niet onderschatten. „Vooral voor ouderen zijn de fora een manier om te delen wat ze weten over bedrijven, en tips te geven over de fouten die je als belegger niet moet maken.”

En daar ligt je kracht: je nuchtere kijk op de business, niet geleid door emotie.

Natal 8 april 2019 19:20

quote:
BassieNL schreef op 8 april 2019 19:16:
[...]
En daar ligt je kracht: je nuchtere kijk op de business, niet geleid door emotie.

Ja , Maar dan wel jammer die drammerigheid/wraakzucht

Emmen2019 8 april 2019 19:25

Hoe vaak is er nieuws over Pharming tot op heden gemeld in 2019? Welnu het is niet altijd nieuws via een PB van Pharming maarrrr, Januari 2019 1 x PB Pharming

23 Januari PB Pharming Presenteert op Congres
12 Februari 1x Nieuwsbericht over Frans Koop Advies
25 Februari PB Pharming over Sponsorschap AAAAAI
7 Maart PB Pharming over jaarwinst 2018
29 Maart PB Pharming over Minderheids- belang in Ampulvuller

Me dunkt een gemiddelde van bijna 2 x een PB of nieuws bericht , kunnen we in April dus best nog wel 1 of 2 PB of nieuws bericht verwachten lijkt mij :-)

Beursgoeroe 8 april 2019 19:31

en zo kabbelen we voort ……...

BassieNL 8 april 2019 19:31

quote:
Emmen2019 schreef op 8 april 2019 19:25:
Hoe vaak is er nieuws over Pharming tot op heden gemeld in 2019? Welnu het is niet altijd nieuws via een PB van Pharming maarrrr, Januari 2019 1 x PB Pharming

23 Januari PB Pharming Presenteert op Congres
12 Februari 1x Nieuwsbericht over Frans Koop Advies
25 Februari PB Pharming over Sponsorschap AAAAAI
7 Maart PB Pharming over jaarwinst 2018
29 Maart PB Pharming over Minderheids- belang in Ampulvuller

Me dunkt een gemiddelde van bijna 2 x een PB of nieuws bericht , kunnen we in April dus best nog wel 1 of 2 PB of nieuws bericht verwachten lijkt mij :-)

Allemaal flutnieuws.

voda 8 april 2019 19:31

quote:
Emmen2019 schreef op 8 april 2019 19:25:
Hoe vaak is er nieuws over Pharming tot op heden gemeld in 2019? Welnu het is niet altijd nieuws via een PB van Pharming maarrrr, Januari 2019 1 x PB Pharming

23 Januari PB Pharming Presenteert op Congres
12 Februari 1x Nieuwsbericht over Frans Koop Advies
25 Februari PB Pharming over Sponsorschap AAAAAI
7 Maart PB Pharming over jaarwinst 2018
29 Maart PB Pharming over Minderheids- belang in Ampulvuller

Me dunkt een gemiddelde van bijna 2 x een PB of nieuws bericht , kunnen we in April dus best nog wel 1 of 2 PB of nieuws bericht verwachten lijkt mij :-)

Hier een completer overzicht:

Laatste nieuws over Pharming
29/03/2019 07:32 Pharming wil minderheidsbelang in partner (DFT)
08/03/2019 17:47 AEX zakt stevig door zorgen economie (DFT)
07/03/2019 17:52 Kleine domper bij Pharming in groeiverhaal (DFT)
07/03/2019 15:50 Europese beurzen in de min na ECB-besluit (DFT)
07/03/2019 07:36 Jaarwinst voor biotechnoloog Pharming (DFT)
25/02/2019 07:36 Pharming wordt sponsor van AAAAI-stichting (DFT)
20/02/2019 19:21 Biotech-fondsen fors goedkoper (DFT)
07/12/2018 12:32 Beurs: Biotech en Ajax winnen op hoger Damrak (DFT)
07/12/2018 07:26 Positieve uitslag bij studie met Ruconest (DFT)
05/11/2018 16:59 'Pharming is interessant doelwit overname' (DFT)
25/10/2018 19:00 Pharming weerstaat concurrentie (DFT)

Meer nieuws »

www.trivano.com/aandeel/pharming.450....

