Australian “Watchdog” Recommends Greater Scrutiny for Tech Giants

Google (GOOGL) and Facebook (FB) are no strangers to inhospitable interactions with governments. With both having dealt with legal battles in the US and Facebook facing European inquiries, the recent report by the Australian competition regulator recommending more supervision of the tech giants isn’t surprising.
The Australian Competition and Consumer Commission (ACCC) looked into the market power and public influence of some of the top tech companies in the world. The report the commission released suggested creating a new organization to keep a close eye Facebook and Google in particular.
But the new commission isn’t the only thing that may come from the report. ACCC chairman Rod Sims explained that because of the information that was collected during the process of creating the report, five new investigations are underway. Sims didn’t state which companies were the subject of these inquiries.
Sims noted, “Some of them are allegations that could sit under competition law which would go to issues of market power. Five investigations is quite a lot.”

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Australian regulator says probe of tech giants spurs five investigations

Australia’s competition regulator says it has five investigations afoot as a result of its examination of the market power and public influence of tech giants such as Facebook Inc and Alphabet Inc’s Google. …..

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“Contrasts” – Vista Partners Daily Market Recap 12/7/2018

Several contrasts emerged on Friday, the first being between plunging stocks and soaring oil prices after OPEC agreed to slash its output by 1.2 million barrels per day. After opening with gains, stocks quickly slid with the S&P 500 ending down 2.33% (62.87 points) and the Nasdaq falling 3.05% (219.01 points). The Dow also performed poorly, as it plummeted 2.24% to end the session.

Individually, components of the Dow were down across the board, with every company in the index reporting losses. Intel (INTC) suffered the worst losses as it saw shares decrease 4.40%. Cisco (CSCO) wasn’t too far behind with a fall of 4.03%, and Microsoft (MSFT) rounded out the bottom three as it tumble 4.00%.

Atossa Genetics (ATOS) managed to buck the trend and end the day with gains of 1.54%.

An investment in the leveraged vehicle,  VelocityShares Daily 2x VIX ST ETN (TVIX) or the TVIX a many call it, produced another amazing day with a 14.70% increase on Friday!

The second contrast apparent today was between the volatility of the markets and the generally solid economic data. The jobs report for November showed that job growth was positive for the month but under economists’ predictions, and it showed that unemployment had held steady at 3.7%.

Paul Ashworth of Capital Economics had this to say about the apparent contrast. “The slightly more modest 155,000 gain…is still a solid gain that suggests economic growth is gradually slowing back toward its potential pace. There is nothing here to suggest the economy is suffering a more sudden downturn.”

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Stocks tumble, crude oil surges on OPEC deal

Stock got slammed on Friday, and crude oil surged on an OPEC deal…

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“Spinners” – Vista Partners Daily Market Recap 12/6/2018

We were hit with a rough morning of trading that seemed to be a reaction to the overnight arresting of the Chinese Company’s (Huawei) CFO Meng Wanzhou by Canadian authorities (also facing extradition to the US), which in turn lit fears around the trade wars and sent the markets crashing. However, some news from the Fed today helped to buoy the markets into the close.

At the end of the day, the S&P 500 dropped .15% as of market close, as the energy sector lead declines. The Dow was down only .32% after sliding quickly as many as 784.85 points earlier in the day. The Nasdaq jumped .42%, or 29.83 points as it moved into to positive territory at the close. All in it was another day of yo-yo that surely kept is all spinning.

Components of the Dow were also mixed, with Boeing (BA) leading the losers with a drop of 3.09%. JP Morgan (JPM) also had a rough day with losses of 1.90%. On the other side of the spectrum, Cisco (CSCO) ended the day up 2.20%.

Outside the Dow, Atossa Genetics (ATOS) was down 2.99% as the session closed.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Stocks pare losses, Nasdaq closes in the green

Stocks pared losses after enduring a rollercoaster session ignited after the arrest of a Chinese telecommunications company executive muddled prospects of a U.S.-China trade resolution…

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A Growing List of Inspirational Quotes For Success!

