http://clinicaltrials

Junta de accionistas para 19 junio de 2015

Se planta la aprobacin de 75 millones de acciones ms de acciones ordinarias (de 200 millones a 275), adems de las de bonus y demsEstimacin: $3.47 million in Q1 or $3.81 million in Q2 Consensus is -$0.09 EPS or a loss of $13.58 million.23-4-2015

http://seekingalpha.com/article/3092776-galena-biopharma-is-a-worthwhile-gamble-for-the-short-or-long-term10-4-2015

Folate Binding Protein and Anagrelide Control Release Data In May/June

Possible Early FDA approval

Anagrelide CR - A better reformulated, patented version of Anagrelide Instant Release. Anagrelide IR causes many serious side effects and still garners almost $500 Million in annual revenues. Gale's CR Version has proven to work, provide an equal drug benefit without the many serious side effects and also allows for greater dosage for those patients who require it.

These Mid Stage Results are out in May/June as well - I expect sooner as the Phase 2 trials enrolled a full 6 months early due to very strong patient demand. Additionally, Shire (who owns the IR version) has been rumoured to be eyeing this drug for buyout / partnership while they are on their recent buying binge

Se esperan datos top-line para mediados de 2015 . Earnings 7 de mayoPhase 2a GALE301

Phase 1 GALE401

Phase 2 GALE401Deficiencias comunicadas en farmacovigilancia por la FDA (11-12-2013) que lo peor es que no han incluido en el informe trimestral ni han respondido a la FDA adecuadamente. No son de fiar.24-11-2015

En dilucin ATM con Lincoln entrada 1,60

http://www.thestreet.com/story/12963541/1/galena-shunned-by-wall-street-forced-to-seek-pricey-vulture-financing.html?puc=yahoo&cm_ven=YAHOO

5-2-2015

Galena Biopharma Announces Orexo's Filing of a Patent Infringement Lawsuit Against Actavis Concerning Abstral(R) (fentanyl) Sublingual Tablets in the U.S.

PORTLAND, Ore., Feb. 5, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that its partner, Orexo AB, has filed a patent infringement lawsuit in United States District Court for the District of New Jersey, against Actavis Laboratories FL, Inc., Andrx Corporation, Actavis, Inc. and Actavis Pharma, Inc. (collectively "Actavis").

The lawsuit was filed in response to the Abbreviated New Drug Application ("ANDA") filed by Actavis. In its application, Actavis seeks to market and sell generic versions of Abstral (fentanyl) sublingual tablets in the U.S. prior to the expiration of Orexo's U.S. patents for Abstral listed in the FDA's Orange Book. The listed patents are U.S. patents 6,759,059, 6,761,910 and 7,910,132 with expiration dates in September 2019. Galena currently markets Abstral and is the owner of the New Drug Application in the United States.

Because Orexo initiated a lawsuit against Actavis in a timely manner, the FDA is statutorily precluded from approving Actavis' ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. The 30-month stay period began as of the date Orexo received the Notice Letter from Actavis that notified Orexo of the ANDA filing.

Mark W. Schwartz, Ph.D., President and Chief Executive Officer of Galena Biopharma, commented, "We are confident in the patents listed in the FDA's Orange Book and fully support our partner, Orexo, as they vigorously enforce the intellectual property rights around Abstral. Given the significant sales growth and future market potential for Abstral, ANDA filings of generic versions are not entirely unexpected.Our overall strategy and revenue projections for Abstral are unchanged, and we look forward to continued growth and increased market penetration during 2015."

15-01-2015

Competencia, deduzco y cay en AH.

Galena Biopharma and its partner, Orexo AB (Orexo) have received a "Paragraph IV" patent certification notice from Actavis Laboratories, FL (Actavis). The Notice Letter advises Galena of Actavis filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval of generic versions of Abstral (fentanyl) sublingual tablets prior to the expiration of Orexos patents listed in the Orange Book. Galena currently markets Abstral and is the owner of the New Drug Application in the United States.

