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Sesen's (SESN) Bladder Cancer Drug Vicineum Gets CRL From FDA
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Sesen Bio, Inc.’s shares significantly declined 57% on Aug 13, after the company announced that the FDA has refused to approve its new drug application (“NDA”) for Vicineum (oportuzumab monatox-qqrs). The NDA is seeking approval for the candidate for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”).
The FDA issued a complete response letter (“CRL”) indicating that it will not approve Vicineum’s NDA in its present form. The letter also provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues pertaining to a recent pre-approval inspection as well as product quality.
Sesen’s stock has rallied 56.3% so far this year in comparison with the industry’s 0.4% increase.
Image Source: Zacks Investment Research
Vicineum — Sesen’s lead product candidate for BCG-unresponsive NMIBC — is a locally administered fusion protein designed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. The candidate targets epithelial cell adhesion molecule (“EpCAM”) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A.
We remind investors that the FDA earlier granted Priority Review designation to the candidate for the given indication. Vicineum is currently in the follow-up stage of a phase III registration study in the United States for the treatment of BCG-unresponsive NMIBC.
Sesen is also planning to request for a Type A meeting with the FDA to discuss the next steps that are needed to be taken for the approval of Vicineum.
Per the company, Vicineum promotes anti-tumor immune response that may potentially combine well with immuno-oncology drugs such as checkpoint inhibitors. In this regard, the U.S. National Cancer Institute is exploring the candidate in combination with AstraZeneca’s (AZN - Free Report) immune checkpoint inhibitor, Imfinzi (durvalumab).
In Europe, the company anticipates potential approval of the drug in 2022. The drug will be marketed under the trade name Vysyneum. It has also entered into collaborations in multiple countries like China, Turkey, and Middle East and North Africa nations for the drug’s commercial launch.
Moderna’s earnings per share estimates for 2021 have increased from $24.71 to $29.04 in the past 30 days. The same for 2022 has risen from $17.83 to $22.26 over the same period. The stock has rallied 273.1% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.26 to $13.13 over the same period.
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Sesen's (SESN) Bladder Cancer Drug Vicineum Gets CRL From FDA
Sesen Bio, Inc.’s shares significantly declined 57% on Aug 13, after the company announced that the FDA has refused to approve its new drug application (“NDA”) for Vicineum (oportuzumab monatox-qqrs). The NDA is seeking approval for the candidate for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”).
The FDA issued a complete response letter (“CRL”) indicating that it will not approve Vicineum’s NDA in its present form. The letter also provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues pertaining to a recent pre-approval inspection as well as product quality.
Sesen’s stock has rallied 56.3% so far this year in comparison with the industry’s 0.4% increase.
Image Source: Zacks Investment Research
Vicineum — Sesen’s lead product candidate for BCG-unresponsive NMIBC — is a locally administered fusion protein designed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. The candidate targets epithelial cell adhesion molecule (“EpCAM”) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A.
We remind investors that the FDA earlier granted Priority Review designation to the candidate for the given indication. Vicineum is currently in the follow-up stage of a phase III registration study in the United States for the treatment of BCG-unresponsive NMIBC.
Sesen is also planning to request for a Type A meeting with the FDA to discuss the next steps that are needed to be taken for the approval of Vicineum.
Per the company, Vicineum promotes anti-tumor immune response that may potentially combine well with immuno-oncology drugs such as checkpoint inhibitors. In this regard, the U.S. National Cancer Institute is exploring the candidate in combination with AstraZeneca’s (AZN - Free Report) immune checkpoint inhibitor, Imfinzi (durvalumab).
In Europe, the company anticipates potential approval of the drug in 2022. The drug will be marketed under the trade name Vysyneum. It has also entered into collaborations in multiple countries like China, Turkey, and Middle East and North Africa nations for the drug’s commercial launch.
SESEN BIO, INC. Price
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Zacks Rank & Stocks to Consider
Sesen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Moderna (MRNA - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Moderna’s earnings per share estimates for 2021 have increased from $24.71 to $29.04 in the past 30 days. The same for 2022 has risen from $17.83 to $22.26 over the same period. The stock has rallied 273.1% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.26 to $13.13 over the same period.