Galena Biopharma, Inc. (GALE)

Oncology Corporate Profile

Stock Performance

1.3900
0.0000

HQ Location

310 N. State Street, Suite 208
Lake Oswego, OR 97034

Company Description

Galena Biopharma, Inc. is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.

Website: http://www.galenabiopharma.com/

This company does not have any commercial products
  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
GALE-301immunotherapy (peptide-based)Ovarian cancerII
NeuVax™immunotherapy (peptide-based)Ductal Carcinoma in Situ (DCIS)II
NeuVax™immunotherapy (peptide-based)Gastric cancerII
NeuVax™ (+ trastuzumab)immunotherapy (peptide-based)Breast cancerII
NeuVax™ (+ trastuzumab)immunotherapy (peptide-based)Triple negative Breast cancerII
GALE-301 (+ GALE-302)immunotherapy (peptide-based)Breast cancerI
GALE-301 (+ GALE-302)immunotherapy (peptide-based)Ovarian cancerI

View additional information on product candidates here »

Source: http://www.galenabiopharma.com/

Recent News Headlines

Galena Biopharma to Present NeuVax™ (nelipepimut-S) Interim Safety Data at the European Society for Medical Oncology 2016 Congress

9/29/2016 12:21 pm

(StreetInsider) Sept 29, 2016 - Galena Biopharma, Inc., a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today announced that interim safety data from the Company's NeuVax™ (nelipepimut-S) Phase 2b combination study will be presented at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark.

Galena Craters on Breast Cancer Vaccine Study Failure

6/29/2016 12:28 pm

(TheStreet) June 29, 2016 - Galena stopped the phase III study of Neuvax after independent data monitors examining interim data concluded the experimental breast cancer vaccine was ineffective at preventing the recurrence of tumors compared to a placebo.

Galena Biopharma Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302

6/13/2016 12:18 pm

(MarketWatch) June 10, 2016 - Galena Biopharma, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted two orphan-drug designations for Galena's two cancer immunotherapy peptides derived from Folate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302 (E39’).

Galena Biopharma Receives Fast Track Designation for NeuVax™ (nelipepimut-S) PRESENT Clinical Trial

6/1/2016 11:46 am

(Yahoo! Finance) June 1, 2016 - Galena Biopharma, Inc. today announced the U.S. Food and Drug Administration (FDA) has designated NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care.

Galena Biopharma Presents GALE-301/GALE-302 Clinical Booster Data at the American Association for Cancer Research (AACR) Annual Meeting

4/19/2016 01:35 pm

(EconoTimes) Apr 19, 2016 - Galena Biopharma, Inc. today announced that data from the booster phase of the Company’s GALE-301/GALE-302 Phase 1/2a clinical trial was presented at the American Association for Cancer Research (AACR) Annual Meeting.

TESARO Submits New Drug Application for Intravenous Rolapitant to the U.S. Food and Drug Administration

3/14/2016 11:03 am

(StreetInsider) Mar 14, 2016 - TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant to the U.S. Food and Drug Administration (FDA).

Galena Named Target of Federal Criminal Probe Into Painkiller Use

3/11/2016 11:54 am

(TheStreet) Mar 11, 2016 - Galena Biopharma is the target of a federal criminal investigation that has already led to the arrests of two Alabama doctors, charged with allegedly running a fraudulent pill mill and taking kickbacks to prescribe painkillers.

AACR Supports Obama Administration's Commitment to More Federal Funding to Fight Cancer

2/2/2016 12:01 pm

(AACR) Feb 1, 2016 - Group stands ready to work with Vice President Biden's "Cancer Moonshot Task Force”.

Galena Biopharma To Sell Zuplenz® (ondansetron) Oral Soluble Film, Completing Divestiture Of Commercial Operations

12/18/2015 11:53 am

(TheStreet) Dec 18, 2015 - Galena Biopharma, Inc., a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced it has entered into an agreement for the sale of its Zuplenz® (ondansetron) Oral Soluble Film product to Midatech Pharma Plc in a deal valued at up to $29.75 million, with $3.75 million cash upfront and up to $26 million in additional cash upon the achievement of certain sales milestones.