Galena is working closely with its partner Orexo to review the details of this Notice Letter and decide on the response within the statutory timeline of 45 days from receipt of the Notice. Together with our partner Orexo, Galena intends to vigorously enforce the intellectual property rights around Abstral.

18-11-2014

Roth Capital affirms Galena Biopharma (Nasdaq: GALE) at Buy with a price target of $8 following an update on Phase 2 GALE-401 enrollment.Reclutamiento completado GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial11-11-2014

Galena Biopharma Doses First Patient in Phase 2 Clinical Trial With NeuVax(TM) (nelipepimut-S) in Combination With Herceptin(R) (trastuzumab) to Treat High-Risk HER2 3+ or HER2 Gene-Amplified Breast Cancer Patients

Datos presentacin oncolgica 7-11-2014

Phase 1/2a trial of GALE-301, a Folate Binding Protein (FBP)-derived immunotherapy. Buenos datos de seguridad y eficacia. Adems, el compuesto consigue un 38% de reduccin de reaparicin de tumores en los ovarios.

After a median follow-up of 13 months, there have been 11/22 (50%) recurrences in the control group compared to 9/29 (31%) recurrences in the vaccine group, a 38% reduction in relative risk of recurrence. The study was not powered for efficacy but rather, a clinical proof of concept study. GALE-301 generates a long lasting immune response, which generates tumor lysing CD8 T cells, bypassing the need for active receptor or ligand binding to generate efficacy.

http://www.streetinsider.com/Corporate+News/Galena+Biopharma+%28GALE%29+Issues+Encouraging+Update+on+GALE-301+Phase+12a+as+Ovarian+Cancer+Treatment/9988362.html?si_client=intbroInforme 6-11-2014On January 12, 2014, we acquired exclusive worldwide license to develop and commercialize GALE401 (anagrelide CR), a patented, controlled-release formulation of anagrelide, through our acquisition of Mills Pharmaceuticals, LLC (Mills) under a unit purchase agreement. Under the terms of the unit purchase agreement, we made an up-front cash payment of $2 million to the former Mills owners and also agreed to make additional contingent payments to the former owners upon the achievement of certain development milestones relating to GALE401, including 2,000,000 shares of our common stock upon initiating the first clinical trial of GALE401 in patients with essential thrombocythemia, or ET, and an additional 2,000,000 shares upon initiating a Phase 3 clinical study of GALE401. The number of shares issuable upon the milestones is subject to increase based on a formula specified in the purchase agreement, up to a maximum of 3,000,000 shares for each milestone, in the event the fiveday average trailing closing price of our common stock (the Average Price) is less than $4.84 at the time the applicable milestone is achieved. Similarly, the number of shares issuable upon achievement of the milestones is subject to decrease based on such formula if the Average Price exceeds $6.84 at the time of achievement of the applicable milestone.We achieved the milestone relating to the initiation of the first clinical trial of GALE-401 in the third quarter of 2014 and issued 3,000,000 shares of common stock to the former owners, the maximum under the unit purchase agreement as our five-day average trailing close price of our common stock was less than the low end of the collar of $4.84 . We will record as an addition to the GALE-401 intangible asset the fair value of the shares delivered in payment of each milestone under the Mills unit purchase agreement. The addition to the intangible asset for the fair value of the shares will increase our additional paid-in capital by the same amount, less the par value of the milestone shares. As a result of the achievement of the initiation of the first clinical trial of GALE-401, we recorded an addition to GALE-401 asset and additional paid in capital in the amount of $6.8 million , or the fair value of the shares issued. The milestone payments will have no effect on our net loss. On July 17, 2014, we entered into a definitive license and supply agreement with MonoSol Rx, LLC (MonoSol) for the U.S. commercial rights to Zuplenz (ondansetron) Oral Soluble Film, an FDA approved product for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Refer to Note 12 for details of the transaction. In conjunction with the acquisition of NeuVax TM , the company acquired rights and assumed obligations under a license agreement among Apthera and The University of Texas M. D. Anderson Cancer Center (MDACC) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) which grants exclusive worldwide rights to a U.S. patent covering the nelipepimut-S peptide and several U.S. and foreign patents and patent applications covering methods of using the peptide as a vaccine. Under the terms of this license, we are required to pay an annual maintenance fee of $200,000 , a milestone payment of $200,000 upon commencing the Phase 3 PRESENT trial of NeuVax and other clinical milestone payments, as well as royalty payments based on sales of NeuVax or other therapeutic products developed from the licensed technologies.On March18, 2013, we acquired Abstral (fentanyl) Sublingual Tablets for sale and distribution in the United States from Orexo AB (ORX.ST), an emerging specialty pharmaceutical company based in Sweden. Abstral has been approved by the U.S. Food and Drug Administration (FDA) and is a transmucosal immediate-release fentanyl (TIRF) product. Under our agreement with Orexo, we assumed responsibility for the U.S. commercialization of Abstral and for all regulatory and reporting matters in the U.S. We also agreed to establish and maintain through 2015 a specified minimum commercial field force to market, sell and distribute Abstral and to use commercially reasonable efforts to reach the specified sales milestones. Orexo is entitled to reacquire the U.S. rights to Abstral from us for no consideration if we breach our obligations to establish and maintain the requisite sales force throughout the marketing period. We expect to maintain our sales efforts beyond this date. We officially launched U.S. commercial sales of Abstral in October 2013. Preferred Stock The company has authorized up to 5,000,000 shares of preferred stock, $0.0001 par value per share, for issuance. The preferred stock will have such rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the companys board of directors upon its issuance. To date, the company has not issued any preferred shares. Common Stock The company has authorized up to 200,000,000 shares of common stock, $0.0001 par value per share, for issuance. 3-11

