Mein Tipp: Zogenix (ZGNX)
http://www.google.com/finance?…NX&ei=gbflUMCLEYiOwAP86gE

Haben mit "Sumavel" ein Medi zugelassen welches über 30Mio in die Kasse bringt.

Grund für den Kurssturz anfangs Dezember von USD 3.00 auf bis auf USD 1.11 ist der negative Panel Vote gegen "Zohydr"o... Nicht weil es nicht wirkt sondern wegen bedenken gegen den Missbrauch von Opiaten... Der FDA Zulassungsentscheid ist für den 01.03.12 angesetzt.

Heute PI Daten zu "Relday" - aktuell 1.46 +0.09 (6.57%). Bin seit USD 1.23 dabei, Target bis ende Januar USD 2.00.

7:43AM Zogenix expects to report Q4 2012 gross product sales of ~$13.5 mln on 145,200 units shipped, with unit volume up ~9% sequentially from Q3 2012 and 26% from Q4 2011 (ZGNX) 1.49 : Co announced preliminary unaudited gross product sales for the quarter ended December 31, 2012. Zogenix expects to report fourth quarter 2012 gross product sales of ~$13.5 mln on 145,200 units shipped, with unit volume up ~9% sequentially from third quarter 2012 and 26% from fourth quarter 2011. For the full year 2012, Zogenix announced preliminary unaudited net product revenue of ~$36 mln, up ~18% over 2011 and slightly below previously issued guidance of $37 mln for 2012. Preliminary unaudited cash and cash equivalents as of December 31, 2012 were ~$41.2 mln.

http://finance.yahoo.com/marketupdate/inplay#zgnx

Watch- Liste

DCTH ZGNX NRI GENE u natürlich TTNP :smile:

Aktuell investiert in PSDV

EP im 1.30iger $ Bereich

Merck Serono und Opexa Therapeutics schließen Options- und Lizenzvereinbarung für die Entwicklung von Tcelna(TM)(Imilecleucel-T) zur Behandlung der Multiplen Sklerose

3.19

+1.98(163.60%)

http://www.google.com/finance?…XA&ei=yl0RUbDSCYGOwAPG_QE

DNDN 6.59 +0.43 (6.93%)

Wichtig ist über USD 6.20 (=200 Tageslinie) sowie 40Mio Short... EU Zulassung von Provenge steht an

Neurologix für 0.002 wäre was für Hazardeure, Wilex (gepusht von Börsenbrief) für Spekulanten.

IPXL 19.76$

Impax Laboratories Inc : FDA Issues Complete Response Letter for RYTARY? (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application

01/21/2013| 08:05am US/Eastern

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for RYTARY? (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.

The complete response letter indicates that the FDA requires a satisfactory re-inspection of the company's Hayward facility as a result of the warning letter issued in May 2011 before the company's NDA may be approved due to the facility's involvement in the development of RYTARY, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.

"We will work with the FDA on the appropriate next steps for the RYTARY application," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. "We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson's disease."

A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review cycle for a drug is complete and the application is not yet ready for approval.

About RYTARY ^TM (IPX066)

RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.

RYTARY has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing.

About the Impax GSK collaboration

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

http://bit.ly/VkrUnv

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HPTX 18.90$

Hyperion Therapeutics Inc. : Hyperion Therapeutics' RAVICTI(TM) (glycerol phenylbutyrate) Liquid Receives FDA Approval for Treatment of Urea Cycle Disorders

02/01/2013| 03:35pm US/Eastern

• Anticipated market launch by end of April 2013
• Patent allowance extends coverage to 2032

SOUTH SAN FRANCISCO, Calif., Feb. 1, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the U.S. Food and Drug Administration (FDA) has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013.

Separately, Hyperion announced it has received notification from the U.S. Patent & Trademark Office (USPTO) of the allowance of the claims of patent application number 13/417,137 entitled, METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS, which discloses optimal measurement timing and target levels for blood ammonia in UCD patients. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires in March 2032. After issuance, Hyperion plans to list this patent in FDA's Approved Drug Products with Therapeutic Equivalence, or Orange Book.

