Eton Pharmaceuticals: Following FDA Approval, This 5-Star Analyst Says ‘Buy’, , on September 30, 2020 at 10:57 pm

By
On September 30, 2020
Tags:

A green light from the FDA can change everything for a healthcare company. This might just be the case for Eton Pharmaceuticals (ETON).On September 29, the company announced that the FDA had given Alkindi Sprinkle, its taste-neutral sprinkle (granule) formulation of hydrocortisone designed as a replacement therapy for pediatric adrenal insufficiency (AI), its stamp of approval.The verdict came on the previously scheduled PDUFA date. Additionally, six clinical studies, including the first and only interventional Phase 3 study of oral hydrocortisone for pediatric AI in neonates to children under eight years of age, served as the basis for the approval. Before the therapy got the FDA approval, oral hydrocortisone was only approved in tablet formulations of 5mg and stronger, with many pediatric patients requiring significantly lower doses. Alkindi Sprinkle will be available in 0.5mg, 1mg, 2mg and 5mg strengths, which will give clinicians flexibility to individualize dosing based on each patient’s needs in accordance with the instructions for dosage and administration.Weighing in on the development for H.C. Wainwright, 5-star analyst Raghuram Selvaraju stated, “In our view, the drug could be launched with a very small, targeted sales effort and may generate peak sales of $57 million by 2026. This is the third agent from Eton’s pipeline to receive regulatory approval —after Biorphen in October 2019 and Alaway a few days ago—and this ought to be viewed as further validation of Eton’s pharmaceutical product development capabilities.”According to management, the product could be commercially available in Q4 2020. That being said, the rest of its pipeline could also serve as significant upside drivers, in Selvaraju’s opinion.ETON currently has three more product candidates under review at the FDA. In May, the company submitted a first-to-file challenge on Elcys (DS-300), which is a cysteine hydrochloride injection designed as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN), with an approval potentially coming in 2H21.New Drug Applications (NDAs) for DS-100, its dehydrated alcohol injection for the treatment of methanol poisoning, and ET-104, its potential treatment for partial seizures in patients with epilepsy, have also been submitted. Both candidates could be approved and launched in 2021.Everything that ETON has going for it convinced Selvaraju to keep a Buy rating on the stock. Along with the call, he bumped up the price target from $18 to $20, suggesting 153% upside potential. (To watch Selvaraju’s track record, click here)Turning now to the rest of the Street, other analysts agree with Selvaraju. 3 Buys and no Holds or Sells translate to a Strong Buy consensus rating. At $15.67, the average price target implies 100% upside potential. (See ETON stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.,

Eton Pharmaceuticals: Following FDA Approval, This 5-Star Analyst Says ‘Buy’A green light from the FDA can change everything for a healthcare company. This might just be the case for Eton Pharmaceuticals (ETON).On September 29, the company announced that the FDA had given Alkindi Sprinkle, its taste-neutral sprinkle (granule) formulation of hydrocortisone designed as a replacement therapy for pediatric adrenal insufficiency (AI), its stamp of approval.The verdict came on the previously scheduled PDUFA date. Additionally, six clinical studies, including the first and only interventional Phase 3 study of oral hydrocortisone for pediatric AI in neonates to children under eight years of age, served as the basis for the approval. Before the therapy got the FDA approval, oral hydrocortisone was only approved in tablet formulations of 5mg and stronger, with many pediatric patients requiring significantly lower doses. Alkindi Sprinkle will be available in 0.5mg, 1mg, 2mg and 5mg strengths, which will give clinicians flexibility to individualize dosing based on each patient’s needs in accordance with the instructions for dosage and administration.Weighing in on the development for H.C. Wainwright, 5-star analyst Raghuram Selvaraju stated, “In our view, the drug could be launched with a very small, targeted sales effort and may generate peak sales of $57 million by 2026. This is the third agent from Eton’s pipeline to receive regulatory approval —after Biorphen in October 2019 and Alaway a few days ago—and this ought to be viewed as further validation of Eton’s pharmaceutical product development capabilities.”According to management, the product could be commercially available in Q4 2020. That being said, the rest of its pipeline could also serve as significant upside drivers, in Selvaraju’s opinion.ETON currently has three more product candidates under review at the FDA. In May, the company submitted a first-to-file challenge on Elcys (DS-300), which is a cysteine hydrochloride injection designed as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN), with an approval potentially coming in 2H21.New Drug Applications (NDAs) for DS-100, its dehydrated alcohol injection for the treatment of methanol poisoning, and ET-104, its potential treatment for partial seizures in patients with epilepsy, have also been submitted. Both candidates could be approved and launched in 2021.Everything that ETON has going for it convinced Selvaraju to keep a Buy rating on the stock. Along with the call, he bumped up the price target from $18 to $20, suggesting 153% upside potential. (To watch Selvaraju’s track record, click here)Turning now to the rest of the Street, other analysts agree with Selvaraju. 3 Buys and no Holds or Sells translate to a Strong Buy consensus rating. At $15.67, the average price target implies 100% upside potential. (See ETON stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

,

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

168 Robinson Road
#12-01 Capital Tower
Singapore 068912

New York

Coming Soon!

Dubai

Coming Soon!

Market Coverage