HIV Vaccine Proves 100% Effective

Overall, 27 of 27 vaccinated participants showed a positive response

The study evaluated a four-dose regimen of PENNVAX-GP DNA

ino#Inovio Pharmaceuticals $INO announced that its #HIV vaccine, #PENNVAX-GP, produced amongst the highest overall levels of immune response rates ever demonstrated in a human study by an HIV vaccine.

The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody immune response as well as a T cell immune response to both potentially prevent and treat HIV.

These preliminary results are from a study supported by the HIV Vaccine Trials Network, or HVTN, and the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH, in collaboration with Inovio.

The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal, or ID, or intramuscular, or IM, administration in combination with a DNA encoded immune activator, IL-12, or INO-9012.

Overall, 71 of 76 evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens. Similarly, 62 of 66 evaluated participants demonstrated an env specific antibody response. None of the placebo recipients demonstrated either a cellular or an antibody response in the study.

Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 participants demonstrated a cellular response and 27 of 28 demonstrated an HIV env specific antibody response.

Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 demonstrated a cellular response and 19 of 21 demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration.

INO closed at $7.13, last traded at $9.90 in pre-market.

Other shares to watch: $AMGN $BIIB $ABBV $MRK $PFE

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Global Sources Sold for $18 per share

stockwinners com#GlobalSources $GSOL  has entered into an Agreement and Plan of Amalgamation with Expo Holdings and Expo Holdings II, a wholly-owned subsidiary of Parent.

Subject to the terms and conditions set forth each shareholder to receive an amount equal to $18.00 in cash, without interest. The Amalgamation Consideration represents a premium of 50.0% over the company’s closing price of $12.00 per Share on May 22, 2017, the last trading day prior to the date that the Company entered into the Amalgamation Agreement, and a premium of 72.65% to the volume-weighted average closing prices of the Shares during the 30 trading days prior to May 22, 2017.

The Company expects to hold a special meeting of its shareholders to consider and act upon the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement as promptly as practicable. Details regarding the record date for, and the date, time and place of, the special meeting will be included in a press release when finalized.

Shares of Global Sources last traded at $17.88.

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GE Receives $15 Billion Contract from Saudi Arabia

Building on its more than 80 years of partnership and experience in the Kingdom, #GE said it has taken significant steps in supporting the delivery of Saudi Vision 2030, announcing this weekend in partnership with the Kingdom a range of Memorandums of Understanding and projects valued at $15B – of which almost $7B are GE technology and solutions – across multiple sectors and partners aimed at creating a truly diverse and sustainable economic platform.

The initiatives touch upon the key pillars within #SaudiVision 2030, focusing on transforming the nation into a global investment leader and geographic hub and the upscaling of industrial skills and capabilities.

Among the projects, GE will help make Saudi power generation more efficient and provide digital technology to the operations of oil firm Saudi Aramco, aiming to create $4 billion of annual productivity improvements at Aramco. It will cooperate in medical research and training.

The agreements also place significant emphasis on human capital development and the digital transformation across multiple sectors, with the expanded application of GE’s Predix platform, which utilizes cloud-based data analytics to better ensure and enhance manufacturing efficiency.

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FDA Approves Puma’s Breast Cancer Drug, Shares Jump

The #FDA said in briefing documents ahead of Wednesday’s advisory panel on #Puma Biotechnology’s breast cancer drug, “In conclusion, the totality of evidence demonstrating the magnitude of activity of neratinib to treat HER2 positive breast cancer across multiple clinical settings, plus the strong neoadjuvant data, provides robust scientific and clinical rationale for proceeding into the adjuvant setting with neratinib.

An unmet medical need exists during the ‘extended adjuvant period’ or the time after standard of care adjuvant therapy with other anti-HER2 therapy has been completed. Patients who have completed their 1 year of trastuzumab adjuvant therapy have no options for further anti-HER2 treatment and enter into a “watch and wait” period. In the interest of being able to turn this time into a period of active anti-HER2 therapy with the intent to provide further improvement in iDFS, neratinib was studied as extended adjuvant therapy in a multicenter randomized, double blind placebo controlled Phase 3 Study 3004 (N=2840) which demonstrated clinically meaningful and statistically significant improvement in iDFS with a manageable safety profile consistent with other approved agents within the class of TKIs targeting EGFR and HER2.

