Gamida Cell Ltd (GMDAQ)

[midastouch017]

Gamida Cell Receives Early Approval for Omisirge Pricing and Adoption Concerns Remain

https://beststocks.com/gamida-cell-receives-early-approval-for-omisi/

Yasmim Mendonça April 20, 2023

On April 20, 2023, Gamida Cell Ltd received the green light for its revolutionary allogeneic cell therapy, Omisirge. The approval was granted two weeks before the scheduled PDUFA date of May 01, which is a testament to Gamida’s ability to execute a complex cellular therapeutic. This successful execution puts any doubts about drug product execution at bay.

Initially, the pricing for Omisirge was quoted at $338,000, which was higher than Needham’s expectation of approximately $200,000. However, this pricing is more in line with typical cellular therapeutics, and the clear clinical benefits of Omisirge, particularly for patients who cannot find a match, justify the cellular therapeutic price point. Despite this, there are concerns that the high price point may negatively impact adoption and coverage.

Shortly after the approval, Gamida Cell announced an equity offering of 17.5 million shares and accompanying warrants to purchase 17.5 million shares at $1.30 for approximately $22.8 million in gross proceeds. As a result, the Needham analyst reduced the price target to $6 from $8 with a Buy rating to account for dilution and the expectation of a more conservative launch trajectory.

Despite the approval, the analyst notes that a longer-term financial overhang remains for Gamida Cell. The peak penetration forecast assumes Omisirige is used in a little under 2,000 patients each year.

Gamida Cell Ltd Shows Potential Turnaround with +383.38% Median Target Increase: Buy Stock According to Investment Analysts
Gamida Cell Ltd stock has shown signs of a potential turnaround, with a median target of 8.00, representing a +383.38% increase from the last price of 1.66. The current consensus among five polled investment analysts is to buy stock in Gamida Cell Ltd. The company reported earnings per share of -$0.28 for the current quarter, with sales of $0.00 and is set to report its earnings on May 09, 2023. Gamida Cell Ltd is focused on developing innovative cell therapies for treating cancer and other serious diseases, with a strong pipeline of additional cell therapies in development. The company has also recently announced partnerships with several major pharmaceutical companies.
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