Galena Biopharma (NASDAQ:GALE): Q3 EPS of -$0.05 beats by $0.06.

Revenue of $1.6M (+36.8% Y/Y) misses by $1.06M.

Press Releasehttp://investors.galenabiopharma.com/secfiling.cfm?filingid=1390478-14-58&CIK=139047823 octubre

S3 de 2 millones de acciones para el colocador a un precio mximo de 1,66. Dilucin ATMOctubre

Patentes:1. Galena Biopharma (Nasdaq: GALE) announced the Notice of Allowance of a U.S. patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab; Genentech/Roche)2. Aprobada la misma en Japn

http://www.streetinsider.com/Litigation/Galena+Biopharma+%28GALE%29+Receives+NeuVax-Related+Patent+Notice+of+Allowance+from+USPTO/9895115.html?si_client=intbro

Septiembre 2014. Sobre las acusaciones de manipulacin

Comunicado sobre la historia de los artculos de pumpeo. Resumo: que ellos no tuvieron nada que ver, que fue la empresa Lidingo. El CEO de GALE resulta que actu al margen y contrat a dicha empresa para comprar a los articulistas y como pago a la empresa se le dio un puado de acciones de GALE. Vamos, que no, que ellos no fueron.9-9

Galena Biopharma Doses First Patient in GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial GALE-401 in Phase 2 Study in Patients With Elevated Platelet Counts in Myeloproliferative Neoplasms (MPNs) Including Essential Thrombocythemia (ET)

Agosto 2014

Abstral sales in the second quarter were flat sequentially and weren't down only because of a large order from a single customer. Galena warned third-quarter sales of Abstral could be negatively affected by this large order. Looking ahead, Abstral sales will also be hurt by Express Scripts (ESRX_) adding the cancer painkiller to its 2015 formulary exclusion list.http://finance.yahoo.com/news/galena-biopharma-reports-second-quarter-203500437.htmlVentas de Monosol no irn a ningn lado segn el BAstardo

http://www.thestreet.com/story/12781204/1/galena-gives-sales-team-another-useless-product-to-promote.html?puc=yahoo&cm_ven=YAHOO

