Sesen Bio Inc (NASDAQ:SESN)
The 2 analysts offering 12-month price forecasts for Sesen Bio Inc have a median target of 1.85, with a high estimate of 3.00 and a low estimate of 0.70. The median estimate represents a +264.46% increase from the last price of 0.51.
Similarly 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.
…
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 |
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.
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.
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 |
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.
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.
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 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.
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.
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.
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.
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).