"With FDA approval of RAVICTI, we are now in a position to commercialize Hyperion's first product. Furthermore we believe that the allowed claims, once issued, will provide important protection for the use of RAVICTI to treat UCD," said Donald J. Santel, Hyperion's chief executive officer. "We thank our clinical trial patients, their families, our investigators and study coordinators, the UCD Consortium, and the National Urea Cycle Disorders Foundation - in particular NUCDF Executive Director Cynthia Le Mons - for their collaboration and support of our development efforts."

The FDA approval of RAVICTI was based on a New Drug Application (NDA) that included data from 10 clinical trials, including six in UCD patients, that involved 23 sites, over 50 investigators and sub-investigators, and approximately a dozen referring metabolic specialists throughout North America. As part of FDA approval, Hyperion agreed to post-marketing requirements that include: studies of RAVICTI safety, ammonia control, and pharmacokinetics in pediatric UCD patients in the first two months of life and from two months to two years of age; studies in healthy adults to examine drug-drug interaction and whether RAVICTI metabolites are present in breast milk; a randomized controlled clinical trial to assess the safety and efficacy of RAVICTI in treatment-naïve patients with UCD; and a UCD registry of approximately 10 years duration. Importantly, the FDA did not require a Risk Evaluation and Mitigation Strategy (REMS) program.

"We believe the RAVICTI development program has brought not only a promising new drug to the UCD community, but also a much deeper understanding of UCD treatment," said Dr. Bruce F. Scharschmidt, M.D., Hyperion's chief medical officer and senior vice president. "The post-marketing studies and registry represent additional opportunities to expand our knowledge in areas that are important to the community, particularly in very young children, a population in which few systematic studies have been done."

Hyperion intends to commercially launch RAVICTI by the end of April. As part of the commercialization of RAVICTI, Hyperion today announced the launch of a dedicated call center, Hyperion UCD Support Services, which will serve as an integrated resource for patients and their physicians in the areas of RAVICTI prescription intake, reimbursement adjudication, patient financial support, and ongoing compliance support. Together with distribution via two specialty pharmacies, the Company believes that its UCD Support Services program will provide better support to UCD patients, their families and their physicians and help them better manage their disease.

RAVICTI Indications, Usage and Safety Information

RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients

http://bit.ly/XFT7Rg

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sry, an welchem Börsenplatz kaufst du die denn? Schon in $ und nicht € oder.

b00n hat am 21.02.2013 - 15:14 folgendes geschrieben:

b00n hat am 21.02.2013 - 15:10 folgendes geschrieben:

Taglich Brothers started coverage on shares of CEL-SCI Corp. (NYSE: CVM) in a research report sent to investors on Wednesday morning. The firm issued a buy rating on the stock.

“If Multikine secures regulatory clearance and launches in the US and Western Europe by 2018, it should, with relatively modest market penetration and a price per treatment of $50,000, achieve annualized revenue of $700 million (revenue per share of around $1.15) by 2020. … Multikine improves a patient’s chance of survival by acting directly to destroy tumors and strengthening the immune system’s response to the disease before it is compromised by surgery or radiation/chemotherapy.,” Taglich Brothers’ analyst commented.

CEL-SCI Corp. opened at 0.2652 on Wednesday. CEL-SCI Corp. has a 1-year low of $0.26 and a 1-year high of $0.65. The stock’s 50-day moving average is currently $0.27. The company’s market cap is $81.9 million.

CEL-SCI Corp. last announced its earnings results on Friday, February 8th. The company reported ($0.01) earnings per share (EPS) for the quarter. On average, analysts predict that CEL-SCI Corp. will post $-0.05 earnings per share for the current fiscal year.

CEL-SCI Corporation (CEL-SCI) is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.[Blocked Image: http://www.americanconsumernews.net/scripts/viewcount.ashx?type=a&id=138717]

also wenn das so eintritt dann ist hier die rede von mind. einer verdreissigfachung. (ohne berücksichtigung dilutiver massnahmen bis dann)

Valorennr. in USD? Besten Dank