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And the FDA did agree to the protocol. Look back about 3 years. This is why the stock isn’t at 5 cents. Of course there is no guarantee BetOnMace met any endpoints. More will be revealed.
Talicia needs approval. Should get it. Less than a month
maybe under 5.5. lol
not making any big bets on it, but that is the theory....
Not necessarily as it is one of the pre-defined sub-group analyses in BetOnMace.
We shall see
May work better with Crestor than Lipitor. That was the indication based on earlier trials.
I’m adding at these prices. Confident fda will approve Talicia
Why would anyone hold on to this stock?
OTOH, there is much more information to come out. AHA in November and others
The facts are easy. It missed its primary endpoint. The balance sheet shoes little cash.
I’m guessing relative. But it’s a guess.
Endpoint not met. Very little cash. Facts. Rumors abound
Your posts are generally both hilarious and right on target
Fun times. Almost halfway back
I’m guessing after the nda.
Is this a relative or a coincidence?
Or right after the next taise
Under 7 for me
Couple of part timers?
short covering? possibly to be followed by more shorting?
Realistically...the company has little chance of being able to raise any funding, so there is likely to be a sale or simply a transfer of IP to Hepalink/ORI
Even if the secondary endpoints are exceeded it is back to phase 2 and there's no cash.
The market knew what was coming ...
sucks big time.
oh well....
lol. you have got to be kidding.
Of course. Big flops are sometimes buried in late Friday afternoon
hope it is not at 4:01 this afternoon....
the data release should come first. but with RVX who knows?
Good idea. Midas do you want to weigh in on this.
I was/am waiting for 6's to add.
I did not see anything gloomy in it either. The short-term stock price is independent of company direction and results. At least it seems that way.
Sell any news at all seems to be the norm, and sell any post by MidasTouch. Ha!
Here we go.... hope I have the right number of shares....
Resverlogix to Host BETonMACE Webcast and Conference Call
CALGARY, Alberta, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX: RVX) today announces that, in connection with BETonMACE topline results, expected to be announced on September 30, 2019, the company plans to hold a webcast and conference call that same morning at 8:30 am ET.
It is highly recommended to access the webcast over the Internet using the following LINK. A replay of the webcast (using the same link provided) will be available for one month following the conclusion of the event.
If dialing in by phone, dial 1-800-319-4610 (within Canada / USA) or +1-604-638-5340 (International Toll). Callers should dial-in at least 15 min prior to the scheduled start time. A teleconference replay will be available for two weeks following the conclusion of the event and can be accessed by dialing 1-800-319-6413 (within Canada / USA) or +1-604-638-9010 (International Toll) and using the replay access code: 3629#.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
Follow us on:
• Twitter: @Resverlogix_RVX
• LinkedIn: https://www.linkedin.com/company/resverlogix-corp-/
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com
This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to a BETonMACE conference call and webcast and the potential role of apabetalone in the treatment of high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
RedHill Biopharma Provides H2/2019 R&D Update
TEL-AVIV, Israel and RALEIGH, N.C., Sept. 26, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases, today provided a periodic R&D update.
RHB-105 (Talicia®)1 - H. pylori Infection
The New Drug Application (NDA) for RHB-105 (Talicia) is under priority review by the U.S. Food and Drug Administration (FDA), with an assigned target Prescription Drug User Fee Act (PDUFA) action date of November 2, 2019.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Infections
In light of positive data received from the ongoing non-clinical program with RHB-204, RedHill plans to initiate pivotal Phase 3 study activities with RHB-204 for the treatment of pulmonary NTM infections in the fourth quarter of 2019, subject to additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as the first stand-alone, first-line treatment for Mycobacterium avium complex (MAC) disease, the most common cause of pulmonary NTM infections2.
