Home Market News Micro Cap Stocks Analyst Upgrades Outlook Therapeutics’ Prospects After FDA Agreement, Easing Investor Concerns

Analyst Upgrades Outlook Therapeutics’ Prospects After FDA Agreement, Easing Investor Concerns

0
Analyst Upgrades Outlook Therapeutics’ Prospects After FDA Agreement, Easing Investor Concerns

In a recent development, Outlook Therapeutics Inc (NASDAQ: OTLK) completed Type A Meetings with the FDA to address concerns outlined in the Complete Response Letter (CRL).

Although the FDA requested an additional clinical trial for the approval of ONS-5010 in wet AMD treatment, Outlook Therapeutics reached an agreement in principle with the FDA on a trial design that may allow for resubmission of the ONS-5010 Biologics License Application (BLA) by end of 2024 and subsequent approval by mid-2025.

Notably, HC Wainwright upgraded Outlook Therapeutics from Neutral to Buy, citing enhanced visibility and a faster path to market. The price target for the stock has also been increased from $1 to $2.

Despite the positive news, some investors were initially concerned, leading to a sharp decline in Outlook Therapeutics’ shares. These investors hoped that the company could avoid conducting a large clinical trial, but the need for an additional trial will require additional financing.

Analyst Douglas Tsao estimates the cost of the new study to be between $35 million and $40 million.

Over the years, many investors have had concerns about the ONS-5010 development program, primarily due to the unique requirement of a single, comprehensive, and well-controlled trial. The issuance of the complete response letter by the FDA acknowledged this skepticism. However, now that the company and FDA have reached an agreement, HC Wainwright believes that there is a clear and straightforward path to approval, which will gradually restore investor confidence.

As of the last check on Friday, OTLK shares were up 22.6% at $0.42.