We believe it is necessary to continue to inspire all to be their personal best in life and in investing. We also believe that keeping inspired and learning from others is an essential element to building long-term financial and emotional wealth.

With this in mind, we commit to grabbing ideas and thoughts from those that are successful in life and from investors who have conquered the markets and would encourage you to do so as well.

Here is a list of inspiring quotes that we will continue to add to over time. So please enjoy them today and come back regularly to continue to find inspiration as we add to this list.

  1. “I will tell you how to become rich. Close the doors. Be fearful when others are greedy. Be greedy when others are fearful.” – Warren Buffett
  2. “Bottoms in the investment world don’t end with four-year lows; they end with 10- or 15-year lows.” – Jim Rogers
  3. “The stock market is filled with individuals who know the price of everything, but the value of nothing.” – Phillip Fisher
  4. “The individual investor should act consistently as an investor and not as a speculator.” – Ben Graham
  5. “Financial peace isn’t the acquisition of stuff. It’s learning to live on less than you make, so you can give money back and have money to invest. You can’t win until you do this.” – Dave Ramsey
  6. “Invest in yourself, you can afford it, trust me.”- Rashon Carraway
  7. “The wisest rule in investment is: when others are selling, buy. When others are buying, sell.” –  Jonathan Sacks
  8. “Formal education will make you a living; self-education will make you a fortune.” – Jim Rohn
  9.  “Investing puts money to work. The only reason to save money is to invest it.” – Grant Cardone
  10. “You will come to know that what appears today to be a sacrifice will prove to be the greatest investment that you will ever make.” – Gordon B. Hinkley
  11. “In the short run, the market is a voting machine but in the long run, it is a weighing machine.”― Benjamin Graham
  12. “In the short run, the market is a voting machine but in the long run, it is a weighing machine.” ― Benjamin Graham 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Vista Partners Inspirational Quote of the Day via Peter Lynch (12-5-18)

“If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.” – Peter Lynch

Peter Lynch is an American investor, mutual fund manager, and philanthropist. As the manager of the Magellan Fund at Fidelity Investments between 1977 and 1990, Lynch averaged a 29.2% annual return, consistently more than doubling the S&P 500 market index and making it the best performing mutual fund in the world.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Cybersecurity Firm Finjan (FNJN) Files Complaint Against Qualys (QLYS) for Patent Infringement!

Established over 20 years ago, Palo Alto-based, Finjan (Nasdaq: FNJN) is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation.

Today, Finjan announced that — after three years of “good faith efforts” to resolve a patent dispute with Qualys, Inc. ( “Qualys”) (NasdaqGM: QLYS) — its subsidiary Finjan, Inc. (“Finjan”) has filed a patent infringement lawsuit against Qualys, a Delaware corporation with headquarters in Foster City, California, in the U.S. District Court for the Northern District of California.

Finjan filed the Complaint (Case No. 3:18-cv-07229), on November 29, 2018, and alleges that Qualys’ products and services infringed and are continuing to infringe at least seven of Finjan’s U.S. patents. Specifically, Finjan asserts that Qualys’ Malware Detection Systems (MDS), Web Application Firewall (WAF), Web Application Scanner (WAS), and Vulnerability (VM) solutions, including Qualys Cloud Platform products, infringe U.S. Patent Nos. 6,154,844; 6,965,968; 7,418,731; 7,975,305; 8,141,154; 8,225,408; and 8,677,494 (collectively “the Asserted Patents”). Finjan is seeking, among other things, a jury trial, past damages not less than a reasonable royalty, enhanced damages for willful, wanton and deliberate infringement, and reasonable attorneys’ fees and costs for infringement of each of the Asserted Patents. Additionally, Finjan is seeking preliminary and permanent injunctive relief against Qualys and those in privity with them, from infringing and inducing the infringement of the ‘968, ‘731, ‘305, ‘154, and ‘408 Patents.

