SA News • Tue, Dec. 9
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Tue, Dec. 9, 12:38 PM
- RedHill Biopharma Ltd. (RDHL +12.2%) submits a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking approval for the 5-HT3 receptor Bekinda (ondansetron) (formerly RHB-102) for the treatment of cancer therapy-induced nausea and vomiting.
- The MAA has been submitted under the European Mutual Recognition Procedure with the UK as the reference European member state.
- The 5-HT3 market is estimated at ~$940M worldwide with Europe representing ~1/3 of the total.
- CINV-related tickers: (OTC:ESALF) (OTCPK:ESALY -3%) (OPK +1.1%)(GALE +1.8%)(INSY +0.7%)(HRTX +1.3%)(TSRO +2.9%)(GWPH +4.5%)
Fri, Oct. 10, 10:50 AM
- The FDA approves Akynzeo (netupitant and palonsetron) for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a combination of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting in the acute phase (24 hours) after the start of chemo. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (25 - 120 hours) after the start of chemo.
- Akynzeo is distributed in the U.S. by Eisai (OTC:ESALF)(OTCPK:ESALY -0.2%) under license from Lugano, Switzerland-based Helsinn Healthcare S.A.
- Related tickers: (OPK -1.6%)(GALE -6.1%)(INSY -1.9%)(HRTX -2.7%)(RDHL)(TSRO -0.8%)(GWPH -4.6%)
Mon, Aug. 4, 10:38 AM
Mon, Aug. 4, 8:07 AM
Wed, Jun. 25, 12:47 PM
Wed, Jun. 25, 10:35 AM
- Heron Therapeutics (HRTX -11.3%) prices its public offering of 4.5M shares of common stock at $11.75 per share. Underwriters over-allotment is 675K shares. Gross proceeds will be ~$60M (assumes full exercise of over-allotment). Net proceeds will be used for general corporate purposes including funding ongoing and future clinical trials. Closing date is June 30.
- A component of the deal is the offering of pre-funded warrants to certain existing large shareholders at a price of $11.74 per warrant to purchase an aggregate of 600K shares of common stock.
Thu, Jun. 19, 5:49 PM
Thu, Jun. 5, 12:49 PM
Mon, Jun. 2, 2:22 PM
- Considering the fast start-up of its Sustol (granisetron) Phase 3 clinical trial, Heron Therapeutics (HRTX -2.2%) now plans to include the results in the resubmission of its NDA to the U.S. Food and Drug Administration in Q4.
- Sustol is being developed for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting.
- The FDA rejected the initial NDA from A.P. Pharma in March 2013. In its CRL to the company, it cited the need to refine a QA test method, a human factors validation study evaluating the usability of the syringe system and a re-analysis of Phase 3 data to align the patient groups with updated ASCO guidelines.
- Press release
Thu, May. 8, 9:33 AM
Wed, Mar. 5, 8:19 AM
Mar. 28, 2013, 2:12 PMAP Pharma (APPA.OB -32.6%) dives after FDA denies approval for chemotherapy nausea treatment citing issues with AP's syringe administration system and manufacturing facilities. SA contributor Smith on Stocks says the issues are resolvable and, consistent with the company's own projections, sees approval in H1 2014. | Comment!
Jan. 14, 2013, 2:32 PMInvestors interested in the prospects of young biotech companies might want to take a look at this Seeking Alpha article. It's a list of the upcoming FDA approval decision dates for Q1 2013, and with many of these developing firms having a good portion of their businesses riding on FDA approval decisions for their newly developed drugs, the stocks are likely to be sensitive to any positive or negative news over the near term. | Comment!
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