Gilead’s Remdesivir Becomes First Virus Treatment to Win FDA Nod, , on October 23, 2020 at 8:42 am

By
On October 23, 2020
Tags:

(Bloomberg) — The U.S. Food and Drug Administration approved Gilead Sciences Inc.’s antiviral therapy remdesivir on Thursday, making it the first drug to obtain formal clearance for treating the coronavirus.Regulators had granted an emergency-use authorization for remdesivir earlier this year, and since then the drug has become a widely used therapy in hospitalized Covid-19 patients. It was given to President Donald Trump this month when he was diagnosed with the virus.The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for Covid-19 patients even as other drugs for the disease begin to reach the market.“Veklury is now the first and only approved Covid-19 treatment in the United States,” Gilead said in a statement. While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.The drug hasn’t been proven to reduce deaths from Covid-19. In a World Health Organization trial, the medicine failed to reduce fatalities, according to preliminary results that were posted on preprint servers last week.Gilead has criticized the WHO study. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the findings don’t negate other results.Shares of Gilead gained 6.3% in pre-market trading on Friday. Analysts estimate that remdesivir will have sales of $2.17 billion this year, according to 13 surveyed by Bloomberg.The company said in June that it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.Read more: Gilead Chooses Middle Ground in Pricing of Coronavirus DrugThe approval is based on a U.S. government-sponsored trial involving more than 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.Read more: Where Are We in the Quest for Coronavirus Treatments?: QuickTake(Updates with pre-market trading in seventh paragraph. An earlier version of this article misspelled the drug name in the headline.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.,

Gilead’s Remdesivir Becomes First Virus Treatment to Win FDA Nod(Bloomberg) — The U.S. Food and Drug Administration approved Gilead Sciences Inc.’s antiviral therapy remdesivir on Thursday, making it the first drug to obtain formal clearance for treating the coronavirus.Regulators had granted an emergency-use authorization for remdesivir earlier this year, and since then the drug has become a widely used therapy in hospitalized Covid-19 patients. It was given to President Donald Trump this month when he was diagnosed with the virus.The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for Covid-19 patients even as other drugs for the disease begin to reach the market.“Veklury is now the first and only approved Covid-19 treatment in the United States,” Gilead said in a statement. While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.The drug hasn’t been proven to reduce deaths from Covid-19. In a World Health Organization trial, the medicine failed to reduce fatalities, according to preliminary results that were posted on preprint servers last week.Gilead has criticized the WHO study. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the findings don’t negate other results.Shares of Gilead gained 6.3% in pre-market trading on Friday. Analysts estimate that remdesivir will have sales of $2.17 billion this year, according to 13 surveyed by Bloomberg.The company said in June that it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.Read more: Gilead Chooses Middle Ground in Pricing of Coronavirus DrugThe approval is based on a U.S. government-sponsored trial involving more than 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.Read more: Where Are We in the Quest for Coronavirus Treatments?: QuickTake(Updates with pre-market trading in seventh paragraph. An earlier version of this article misspelled the drug name in the headline.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

,

Instant Quote

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.

High West Capital 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.

High West Capital 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 High West Capital Partners, LLC’s internal lending policies. High West Capital 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.

Singapore

+65 3105 1295

Taiwan

Coming Soon!

Hong Kong

R91, 3rd Floor,
Eton Tower, 8 Hysan Ave.
Causeway Bay, Hong Kong
+852 3002 4462

Market Coverage