– Sell. Zacks’ proprietary data indicates that SESEN BIO, INC. is currently rated as a Zacks Rank 4 and we are expecting a below average return from the SESN shares relative to the market in the next few months.
Similarly Why did sesen bio stock drop today? Why Sesen Bio Stock Got Slammed Today
The biotech, which concentrates on developing treatments for cancer, saw its share price dive by nearly 18% on the day. In August, the company’s Biologics License Application (BLA) was rejected by the Food and Drug Administration (FDA).
Who owns SESN? Top 10 Owners of Sesen Bio Inc
| Stockholder | Stake | Shares owned |
|---|---|---|
| BlackRock Fund Advisors | 6.27% | 12,501,509 |
| The Vanguard Group, Inc. | 5.99% | 11,951,290 |
| Geode Capital Management LLC | 2.26% | 4,511,761 |
| SSgA Funds Management, Inc. | 2.15% | 4,286,758 |
Additionally, Will Vicinium get approved?
The FDA has issued a complete response letter to Sesen Bio, denying the approval of the Biologics License Application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.
What does SESN Bio do?
At Sesen Bio, we are committed to saving and improving the lives of patients with cancer. We are a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
Who owns sesen bio? Major institutions are defined as firms or individuals that exercise investment discretion, over the assets of others, in excess of $100 Million.
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New and Sold Out Positions.
| OWNER NAME | SUSQUEHANNA INTERNATIONAL GROUP, LLP |
|---|---|
| SHARES HELD | 642,553 |
| CHANGE (SHARES) | -53,619 |
| CHANGE (%) | -7.702% |
| VALUE (IN 1,000S) | $366 |
What is Vicinium? Vicinium is a single protein drug consisting of an Epithelial Cell Adhesion Molecule (EpCAM)-specific antibody fragment fused to a potent pseudomonas toxin. After intravesical instillation, Vicinium binds EpCAM, is internalized and kills tumor cells by inhibiting protein synthesis.
What is Adstiladrin? Adstiladrin is given by catheter directly into the bladder. It consists of a type of virus that is able to introduce a gene into cells of the bladder. This gene then stimulates the cells of the bladder to produce high quantities of a protein that the body uses to fight cancer.
What is Instiladrin?
INSTILADRIN is a non-replicating adenovirus. vector harboring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the. epithelial cell lining in the bladder.
Is Vicinium approved? The FDA accepted the Sesen Bio’s application for Vicineum in February 2021, and the application was granted priority review. Non-muscle invasive bladder cancer is, as the name suggests, bladder cancer that occurs in the surface of the bladder cancer (the inside surface), not the muscle tissue of the organ.
What is Vicineum?
Vicineum is a targeted fusion protein designed to overcome the fundamental efficacy and safety challenges inherent in existing antibody-drug conjugates. bringing new hope for treating bladder cancer.
How is Vicinium administered? Induction – 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance – 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Is Nadofaragene Firadenovec FDA approved?
Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2020; (published online Nov 27.) FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer.
What is BCG unresponsive?
BCG unresponsive disease is defined as: Having received at least two courses of BCG – 5/6 instillations of induction and 2/3 maintenance doses, except for patients that have high-grade T1 disease at first evaluation after induction. Within 6 months of last exposure to BCG.
What does BCG treat? Bacillus Calmette-Guerin or BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer. It’s used to help keep the cancer from growing and to help keep it from coming back. BCG is a germ that’s related to the one that causes tuberculosis (TB), but it doesn’t usually cause serious disease.
What is FDA complete response letter? A complete response letter reflects FDA’s complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.
What is China Ind?
Historically, the review and approval of a Chinese investigational new drug (IND) has taken a year or even longer to complete, and new drug application (NDA) approval for a new drug lagged behind Western countries by four or five years.
How is Vicineum administered? Vicineum is administered in a 12 week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week.
Who makes Nadofaragene Firadenovec?
FKD Therapies Oy (FKD) has led the development and regulatory filing of nadofaragene firadenovec, which has been studied in 33 centers across the U.S. in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).
Is BCG FDA approved? BCG is approved by the U.S. Food and Drug Administration (FDA) to treat patients in the United States. BCG is also used to treat bladder cancer patients in many other countries around the world.