Galena Settles Class Action Insider Trading Suits for $20M

12/11/2015 12:48 pm

(Portland Business Journal) Dec 10, 2015 - The erstwhile Portland bioscience company, Galena Biopharma Inc., has settled two class action lawsuits over alleged insider trading for $20 million.

If Cancer Becomes Biden’s Cause, a Bold but Polarizing Doctor Is On Call

11/2/2015 12:01 pm

(New York Times) Nov 1, 2015 - One day last winter, desperate as his son fought for his life against a killer brain cancer, Vice President Joseph R. Biden Jr. and his family reached out to one of America’s most famous, and controversial, doctors for help.

Merck CEO Says Drug-Price Debate Doesn't Account for R&D Risks

11/2/2015 12:01 pm

(Bloomberg) Oct 30, 2015 - Talking drug prices with President Barack Obama was just the start. Merck & Co.’s chief executive officer says he’s on a campaign to change a perception most Americans have: that pharmaceutical companies charge too much for their drugs.

Drug Makers Buy Pricey Vouchers to Speed Products to Market

11/2/2015 12:01 pm

(Wall Street Journal) Nov 1, 2015 - AbbVie, Sanofi are among those paying large sums for ‘priority review’ at FDA.

ASCO-AACI Launch Survey to Assist Researchers in Managing Clinical Trials; Survey Closes November 15

11/2/2015 12:00 pm

(ASCO in Action) Nov 1, 2015 - On November 1, ASCO and the Association of American Cancer Institutes (AACI) launched a survey to assess administrative and/or regulatory burdens associated with conducting and managing clinical trials.

ASCO Commends FDA for First-Ever No-Tobacco-Sale Order

11/2/2015 12:00 pm

(ASCO in Action) Oct 30, 2015 - The U.S. Food and Drug Administration (FDA) recently initiated the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors.

Loss of Insurance Plans Could Devastate Cancer Patients

11/2/2015 12:00 pm

(Houston Chronicle) Oct 31, 2015 - As the health insurance enrollment season opens Sunday, it's what missing from the list of options that frightens Martha Gardenier most.

Statement from American Society of Hematology President David A. Williams, MD, on Passage of the Bipartisan Budget Act of 2015

11/2/2015 12:00 pm

(ASH) Oct 30, 2015 - Early this morning, the Senate passed the Bipartisan Budget Act of 2015, a compromise between Congress and the White House that will provide relief from harmful sequestration cuts for the next two years.

Foundation Medicine Announces Roche Pharmaceuticals (Israel) Ltd. to Commence Commercial Activities in Support of its Molecular Information Products in Oncology

11/2/2015 12:00 pm

(TheStreet) Nov 2, 2015 - Israel selected as the first ex-US launch country for Foundation Medicine’s products.

Merck and Selvita Announce Drug Discovery Collaboration

11/2/2015 12:00 pm

(Selvita) Nov 2, 2015 - Focus is to discover small molecule lead candidates for multiple oncology indications.

OSE Pharma Receives Positive Opinion From Several European Countries To Start Pivotal Phase 3 Trial of Tedopi®

11/2/2015 12:00 pm

(OSE Pharma SA) Nov 2, 2015 - OSE Pharma SA, an immuno-oncology company developing a T-specific immunotherapy for late-stage cancer patients, announces that the regulatory authorities in 7 European countries have issued a positive opinion to initiate its pivotal Phase 3 clinical trial of Tedopi® for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

SERMO Poll: 72% of Doctors Support Prophylactic Surgery for Women with BRCA Mutations

11/2/2015 12:00 pm

(SERMO) Oct 30, 2015 - Doctors do not support universal testing for BRCA gene mutations.

LUNGevity's New Online Tool Empowers Patients to Find and Enroll in Clinical Trials

11/2/2015 12:00 pm

(LUNGevity) Nov 2, 2015 - LUNGevity has joined forces with Lilly Oncology to develop an online tool that streamlines the process and eases navigation of clinical trial searches.