Finjan has pending infringement lawsuits and appeals against Palo Alto Networks (PANW); ESET and its affiliates; Cisco Systems, Inc. (CSCO); SonicWall, Inc.; Bitdefender and its affiliates; Juniper Networks; Zscaler, Inc.; Check Point (CHKP) and its affiliates; Rapid7, Inc. and Fortinet, Inc. (FTNT) relating to, collectively, more than 20 patents in the Finjan portfolio. The court dockets for the foregoing cases are publicly available on the Public Access to Court Electronic Records (PACER) website, www.pacer.gov, which is operated by the Administrative Office of the U.S. Courts.

Finjan won a significant settlement against Symantec (SYMC) earlier in 2018 where one of SYMC’s units have agreed to pay $65 million with a possibility of up to $45 million more.

 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

 

 

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Finjan Files a Complaint Against Qualys for Patent Infringement in the Northern District of California

EAST PALO ALTO, Calif., Dec. 03, 2018 — Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, today announced that — after three years of good faith efforts to…

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Vista Partners Inspirational Quote of the Day via George H.W. Bush

“Freedom and the power to choose should not be the privilege of wealth. They are the birthright of every American.” – George H. W. Bush

 

 

George Herbert Walker Bush was born on June 12, 1924, in Milton, MA & recently past away on November 30, 2018, in Houston, TX. President Bush was an American politician who served as the 41st President of the United States from 1989 to 1993. Prior to assuming the presidency, Bush served as the 43rd Vice President of the United States from 1981 to 1989.




ASH MEETING UPDATE: Fate Therapeutics Presents Off-the-Shelf CAR T & NK Cell Cancer Immunotherapy Pipeline (Shares Hit New All-Time High)

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA.

Today Fate Therapeutics announced new preclinical data on the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived, off-the-shelf cell-based cancer immunotherapy pipeline at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition. Last week, the Company announced that the U.S. Food and Drug Administration (FDA) allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master iPSC line. The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product.

Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “Fate Therapeutics is at the forefront in developing off-the-shelf, cell-based cancer immunotherapies, and is rapidly progressing multiple iPSC-derived CAR T- and NK cell product candidates that have the potential to disrupt autologous and allogeneic approaches to cell therapy. The clearance of our FT500 IND by the FDA is a landmark achievement and serves as a roadmap for advancement of our iPSC-derived cell product pipeline into clinical development. We believe the use of clonal master iPSC lines uniquely enables the production of multi-functional, cell-based cancer immunotherapies that are uniformly engineered, are available for off-the-shelf administration to patients and can be effectively combined in multi-dose, multi-cycle regimens with well-established immune-oncology agents, such as checkpoint inhibitor blockade and monoclonal antibody therapy, including in earlier lines of therapy.”

Several of the Company’s iPSC-derived cell product candidates undergoing development were discussed during an investor event at ASH by its collaborating experts in the field of cell-based cancer immunotherapy including:

  • Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering & Gene Transfer and Gene Expression Laboratory, Memorial Sloan Kettering Cancer Center;
  • Jeffrey S. Miller, M.D., Deputy Director, Masonic Cancer Center, University of Minnesota; and
  • Dan S. Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine, Director of Cell Therapy, University of California – San Diego.

FT500
The clinical trial of FT500 is intended to evaluate the safety and tolerability of multiple doses of FT500, in multiple dosing cycles with nivolumab, pembrolizumab or atezolizumab, in subjects that have progressed or failed on immune checkpoint blockade (CPB) therapy. Although CPB therapy can lead to prolonged responses, refractory disease and progression after initial response remain major causes of mortality. In patients receiving CPB therapy, mutations in beta-2-microglobulin (B2M), an essential component for the stable presentation of antigens by tumor cells, have been identified in approximately 30% of patients with progressing disease and are associated with poor overall survival. Investigators have demonstrated in various tumor model systems that NK cells have the potential to rescue CPB therapy by recognizing and killing B2M-deficient target cells. An oral presentation at ASH by Dr. Miller showed that FT500 synergizes with T cells and anti-PD1 antibody to produce pro-inflammatory cytokines and completely clear target cancer cells in an in vitro three-dimensional tumor spheroid model.

