Fol News

Tutti gli approfondimenti
Tutte le notizie

Keryx Biopharmac. (KERX) - Atto 4

In Giappone sono di manica larga, penso che approveranno anche Zerenex.
 
Giappone come rampa di lancio

stetteo ha scritto:
In Giappone sono di manica larga, penso che approveranno anche Zerenex.
Clicca per espandere...


Speriamo che tu abbia ragione; certo che tutta questa lentezza non mi piace.
11 mesi sono passati e non abbiamo ancora nessuna risposta.
 
Patente ottenuta

Keryx Biopharmaceuticals Announces Issuance of U.S. Patent for Zerenex(TM) Covering Orally Administrable Forms of Ferric CitrateGlobeNewswire(Wed, Dec 18)

Fino al 2024 avremo il brevetto, non male.

Ora tutti ad aspettare il 7 giugno 2014, con la prima risposta della FDA.
 
Sussulto di Keryx, speriamo che continui così.
 
hasdomar ha scritto:
Mi sa che perdi i 1300 puliti che hai messo in tasca qualche giorno fa. E anche qualche cosa di piu':wall:

Oggi chiude a 1,28$ e mi sa che la fine del movimento al ribasso lo troviamo a 0,80. Giusto come AEZS. Poi puo' darsi benissimo che mi sbaglio;)
Clicca per espandere...

Il 19.4.2012 parlavo della similitudine dei due grafici per un certo periodo. Poi kerx ha preso il volo.:)
 
Praticamente kerx non l'ho piu' seguita da quaisi 2 anni, se non con un paio di interventi estemporanei.;)
 
Pre-open entusiasmante, superati i 15,5$


rocket19.jpg
 
stetteo ha scritto:
In Giappone sono di manica larga, penso che approveranno anche Zerenex.
Clicca per espandere...

CVD

8:01 am Keryx Biopharma announces marketing approval of ferric citrate in Japan (KERX) : Co announces that its Japanese partner, Japan Tobacco, has received manufacturing and marketing approval of ferric citrate from the Japanese Ministry of Health. Ferric citrate, to be marketed in Japan by JT's subsidiary, Torii Pharmaceutical, under the brand name Riona, is indicated as an oral treatment for the improvement of hyperphosphatemia in patients with chronic kidney disease (:CKD), including dialysis and non-dialysis dependent CKD. Keryx will receive $10 mln for the marketing approval milestone. Keryx will also receive double-digit tiered royalties, as well as up to an additional $55 mln upon certain annual net sales milestones. "This first regulatory approval of ferric citrate is a monumental achievement for the Zerenex program." The US New Drug Application for Zerenex is currently under review by the FDA with a PDUFA goal date of June 7

OK!
 
NEW YORK, Jan. 22, 2014 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced the pricing of an underwritten public offering of common stock consisting of 6,900,000 shares at $14.50 per share. In connection with this offering, Keryx granted to the underwriters a 30-day option to purchase additional shares of common stock, equal to up to 15% of the number of shares of common stock sold in the offering. Keryx intends to use the net proceeds from the sale of our common stock to fund pre-launch/launch inventory build-up and pre-commercial/commercial activities related to Zerenex, the ongoing development of Zerenex in pre-dialysis, and other general corporate purposes.

J.P. Morgan Securities LLC is acting as sole book-running manager in the offering. The co-managers for the offering are Oppenheimer & Co. Inc., JMP Securities LLC, Stifel, Nicolaus & Company, Incorporated, Roth Capital Partners, LLC, Brean Capital, LLC, Ladenburg Thalmann & Co. Inc., and H.C. Wainwright & Co., LLC. Maxim Group LLC and Trout Capital LLC are acting as advisors to the company.

The securities described above are being offered by Keryx pursuant to a Form S-3 shelf registration statement (including a base prospectus) previously filed with the Securities and Exchange Commission ("SEC"). Before you invest, you should read the prospectus in the registration statement and related prospectus supplement that Keryx has filed with the SEC for more complete information about Keryx and this offering. The prospectus supplement is available for free by visiting EDGAR on the SEC's website located at U.S. Securities and Exchange Commission | Homepage. Copies of the prospectus supplement and accompanying prospectus may also be obtained from the offices of J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 (telephone: 866-803-9204).
 
Siamo in una fase di stanca; comunque la data da segnare in rosso sul calendario è il 7 giugno, giorno in cui la FDA esprimerà il suo giudizio. Sarà positivo ? Sarà negativo ?
Io fremo al pensiero di tale verdetto.
 
Keryx announces submission of MAA for Zerenex to EMA
Keryx Biopharmaceuticals announced it has submitted a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease, or CKD, including dialysis- and non-dialysis dependent CKD. The MAA will be reviewed by the EMA Committee for Medicinal Products for Human Use and the review will be conducted under the Centralized Authorization Procedure. An approval under the Centralized Authorization Procedure provides one marketing authorization which is valid in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
 
Notizia accolta con freddezza e prezzo addirittura in calo.
 
Devi accedere o registrarti per poter rispondere.
Indietro