Key Developments: Galena Biopharma Inc (GALE.PH)

GALE.PH on Philadelphia Stock Exchange

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29 Jan 2015
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Latest Key Developments (Source: Significant Developments)

Galena Biopharma Inc reaffirms FY 2014 revenue outlook
Thursday, 8 Jan 2015 07:00am EST 

Galena Biopharma Inc:Reiterates FY 2014 net revenues guidance to fall in the middle of $8-$10 mln range.FY 2014 revenue of $8.7 mln - Thomson Reuters I/B/E/S.  Full Article

Galena Biopharma Inc announces purchase agreement for up to $55.0 mln with Lincoln Park Capital Fund, LLC
Thursday, 20 Nov 2014 04:20pm EST 

Galena Biopharma Inc:Announces execution of a purchase agreement for up to $55.0 million with Lincoln Park Capital Fund, LLC (LPC).Under the terms of the purchase agreement dated Nov. 18, 2014, LPC initially purchased $5.0 million of Galena common stock at a price of $2.00 per share.Thereafter, at its sole discretion, Galena may sell up to $50 million worth of common stock to LPC over the 36 month term of the purchase agreement.Plans to use the proceeds received for its commercial and product development activities and for other working capital and general corporate purposes.  Full Article

Galena Biopharma Inc presents GALE-301 (Folate Binding Protein Immunotherapy) phase 2a clinical trial data at the Society for Immunotherapy of Cancer (SITC) 29th Annual Meeting
Friday, 7 Nov 2014 07:05am EST 

Galena Biopharma Inc:Announced data from its Phase 1/2a trial of GALE-301, a Folate Binding Protein (FBP)-derived immunotherapy, will be presented on Nov. 07 at the upcoming Society for Immunotherapy of Cancer (SITC) 29(th)Annual Meeting.GALE-301 is a peptide immunotherapy given as an adjuvant treatment to prevent recurrences in high-risk, ovarian and endometrial cancer patients rendered disease-free after completing standard of care therapy.Says the Phase 2a is an open-label trial with two arms consisting of HLA-A2 positive patients treated with the FBP peptide in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) and HLA-A2 negative patients followed prospectively as an untreated control group.Says the primary objectives of the trial are to measure the immune response, time to recurrence and overall survival between treatment arms. The preliminary results indicate GALE-301 is well tolerated and elicits a strong in vivo immune response.Says the study was not powered for efficacy but rather, a clinical proof of concept study.Says 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.  Full Article

Galena Biopharma Inc reaffirms FY 2014 revenue guidance - Conference Call
Monday, 3 Nov 2014 05:00pm EST 

Galena Biopharma Inc:Says it remain confident in achieving FY 2014 net revenue guidance of $8 million to $10 million.FY 2014 revenue of $10 million - Thomson Reuters I/B/E/S.  Full Article

Galena Biopharma Inc lowers FY 2014 revenue guidance - Conference Call
Thursday, 25 Sep 2014 05:00pm EDT 

Galena Biopharma Inc:Adjusts guidance for FY 2014 net revenues to $8 million to $10 million.FY 2014 revenue of $12 million - Thomson Reuters I/B/E/S.  Full Article

Galena Biopharma appoints Mark W. Schwartz, Ph.D., as President and Chief Executive Officer
Thursday, 21 Aug 2014 07:05am EDT 

Galena Biopharma Inc:Appoints Mark W. Schwartz, Ph.D as President and Chief Executive Officer, effective immediately.Replaces Mark J. Ahn, Ph.D. who has resigned as the President and CEO and as a director.  Full Article

Galena Biopharma Inc maintains FY 2014 revenue guidance - Conference call
Monday, 11 Aug 2014 05:00pm EDT 

Galena Biopharma Inc:Maintains net revenue guidance of $11 mln to $15 mln for FY 2014, leaning towards lower end of that range.FY 2014 revenue of $14 mln - Thomson Reuters I/B/E/S.  Full Article

Galena Biopharma Inc enters into definitive agreement to license U.S. rights for Zuplenz (ondansetron) Oral Soluble Film
Tuesday, 22 Jul 2014 07:05am EDT 

Galena Biopharma Inc:Says it has entered into a definitive agreement to license the U.S. rights for the commercial product Zuplenz oral soluble film.The asset was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm, and manufacturer of the product.Under the terms of the license agreement, upon effectiveness of the license and transfer to Galena of the New Drug Application (NDA) for Zuplenz, Galena will pay MonoSol Rx a total of $5,000,000 in cash and stock.The license agreement also provides for fixed double-digit royalties on net sales and pre-specified, one-time sales milestones.Zuplenz has issued and pending U.S. patent applications with an anticipated expiration date of 2029.Galena expects to launch Zuplenz in early 2015.  Full Article

Brower Piven announces filing of class action lawsuit against Galena BioPharma, Inc
Friday, 25 Apr 2014 01:39pm EDT 

Brower Piven:Announces that class action lawsuit has been commenced on behalf of purchasers of Galena Biopharma, Inc. common stock during the period between May 9, 2013 and March 17, 2014.Complaint alleges that throughout the class period defendants misrepresented and/or failed to disclose that it hired a promoter, The DreamTeam Group, to boost Galena's share price.Promoter posted misleading articles on Galena's behalf without properly disclosing its paid marketing relationship.As a result, its statements were materially false and misleading at all relevant times.  Full Article

Howard G. Smith files an expanded class period in shareholder lawsuit Galena Biopharma
Tuesday, 22 Apr 2014 10:32am EDT 

Howard G. Smith:Files class action lawsuit against Galena Biopharma, Inc. in the United States District Court for District of Oregon has been expanded to include all purchasers of Galena common stock between May 9, 2013 and March 17.Complaint alleges that throughout the Class Period defendants hired a promoter - The DreamTeam Group - to boost Galena's share price.Promoter posted misleading articles on Galena's behalf without properly disclosing its paid marketing relationship.  Full Article

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