Outlook Therapeutics Inc. (NASDAQ:OTLK) shares are rising in Wednesday premarket trading after the company announced the FDA accepted its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA.
The FDA acknowledged receipt of the application on Tuesday. If approved, ONS-5010/LYTENAVA would become the first FDA-approved ophthalmic formulation of bevacizumab.
The agency classified the filing as a Class 1 review and set a target action date of July 29.
Previous Rejections For Outlook Therapeutics Eye Drug
In January, the FDA issued a complete response letter (CRL) to Outlook Therapeutics' resubmission of the biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg).
The letter indicated that the FDA cannot approve the application in its present form for wet age-related macular degeneration (wet AMD).
By April, Outlook Therapeutics submitted a formal dispute resolution request (FDRR) to the FDA regarding its ONS-5010/LYTENAVA.
Last August, the FDA issued a CRL to ONS-5010 resubmission. The CRL included only one deficiency for a lack of substantial evidence of effectiveness.
In August 2023, Outlook Therapeutics received a complete response letter from the FDA regarding ONS-5010.
Technical Outlook
The stock has shown a 12-month performance decline of 7.10%, but recent price action indicates a strong upward momentum.
Currently, the stock is trading at $1.64, which is significantly above its 20-day SMA of 75 cents, indicating bullish sentiment, with the price sitting 119.9% above this moving average.
Momentum indicators show the Relative Strength Index (RSI) at 86.22, suggesting the stock is overbought and could trigger a near-term pullback.
This high RSI level reflects a strong upward trend, but it also raises caution for investors as it may signal that the stock is stretched.
- Key Resistance: $1.87 — a level that could act as a barrier based on recent price action.
- Key Support: $1.50 — a nearby level where buyers previously stepped in.
OTLK Stock Price Activity: Outlook Therapeutics shares were up 4.46% at $1.64 during premarket trading on Wednesday, according to Benzinga Pro data.
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