Is Celsion A Good Investment?

by | Last updated on January 24, 2024

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There are

currently 1 buy rating for the stock

. The consensus among Wall Street equities research analysts is that investors should “buy” Celsion stock. View analyst ratings for Celsion or view top-rated stocks.

Will celsion go up?

The 1 analysts offering 12-month price forecasts for Celsion Corp have a median target of 3.00, with a high estimate of 3.00 and a low estimate of 3.00. The median estimate represents a

+198.51% increase

from the last price of 1.00.

What does celsion Corp do?

Celsion Corporation is a fully integrated biopharmaceutical company focused on developing a

portfolio of innovative cancer treatments

, including directed chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies.

Is ThermoDox FDA approved?

ThermoDox® has received

U.S. FDA

Fast Track Designation and has been granted orphan drug designation for primary liver cancer in both the U.S. and Europe . Further, the U.S. FDA has provided ThermoDox® with a 505(b)(2) registration pathway.

Will celsion get FDA approval?

Celsion’s immunotherapy candidate, GEN-1, has received a

fast-track designation

from the U.S. Food and Drug Administration (FDA) for advanced ovarian cancer. This designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions.

What is ThermoDox?

ThermoDox® is

an investigational, proprietary heat-activated formulation of liposomal doxorubicin

, an approved and frequently used oncology drug for the treatment of a wide range of cancers, and is currently being investigated in clinical trials for its potential to treat patients with intermediate (tumor size 3 to 7 …

How long does FDA fast track approval take?

The drug developer must request the Fast Track designation. The request can be made at any time during the development process and the FDA will review and make a decision

within sixty days

.

Is ThermoDox successful?

The prospective subgroup demonstrated a remarkable 7 1⁄2 years plus survival when treated with ThermoDox

®

plus RFA. A successful study has

“blockbuster” revenue potential

and more importantly, will be transformational for patients with HCC, with over 750,000 incidence annually, the largest unmet need in oncology.”

What is FDA fast track approval?

Fast track is a process designed to facilitate the development,

and expedite the review of drugs to treat serious conditions and fill an unmet medical need

. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

How much faster is FDA fast track?

According to a 2017 document by FDA officials, the traditional drug development process can take 9.5 to 14 years; expedited drugs

can take 5.5. to 11 years

.

How do I get fast track designation?

To be eligible for the fast track program, an applicant must

submit a request with supporting documentation for fast track

designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met.

How long is FDA priority review?

A Priority Review designation means FDA’s goal is to take action on an application

within 6 months

(compared to 10 months under standard review).

What are the key steps that need to be taken before a drug can be approved by the FDA?

A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process:

discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring

.

What are the 4 fast track programs?

In order to incentivize the development of drugs to fill an unmet medical need for a serious condition, FDA has developed various programs to expedite drug development and review. These four programs are:

fast track, breakthrough therapy

When can I apply for fast track designation?

Fast Track designation can be requested at any point in the development process—as

early as Investigational New Drug Application (IND) application submission

and generally prior to Biologics License Application (BLA) or New Drug Application (NDA) submission.

How fast can fast track run?

So far, the fastest anyone has run is

about 271⁄2 miles per hour

, a speed reached (briefly) by sprinter Usain Bolt just after the midpoint of his world-record 100-meter dash in 2009.

James Park
Author
James Park
Dr. James Park is a medical doctor and health expert with a focus on disease prevention and wellness. He has written several publications on nutrition and fitness, and has been featured in various health magazines. Dr. Park's evidence-based approach to health will help you make informed decisions about your well-being.