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 |
Similarly What does Sesen 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 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, 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.
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 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.
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.
Is Vicineum 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.
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.
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.
How are drugs approved in China?
National Medical Products Administration
The drug category in which an applicant chooses to register determines the clinical trial application review and approval or filing process. Per the SC-IRP, the SAMR-Org, and CHN-21, China established the State Administration for Market Regulation (SAMR).
What is Hgrac China? Human Genetic Resources Administration of China (HGRAC) is the entity in China charged with the review and approval of the applications.
Is there an FDA in China?
Established in November 2008, the Office of Global Policy and Strategy’s (OGPS) China Office serves as the lead for the FDA’s on-site presence in China.
Is SESN stock a good buy?
During the day the stock fluctuated 5.20% from a day low at $0.50 to a day high of $0.53. The price has fallen in 7 of the last 10 days and is down by -15.99% for this period.
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Predicted Opening Price for Sesen Bio Inc. of Monday, April 18, 2022.
| Fair opening price April 18, 2022 | Current price |
|---|---|
| $0.51 | $0.51 (Undervalued) |
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 BCG refractory? BCG refractory is when there is failure to achieve a disease-free state within 6 months after initial BCG, with either maintenance or re-treatment at 3 months because of either persistent or rapidly recurrent disease.
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.
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.
How long does it take for a drug to be approved in China?
A very substantial change is the approval time for a clinical trial application (CTA). In the past, it took two to three years for CTA approval. And now, by default, it is a 60 working day “silent approval,” meaning if no response is received in 60 working days the application is approved.
What is the FDA equivalent in China? The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.
What is the Japanese equivalent of the FDA?
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.