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Eton's Ophthalmic Solution Candidate Gets CRL, Shares Fall

Zacks Equity Research

Shares of Eton Pharmaceuticals, Inc. ETON plunged more than 15% on Jul 15 after its partner announced that the FDA has issued a complete response letter (“CRL”) to a regulatory application seeking approval for ophthalmic solution candidate, EM-100. The candidate is being developed for treating ocular itching associated with allergic conjunctivitis.

The company stated that the FDA did not raise any concern related to clinical data in its CRL. A response to the CRL will be submitted soon. The company remains confident about receiving approval for the candidate.

Shares of the company have increased 14.7% so far this year against the industry’s decrease of 0.2%.

 

EM-100 is a bio-equivalent of ophthalmic drug molecule, ketotifen, sold by Novartis NVS through a subsidiary under the trade name Zaditor. Eton announced positive top-line data from a phase III study comparing EM-100 to ketotifen. Data from the study showed that EM-100 is non-inferior to the comparator product. The candidate also demonstrated statistically significant superiority versus placebo.

In February, Eton sold U.S. commercialization rights for EM-100 to Bausch Health BHC. The candidate, following a potential approval, will be the first FDA-approved, preservative-free formulation for treating the aforementioned indication. Per IQVIA data, the market for anti-allergy ophthalmic products in the United States is more than $600 million.

Please note that the FDA has issued a CRL to a previously abbreviated new drug application for EM-100 last year. The company re-submitted a regulatory application following the completion of the bio-equivalence study of EM-100 with Zadiator.

Eton does not have any marketed drugs in its portfolio. However, the company expects to gain marketing rights for a few of its pipeline candidates by the end of this year. Although a CRL for EM-100 will likely delay its launch, the company has a new drug application (“NDA”) for ET-202 under review. The company is seeking approval of ET-202 as ready-to-use injectable formulation of phenylephrine in hospital setting. A decision is expected from the FDA in October.

Meanwhile, NDAs for two pipeline candidates – DS-300 and DS-200 – were repealed by the FDA as the regulatory authority recently approved two products containing the active ingredient of the candidates. The FDA informed that the company can file an abbreviated new drug application for DS-300. However, the status of DS-200 is uncertain and the company is in discussion with the FDA.

Apart from these candidates, the company has multiple pipeline candidates in several stages of development.

Eton Pharmaceuticals, Inc. Price

 

Eton Pharmaceuticals, Inc. Price

Eton Pharmaceuticals, Inc. price | Eton Pharmaceuticals, Inc. Quote

Zacks Rank & Stock to Consider

Eton currently carries a Zacks Rank #3 (Hold).

Axovant Sciences Ltd. AXGT is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Axovant’s loss estimates have narrowed from $7.00 to $5.34 for 2019 and from $6.48 to $3.59 for 2020 over the past 60 days.

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