they may as well wait until then to break any real bad news
exactly after they told shareholders they would investigate the IDMC recommendation and provide more info in a conference call, so I ask again how can they be buying or selling if their may be potential news that may influence the stock?
Unless this is different because it is " combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF)," why did the FDA Grant FAst track?
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.
owngraded by analysts at Raymond James from an “outperform” rating to a “market perform” rating in a note issued to investors on Wednesday, The Fly reports.
Shares of Galena Biopharma (NASDAQ:GALE) traded down 86.1527% during midday trading on Wednesday, reaching $0.2811. 45,134,380 shares of the company’s stock were exchanged. The stock’s market cap is $51.11 million. Galena Biopharma has a one year low of $0.28 and a one year high of $2.49. The company’s 50-day moving average is $1.86 and its 200-day moving average is $1.30.
Galena Biopharma (NASDAQ:GALE) last released its earnings results on Tuesday, May 10th. The biotechnology company reported ($0.07) EPS for the quarter, missing the Zacks’ consensus estimate of ($0.06) by $0.01. During the same period in the previous year, the business earned ($0.08) earnings per share. Equities analysts expect that Galena Biopharma will post ($0.29) earnings per share for the current fiscal year.
Analyst Kumaraguru Raja, PhD, commented today:
• Await clarity on other NeuVax trials. While the trials are ongoing/planned, we await clarity on next steps for the NeuVax Phase 2 combination trials with Herceptin in breast cancer, Phase 2 trial with NeuVax as a single agent in ductal carcinoma in situ (DCIS) and gastric cancer Phase 2 trial, following the negative outcome from the interim analysis of PRESENT trial
• Update expected next week. The company will evaluate data from the PRESENT trial and will provide an update on the path forward. We believe that the focus should be on developing the most promising assets in the pipeline while conserving resources
• Focus shifts to GALE-301/302 and GALE-401. Phase 1b trial with GALE-301 and sequential GALE-302 (attenuated E39 peptide) booster vaccine showed encouraging results in 2Q16, both were safe and had similar immunogenicity; Phase 1/2a trial in ovarian & endometrial cancer recurrence, two-year data expected in 4Q16. GALE-401 (anagrelide CR) confirmation of 505(b)2 pathway is expected in 2H16
until of course during the call next week they discontinue all trails, it just surprising that FDA gave NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program
to me it seems the leadership was feeding misinfirmation