Loughborough University Unveils World’s First Lab-In-A-Briefcase

11/2/2015 11:05 am

(Loughborough University [UK]) Oct 30, 2015 - Academics at Loughborough University hope to boost early detection rates of cancer in developing countries with their portable lab-in-a-briefcase that can operate even at high temperatures.

ACCC Advocacy Alert: Budget Deal Includes New Outpatient Reimbursement Policy

11/2/2015 11:05 am

(ACCC Advocacy Alert) Oct 30, 2015 - This week, the U.S. House of Representatives proposed a policy as part of a broader budget deal that would lower reimbursement rates for services provided at newly acquired provider-based (PBD) off-campus hospital outpatient departments (HOPDs).

CMS Releases Three Final Rules: 2016 Medicare Physician Fee Schedule, 2016 Hospital Outpatient Prospective Payment System, and Medicaid Rule Addressing Access to Covered Services

11/2/2015 11:05 am

(ASCO in Action) Oct 30, 2015 - This afternoon, the Centers for Medicare & Medicaid Services (CMS) released its final rule on the 2016 Medicare Physician Fee Schedule.

Galena Biopharma Collaborates With the National Cancer Institute on a Phase 2 Clinical Trial With NeuVax(TM) (nelipepimut-S) in Ductal Carcinoma in Situ Patients

9/30/2015 11:37 am

(NASDAQ) Sept 30, 2015 - Galena Biopharma, Inc. today announced a collaboration with the National Cancer Institute (NCI) to initiate a new, Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in patients diagnosed with Ductal Carcinoma in Situ (DCIS).

Galena Biopharma Announces Independent Data Safety Monitoring Committee Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax(TM) PRESENT Trial

8/24/2015 11:15 am

(TheStreet) Aug 24, 2015 - Galena Biopharma, Inc. today announced that the Independent Data Monitoring Committee (IDMC) has recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial.

Galena Biopharma Launches Zuplenz(R) (ondansetron) Oral Soluble Film

7/29/2015 11:54 am

(Galena Biopharma) July 29, 2015 - Galena Biopharma, Inc. today announced the product launch for Zuplenz® (ondansetron) Oral Soluble Film in the United States.

MD Anderson Regains Top Cancer-Care Ranking

7/21/2015 12:00 pm

(Houston Chronicle) July 20, 2015 - M.D. Anderson Cancer Center has regained the No. 1 designation for cancer care in U.S. News & World Report's annual rankings of hospitals, a year after a drop to No. 2 ended seven straight years atop the list.

Appeal Court Clears Inspectors In French Breast Implants Case

7/2/2015 11:04 am

(Reuters) July 2, 2015 - A French appeal court on Thursday overturned a negligence conviction against certification agency TUV Rheinland for its role in approving faulty breast implants produced with counterfeit silicone by manufacturer PIP until its 2010 closure.

'Trip Wire': UPMC Says It Cut Highmark Members After Insurer Stopped Paying Higher Rates For Cancer Treatment

5/28/2015 12:04 pm

(Pittsburgh Business Times) May 27, 2015 - UPMC decided to deny some 182,000 Highmark Medicare Advantage plan members in-network access to its doctors and hospitals after the health insurer last year said it would not pay UPMC higher rates for administering cancer–fighting drugs, a lawyer for the hospital giant argued Wednesday morning.

Galena Biopharma Rises on Cancer Therapy Study

5/28/2015 06:44 am

(Yahoo! Finance/Associated Press) May 27, 2015 - Shares of Galena Biopharma rose Wednesday after the cancer drug developer reported promising data from a clinical study of a second potential cancer vaccine.

What Adverse Event Reports? FDA Warns Galena For a Lack of Procedures

4/23/2015 12:55 pm

(Wall Street Journal/Pharmalot blog) Apr 22, 2015 - File this under 'Please consult our handbook for proper procedures.' In May 2013, Galena Biopharma acquired Abstral, an opioid painkiller that comes in a tablet and is prescribed for cancer patients.

Galena Biopharma Completes Over-Enrollment of NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial

4/14/2015 12:13 pm

(NASDAQ) Apr 14, 2015 - Galena Biopharma, Inc. today announced the completion of enrollment in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial.

