By Connor Hart
Shares of Outlook Therapeutics jumped after the company said it continues to progress the development of its treatment for wet age-related macular degeneration, which causes blurred or reduced central vision.
The stock rose 18% to $2.01 in midday trading Friday. Shares have plunged 75% this year.
The Iselin, N.J., biopharmaceutical company said it plans to launch its treatment, Lytenava, in the United Kingdom and Germany, likely in the first half of 2025. Lytenava was granted marketing authorization in both the UK and the European Union earlier this year.
The treatment previously failed to meet a pre-specified non-inferiority endpoint set by the Food and Drug Administration for approval in the U.S., the company said. New data from a current trial is expected to be released next month. Upon receipt, the company plans to resubmit an application to the FDA, targeted for the first quarter, setting the stage for potential U.S. approval in the second half of the year.
"We believe that 2025 holds significant opportunity for Outlook Therapeutics and we remain confident in the potential of Lytenava to provide a meaningful impact globally for the treatment of wet AMD," Chief Executive Lawrence Kenyon said.
For its fiscal year ended Sept. 30, Outlook reported a net loss of $75.4 million, or $4.06 a share, compared with a net loss of $59 million, or $4.72 a share, in the prior year. It ended the year with cash and cash equivalents of $14.9 million.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
December 27, 2024 13:04 ET (18:04 GMT)
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