Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

quote:

Beur schreef op 25 februari 2014 13:58:

[...]Er waren amendments (= aanpassingen) noodzakelijk, waardoor de oorspronkelijke BLA wijzigde en waarna Pharming natuurlijk nieuwe info moest overleggen.

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Beur schreef op 25 februari 2014 14:14:

[...]Heb ze net weer verkocht. Ben zeer tevreden!

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Ksino schreef op 25 februari 2014 13:37:

Super nieuws, vandaar de opleving, nu zeker niet meer wegdoen :
roth2.bluematrix.com/sellside/EmailDo...

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Pharming Group NV (OTC: PHGUF) | PHARM.AS - €0.60 - AEX | Buy

PHARM: PDUFA Extension a Non-Event; Reiterate Buy


The PDUFA date for Ruconest has been extended three months to July 16, 2014 based on file submissions to the FDA representing a "major amendment" to the BLA. This triggered the automatic 3-month extension. We believe the extension is a non-event and expect full approval of Ruconest based on the positive Phase III program, under SPA. Reiterate Buy and $3 target.



Event

Pharming and Salix (SLXP-Buy) announced that the FDA has extended the PDUFA date for Ruconest from April 16 to July 16, 2014. We discussed the extension with management. As part of the "back and forth" between the companies and the FDA, responses were provided on February 13th which was considered a "good size package" and therefore considered a major amendment to the BLA filing. Therefore, this triggered the 3-month standard extension.

Impact

We believe the PDUFA extension is a non-event and believe that Ruconest will receive full FDA approval for the treatment of acute HAE. Recall that the BLA was filed off of a positive Phase III program, under SPA. Overall we believe two major factors (of several) will help propel Pharming forward this year; 1) Shire acquisition of ViroPharma for $4.2 billion (Ruconest represents a pure and safer threat to Cinryze) and 2) Salix' acquisition of Santarus (Pharming's U.S. partner). Ruconest is approved ex-U.S. for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. PHARM has also partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a division of Sinopharm, for commercialization of Ruconest in China. We believe that the drug is poised to take over a significant share of the HAE market, given its low COGS allowing for competitive pricing, safety, convenience, and strong efficacy. Ruconest benefits from a benign safety profile, with no thromboembolic events seen to date, compared to plasma derived Cinryze and Berinert with an incidence of ~3.4% rate of thrombosis events. This may be attributable to the plasma derived Cinryze and Berinert with ~20-25% impurities in their formulations.

Action

We reiterate our Buy rating and $3 price target. The company's strategy to expand geographies through collaborations and to develop therapies for rare diseases will bear fruit over the long term, in our opinion. Given the pricing power of orphan drugs and the expanding markets in these indications due to better diagnoses, we believe that Pharming is well-positioned for commercial success.

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duc1 schreef op 25 februari 2014 14:21:

Wie zag er nog meer een bied van 2,7 miljoen stukjes vlak voor de Freeze ?
Bij Alex zag ik hem duidelijk, daarna ook meteen weer weg ?

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pollio schreef op 25 februari 2014 14:21:

Oeps, terug in gang !

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Beursduivel.. schreef op 25 februari 2014 14:28:

[...]

heb ik ook gezien!

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Stockker schreef op 25 februari 2014 14:26:

Ik zeg winsten nemen en morgen weer terugkomen.
Het gebeurt nagenoeg nooit dat Pharming sluit op DH.

Ik zeg niet dat het onmogelijk is, maar het lijkt me onwaarschijnlijk.

Dit is gebaseerd op het gedrag van de koers over de afgelopen 30/35 dagen, en verder niks.

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ooievaar49 schreef op 25 februari 2014 14:28:

Och, meedoen is belangrijker dan winnen:)

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Bernardo schreef op 25 februari 2014 14:28:

[...] Nieuws van gisteren toen ze hier nog aan het verkopen waren.

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machmit schreef op 25 februari 2014 14:29:

[...] Zeker doen, maar morgen zou de koers nog wel eens veel hoger kunnen zijn. Ik schat 0,65 om te beginnen.

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kammetje schreef op 25 februari 2014 14:26:

[...]
Jammer.

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MaranV schreef op 25 februari 2014 14:33:

30% sluiten ? ik gok er op :)