The sponsor believes the totality of the data support approval of #neratinib 240 mg po qd for 1 year in the extended adjuvant setting in order to provide physicians and patients with a new strategic therapeutic option to reduce the rate of recurrence of HER2 positive breast cancer.”

See our earlier blog regarding this stock.

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Blackstone to Launch $40 Billion Investment Fund with Saudi Arabia

#Blackstone $BX to launch $40B infrastructure vehicle, new infrastructure business – Blackstone and the Public Investment Fund of Saudi Arabia announced the execution of a memorandum of understanding in relation to the launch of a new investment vehicle dedicated to infrastructure with an anchor $20B contribution by PIF. Blackstone anticipates that the program will have $40B in total equity commitments in a permanent capital vehicle, including $20B to be raised from other investors.

“The MOU is non-binding and the parties will continue their negotiation to agree definitive documentation… This collaboration between PIF and Blackstone is the culmination of a year’s discussions between the two institutions, which began in May 2016…

Blackstone’s new program will help the United States address its significant need for infrastructure improvement,” Blackstone noted. Overall, through the equity in this vehicle and additional debt financing, Blackstone expects to invest in more than $100B of infrastructure projects, principally in the United States, the company said.

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Russell 2000 Maybe the Canary in the Mine

 

Russell 2000 Technical on Stockwinners.com

The Russell 2000 Index is a small-cap stock market index of the bottom 2,000 stocks in the Russell 3000 Index. The index is maintained by FTSE Russell, a subsidiary of the London Stock Exchange Group.

The Russell 2000 is by far the most common benchmark for mutual funds that identify themselves as “small-cap”, while the S&P 500 index is used primarily for large capitalization stocks. It is the most widely quoted measure of the overall performance of the small-cap to mid-cap company shares.

The #Russell2000 $RUT has been in a distinct downtrend since hitting a peak of price on April 26. It is in a technically more fragile state on a short time frame than the large-cap indexes.

Pulling back to a 1-year view shows a different perspective, notably on a closing price basis chart. In that case the index has been trapped in a range since late November/early December 2016.

Resistance is easy enough to spot at 1400, a level that has only been briefly breached before selling resumes.

For support on the 1-month time frame it is the 1380 area that is key. A breakdown below 1380 that does not produce a bounce would be a distinct negative technically on a multi-month basis, but not a yearly basis. Next significant support would be at the 1360 area.

If there was a breakdown below 1360, the 1340 area would be the next level of importance. While the index is in a more bearish state on a relatively short time frame, only a break below 1340 that persists below 1340 would break the longer-term uptrend. And even then, a break below 1300 would be needed to snap the multi-year uptrend.

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Coherus Biosciences Could Skyrocket

COHERUS BIOSCIENCES LOGOCoherus Biosciences $CHRS could skyrocket in the next few weeks if it receives FDA’s approval, research firms Credit Suisse and Maxim argue.

BACKGROUND: Coherus Biosciences is a developer of #biosimilars — nearly identical copies of original biologic drugs — whose product pipeline includes #CHS-1701, a biosimilar of Amgen’s $AMGN #Neulasta, and CHS-1420, a biosimilar of #AbbVie’s $ABBV #Humira.

The FDA has set an action date of June 9 for its review of CHS-1701, and while CHS-1420 is further out, #Coherus said in its earnings report last week that it expects a May 17 decision in part of its patent battle with AbbVie.

CREDIT SUISSE SAYS COHERUS COULD DOUBLE OR MORE: Last week, Credit Suisse’s Alethia Young highlighted two “major” catalysts for Coherus over the next two months: The possible invalidation of AbbVie’s “135” patent for Humira — which Young calls the “key dosing patent” that would allow Coherus to launch CHS-1420 before 2022 — and the FDA’s decision on CHS-1701. The analyst thinks the “bigger mover” is the 1701 event and she expects “on-time approval” of the product on June 9, though Young cautions that the lack of an Advisory Committee meeting “lowers the visibility” into the agency’s ultimate decision. The analyst reiterates her Outperform rating on the stock and says it could jump 110%-200% or fall 40%-65% as the above mentioned events play out over the next month. Young’s report builds on an April 19 note in which she forecast a 90% chance of CHS-1701 launching in 2018 and a 75% chance of CHS-1420 launching in the U.S. in 2020, adding that Coherus becomes a likely takeover target if those regulatory and patent decisions are settled in its favor.

