On Thursday, Following Stocks were among the “Top 100 Gainers” of U.S. Stock Market: Abercrombie & Fitch Co. (NYSE:ANF), Oncolytics Biotech Inc. (NASDAQ:ONCY), TG Therapeutics, Inc. (NASDAQ:TGTX), Synthetic Biologics Inc. (NYSEMKT:SYN)
Latest NEWS regarding these Stocks are depicted underneath:
Abercrombie & Fitch Co. (NYSE:ANF)
Abercrombie & Fitch Co. (ANF), declared that Joanne Crevoiserat, Executive Vice President and Chief Financial Officer is planned to present at the Telsey Advisory Group 7th Annual Spring Consumer Conference in New York on Tuesday, March 24, 2015 at 10:00 AM EST.
Abercrombie & Fitch Co., through its auxiliaries, operates as a specialty retailer of casual apparel for men, women, and kids. It operates through three segments: U.S.
Oncolytics Biotech Inc. (NASDAQ:ONCY)
Oncolytics Biotech Inc. (ONCY), declared its financial results and operational highlights for the year ended December 31, 2014 .
“The activities of the Corporation in 2014 have laid the groundwork enabling us to plan and execute our late stage clinical strategy,” said Dr. Brad Thompson , President and CEO of Oncolytics. “We are looking forward to finalizing the plans for and initiating our registration studies for REOLYSIN®.”
Oncolytics Biotech Inc., a development stage biopharmaceutical corporation, focuses on the discovery and development of pharmaceutical products for the treatment of cancers.
TG Therapeutics, Inc. (NASDAQ:TGTX)
Formerly on March 11, TG Therapeutics, Inc. (TGTX), declared its financial results for the fourth quarter and year ended December 31, 2014 and offered recent corporation developments together with a business outlook for 2015.
Recent Developments & Highlights:
Commenced the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib
Presented updated data from the Phase 2 trial of TG-1101 in combination with ibrutinib at the 56th American Society of Hematology (ASH) Annual Meeting in December, highlights from the presentation comprised of:
95% (19/20) Overall Response Rate (ORR) in Patients with High-Risk CLL, the patient population to be studied in GENUINE Phase 3 Clinical trial
Combination of TG-1101 + ibrutinib was well tolerated with limited Grade 3/4 events
Presented updated data from the Phase 1 dose escalation trial of TGR-1202 at ASH in December, highlights from the presentation comprised of:
93% of evaluable CLL patients (13/14) treated at therapeutic dose levels achieved a nodal PR, with 50% (7/14) achieving an objective response per iwCLL (Hallek 2008) criteria
No drug related hepatic toxicity or colitis observed to date with a median time on study of about 6 months and some patients on study for over 1.5 years
Presented preliminary data from Phase 1/2 dose escalation study of TG-1101 in combination with TGR-1202 at ASH in December, highlights from the presentation comprised of:
100% of evaluable CLL/SLL patients (9/9) had nodal reductions, with 6 of 9 patients achieving an objective response per iwCLL (Hallek 2008) criteria and the remaining patients on study awaiting further assessment
43% ORR in Diffuse Large B-cell Lymphoma (DLBCL) (3/7), with 2 patients achieving an independently confirmed Complete Response (CR)
The combination of TG-1101, TGR-1202, and ibrutinib (“Triple Therapy”) was safely administered to 5 patients, and no Grade 3 or 4 events were observed
2 of the first 3 evaluable patients responded to the Triple Therapy, counting an ibrutinib-refractory and rituximab-refractory patient with Follicular Lymphoma
Reached a global partnership to develop and commercialize anti-PD-L1 and anti-GITR antibody research programs in the field of hematologic malignancies.
TG Therapeutics is a biopharmaceutical corporation focused on the attainment, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Presently, the corporation is developing two therapies targeting hematological malignancies.
Synthetic Biologics Inc. (NYSEMKT:SYN)
Synthetic Biologics Inc. (SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, declared positive pharmacokinetics (PK) results from both the Phase 1a and 1b studies of SYN-004, which is being developed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection.
The Phase 1a, single-ascending dose PK study offered data to support Synthetic Biologics’ hypothesis that SYN-004 taken orally was not systemically accessible in the dose range tested. The PK data from this study measured blood levels of a single dose of SYN-004 in participants over a 10-fold dose range. Minimal levels of SYN-004 were observed in the bloodstream across the dose range investigated in the participants.
The Phase 1b, multiple-ascending dose PK study offered data to further support that SYN-004 is not systemically accessible, as no meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period. The PK data confirm Synthetic Biologics’ expectations based on previous data from the first generation enzyme (P1A).
In addition, no clinically noteworthy safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies. Synthetic Biologics intends to continue the clinical development of SYN-004 in a Phase 2a clinical trial to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, therefore potentially protecting the gut microbiome and preventing C. difficile infection.
Presently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection. The U.S. Centers for Disease Control and Prevention (CDC) has identified C. difficile infection as an “urgent public health threat” that occurs mostly in people who have had recent medical care with IV antibiotics. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections and 30,000 C. difficile-related deaths in the United States each year. About 118 million doses of IV beta-lactam antibiotics that could be inactivated in the GI tract by SYN-004, were administered to about 14 million hospitalized U.S. patients during 2012.
Synthetics Biologics, Inc., a biotechnology corporation, focuses on development of novel anti-infective biologics and drug candidates targeting specific pathogens that cause serious infections and other diseases.
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