Galena Biopharma, Inc. (NASDAQ: GALE) saw its shares jump on Wednesday after a key U.S. Food and Drug Administration (FDA) approval. The company announced that it has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase 3 trial.
After a productive meeting with the FDA, Galena has confirmed the development program and proposed clinical trial are appropriate for a New Drug Application (NDA) filing.
The Phase 3 clinical trial will enroll patients with essential thrombocythemia who have either failed or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy (BAT) that will include a sizable subpopulation of patients treated with anagrelide immediate release.
Galena expects to finalize the Phase 3 clinical trial protocol and initiate the trial in the second quarter of 2017.
Mark W. Schwartz, Ph.D., President and CEO of Galena, commented:
Confirmation of the 505(b)(2) regulatory pathway and preliminary agreement with the Agency on our Phase 3 clinical trial design is a significant step forward for our late stage program. Our controlled release version of anagrelide can offer a potential treatment option for patients with ET who have failed hydroxyurea. We remain on track to initiate the trial in the second quarter of 2017.
short term trading: Stage Stores, Inc.(SSI)
Advisors’ Opinion:
- [By Paul Ausick]
Stage Stores Inc. (NYSE: SSI) dropped nearly 20% on Monday to post a new 52-week low of $3.21 after closing at $4.00 on Friday. Volume was more than 5 times the daily average of about 650,000 shares. The company posted poor holiday season sales last Friday and lowered its guidance.
- [By Lisa Levin]
Stage Stores Inc (NYSE: SSI) was down, falling around 16 percent to $3.35 as the company reported a drop in its holiday season same-store sales and lowered its earnings guidance. The retailer’s same-store sales dropped 7.3 percent for the nine-week period ending December 31, 2016.
short term trading: Innoviva, Inc. (INVA)
Advisors’ Opinion:
- [By Sean Williams]
Shares of Innoviva (NASDAQ:INVA), a biotechnology royalty company that develops respiratory therapeutics and is perhaps best known as GlaxoSmithKline’s (NYSE:GSK) development partner for its multiple next-generation COPD and asthma products, fell as much as 11% on Thursday. The reason behind Innoviva’s bad day can be traced to a proxy battle with activist hedge fund Sarissa Capital Management over seats on its board.
short term trading: Las Vegas Sands Corp.(LVS)
Advisors’ Opinion:
- [By Ben Levisohn]
Wynn wasn’t the only Macau casino operator that took it on the chin today. Las Vegas Sands (LVS) tumbled 13% to $54.67, while Melco Crown Entertainment (MPEL) plunged 14% to $16.87, and MGM Resorts International (MGM) dropped 4.3% to $28.65.
- [By WWW.THESTREET.COM]
Cramer recalled how, in 2009, colleague Dan Fitzpatrick correctly identified Las Vegas Sands (LVS) as it broke out of its $10 a share funk and soared to $48, almost in a straight line. This technical move was brought on by Sands’ red-hot properties in Macau.
- [By Wayne Duggan]
The firm has a Market-Perform rating on the China unit of Las Vegas Sands Corp. (NYSE: LVS).
All four stocks are up between 3.8 and 11.2 percent in the past month.
short term trading: Coupa Software Incorporated (COUP)
Advisors’ Opinion:
- [By Taylor Cox]
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