$ARRY news,
Advancing Preclinical Autoimmune Studies & Accelerated FDA Approvals Producing Rewards in Biotech Sector
48 minutes ago - DJNF
CORAL SPRINGS, Florida, September 20, 2016 /PRNewswire/ --
Biotech & Pharma companies aim to create enhanced treatments & therapies for autoimmune diseases such as arthritis, cancer and other rare disease conditions through the latest preclinical studies, seeking accelerated FDA approvals and protocol assessments that include advancements from Sarepta Therapeutics, Inc. (NASDAQ: SRPT), Regen BioPharma Inc. (OTCBB: RGBP), Novavax, Inc. (NASDAQ: NVAX), PTC Therapeutics, Inc. (NASDAQ: PTCT) and Array BioPharma (NASDAQ: ARRY).
Regen BioPharma Inc. (OTCQB: RGBP), (OTCQB: RGBPP) today announced completion of experiments demonstrating immunological effects of its novel NR2F6 small molecule modulators. These experiments were conducted in collaboration with Dr. Xiaojing Ma, Professor of Microbiology and Immunology at Weill Cornell Medical College. The experiments revealed that administration of Regen's proprietary compounds RG-NA01, RG-NI01 and RG-NI02 prevented cells of the immune system from producing the inflammatory factors interleukin-2, interferon-gamma, tumor necrosis factor-alpha and, importantly, interleukin-17a. These factors are critically involved in the immune response found in autoimmune diseases such as rheumatoid arthritis and psoriasis.
Read the full Regen BioPharma (RGBP) release at: http://financialnewsmedia.com/profiles/rgbp.html
The company is currently developing small molecule drugs that target NR2F6 and either inhibit production of these factors or, in other cases, stimulate their production. The goal is to have a series of compounds that can modulate the immune system up or down. Regen has recently filed a composition of matter patent application covering these novel NR2F6 small molecule modulators. NR2F6 is a molecular switch which controls genes associated with the immune response.
"We are delighted to discover that our lead compounds have a cellular effect, even though these compounds are not optimized yet," said Harry M. Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen. "These preclinical experiments firmly support our initial screening data which discovered these compounds. Now, it is a matter of optimizing these compounds to improve their efficacy. To date, no one in the world has reported the discovery of molecules, natural or synthetic, which activate or inhibit NR2F6 except Regen."
In other Biotech performances and developments in the markets this week:
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, yesterday announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EXONDYS 51(TM) (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This indication is based on an increase in dystrophin in skeletal muscles observed in some patients treated with EXONDYS 51. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. The most common adverse reactions compared to a placebo group were vomiting (38%) and balance disorder (38%) with contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection also reported more frequently than placebo (>= 10%).
Novavax, Inc. (NASDAQ: NVAX) last week announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.
PTC Therapeutics, Inc. (NASDAQ: PTCT) closed up over 20% on Monday at $10.99 on over 9.1 Million shares traded by the market close. PTC Therapeutics announced last week that on September 8, 2016 it approved non-statutory stock options to purchase an aggregate of 22,900 shares of its common stock to eleven new employees. The awards were made pursuant to the NASDAQ inducement grant exception as a component of our new hires' employment compensation.
Array BioPharma (NASDAQ: ARRY) announced recently that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux(R) (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.
DISCLAIMER: FN Media Group LLC (FNMG) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNMG is NOT affiliated in any manner with any company mentioned herein. FNMG and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNMG has been compensated three thousand seven hundred dollars for news coverage of the current press release issued by Regen BioPharma Inc. by a non-affiliated third party. FNMG HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.
Contact Information:
Company: FN Media Group, LLC
Phone: +1-(954)345-0611
Contact email: editor@financialnewsmedia.com
SOURCE FN Media Group LLC
(END) Dow Jones Newswires
September 20, 2016 08:30 ET (12:30 GMT)
Advancing Preclinical Autoimmune Studies & Accelerated FDA Approvals Producing Rewards in Biotech Sector
48 minutes ago - DJNF
CORAL SPRINGS, Florida, September 20, 2016 /PRNewswire/ --
Biotech & Pharma companies aim to create enhanced treatments & therapies for autoimmune diseases such as arthritis, cancer and other rare disease conditions through the latest preclinical studies, seeking accelerated FDA approvals and protocol assessments that include advancements from Sarepta Therapeutics, Inc. (NASDAQ: SRPT), Regen BioPharma Inc. (OTCBB: RGBP), Novavax, Inc. (NASDAQ: NVAX), PTC Therapeutics, Inc. (NASDAQ: PTCT) and Array BioPharma (NASDAQ: ARRY).
Regen BioPharma Inc. (OTCQB: RGBP), (OTCQB: RGBPP) today announced completion of experiments demonstrating immunological effects of its novel NR2F6 small molecule modulators. These experiments were conducted in collaboration with Dr. Xiaojing Ma, Professor of Microbiology and Immunology at Weill Cornell Medical College. The experiments revealed that administration of Regen's proprietary compounds RG-NA01, RG-NI01 and RG-NI02 prevented cells of the immune system from producing the inflammatory factors interleukin-2, interferon-gamma, tumor necrosis factor-alpha and, importantly, interleukin-17a. These factors are critically involved in the immune response found in autoimmune diseases such as rheumatoid arthritis and psoriasis.
Read the full Regen BioPharma (RGBP) release at: http://financialnewsmedia.com/profiles/rgbp.html
The company is currently developing small molecule drugs that target NR2F6 and either inhibit production of these factors or, in other cases, stimulate their production. The goal is to have a series of compounds that can modulate the immune system up or down. Regen has recently filed a composition of matter patent application covering these novel NR2F6 small molecule modulators. NR2F6 is a molecular switch which controls genes associated with the immune response.
"We are delighted to discover that our lead compounds have a cellular effect, even though these compounds are not optimized yet," said Harry M. Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen. "These preclinical experiments firmly support our initial screening data which discovered these compounds. Now, it is a matter of optimizing these compounds to improve their efficacy. To date, no one in the world has reported the discovery of molecules, natural or synthetic, which activate or inhibit NR2F6 except Regen."
In other Biotech performances and developments in the markets this week:
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, yesterday announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EXONDYS 51(TM) (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This indication is based on an increase in dystrophin in skeletal muscles observed in some patients treated with EXONDYS 51. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. The most common adverse reactions compared to a placebo group were vomiting (38%) and balance disorder (38%) with contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection also reported more frequently than placebo (>= 10%).
Novavax, Inc. (NASDAQ: NVAX) last week announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.
PTC Therapeutics, Inc. (NASDAQ: PTCT) closed up over 20% on Monday at $10.99 on over 9.1 Million shares traded by the market close. PTC Therapeutics announced last week that on September 8, 2016 it approved non-statutory stock options to purchase an aggregate of 22,900 shares of its common stock to eleven new employees. The awards were made pursuant to the NASDAQ inducement grant exception as a component of our new hires' employment compensation.
Array BioPharma (NASDAQ: ARRY) announced recently that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux(R) (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.
DISCLAIMER: FN Media Group LLC (FNMG) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNMG is NOT affiliated in any manner with any company mentioned herein. FNMG and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNMG has been compensated three thousand seven hundred dollars for news coverage of the current press release issued by Regen BioPharma Inc. by a non-affiliated third party. FNMG HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.
Contact Information:
Company: FN Media Group, LLC
Phone: +1-(954)345-0611
Contact email: editor@financialnewsmedia.com
SOURCE FN Media Group LLC
(END) Dow Jones Newswires
September 20, 2016 08:30 ET (12:30 GMT)
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
