Hot Pharma Stocks / Ideen / Blockbuster

    CVM

    The share price of CEL-SCI Corporation(NYSEAMEX:CVM) plunged -12.60% during last trading day, ending at $0.215. Its CEO Kersten Geert R bought 348,125 shares on March 26 at a cost of $0.21 per share for $74,498. At recent closing price, the company has a market cap of $66.43million. The stock has a 52 week worst hit of $0.21 and a 52 week high of $0.58. The P/S ratio is 255.49 and P/B ratio 7.17. The beta value is 2.17. CVM’s RSI amounts to 17.71.



    hab grad keine mehr. Im Mai an der GV wird über einen R/S entschieden.

    BCRX


    BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it received a preliminary comment letter from the U.S. Food & Drug Administration (FDA) that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of intravenous (i.v.) peramivir. The letter was sent in response to questions BioCryst submitted to the FDA in advance of an upcoming Type C regulatory meeting regarding i.v. peramivir. The FDA also suggested the Company request a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in its preliminary comment letter.



    http://www.news-medical.net/ne…rom-FDA-on-peramivir.aspx



    Pre-market: 1.56 +0.37 (31.09%)

    pSivida news

    pSivida hat gleich mehrere heisse Eisen im Feuer:



    Neben der Eigenentwicklung von Wirkstoffen inkl. Dosierungstechnologie in der Ophthalmologie arbeiten sie mit Alimera (Illuvien Lancierung dieses Jahr in UK und DE, resubsmission in US auch diese Woche) sowie Pfizer zusammen.


    Und nun kommt eine weitere Zusammenarbeit zustande mit einem Global Player aus der Pharmabranche --> siehe news von heute.



    Meldung vom 04.04.2013:


    WATERTOWN, Mass.--(BUSINESS WIRE)--

    pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that it has signed a funded technology evaluation agreement with a leading global pharmaceutical company. The agreement will evaluate pSivida’s proprietary Durasert™ and Tethadur™ technologies for this pharmaceutical company’s select products in ophthalmology. The Durasert technology system delivers specific quantities of drugs directly to a target site in the body at controlled rates for predetermined periods of time ranging from weeks to months. Tethadur is pSivida’s proprietary technology for the delivery of proteins, peptides and antibodies.


    “We are extremely pleased to be working with another global pharmaceutical company to apply our unique technologies to develop transformational products in ophthalmology,” said Dr. Paul Ashton, pSivida president and CEO.

    pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN®, partnered with Alimera and approved in multiple EU countries. Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.


    Meldung vom 01.04.2013


    WATERTOWN, Mass.--(BUSINESS WIRE)--


    pSivida Corp. (PSDV)(PVA.AX), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).


    Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.


    “We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”


    pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.

    b00n hat am 26.03.2013 - 18:39 folgendes geschrieben:

    ja so ist es, es kommt ein Reverse Split, gestern angekündet, 1:5

    b00n hat am 01.04.2013 - 14:49 folgendes geschrieben:

    läuft weiter nach bekannt werden eines Hedgefunds ausstieg.


    habe 1.32er von gestern :)

    BCRX


    Pre-market: 2.00 +0.30 (17.65%)



    BioCryst Pharmaceuticals, Inc. (BCRX) saw shares advancing 28.79% or $0.38 per share to close Friday at $1.70 on volume of 6,340,651 shares traded. A new strain of bird influenza in China sparked shares of BioCryst Pharmaceuticals, a developer of the drug Peramivir, higher on Friday. China's Food and Drug Administration said it expedited approval of intravenous anti-influenza drug Peramivir "to satisfy demand." The drug is "effective and provides an alternative to patients who cannot inhale or take drugs orally," according to a statement on its website on Saturday. The deadly H7N9 virus has killed six people since March & a further outbreak could send shares of BCRX even higher. How high could shares rise? Find out our thoughts at: http://squawkboxstocks.com/reports/BCRX

    b00n hat am 08.04.2013 - 15:15 folgendes geschrieben:

    hu in der obigen news heissts noch china beschleunigt zulassung...


    nun das:



    BioCryst shares surge as China FDA approves production of its anti-flu drug



    http://www.proactiveinvestors.…-anti-flu-drug-42441.html


    nice

    b00n hat am 05.04.2013 - 11:28 folgendes geschrieben:

    Quote

    b00n hat am 26.03.2013 - 18:39 folgendes geschrieben:

    ja so ist es, es kommt ein Reverse Split, gestern angekündet, 1:5

    der split ist vollzogen 1:5 usa aktuell 1.85

    CPRX

    bin gestern zu 0.52 in.



    ---


    Aegis initiated coverage on shares of Catalyst Pharmaceutical Partners (NASDAQ: CPRX). The firm issued a buy rating and a $2.50 target price on the stock.


    -----



    Catalyst Pharma are Zacks Rank #1 (Strong Buy)

    b00n hat am 19.04.2013 - 13:20 folgendes geschrieben:

    Sauber gemacht.

    DARA Biosciences Inc

    DARA



    DARA Biosciences Inc : DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis

    04/22/2013| 09:06am US/Eastern
    DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis
    Gelclair Launch Expected to Provide Additional Commercial Revenue for DARA in 2013

    RALEIGH, NC and LUGANO, SWITZERLAND -- (Marketwired) -- 04/22/13 -- DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, and the Swiss pharmaceutical Helsinn Group, a leading player in the cancer supportive care arena, announced today that DARA has reintroduced Gelclair®into the U.S. market. Gelclair is manufactured by the Helsinn Group and is an FDA-cleared product indicated for the treatment of oral mucositis.

    Oral mucositis is a painful inflammation and ulceration of the surface of the mouth and throat, which can result from a variety of cancer treatments, including radiation therapy and chemotherapy. Gelclair provides oral mucositis patients rapid and effective relief of pain. Oral mucositis is common in cancer patients undergoing chemotherapy or radiation therapy and occurs when the protective oral mucosa is denuded, potentially resulting in pain, infection, weight loss, decreased quality of life, treatment delay and increased economic costs.

    David J. Drutz, MD, DARA's chief executive officer and chief medical officer, stated, "We are thrilled to be launching Gelclair®, our third product into the U.S. market, having recently introduced Soltamox® (tamoxifen citrate) oral solution, the first and only liquid version of tamoxifen citrate. We believe this underpins our mission of becoming a leader in the oncology and oncology supportive care market and exemplifies our commitment to executing against our corporate plan."

    Helsinn Group Chief Executive Officer, Riccardo Braglia, said, "We are pleased that DARA is launching Gelclair® in the United States and importantly, that U.S. patients will again be able to benefit from this treatment. We believe this is an important milestone in building the long-term relationship between our companies. It will also add the most important market worldwide to the other 30 where Gelclair is already marketed in Europe, Latin America and Asia."

    ..mehr

    http://www.4-traders.com/DARA-…leared-Oral-Gel-16766442/

    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.