AstraZeneca Gets FDA Nod To Resume US Covid-19 Trial, , on October 25, 2020 at 7:03 am

By ILP
On 10/25/2020
Tags:

AstraZeneca announced on Friday that the US Food and Drug Administration (FDA) has authorized the restart of the US late-stage trial of AZD1222, its coronavirus vaccine candidate, which it is developing together with Oxford University.AstraZeneca (AZN) said that that the FDA reviewed all safety data from trials and concluded it was safe to resume the trial. AZD1222’s clinical trials have now resumed globally as regulators in the UK, Brazil, South Africa and Japan over the past weeks confirmed that it was safe to do so.On Sept. 6, all global clinical trials of AstraZeneca/Oxford’s vaccine candidate were halted after an adverse event as a UK participant became seriously ill. The trials were paused to allow the review of safety data by independent committees, and international regulators. The company said the voluntary move was triggered by its standard review process, but did not disclose any further information.AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” said AstraZeneca CEO Pascal Soriot. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”The drugmaker added that “it is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety”.AstraZeneca expects to receive results from late-stage trials later this year, depending on the infection rate within the populations where the clinical trials are being conducted. Once the results are available, data readouts will be submitted to regulators and published in peer-reviewed scientific journals.In addition, rolling reviews of the vaccine programme have already begun in some countries where this regulatory pathway is possible, providing regulators access to data as soon as they become available.AZN shares, which have lost more than 4% over the past month as a result of the clinical trial halt, are still up 4.3% on a year-to-date basis. (See AstraZeneca stock analysis on TipRanks)SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (25% upside potential) suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with COVID vaccine programs until the exact nature of the event is clear.As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.Overall, AZN scores a Strong Buy consensus from the analyst community with 4 unanimous Buy ratings. Looking ahead, the $77.38 average analyst price target puts the upside potential at a promising 49% in the coming 12 months.Related News: Gilead’s Covid-19 Remdesivir Drug Scores FDA Approval; Shares Surge Xeris Wins FDA Fast Track Path For Epilepsy Treatment; Shares Spike 9% AbbVie Submits US, EU Rinvoq Applications For Atopic Dermatitis More recent articles from Smarter Analyst: * RBC Turns Bullish On PulteGroup, Sees 21% Upside * Gentex 3Q Profit Outperforms After Cost Cutting Spree * Illinois Tool Gains On 3Q Sales Beat; Analyst Sticks To Hold * Autoliv’s 3Q Earnings Rise As Demand Picks Up; Street Says Hold,

AstraZeneca Gets FDA Nod To Resume US Covid-19 TrialAstraZeneca announced on Friday that the US Food and Drug Administration (FDA) has authorized the restart of the US late-stage trial of AZD1222, its coronavirus vaccine candidate, which it is developing together with Oxford University.AstraZeneca (AZN) said that that the FDA reviewed all safety data from trials and concluded it was safe to resume the trial. AZD1222’s clinical trials have now resumed globally as regulators in the UK, Brazil, South Africa and Japan over the past weeks confirmed that it was safe to do so.On Sept. 6, all global clinical trials of AstraZeneca/Oxford’s vaccine candidate were halted after an adverse event as a UK participant became seriously ill. The trials were paused to allow the review of safety data by independent committees, and international regulators. The company said the voluntary move was triggered by its standard review process, but did not disclose any further information.AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” said AstraZeneca CEO Pascal Soriot. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”The drugmaker added that “it is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety”.AstraZeneca expects to receive results from late-stage trials later this year, depending on the infection rate within the populations where the clinical trials are being conducted. Once the results are available, data readouts will be submitted to regulators and published in peer-reviewed scientific journals.In addition, rolling reviews of the vaccine programme have already begun in some countries where this regulatory pathway is possible, providing regulators access to data as soon as they become available.AZN shares, which have lost more than 4% over the past month as a result of the clinical trial halt, are still up 4.3% on a year-to-date basis. (See AstraZeneca stock analysis on TipRanks)SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (25% upside potential) suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with COVID vaccine programs until the exact nature of the event is clear.As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.Overall, AZN scores a Strong Buy consensus from the analyst community with 4 unanimous Buy ratings. Looking ahead, the $77.38 average analyst price target puts the upside potential at a promising 49% in the coming 12 months.Related News: Gilead’s Covid-19 Remdesivir Drug Scores FDA Approval; Shares Surge Xeris Wins FDA Fast Track Path For Epilepsy Treatment; Shares Spike 9% AbbVie Submits US, EU Rinvoq Applications For Atopic Dermatitis More recent articles from Smarter Analyst: * RBC Turns Bullish On PulteGroup, Sees 21% Upside * Gentex 3Q Profit Outperforms After Cost Cutting Spree * Illinois Tool Gains On 3Q Sales Beat; Analyst Sticks To Hold * Autoliv’s 3Q Earnings Rise As Demand Picks Up; Street Says Hold

,

Contact Us

Please use our Instant Quote form to see if you're pre-qualified for a non-recourse stock loan, or if you have any questions or feedback, please email, call or chat with us.

deals@internationalliquiditypartners.com

+44 20 3994 1588

Headquarters: Hunkins Waterfront Plaza, Charlestown, Nevis

Open 24 hours a day / 7 days a week / 365 days a year

 

 

 

Frequently Asked Questions

What Is Securities-Based Lending?
Securities-based lending, or a stock loan, is the practice of using market investments such as stocks, ETF’s, warrants, bonds, or real estate investment trusts as collateral for a loan.
How much money can I get for my securities?
Borrow up to 80% of the value of your pledged investments giving you the capital you need to expand your business, purchase real estate, or tackle a costly project.
What happens if my securities lose value?
With a non-recourse stock loan, you can walk away from your securities at any time and keep the loan money with no negative credit consequences even if the investments lose value.
Is my information safe with ILP?
We pride ourselves on outstanding service and make client confidentiality our top priority. You can always be absolutely certain your information is safe with us.
How long does it take for the disbursement of funds?
Most of the transactions we process take less than 7 days from application to the disbursement of funds giving you cash quickly when you need it most.
What credit score do I need to qualify?
There are no credit checks or personal guarantees necessary with our services. Your pledged securities are the only collateral required for the loan you receive.