FT516
FT516 is a universal, off-the-shelf NK cell product candidate manufactured from a clonal master iPSC line engineered to uniformly express a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor. Since CD16 binds the Fc region of tumor-bound antibodies, FT516 can be combined with FDA-approved monoclonal antibody therapies to target a broad spectrum of tumor-associated antigens. In preclinical studies, FT516 exhibits potent and persistent anti-tumor activity in vitro and in vivo against multiple tumor types, including in combination with monoclonal antibody therapies that target CD20, HER2 and EGFR. The Company plans to submit an IND to the FDA by the end of 2018 to evaluate the safety and tolerability of multiple doses of FT516 in multiple dosing cycles in combination with FDA-approved monoclonal antibody therapy.

FT596
FT596 is a universal, off-the-shelf chimeric antigen receptor (CAR) NK cell product candidate that expresses a proprietary CAR targeting CD19, a novel IL-15 receptor fusion for cytokine-independent persistence, and a hnCD16 Fc receptor for augmented antibody-dependent cellular-cytotoxicity (ADCC). A poster presentation at ASH by scientists from the Company and the University of California – San Diego highlighted new in vivo data demonstrating that FT596 displays long-term persistence without systemic cytokine support. Additionally, FT596 prevents tumor progression and promotes sustained long-term survival in a B-cell leukemia xenograft model. Moreover, as proof-of-concept for the mitigation of antigen escape, FT596 in combination with rituximab completely eliminates CD19+ and CD19- B-cell tumor cells in a co-culture cytotoxicity assay.

FT538
FT538 is a universal, off-the-shelf NK cell product candidate that expresses both a novel IL-15 receptor fusion for cytokine-independent persistence and a hnCD16 Fc receptor for augmented ADCC, and additionally lacks CD38 expression to eliminate fratricide when combined with CD38-targeting monoclonal antibody therapy. A poster presentation at ASH by scientists from the Company and the University of Minnesota highlighted new in vitro data showing that FT538 in combination with daratumumab is resistant to fratricide and eliminates multiple myeloma cancer cells in a serial re-challenge assay. The Company is investigating the additional therapeutic benefit of including a novel humanized CAR targeting B-cell Maturation Antigen (BCMA) as a dual-targeting mechanism to address multiple myeloma and other BCMA-positive malignancies.

FT819
FT819 is an off-the-shelf, TCR-less CD19 CAR T-cell product candidate manufactured from a clonal master iPSC line that is undergoing preclinical development under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Dr. Sadelain. FT819 is engineered to completely eliminate expression of the T-cell receptor and to insert a next-generation CAR receptor into the T-cell receptor alpha locus, a strategy which is intended to convey enhanced safety and efficacy while eliminating the possibility of graft-versus-host disease. A poster presentation at ASH by scientists from the Company and MSK showcased new in vivo data demonstrating that FT819, when thawed and directly infused, effectively controls tumor progression compared to peripheral blood CAR T cells in a preclinical mouse model of acute lymphoblastic leukemia.

A copy of the Company’s presentation from its ASH investor event can be accessed under “Events & Presentations” in the Investors & Media section of the Company’s website at www.fatetherapeutics.com.

FATE’s  iPSC Product Platform

The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

FATE shares hit a new all-time high of $17.95 before settling at $16.98.

Fate Therapeutics Presents Off-the-Shelf CAR T and NK Cell Cancer Immunotherapy Pipeline at ASH Annual Meeting

Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced new preclinical data on the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived, off-the-shelf..

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“Free Falling” – Vista Partners Daily Market Recap 12/4/2018

After a strong showing yesterday, the market was in a free fall on Tuesday as stocks went crashing. The S&P 500 shed 3.24% during today’s session while the Nasdaq plummeted 3.80%. The Dow plunged 3.10% as the market closed.

Individual components of the Dow were down across the board, with every single company ending the day in the red. Caterpillar (CAT) led declines with a loss of 6.93%. Other companies seeing heavy losses include Boeing (BA), with a drop of 4.85%, and Intel (INTC), which sank 4.75%.

Outside the Dow, Atossa Genetics (ATOS) didn’t fare much better. It dropped 2.90% during today’s session after impressive gains yesterday.