Andre.A 8 april 2019 19:31

quote:
Emmen2019 schreef op 8 april 2019 18:43:
Persoonlijk heb ik vandaag 1 Positief Punt gezien :-) we zijn niet direct weer onder de 0,850 geschoten gelet op het vele rood vandaag op de koers borden :-)

Koers ontwikkeld zich positief, dalingen gaan met lage omzetten de stijgingen met hoge.

Emmen2019 8 april 2019 19:37

Voda: Allen Specifieke PB Pharming en Nieuws wat echt alleen over Pharming gaat en dan ook nog alleen 2019 :-) dan wordt jou lijst een stuk kleiner :-)

BassieNL : mee eens maar beter iets dan helemaal niets , en zeker in de BiopHpharma

Emmen2019 8 april 2019 19:47

AndreA : Mee eens , ben erg benieuwd of die 2 dagen met Hoger Volume deze week ook weer terug komen , zou het UP Sigment van de afgelopen 2 weken ondersteunen.

Louis7 8 april 2019 20:10

Ondertussen in de US, Pharming Group N.V. $ 0.9798 + 6.91% (volume 53.000).
www.marketwatch.com/investing/stock/p...

wiegveld 8 april 2019 20:12

6 things to know before the readout of BioCryst Pharma’s pivotal clinical trial.

A pivotal moment for BioCryst Pharmaceuticals (BCRX) is approaching.

In the next few months, the Durham, N.C.-based biotech will announce results from a Phase 3 clinical trial of its lead drug targeting a rare, genetic disease called hereditary angioedema. The outcome of the study is super important for BioCryst. Positive results mean a likely marketing approval and hundreds of millions of dollars in sales. If the study fails, BioCryst’s drug-development efforts start from scratch.

Here are six things to know about BioCryst’s drug that will help you prepare for the Phase 3 clinical trial readout.

wiegveld 8 april 2019 20:13

Hereditary angioedema is a rare, genetic disease that is debilitating for patients, and can be fatal.

It’s caused by a defect in a gene that controls the production of a blood protein called C1 inhibitor. When C1 inhibitor malfunctions or is absent, the body starts making excessive amount of two related proteins, which in turn causes blood vessels to release fluid into the body.

For hereditary angioedema (HAE) patients, this cascade of protein malfunction results in recurrent episodes or “attacks” of swelling (edema) in different parts of the body, including the hands, feet, face, and airway. Airway swelling can cause asphyxiation, which is why HAE can be deadly. HAE attacks can also occur in the intestinal wall, which causes patients to experience severe bouts of abdominal pain, nausea, and vomiting. HAE affects approximately one in 50,000 people.

wiegveld 8 april 2019 20:13

BioCryst is attempting to bring a more convenient treatment option to HAE patients.

There are seven approved medicines to treat HAE that work by either delivering functional C1 inhibitor to the body, or by suppressing the downstream production of the misbehaving, tissue-swelling proteins. These drugs are used to either prevent HAE attacks — so-called prophylaxis treatment — or to ameliorate attacks after they occur. All of these approved HAE medicines are administered with regular injections under the skin or via intravenous infusion.

BioCryst is hoping its drug, called BCX7353, will be the first approved oral therapy for the prevention of HAE attacks. The capsule, taken once per day, works by suppressing the production of the downstream proteins that cause blood vessels to release fluid.

wiegveld 8 april 2019 20:13

The primary goal of the BioCryst Phase 3 study is to reduce the frequency of HAE attacks.

The study, called APeX-2, is evaluating two doses of BCX7353 compared against a placebo. More than 120 patients with HAE were enrolled. The primary endpoint of the study is the rate of HAE attacks over 24 weeks, confirmed by the participating doctors. There are a few subtle differences, but BioCryst is basically relying on the same Phase 3 trial design that other companies used to secure approval of their HAE drugs.

Enrollment into the APeX-2 study was completed last November, which means BioCryst should have started data collection and analysis this month and have top-line results ready at the end of May or June. Publicly, BioCryst has told investors to expect a readout of APeX-2 in the second quarter.

wiegveld 8 april 2019 20:14

A previously conducted Phase 2 study of BCX7353 gives BioCryst confidence in the outcome of the Phase 3.

The Phase 2 study, called APeX-1, was published last July in the New England Journal of Medicine. Four doses of BCX7353 were evaluated against a placebo for four weeks. Seventy-five patients with HAE were enrolled and treated.