Instant Quote

Please fill out your information to see if you are pre-qualified.

Enter the Stock Symbol.

Select the Exchange.

Select the Type of Security.

Please enter your First Name.

Please enter your Last Name.

Please enter your phone number.

Please enter your Email Address.

Please enter or select the Total Number of Shares you own.

Please enter or select the Desired Loan Amount you are seeking.

Please select the Loan Purpose.

Please select if you are an Officer/Director.

International Liquidity Partners, LLC may only offer certain information to persons who are “Accredited Investors” and/or “Qualified Clients” as those terms are defined under applicable Federal Securities Laws. In order to be an “Accredited Investor” and/or a “Qualified Client”, you must meet the criteria identified in ONE OR MORE of the following categories/paragraphs numbered 1-20 below.

International Liquidity Partners, LLC cannot provide you with any information regarding its Loan Programs or Investment Products unless you meet one or more of the following criteria. Furthermore, Foreign nationals who may be exempt from qualifying as a U.S. Accredited Investor are still required to meet the established criteria, in accordance with International Liquidity Partners, LLC’s internal lending policies. International Liquidity Partners, LLC will not provide information or lend to any individual and/or entity that does not meet one or more of the following criteria:

1) Individual with Net Worth in excess of $1.0 million. A natural person (not an entity) whose net worth, or joint net worth with his or her spouse, at the time of purchase exceeds $1,000,000 USD. (In calculating net worth, you may include your equity in personal property and real estate, including your principal residence, cash, short-term investments, stock and securities. Your inclusion of equity in personal property and real estate should be based on the fair market value of such property less debt secured by such property.)

2) Individual with $200,000 individual Annual Income. A natural person (not an entity) who had individual income of more than $200,000 in each of the preceding two calendar years, and has a reasonable expectation of reaching the same income level in the current year.

3) Individual with $300,000 Joint Annual Income. A natural person (not an entity) who had joint income with his or her spouse in excess of $300,000 in each of the preceding two calendar years, and has a reasonable expectation of reaching the same income level in the current year.

4) Corporations or Partnerships. A corporation, partnership, or similar entity that has in excess of $5 million of assets and was not formed for the specific purpose of acquiring an interest in the Corporation or Partnership.

5) Revocable Trust. A trust that is revocable by its grantors and each of whose grantors is an Accredited Investor as defined in one or more of the other categories/paragraphs numbered herein.

6) Irrevocable Trust. A trust (other than an ERISA plan) that (a)is not revocable by its grantors, (b) has in excess of $5 million of assets, (c) was not formed for the specific purpose of acquiring an interest, and (d) is directed by a person who has such knowledge and experience in financial and business matters that such person is capable of evaluating the merits and risks of an investment in the Trust.

7) IRA or Similar Benefit Plan. An IRA, Keogh or similar benefit plan that covers only a single natural person who is an Accredited Investor, as defined in one or more of the other categories/paragraphs numbered herein.

8) Participant-Directed Employee Benefit Plan Account. A participant-directed employee benefit plan investing at the direction of, and for the account of, a participant who is an Accredited Investor, as that term is defined in one or more of the other categories/paragraphs numbered herein.

9) Other ERISA Plan. An employee benefit plan within the meaning of Title I of the ERISA Act other than a participant-directed plan with total assets in excess of $5 million or for which investment decisions (including the decision to purchase an interest) are made by a bank, registered investment adviser, savings and loan association, or insurance company.

10) Government Benefit Plan. A plan established and maintained by a state, municipality, or any agency of a state or municipality, for the benefit of its employees, with total assets in excess of $5 million.

11) Non-Profit Entity. An organization described in Section 501(c)(3) of the Internal Revenue Code, as amended, with total assets in excess of $5 million (including endowment, annuity and life income funds), as shown by the organization’s most recent audited financial statements.

12) A bank, as defined in Section 3(a)(2) of the Securities Act (whether acting for its own account or in a fiduciary capacity).

13) A savings and loan association or similar institution, as defined in Section 3(a)(5)(A) of the Securities Act (whether acting for its own account or in a fiduciary capacity).

14) A broker-dealer registered under the Exchange Act.

15) An insurance company, as defined in Section 2(13) of the Securities Act.

16) A “business development company,” as defined in Section 2(a)(48) of the Investment Company Act.

17) A small business investment company licensed under Section 301 (c) or (d) of the Small Business Investment Act of 1958.

18) A “private business development company” as defined in Section 202(a)(22) of the Advisers Act.

19) Executive Officer or Director. A natural person who is an executive officer, director or general partner of the Partnership or the General Partner, and is an Accredited Investor as that term is defined in one or more of the categories/paragraphs numbered herein.

20) Entity Owned Entirely By Accredited Investors. A corporation, partnership, private investment company or similar entity each of whose equity owners is a natural person who is an Accredited Investor, as that term is defined in one or more of the categories/paragraphs numbered herein.

Please read the notice above and check the box below to continue.

Nevis Office

Main Street
Hunkins Waterfront Plaza
Charlestown, Nevis

New York Office

Coming Soon!

Market Coverage