MAXIM SEES TRANSFORMATIVE DECISIONS: Maxim’s Jason McCarthy argues today that “the best is ahead” as Coherus approaches the inflection points for 1420 and 1701, either of which he says could be “transformative” for the company. The analyst argues that Amgen’s recent lawsuit to protect a Neulasta patent has a low probability of delaying 1701 commercialization, as Coherus doesn’t use the purification process described by that “707” patent. McCarthy also contends that the AbbVie 135 patent fight chances are “in favor of Coherus” due to the latter’s strong focus on intellectual property.

PRICE ACTION: After gaining nearly 11% since its May 8 earnings report, Coherus is down 2% to $21.90 in Monday’s session.

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Crude Oil Higher on Inventories Draw

The American Petroleum Institute #API reported a draw of 5.789 million barrels in UOil barrels on the price chart backgroundnited States #crude oil inventories, compared to analyst expectations that markets would see a crude oil draw of 1.8 million barrels for the week ending May 5.

#Gasoline inventories rose by 3.169 million barrels, according to the API. A draw of 700,000 barrels was expected. Gasoline inventories continue to build up ahead of summer driving season, as refiners continue to turn crude oil into gasoline above demand for the fuel.

So while crude oil has experienced an overall drawdown over the last couple of weeks, it’s being converted to gasoline, and extra inventories are moving from one side of the refinery to the other. Gasoline inventories have continued to build for four weeks in a row, if the EIA confirms this week’s build on Wednesday.

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Investor Encourages Sale of Gigamon

id-gigamon#Elliott Associates said in its SEC filing regarding its new activist stake in #Gigamon, “The Reporting Persons intend to communicate with the Issuer’s management and Board about a broad range of operational and strategic matters, and intend to encourage the issuer to undertake a strategic review process including, without limitation, a potential sale of the Issuer or certain of its businesses or assets, in which the Reporting Persons may participate, as a means of enhancing shareholder value.
The Reporting Persons intend to review their investment in the Issuer on a continuing basis and may from time to time in the future express their views to and/or meet with management, the Board, other shareholders or third parties, including, potential acquirers, service providers and financing sources, and/or formulate plans or proposals regarding the Issuer, its assets or its securities.”
Shares of #Gigamon $GIMO are up 15% to $40.30 following news of the activist stake.

Belden Walks Out on Digi!

logo_digi#Belden $BDC announced that it has rescinded its proposal to acquire 100% of #Digi International $DGII in light of the fiscal second quarter 2017 results and full-year 2017 outlook reported by Digi on May 4, 2017.

Belden’s offer of $13.82 per share in cash, initially disclosed on November 11, 2016, was based on a 10x EBITDA multiple on #EBITDA of $24M implied by the high end of guidance provided by Digi to its shareholders on October 27, 2016.

Earnings before interest, tax, depreciation and amortization (EBITDA).

$DIGI tumbled 13% on the news to close at $10.70. Shares were trading around $10 when the buyout was announced.

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S&P Boosts Disney’s rating to A+ from A

#S&P Global Ratings said today that it raised its long-term corporate credit rating and debt ratings on The Walt Disney $DIS disneyto A+ from A. At the same time, S&P raised short-term corporate credit rating on the company to A-1+ from A-1. The rating outlook is stable.

“We recently completed an extensive peer review of the major U.S. investment-grade and high-speculative grade media, telecommunications, and cable companies we rate… As a result of this review, we have a more favorable view of Disney’s long-term business prospects relative to its peers. We believe Disney will continue to successfully tap its deep reservoir of intellectual property to generate high demand content through its film and television studios… The stable rating outlook on Disney reflects our expectation that the company’s overall business performance will remain strong, particularly at its film and TV studio division and at the cable networks, despite secular pressures in the U.S. We also expect that management will maintain its current financial policy, with adjusted leverage of less than 2x,” the ratings agency and its analysts said.

The rating directly affects how much Disney will be paying on its Corporate debts

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