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RedHill Biopharma Announces Unanimous Positive DSMB Recommendation for Continuation of the Phase III Study with RHB-104 for Crohn's Disease
https://finance.yahoo.com/news/redhill-biopharma-announces-unanimous-positive-120201604.html
Methinks you are right!
SHORTS getting killed!
Nice article about RDHL
https://seekingalpha.com/article/4090679-2-small-cap-biotechs-put-radar
Short Interest as of 7/14/2017 is 174,376.....
http://www.nasdaq.com/symbol/rdhl/short-interest
Short Interest as of 7/14/2017 is 174,376.....
http://www.nasdaq.com/symbol/rdhl/short-interest
Shorts PAINTING THE TAPE again!
Anybody looking for analyst upgrades???
Funny, Shorts painting the tape this week!
AMEN brother, hope we can get some good news!!!
Type in RDHL and you will see this study Results are due in September ...
https://www.biopharmcatalyst.com/calendars/fda-calendar
RedHill reaching critical mass in IBS?
One of the most important developmental programs for RedHill Biopharma (NASDAQ:RDHL) is a bimodal release formulation of the serotonin receptor antagonist ondansetron, which is commonly used to help prevent nausea. RDHL is developing this compound for gastrointestinal disorders, and the 24-mg dose was tested in the phase 3 GUARD study for patients with gastroenteritis or gastritis.
Now, RDHL has announced that a separate study, a phase 2 trial assessing a 12-mg dose of Bekinda for the treatment of irritable bowel syndrome, has enrolled its last patient, charting a course for late-stage development in this indication.
Looking forward: Irritable bowel syndrome afflicts a large number of patients, with many not being able to find relief from various treatment strategies. So it could be a significant coup for RDHL, as there is only one other serotonin receptor antagonist in this field. Ondansetron has a pretty solid place in the management of chemotherapy-induced nausea and vomiting, as part of a large variety of agents in this class. Hopefully it can provide some relief to patients with IBS, too.
Although I like it, someone painted the tape at close.
GOOD JOB!!!
I just bought more shares today!
THANKS, great post!
Short Interest as of 6/30/2017.... 171,083
http://www.nasdaq.com/symbol/rdhl/short-interest
RedHill Biopharma Receives FDA Orphan Drug Designation for YELIVA® for the Treatment of Cholangiocarcinoma
GlobeNewswire•April 4, 2017
Orphan Drug designation allows RedHill to benefit from various development incentives to develop YELIVA® (ABC294640) for cholangiocarcinoma, as well as a seven-year marketing exclusivity period for the indication, if approved for marketing
A Phase IIa clinical study with YELIVA® in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to be initiated in the third quarter of 2017
Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy for which there is a strong need for more effective systemic treatments; the 5-year relative survival rate for patients with cholangiocarcinoma ranges between 2% to 30%, depending on the tumor type and stage at diagnosis
A Phase I study with YELIVA® in patients with advanced solid tumors successfully met its primary and secondary endpoints; of the three cholangiocarcinoma patients in the Phase I study, one patient had a sustained partial response and the other two had prolonged stable disease
RedHill is pursuing several Phase I/II clinical studies with YELIVA®, targeting multiple oncology and inflammatory indications, some of which are supported by National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities
YELIVA® is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory activities
TEL-AVIV, Israel, April 04, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted YELIVA® (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma.
The Orphan Drug designation allows RedHill to benefit from various development incentives to develop YELIVA® for this indication, including tax credits for qualified clinical testing, waiver of a prescription drug user fee (PDUFA fee) upon submission of a potential marketing application and, if approved, a seven-year marketing exclusivity period for the treatment of cholangiocarcinoma.
YELIVA® is a Phase II-stage, proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA® blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.
What is QIDP Status?
The QIDP designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. The QIDP designation allows RedHill to benefit from Fast-Track status, with an expedited development pathway for RHB-104 for the treatment of NTM infections, as well as Priority Review, which provides for a shorter review time by the FDA of a future potential marketing application. If approved for the treatment of NTM infections, RHB-104 would also receive an additional five years of US market exclusivity on top of the standard exclusivity period.
RHB-104
RHB-104 is a proprietary antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
A first Phase III study with RHB-104 for the treatment of Crohn's disease (the MAP US study) is currently ongoing in the US and additional countries. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn's disease, and potentially other autoimmune diseases, are related to Mycobacterium Axium subspecies paratuberculosis (MAP) infection in susceptible patients.
Recently, RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis. Top-line final results from the CEASE MS study suggest meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development.
Methinks, it will probably get BUY & UPGRADES after P3 results!
Don't you guys think we should be getting an analyst upgrade or buy rating?
SHORT INTEREST as of June30, 2017.... 22,896,470
http://www.nasdaq.com/symbol/dcth/short-interest
LORDY, what's going on here???
I refer these analyst reports...
http://www.nasdaq.com/symbol/rdhl/analyst-research
Change of Ownership?
What does that mean for the stock?
Brother I surely hope you are right!!!
GREAT, this link says it's due next month... type in RDHL
https://www.biopharmcatalyst.com/calendars/fda-calendar
Any thoughts on Crohn’s disease P3?
Way to go Investor, wish I had some free cash
Crohn’s disease P3 results coming next month!!!
Lordy,,, we can't take anymore GOOD NEWS!!!
WOW.... all quiet on the home front
Cold feet.... just sold out!
You convince me Paulness..... I'm in @1.49, great posting!
If I can find the funds I will do the same!!!
BIG MONTH,, PHASE 3 results begin!
One thing to say about your post, AMEN