The results: The 125-milligram daily dose of BCX7353 resulted in a 74% reduction in the rate of HAE attacks relative to placebo. The difference was statistically significant. Forty-three percent of the HAE patients treated with the 125-milligram dose of BCX7353 did not suffer attacks during the four weeks of the study, compared to 9% of the placebo patients.

Based on these results, BioCryst chose the 125-milligram daily dose of BCX7353 for use in the Phase 3 clinical trial, along with a slightly higher dose equivalent to 175 milligrams.

wiegveld 8 april 2019 20:14

The Phase 2 study was not blemish free, however.

Two doses of BCX7353 higher than 125 milligrams showed only a 45% reduction in the rate of HAE attacks relative to placebo. The lowest dose tested had a suboptimal result. The U-shaped dose response curve — efficacy of middle dose better than lowest and highest doses — is unusual because BioCryst’s original hypothesis was that higher doses of BCX7353 would lead to greater reduction in HAE attacks.

In fact, the two highest doses of BCX7353 correlated with higher levels of the drug in the bloodstream of patients, as well as greater suppression of the targeted protein. So, why did the two highest doses of BCX7353 underperform?

BioCryst believes some patients may have mistaken gastrointestinal side effects caused by the higher doses as an early signal of abdominal HAE attacks. The symptoms can feel similar, and BCX7353 is known to cause gastrointestinal side effects that increased with dose. Only the 125-milligram dose of BCX7353 had a lower rate of abdominal HAE attacks compared to placebo. But for peripheral HAE attacks (in the hands and feet, for instance) the middle and two higher doses of BCX7353 all showed a significant benefit over placebo.

BioCryst’s assumption about gastrointestinal side effects masking BCX7353 efficacy at the higher doses may turn out to be incorrect. And if that’s the case, the lower doses chosen for the Phase 3 study with more patients enrolled and a longer treatment duration may underperform.

wiegveld 8 april 2019 20:14

To win in the Phase 3, BCX7353 must beat a placebo, but how the drug compares to currently approved HAE medicines is also really important.

As mentioned above, HAE patients have treatment options available. Takhzyro, marketed by Takeda (formerly Shire) is the preventive HAE therapy that serves as the best comparable to BioCryst’s BCX7353. Both drugs work by suppressing the same misbehaving protein. Takhzyro is administered via an injection under the skin. It was approved last August and has launched very strongly.

In the pivotal clinical trial that supported Takhzyro’s approval, an every-two-week injection schedule led to an 87% reduction in the rate of HAE attacks, relative to placebo. When Takhzyro was injected once monthly, the HAE attack rate fell by 73% relative to placebo.

No one expects BCX7353 to beat Takhzyro on efficacy. It doesn’t need to, given the added convenience of a once-daily pill. However, BCX7353 can’t be demonstrably worse, either. How close must it come?

Brian Abrahams, the biotech analyst at RBC (and a BioCryst bull) believes a BCX7353 HAE attack rate reduction in the 55% range or higher will be sufficient for the drug to grab meaningful market share and push BioCryst’s stock price higher. Abrahams views an HAE attack rate reduction greater than 65% as a home-run scenario.

Results that come in 50% or lower might still be sufficient for BioCryst to achieve the primary endpoint of the study, but the meaningfulness of the result will be debated and investors will be disappointed, he added.

One investor who follows BioCryst closely and is slightly more cautious believes the minimum efficacy threshold for real-world success is 60%. He believes a reduction in HAE attack rate in the 50% range will make it very difficult for BCX7353 to compete against Takhzyro.

De amateur 8 april 2019 20:59

Thanks Wiegveld.

snorre42 8 april 2019 21:18

quote:
Louis7 schreef op 8 april 2019 20:10:
Ondertussen in de US, Pharming Group N.V. $ 0.9798 + 6.91% (volume 53.000).
www.marketwatch.com/investing/stock/p...

Omgerekend naar Euro is dat E 0,8701, dus geen schokkend effect. Was vanaf 3 april j.l. niet meer gewijzigd en het volume is voor Amerikaanse begrippen redelijk hoog, maar voor de AScX Pharming met een gemiddeld volume van 7 miljoen nis dit natuurlijk niets. Maar toch, ook ik kijk altijd even, immers je weet nooit wat er nabeurs gaat gebeuren.

Louis7 8 april 2019 21:44

Ruconest, nu ook voor uw kat beschikbaar..
m.facebook.com/story.php?story_fbid=2...

:-)

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