Did Tesaro Just Enter Yet Another Overcrowded Space?
Thu, Jun. 30, 9:42 AM
- TESARO (TSRO -3.6%) announces the initiation of an underwritten public offering of $300M of common stock. Price, volume and terms have yet to be released.
- Update: On July 1, the company announced that its offering is 4.65M shares of common stock at $81/share. Underwriters over-allotment is an additional 697.5K shares. Net proceeds should be ~$355.6M. Closing date is July 7. Yesterday's close was $84.12.
Wed, Jun. 29, 12:46 PM
Wed, Jun. 29, 11:10 AM
Wed, Jun. 29, 9:24 AM
- Clovis Oncology (NASDAQ:CLVS) is up 17% premarket on robust volume in a ripple effect from the bullish action in TESARO (NASDAQ:TSRO) following its announcement of positive late-stage result for PARP inhibitor niraparib.
- Clovis' Phase 2-stage rucaparib is also a PARP inhibitor.
- PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
- Previously: TESARO's niraparib successful in late-stage ovarian cancer study clearing the way for regulatory submission in Q4; shares ahead 69% premarket (June 29)
Wed, Jun. 29, 9:16 AM
Wed, Jun. 29, 9:05 AM
- TESARO (NASDAQ:TSRO) is up 69% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial, NOVA, assessing PARP inhibitor niraparib in women with ovarian cancer, including those who are germline BRCA mutation carriers and those who are not germline BRCA carriers but who have homologous recombination deficient (HRD) tumors [as determined by Myriad Genetics' (NASDAQ:MYGN) myChoice HRD test].
- NOVA was a ~500-subject, double-blind, placebo-controlled study in patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy.
- Patients treated with niraparib experienced median progression-free survival (PFS) of 21.0 months compared to 5.5 months for placebo (p<0.0001) with 62% less risk of dying in the study period (hazard ratio = 0.38).
- The most common treatment-emergent grade 3 (serious) or grade 4 (disabling or life threatening) adverse events were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). The discontinuation rate was 14.7% for niraparib versus 2.2% for placebo.
- There is no currently approved therapy in the U.S. for maintenance treatment of patients with recurrent ovarian cancer following response to platinum.
- The company plans to file regulatory submissions in the U.S. and Europe in Q4.
Jul. 8, 2015, 5:41 PM
Mar. 5, 2015, 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)
Nov. 14, 2014, 5:38 PM
May 12, 2014, 12:47 PM
May 12, 2014, 9:12 AM
May 12, 2014, 9:09 AM
- Tesaro's (TSRO) Rolapitant drug for the prevention of chemotherapy-induced nausea and vomiting (CINV) has met the primary and secondary goals of a Phase III study of 532 cancer patients, achieving statistical significance compared with standard treatments.
- The data adds to the positive results of two other late-stage trials, the results of which Tesaro announced in December.
- Tesaro plans to apply for FDA approval of Rolapitant in mid-2014; the treatment would compete with Merck's Emend.
- The company's shares are +18.7%, while those of Opko Health (OPK), which sold Tesaro rights to Rolapitant for as much as $121M in up-front and milestone payments, are +0.5%. (PR)
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TESARO, Inc. is an oncology-focused biopharmaceutical company. It is dedicated to improving the lives of cancer patients. The company's product portfolio currently consists of three oncology-related product candidates: Rolapitant, Niraparib and TSR-011. TESARO was founded by Leon Moulder, Jr.,... More
Country: United States
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