DRRX

eben heute gehts um remoxy, das kürzlich eingereichte NDA wäre dann für posidur........ (siehe pipelinetable oben)

vagnum hat am 25.03.2013 - 20:44 folgendes geschrieben:

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Ein positives FDA Panel am 02.05.13 würde für Auftrieb sorgen. Bin aber eher zurückhaltend.

2.50$ könnten spekulativ drinliegen.

DELCATH ANNOUNCES ODAC MEETING REVIEW DATE FOR ITS PROPRIETARY DRUG/DEVICE COMBINATION PRODUCT DELCATH HEPATIC DELIVERY SYSTEM

Meeting to be Held May 2, 2013

NEW YORK, Feb. 27, 2013 -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the Company's pending New Drug Application (NDA) for a drug/device combination product with the proposed trade name Melblez KitTM (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System. The ODAC meeting will be convened Thursday, May 2, 2013, to review the NDA with a proposed indication for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

ODAC panels advise the U.S. Food and Drug Administration on the safety and efficacy of proposed new cancer therapies. The FDA is not legally bound to follow the advice of its advisory committees regarding new drug applications. Delcath's NDA was accepted by the FDA for substantive review on October 15, 2012, and was assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2013.

Eamonn P. Hobbs, President & CEO of Delcath Systems, said, "Our team is actively preparing for the ODAC meeting and we look forward to presenting our data for the safety and efficacy of Delcath's system for the treatment of patients with unresectable ocular melanoma metastatic to the liver to the ODAC panel."

The FDA will publish materials, including webcast information, pertaining to the meeting at http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm.

Changes to the Advisory Committee meetings calendars may also be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

[Blocked Image: http://finviz.com/chart.ashx?t=DCTH&ty=c&ta=1&p=d&s=l]

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FDA Panel am 02.05.13

gelegenheit nach heutigem taucher auf einen zock morgen!?

nein. wird vlt. noch. evtl. auch erst morgen..

im moment siehts zwar nach erholung aus

b00n hat am 30.04.2013 - 18:21 folgendes geschrieben:

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Pain Therapeutics Inc. (PTIE) and Durect Corp. (DRRX), partners with Pfizer Inc. (PFE) on the medicine Remoxy, increased in New York trading after the world’s biggest drugmaker highlighted the experimental painkiller’s future on a conference call.

Pain Therapeutics surged 18 percent to $3.87 at 11:42 a.m. New York time, after reaching $4.60 for the biggest intraday climb since November 2005. Durect rose 23 percent to $1.54, after touching $1.85 for its largest gain since March 2001.

Remoxy is an extended-release oxycodone capsule for pain, formulated to limit abuse. The U.S. Food and Drug Administration postponed approval of the medicine in June 2011, after a delay in 2008 when the regulators asked for more laboratory data.

“For Remoxy, we had a productive meeting with the FDA in March and the guidance that we got out of that meeting is certainly helping to inform the next steps,” John Young, head of New York-based Pfizer’s primary care unit, said on a call with analysts and investors today. “We believe we have a path forward and we will publicly communicate further details over coming quarters.”

Pfizer gained the drug in its $3.3 billion acquisition of King Pharmaceuticals in 2011. Austin, Texas-based Pain Therapeutics and Durect, in Cupertino, California, helped develop the therapy and would get royalties on sales.

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mööö. FDA will weitere tests betreffend remoxy. mitte 2015 wieder thema...

na dann hoff ich mal auf posidur.

Vanda Pharmaceuticals Price Target Increased to $17.00 by Analysts at Lazard Capital Markets (VNDA)

aktuell 6.80

b00n hat am 24.04.2013 - 03:54 folgendes geschrieben:

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b00n hat am 22.04.2013 - 19:39 folgendes geschrieben:

Tranzyme Inc. : Tranzyme Pharma and Ocera Therapeutics Announce Merger Agreement

04/23/2013| 08:20pm US/Eastern

http://www.4-traders.com/news/…rger-Agreement--16770351/

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TZYM heute neues 3 monatshoch

CPRX

At March 31, 2013, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $13.2 million and no debt. Catalyst believes that its existing cash and investments will be sufficient to meet its projected operating requirements through the first quarter of 2014

Read more: http://www.nasdaq.com/article/…30516-00288#ixzz2TZq3kzDC

WARSICS hat am 17.05.2013 - 21:28 folgendes geschrieben:

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bin da mal vorsichtig rein. ist ja lange um die 4er marke unterwegs und guter supp.

europe coming wäre ideal.

cheers

in at 4.01

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hooi warsics

gute idee..

First Quarter Highlights:

• Continued new physician interest in PROVENGE^® (sipuleucel-T):
  • Added 33 net new accounts in the first quarter, bringing total number of accounts that have infused to 835
• Demonstrated positive early indicators in effectiveness of direct-to-consumer advertising:
  • Addresses significant need for patient education and awareness
  • First national TV commercial aired March 7
  • Patients contacting Dendreon directly for more information, resulting in a significant increase in call center and relationship marketing activity
• Continued improvement in reimbursement landscape for physicians:
  • Reported average time to payment remains less than 30 days for physicians
• Continued progress with strategic restructuring:
  • The Company believes it can reduce cost of goods sold (COGS) to below 50% of net product revenue in the third quarter 2013 at its current forecast levels
  • Already seeing net benefits in financial results associated with the restructuring initiatives and expect full benefits realized in the third quarter of 2013
• Continued focus on expanding clinical data:
  • Presented data at AUA that further analyzed Phase III IMPACT data to identify prognostic variables that may support early administration of PROVENGE after diagnosis of metastatic castrate resistant prostate cancer
  • Actively evaluating partnering strategies for European expansion; continuing to enroll patients in the sipuleucel-T European Union open-label study; expect a regulatory decision in Europe in the second half of 2013
  • Completed enrollment of PROVENGE and ADT sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
  • Completed enrollment of PROVENGE and Zytiga^®(abiraterone) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
  • Supporting 19 novel investigator initiated trials (IITs) to advance understanding of immunotherapy and the treatment of advanced prostate cancer
  • Named steering committee for Phase II trial for sequencing PROVENGE with Xtandi^® (enzalutamide) and expect to begin enrolling patients in the fourth quarter of 2013

WARSICS hat am 17.05.2013 - 21:35 folgendes geschrieben:

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reizt.

springe mit auf. hab so überraschungen gerne. wenn gezündet wird, ist die freude gegenüber dem kleinen einsatz gross.

thanks for scoutin' mate

edit: in @ 0.587

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jup, die merger geschichte hat potential!

aber nicht vergessen in zuge des mergers wirds unter umständen auch n R/S geben

PPHM

Peregrine Pharma agrees with FDA on lung cancer trial design

http://news.yahoo.com/peregrin…ial-design-134000529.html