About Sesen Bio
In February 2021 , the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a PDUFA date of August 18, 2021 .
Similarly, 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.
…
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 |
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.
Thereof, 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.
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 |
Why did sesen bio stock drop?
Sesen Bio (NASDAQ:SESN) has had a terrible few months after the FDA declined to approve Vicineum in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The stock dropped from a healthy $5 to below $1 at one point and is currently straggling on at $1.22.
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 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.
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 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 a Refusal to File letter FDA?
In general, an FDA refuse-to-file letter notifies a drug company that FDA will not review a marketing application because of significant deficiencies that cannot promptly be resolved, making the application substantially incomplete.
What is FDA CLR?
A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
What is an FDA deficiency letter?
FDA’s requests for additional information needed to complete the review process are colloquially known as deficiencies. FDA may convey deficiencies via interactive review or through a deficiency letter.
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).
What happens if BCG treatment doesn’t work?
BCG failure usually carries a risk of recurrence but rarely of progression. For low-grade failure, intravesical chemotherapy is a valid option. This scenario is different from that where BCG intravesical therapy is unsuccessful in high-risk T1 disease and/or CIS, where a risk of progression may sometimes reach 50%.
Is BCG better than chemo?
BCG is most commonly used in intravesical immunotherapy for NMIBC and appears to be more effective than intravesical chemotherapy in preventing tumor recurrence and progression. Especially for those with high-risk NMIBC, BCG immunotherapy is considered as a gold-standard treatment (29).
Is BCG available now?
A. Merck is the sole maker and supplier of BCG to the United States. While the FDA is exploring opportunities to approve additional strains and supplies of BCG, Merck is still the only approved supplier at this time. There are companies in Japan, Canada, and Europe working to develop their own strains of BCG.
What is the success rate of BCG treatment?
This method of treatment is considered a form of immunotherapy, which is an emerging form of cancer treatment. The success rate for BCG treatment for bladder cancer is about 90%, which is considered the best life-saving rate by any treatment.
Join TheMoney.co community and don’t forget to share this post !
