FDA Refuses Approval for Eton’s New Methanol Poisoning Drug Treatment


Eton Pharmaceuticals (ETON) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) related to a dehydrated alcohol injection for treating methanol poisoning.

After reviewing the NDA, the FDA has declined to approve it in its present form. Eton shares fell about 16.8% to close at $7.06 on May 28.

Amid COVID-19 associated travel restrictions, a pre-approval inspection of the drug’s contract manufacturer in Europe is yet to be completed. According to Eton, the remaining queries raised by the FDA in the CRL will be addressed in the coming months. (See Eton Pharmaceuticals stock analysis on TipRanks)

Recently, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on the stock and lowered the price target to $14 (98.3% upside potential) from $15.

For 2021, Selvaraju expects Eton to report total revenue of $40.8 million, which includes product revenue of $20.5 million and licensing revenue of $20.3 million.

Selvaraju also highlighted near-term catalysts for the stock including sales traction with Alkindi Sprinkle, Alaway sales through partner Bausch + Lomb, and approval for DS-300.

The other analyst covering the stock, B. Riley Financial’s Andrew D’Silva also has a Buy rating on the stock with a price target of $11 (55.8% upside potential).

The two ratings add up to a Moderate Buy consensus rating alongside an average analyst price target of $12.50, implying 77% upside potential.

Shares have dropped about 13% so far this year.

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