Wed, Sep. 2, 11:16 AM
- The FDA approves Merck's (MRK +0.1%) supplemental New Drug Application (NDA) for the use of EMEND (aprepitant), in combination with other antiemetic agents, in pediatric patients at least 12 years old and weighing at least 30 kg (~66 pounds).
- EMEND is a substance P/neurokinin 1 (NK-1) receptor antagonist for the prevention of chemo-induced nausea and vomiting (CINV). It is the only drug of this type cleared for use in patients aged 12 - 17.
- Related ticker: (TSRO +6.3%)
Wed, Sep. 2, 10:33 AM
- The FDA approves Tesaro's (TSRO +4.4%) VARUBI (rolapitant), in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with chemotherapy (CINV) in adult patients. Up to 50% of chemo patients experience delayed CINV (25 - 125 hours after treatment) even when taking a 5-HT3 receptor antagonist (Novartis' Zofran, formerly Glaxo's) and a corticosteroid.
- VARUBI, the company's first approved product, is an antagonist of human substance P/neurokinin 1 (NK-1) receptors with a plasma half-life of ~seven days. Phase 3 results showed a significant reduction in CINV or use of rescue medication when patients were administered a 180 mg dose one - two hours prior to chemo in combination with a 5-HT3 antagonist and dexamethasone.
- Related tickers: (NVS -0.1%)(HRTX +0.2%)(OPK +1%)(INSY +2.7%)(RDHL +1%) (OTC:ESALF) (OTCPK:ESALY) (GALE +0.6%)(GWPH +1.1%)(MRK -0.1%)
Thu, Aug. 6, 4:22 PM
Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Mon, Jul. 13, 8:46 AM
Wed, Jul. 8, 5:41 PM
Sat, May 30, 7:35 PM
- Tesaro (NASDAQ:TSRO) and Merck (NYSE:MRK) will collaborate in a Phase 1/2 clinical trial assessing Tesaro's niraparib and Merck's Keytruda (pembrolizumab) in patients with triple negative breast cancer or ovarian cancer. The study will commence later this year.
- Breast cancer patients that test negative for three receptors have limited treatment options because the most effective new therapies specifically target them: estrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor 2 (HER2). Ovarian cancer is one of the more difficult cancers to treat. There are over 21K new cases per year in the U.S. The five-year survival rate is less than 45%.
- The prevailing opinion in the oncology community is that combining drugs with different mechanisms of action offers the best chance of success in many cancers. This collaboration is an example of this. Niraparib inhibits an enzyme called poly ADP ribose polymerase ((PARP)) while pembrolizumab inhibits (binds to) a protein called programmed cell death 1 (PD-1).
- Merck is advancing Keytruda in a wide variety of cancers, with more than 100 clinical trials planned or in process across more than 30 tumor types.
Thu, Apr. 30, 4:05 PM
Mon, Mar. 9, 4:16 PM
Thu, Mar. 5, 4:35 PM
- Thinly-traded small cap Heron Therapeutics (NASDAQ:HRTX) heads north again delivering another 10% on an 8x surge in volume. Shares have more than doubled since the intermediate low of $7.09 on January 22.
- The party kicked into high gear in early February when the company announced the initiation of a Phase 1 trial evaluating the safety, pharmacokinetics and pharmacodynamics of HTX-011, an investigational pain medicine the utilizes the company's Biochronomer polymer-based drug delivery platform to release the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam over an extended period. HTX-011 has previously shown to significantly reduce pain in a validated animal model for up to 72 hours following surgery, although exactly how this was measured is unclear. The company expects to report the results this quarter. A series of Phase 1b/2 trials is on tap to begin in Q2 assessing HTX-011 in a post-surgical pain setting with results expected before the end of the year.
- The company's lead product candidate is the Phase 3-stage Sustol (granisetron injection, extended release) for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). Granisetron is a 5-HT3 receptor antagonist also formulated in the Biochronomer drug delivery platform. The FDA has approved only one 5-HT3 receptor antagonist to date, GlaxoSmithKline's Zofran (ondansetron hydrochloride) injection in 1991.
- CINV-related tickers: (NYSE:OPK) (NASDAQ:INSY) (NASDAQ:TSRO)
Mon, Mar. 2, 5:15 PM
Fri, Feb. 20, 9:26 AM
- Tesaro (TSRO +2.5%) Q4 results: Revenues: $0; R&D Expense: $29.8M (+57.7%); SG&A: $7.4M (+64.4%); Net Income: ($47.9M) (-105.6%); Loss Per Share: ($1.33) (-84.7%).
- FY2014 results: Revenues: $0; R&D Expense: $118.4M (+56.4%); SG&A: $23.9M (+61.5%); Net Loss: ($171M) (-85.1%); Loss Per Share: ($4.79) (-63.5%); Quick Assets: $256.9M (+97.2%).
- No guidance given.
Thu, Feb. 19, 4:05 PM
Wed, Feb. 18, 5:35 PM
Dec. 9, 2014, 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%)
Nov. 14, 2014, 5:38 PM
TSRO vs. ETF Alternatives
Tesaro Inc is an oncology-focused biopharmaceutical company engaged in improving the lives of cancer patients. The Company is developing three clinical-stage product candidates including rolapitant, niraparib and TSR-011.
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