13 enero 2014 Compra Acquires Mills Pharmaceuticals y subeEntra en el Russell junio 2013Funcionamiento de NeuVax en video

http://www.globenewswire.com/NewsRoom/Attachment/18614While improved diagnostics and targeted therapies have decreased breast cancer mortality in the United States, metastatic breast cancer remains incurable. Up to 25% of resectable node-positive breast cancer patients having no radiographic evidence of disease following surgery and adjuvant chemo/radiation therapy still relapse within three years following diagnosis. These cancer patients presumably still had isolated, undetected tumor cells also known as circulating tumor cells (CTCs) which, over time, led to a recurrence of cancer, either in the breast area (local recurrence) or at a remote location (metastatic disease). Galena is developing peptide vaccine (off-the-shelf) cancer immunotherapies, which address major patient populations of cancer survivors to prevent recurrence. These therapies work by harnessing the patients own immune system to seek out and attack any residual cancer cells. Using peptide immunogens has many clinical advantages, including an excellent safety profile, as these drugs lack the toxicities typical of most cancer therapies. They also feature long-lasting protection through immune system activation and convenient delivery. Abstral

On March18, 2013, we acquired the rights to sell and distribute Abstral (fentanyl) sublingual tablets in the United States from Orexo AB (ORX.ST), an emerging specialty pharmaceutical company based in Sweden. Abstral has been approved by the FDA and is the transmucosal immediate-release fentanyl (TIRF) market leader in Europe by ProStraken/Kyowa Hakko Kirin. Abstral is an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. The innovative Abstral formulation delivers the analgesic power of fentanyl in a convenient and easy to use sublingual tablet, which dissolves within seconds. Abstral provides rapid relief of BTcP, predictable dosing, and is convenient and easy to use. Under our agreement with Orexo, we assumed responsibility for the U.S. commercialization of Abstral and for all regulatory and reporting matters in the U.S. We also agreed to establish and maintain from January1, 2014 through December31, 2015, which we refer to as the marketing period, a specified minimum field sales force to market, sell and distribute Abstral and to use commercially reasonable efforts to reach the specified sales milestones. Galena intends to launch U.S. commercial operations for Abstral in 2013. In exchange for the U.S. rights to Abstral, (1)we paid Orexo $10 million in cash from our cash on hand, and (2)we agreed to pay to Orexo: (a)$5 million in cash upon the earlier of (i) the approval by the FDA of a specified U.S. manufacturer of Abstral and(ii) the first anniversary of the closing; (b)three one-time future cash milestone payments based on our net sales of Abstral; and (c)a low double-digit royalty on future net sales. No further milestone or royalty payments will be due after the date on which all claims of the last remaining licensed patents expire (currently 2019) or become invalidated by a governmental agency. http://marketplayground.com/2013/04/20/galena-biopharma-inc-nasdaqgale-behind-the-analyst-ratings/PRESENT study, which will report interim data in 4Q13 or 1Q14. We believe adjuvant vaccine therapy will ultimately become standard of care for many cancer types, and we view NeuVax as one of the leading new product candidates for this revolutionary treatment modality. Galena also recently acquired an approved product for breakthrough cancer pain, giving the company near-term revenue potential and a commercial presence in oncology.

http://clinicaltrials.gov/ct2/show/NCT01479244?term=nelipepimut&rank=1GALE:

http://clinicaltrials.gov/ct2/show/NCT01570036?term=Galena+Biopharma&rank=2http://clinicaltrials.gov/ct2/show/NCT01479244?term=Galena+Biopharma&rank=1El estudio que tienen entre manos mola mucho, pero es ingente y no acabar hasta 2017 (mayo 2022 sale ahora en los estudios; preliminares en mayo 2015), con lo que entre medio s podran necesitar pasta si no encuentran socios o alguna fuente de financiacin.

http://clinicaltrials.gov/ct2/show/NCT01479244?term=nelipepimut&rank=1