Dec. 18, 2015, 9:15 AM
Dec. 1, 2015, 8:13 AM
- Rosetta Genomics (ROSG -4.2%) Q3 results: Revenues: $2.4M (+700.0%); Operating Expense: $4.1M (+24.2%); Net Loss: ($3.9M) (-14.7%); Loss Per Share: ($0.27) (+6.9%); Quick Assets: $9.6M (-38.5%).
- No guidance given.
Dec. 1, 2015, 8:03 AM
- Rosetta Genomics (NASDAQ:ROSG): Q3 EPS of -$0.27
- Revenue of $2.43M (+800.0% Y/Y)
Nov. 23, 2015, 12:45 PM
Oct. 26, 2015, 4:29 PM
- Rosetta Genomics (NASDAQ:ROSG): 1H EPS of -$0.49.
- Revenue of $2.3M (+310.7% Y/Y).
Oct. 14, 2015, 12:46 PM
Oct. 14, 2015, 9:17 AM
- Rosetta Genomics (NASDAQ:ROSG) raises $8M in new capital via the private placement of 3,333,333 units at $2.40 per unit. Each unit consists of one ordinary share, one Series A Warrant to purchase 1/2 of an ordinary share at $2.75 and one partially pre-funded Series B Warrant with an exercise price of NIS 0.6 (prepaid) plus $0.0001 per share.
- The Series B Warrants are intended to reset the price of the units to 85% of the arithmetic average of the five lowest weighted average prices during the ten trading days following the effective date of the company's resale registration statement to be filed for the private placement.
Sep. 22, 2015, 9:21 AM
Aug. 6, 2015, 11:13 AM
- The New York State Department of Health grants conditional approval for Rosetta Genomics' (ROSG -0.7%) ROS1 lung cancer biomarker by Fluorescence in situ Hybridization (FISH) assay. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. ROS1 by FISH is now available in all 50 states.
Jun. 8, 2015, 9:41 AM
- Thinly traded nano cap Capricor Therapeutics (CAPR +19.4%) is set for an opening gap up in response to its announcement that the FDA has approved its Investigational New Drug (IND) application for the development of Orphan Drug-designated CAP-1002 for the treatment of patients with Duchenne Muscular Dystrophy (DMD)-related cardiomyopathy. The company is currently developing CAP-1002 for the treatment of heart disease.
- A Phase 1/2 study, called HOPE-DUCHENNE, will enroll up to 24 patients.
- Due to the improvement in the treatment of respiratory failure, cardiomyopathy is the leading cause of death in DMD patients.
- CAP-1002 is an "off-the-shelf" cell therapy that will be infused via a catheter into the patients' three coronary arteries in the study.
- DMD-related tickers: (SRPT +1.3%)(OTCPK:SPHDF)(PTCT -2.3%)(SMMT)(PFE -0.2%)(NASDAQ:RNA) (ROSG)(OTCQB:MRNA)(BMRN +0.9%)
May 19, 2015, 5:40 PM
- Based on guidance from the FDA provided in a pre-New Drug Application (NDA) meeting, Sarepta Therapeutics (NASDAQ:SRPT) will begin a rolling NDA submission this week for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). It will file the non-clinical and CMC (Chemistry, Manufacturing and Controls) components by the end of this week and the final component (clinical data) by mid-year.
- Interim CEO Edward Kaye, M.D., says, "We will initiate a rolling NDA submission to facilitate the regulatory review of the submission. [It] marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continuing to work with the Agency towards the goal of providing treatments to patients as quickly as possible."
- Eteplirsen is designed to skip exon 51 in the dystrophin gene, an essential protein in muscle fiber function. A mutation in dystrophin causes DMD. Approved therapies will command premium prices so a number of companies are racing to the regulatory finish line.
- SRPT is up 38% after hours on robust volume.
- DMD-related tickers: (OTCPK:SPHDF) (NASDAQ:PTCT) (NASDAQ:CAPR) (NASDAQ:SMMT) (NYSE:PFE) (NASDAQ:RNA) (NASDAQ:ROSG) (OTCQB:MRNA) (NASDAQ:BMRN)
May 14, 2015, 12:03 PM
- Rosetta Genomics (ROSG +3.5%) announces the availability of two new tests for bladder cancer: one for diagnostic monitoring using urine samples to detect recurrences of FGFR3-positive low grade bladder cancers and the second, in conjunction with Ki-67 expression, using tissue samples for prognosis at initial diagnosis. Both assays will be introduced at the American Urological Association Annual Meeting in New Orleans, May 15 - 19.
- FGFR3 (fibroblast growth factor receptor 3) is one of four FGFRs that play key roles in cell growth and division and the formation of blood vessels. Its analysis is part of the PersonalizeDx portfolio, which Rosetta acquired last month. Urine-based testing may detect low grade bladder tumors that traditional methods might miss.
- Ki-67 is a cellular marker for proliferation.
May 13, 2015, 9:15 AM
May 7, 2015, 12:09 PM
- Tonix Pharmaceuticals (TNXP +0.7%) initiated with Buy rating and $10 (63% upside) price target by Janney Capital.
- Infinity Pharmaceuticals (INFI -0.5%) initiated with Buy rating and $20 (67% upside) price target by Deutsche Bank.
- Intra-Cellular Therapies (ITCI -0.8%) initiated with a Buy rating and $50 (138% upside) price target by SunTrust Robinson Humphrey.
- Onconova Therapeutics (ONTX +1.7%) initiated with Buy rating and $6 (153% upside) price target by H.C. Wainwright.
- CONMED (CNMD +0.9%) initiated with Buy rating and $63 (18% upside) price target by Deutsche Bank.
- Carbylan Therapeutics (CBYL +1.8%) initiated with Outperform rating and $16 (183% upside) price target by Leerink Swann.
- NovaBay Pharmaceuticals (NBY -6.5%) initiated with Buy rating and $2 (251% upside) price target by Maxim Group.
- Rosetta Genomics (ROSG -0.6%) initiated with Outperform rating and $8 (229% upside) price target by Barrington Research.
- Lion Biotechnologies (LBIO -0.5%) initiated with Buy rating and $30 (162% upside) price target by Chardan Capital.
- Shire plc (SHPG +0.5%) initiated with Outperform rating by Exane BNP Paribas.
Apr. 30, 2015, 9:19 AM
Apr. 27, 2015, 10:24 AM
- BioMarin Pharmaceuticals (BMRN +3.5%) concludes its rolling New Drug Application (NDA) with the FDA, as provided under Fast Track and Breakthrough Therapy designations, for drisapersen for the treatment of Duchenne muscular dystrophy (DMD), a fatal genetic disorder affecting ~20K children worldwide each year.
- DMD, usually affecting boys, is caused by a defective gene for dystrophin, an essential muscle protein.
- Drisapersen induces the skipping of dystrophin exon 51 which restores the proper dystrophin reading frame in ~13% of DMD patients. The FDA has also tagged it an Orphan Drug for DMD, which provides a seven-year period of market exclusivity for the indication, if approved.
- DMD-related tickers: (OTCPK:SPHDF)(PTCT -2.1%)(SRPT +2.2%)(CAPR -1.2%)(SMMT +0.9%)(PFE +0.4%)(RNA)(ROSG)(OTCQB:MRNA)
Rosetta Genomics Ltd. engages in the discovery, development, commercialization, marketing, and sale of diagnostic tests and therapeutics based on micro-ribonucleic acids (microRNA). It offers proprietary microRNA technologies such as Rosetta Cancer Origin Test, Rosetta Lung Cancer Test, Rosetta... More
Industry: Diagnostic Substances
Country: United States
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