Shares of Gamida Cell Ltd. (NASDAQ: GMDA), the penny stock, surged 22.5% to close at $2.72 on Wednesday, after the company announced its plan to initiate a rolling Biologics License Application (BLA) submission for omidubicel.
The company’s plan followed the receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA).
Gamida is an advanced cell therapy company seeking cures for cancer and other serious diseases. Notably, omidubicel is a potentially life-saving treatment for patients, who are suffering from blood cancers and need stem cell transplant.
Supporting Data for BLA
As requested by the FDA in late 2021, a revised analysis of the manufacturing data generated at Gamida Cell’s commercial manufacturing facility was conducted. The analysis was intended to show the analytical comparability to the Lonza clinical manufacturing unit that produced omidubicel for the Phase 3 study.
Following the establishment of the analytical comparability between the commercial manufacturing facility and the product produced for the Phase 3 study, as well as positive clinical results of the study, the FDA gave a green signal to the application.
Other Approvals
Omidubicel is the first-of-its-kind bone marrow transplant graft that was granted Breakthrough Therapy Designation by the FDA. It has also received Orphan Drug Designation in the U.S. and EU.
Official Comments
Gamida Cell CEO Julian Adams said, “We are very pleased that our productive interactions with the FDA have resulted in alignment on the omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application…Initiating the BLA submission will move us one step closer toward bringing potentially curative therapies to patients. We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida Cell and the bone marrow transplant community.”
Wall Street’s Take
Following the recent clinical update and considering Gamida Cell to be a top pick for 2022, H.C. Wainwright analyst Vernon Bernardino maintained a Buy rating and a price target of $22 (708.82% upside potential) on the stock.
Consensus among analysts is a Strong Buy based on 7 unanimous Buys. The average Gamida Cell price target of $14.50 implies 433.09% upside potential from current levels. Meanwhile, shares have lost 69.6% over the past year.
Risk Analysis
According to the new TipRanks Risk Factors tool, Gamida Cell is at risk mainly from three factors: Tech and Innovation, Finance & Corporate, and Legal and Regulatory, which contribute 32%, 26%, and 18%, respectively, to the total 84 risks identified for the stock.
Though Gamida Cell appreciated following the positive clinical update, given the already high-risk profile of the company and not so impressive price performance over the past year, investors might want to be cautious before investing in this stock.
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