RHB-104 - Crohn’s Disease
Following positive top-line results from the Phase 3 study with RHB-104 (MAP US study), the last patient enrolled in the open-label extension Phase 3 study with RHB-104 in Crohn’s disease (MAP US2 study) has recently completed their participation in the study. A total of 30 subjects completed 52 weeks of treatment with RHB-104 in the MAP US2 study, with top-line results expected in the fourth quarter of 2019. Following additional regulatory guidance from the FDA on the path for potential approval of RHB-104, RedHill has intensified its collaborations with leading laboratories in the field of detection of Mycobacterium avium paratuberculosis (MAP) bacteria in Crohn’s disease patients, including Baylor College of Medicine and the University of Central Florida’s (UCF) College of Medicine. As previously announced, additional FDA guidance on RHB-104’s potential path to approval is expected in the coming months.
RHB-102 (Bekinda®)1 - Acute Gastroenteritis & Gastritis and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
In addition to the intended adult labeling of Bekinda for use in the treatment of nausea and vomiting associated with acute gastroenteritis and gastritis and for the treatment of IBS-D, RedHill has recently concluded a positive FDA meeting with regard to the pediatric study plans required to potentially obtain pediatric labeling for Bekinda. RedHill is advancing preparations toward a confirmatory Phase 3 study to support a potential NDA filing for Bekinda for the treatment of nausea and vomiting associated with acute gastroenteritis and gastritis.
Yeliva® (opaganib, ABC294640)1 - Cholangiocarcinoma and Additional Indications
Yeliva is being investigated in an ongoing Phase 2a study in advanced cholangiocarcinoma (bile duct cancer). The study has achieved its pre-specified efficacy goal for the first stage of the two-stage study design and is expected to complete enrollment of the full cohort by the end of the year. In addition, the National Cancer Institute (NCI) grant that was previously awarded to the Medical University of South Carolina (MUSC) to support a study with Yeliva in hepatocellular carcinoma (HCC) has been diverted to support a Phase 2 study with Yeliva in prostate cancer. The investigator-sponsored study is expected to be initiated by early 2020 at MUSC Hollings Cancer Center and will be led by Dr. Michael B. Lilly. The study is supported by several pre-clinical studies in early and advanced prostate cancer models, suggesting that the administration of Yeliva disrupts multiple oncogenic-signaling pathways that are deregulated in prostate cancer.
The clinical studies with RHB-105 (Talicia), RHB-104 , RHB-102 (Bekinda) and Yeliva are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institute of Health, which provides access to information on publicly and privately-supported clinical studies. (ClinicalTrials.gov Identifiers: NCT03009396, NCT02757105 and NCT03377179, NCT03198507 respectively).
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S.: Donnatal® - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; EnteraGam® - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools and Mytesi® - an anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. RedHill’s key clinical late-stage development programs include: (i) RHB-105 (Talicia®) for the treatment and eradication of Helicobacter pylori infection with a U.S. NDA submitted and accepted for priority review with a target PDUFA action date of November 2, 2019; (ii) RHB-104, with positive top-line results from a first Phase 3 study for Crohn's disease; (iii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) Yeliva® (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at: www.redhillbio.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks related to the occurrence or timing of the RHB-105 (Talicia®) PDUFA action date, risks related to the commencement or timing of our clinical trials with RHB-104, RHB-204, RHB-102 (Bekinda®) and Yeliva® (ABC294640), risks related to meetings scheduled with the FDA, including with regard to RHB-104 for Crohn’s disease, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully commercialize and promote Donnatal®, EnteraGam® and Mytesi®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 26, 2019, as amended on May 15, 2019. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.
________________________________________
1 RHB-105 (Talicia®), RHB-102 (Bekinda®) and Yeliva® (opaganib, ABC294640) are investigational new drugs, not available for commercial distribution. Talicia®, Bekinda® and Yeliva® are proposed tradenames and are subject to FDA review and approval.
2 Wassilew N et al. Pulmonary disease caused by non-tuberculous mycobacteria. Respiration 91.5 (2016): 386-402
Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com
Is there something in today's update that is a surprise? I don't see the reason for the pullback.
let's see....down about 35% since the split?
about time.
Shouldn’t be. But who knows. Volume popped today with a double digit drop. Could not resist a nibble but watching close and will ditch them if needed.
Still have the 40 and 50 cent shares from early 2015. They looked prettier at $3.50 each
I added a bit today
Nosedive. Into data. Accelerating after database lock. Grim
Sure. Why not? The length of the trial alone makes results likely positive
But it will be approved.