On the other side of the coin a bet, trade on investment in the VelocityShares Daily 2x VIX ST ETN (TVIX), a “bet against the broad markets,” paid off handsomely today as it closed at $44.47 up +25.13% on the day! Thank you triggered algorythmic trades!

Two major factors are being blamed for today’s sudden downturn. The first was yesterday’s inversion of the 3-year and 5-year notes, a warning sign pointing to a possible recession. This was the first inversion since 2007 and served to spook already wary investors.

The second factor was the contradictions from the White House on the exact nature of the trade deal with China that President Trump had touted this weekend. These differing reports led many to believe that the deal may not be as solid as the president had made it seem. Basically fear crept back into the markets prior to tomorrow’s closure of the markets in honor of George H. W. Bush.

Jim Tierney, with Alliance Bernstein sees a very bleak future as quite possible if Trump isn’t able to assure investor’s that the trade tensions are under control. “If we have a trade problem, I think that risks bringing a number of developing economies to the brink of recession. It also puts a huge tax of U.S. consumers, and the combination of those two means a pretty meaningful global slowdown, which would indicate that right now the yield curve is correct in terms of where we’re going,” Tierney noted.

One might also point to the selloff being due in part to the unsettling nature of a Wednesday market closing with all outstanding aforementioned issues directly related to the US unresolved and the worldwide issue of the Brexit situation. The fear surrounding the market was too much for many to handle…understandably so.

Tomorrow will provide a break from today’s turmoil as the market is closing in honor of deceased President George H.W. Bush’s funeral. Rest in peace President Bush.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Stocks nosedive, Dow sheds nearly 800 points

Stocks tanked Tuesday as a slew of concerns over trade tensions and an inversion in part of the U.S. yield curve spooked investors…

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Markets React Well to Atossa Genetics (ATOS) Announcing FDA Approval For “Expanded Access”

Atossa Genetics Inc., (NasdaqCM; ATOS) is a Seattle-based clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. ATOS announced on Monday that the FDA has approved an “expanded access” of Atossa’s proprietary oral Endoxifen in the preoperative setting in a U.S. patient awaiting surgery for breast cancer. Under the FDA Expanded Access IND program, the use of Atossa’s proprietary Endoxifen is restricted to this patient only.

The markets reacted positively to this news on Monday as ATOS shot up over 50% and hit a high of $1.85 while trading north of 16.8 million shares or approximately $28-30 million dollars of trading before closing at $1.38.

Note that Atossa is currently conducting a Phase 2 study of its oral Endoxifen in Australia in the “window of opportunity” between diagnosis of breast cancer and surgery.  Steven C. Quay, Ph.D., MD, President and CEO stated. “Once a patient is diagnosed with breast cancer, there is a window of time, typically a few weeks, before surgery is performed. Our goal with this study is to show that our proprietary oral Endoxifen can modify the cancer activity in ER+ breast cancer during this ‘window of opportunity.’ Because our Phase 1 study indicated that our oral Endoxifen reaches therapeutic levels within 8 hours and therapeutic steady-state levels in only seven days, we are optimistic we can achieve a valuable treatment effect.”

The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with ER+ and HER2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored. The Phase 2 study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.

Steven C. Quay, Ph.D., MD, President and CEO commented further, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient’s physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide “expanded access” (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively. This is the same clinical setting as our Phase 2 ‘window of opportunity’ study of preoperative systemic oral Endoxifen in breast cancer patients which is open for enrollment in Australia.”

Note that expanded access, sometimes called “compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access may be appropriate when all the following apply: patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition; there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; patient enrollment in a clinical trial is not possible; potential patient benefit justifies the potential risks of treatment; providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication. Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects. For more information, see the FDA website: FDA Expanded Use Website

If you found this story interesting you should consider following Atossa Genetics (Nasdaq: ATOS)  please see Atossa the dedicated coverage page at Vista Partners to learn more.

Atossa Genetics Announces FDA Approval of Endoxifen for “Expanded Access” as Preoperative Systemic Endocrine Therapy for a U.S. Breast Cancer Patient

Steven C. Quay, Ph.D., MD, President and CEO commented, “A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic..

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