UVM Biostatistician Helps FDA Approve First Biosimilar Drug

4/8/2015 12:00 am

(University of Vermont) Apr 8, 2015 - Since 2013, Cole has sat on an important FDA panel that assesses applications for new cancer medications and makes recommendations to the federal agency.

Galena Biopharma Expands Patient Population in NeuVax(TM) (nelipepimut-S) and Trastuzumab Phase 2b Combination Clinical Trial in HER2 1+/2+ Patients

3/26/2015 12:27 pm

(The Street) Mar 26, 2015 - Galena Biopharma, Inc. today announced that human leukocyte antigen (HLA) - A24+ or HLA-A26+ women are now eligible for enrollment into the ongoing Phase 2b clinical trial with NeuVax™ (nelipepimut-S) in combination with trastuzumab (Herceptin®; Genentech/Roche).

Bristol-Myers Squibb's $1.6 Billion On New Drug Deals Is Well Spent

3/4/2015 12:02 pm

(Forbes) Mar 3, 2015 - Bristol-Myers Squibb recently entered a couple of agreements worth $1.6 billion to bolster its immuno-oncology drugs portfolio.

Galena Biopharma Enrolls 700th Patient in NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial

2/9/2015 11:43 am

(Stockwatch) Feb 9, 2015 - Galena Biopharma, Inc. today announced enrollment of the 700th patient in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial.

Galena Biopharma Presents GALE-401 (Anagrelide Controlled Release) Clinical Trial Data at the 56th American Society of Hematology (ASH) Annual Meeting & Exposition

12/8/2014 05:39 pm

(CNNMoney) Dec 8, 2014 - Phase 1 results demonstrate GALE-401 reduces platelet counts with tolerable safety profile; preliminary Phase 2 clinical trial data show promising platelet response with top-line data to be presented mid-year 2015.

Galena Biopharma Completes Enrollment in GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial

11/18/2014 11:30 am

(Yahoo! Finance) Nov 18, 2014 - Galena Biopharma, Inc. today announced the completion of enrollment in the GALE-401, or Anagrelide Controlled Release, Phase 2 Clinical Trial.

Merck Announces Positive Study Investigating the Use of KEYTRUDA® (pembrolizumab) Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma

11/17/2014 05:01 am

(CNBC) Nov 16, 2014 - KEYTRUDA demonstrated superiority to chemotherapy for primary endpoint of progression-free survival; findings presented for first time at Society of Melanoma Research (SMR) 2014 International Congress.

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

11/12/2014 12:21 pm

(Galena Biopharma) Nov 11, 2014 - Galena Biopharma, Inc. today announced the dosing of the first patient in a new NeuVax™ (nelipepimut-S) Phase 2 clinical trial to prevent breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified breast cancer patients in combination with Herceptin® (trastuzumab; Genentech/Roche).

Auxilium Adds Poison Pill Against Endo's $2.2B Offer

9/17/2014 07:02 am

(Bloomberg) Sept 17, 2014 - Auxilium Pharmaceuticals Inc. adopted a so-called poison pill shareholder rights plan to try and fend off an unsolicited, $2.2 billion offer from Endo International Plc, a maker of pain drugs.

Biotech Stock Mailbag: Threshold, Galena, CytRx

8/22/2014 11:54 am

(The Street) Aug 22, 2014 – What are your thoughts on Threshold Pharmaceuticals?

Galena CEO Fired Following Stock-Promotions Scandal

8/21/2014 11:48 am

(TheStreet) Aug 21, 2014 - Mark Ahn's forced exit from the troubled Galena follows an internal investigation by the board.

Biotech Stock Mailbag: Exact Sciences, Galena, Amgen

8/15/2014 12:19 pm

(The Street) Aug 15, 2014 - Biotech columnist Adam Feuerstein talks about Exact Sciences' Cologuard, Galena's Neuvax and Abstral, and Amgen's Kyprolis.

ALTTO Fallout Focuses Debate on the Meaning of pCR

7/30/2014 06:04 am

(Medscape Medical News) July 29, 2014 - This summer, results from the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial sparked a controversy that is gathering momentum.