Wed, Feb. 18, 12:51 PM
Wed, Feb. 18, 11:43 AM| 3 Comments
Wed, Feb. 18, 9:15 AM
Tue, Feb. 17, 12:44 PM
Tue, Feb. 17, 10:41 AM
- Thinly-traded nano cap Rosetta Genomics (ROSG +47.7%) sprints on a robust 20x surge in volume in response to its announcement of an allowance from the U.S. Patent and Trademark Office (USPTO) for a patent claiming the use of miR-34a for the treatment of p53-associated cancers and an allowance from the European Patent Office for a patent claiming the specific composition of miR-451, a miR relating to Rosetta's Cancer of Unknown Primary (CUP) testing franchise.
- The p53 protein is a sequence-specific transcription factor that is a major tumor suppressor in mammals. Inactivation of this function is one of the most frequent genetic alterations in human cancer with more than 50% of tumors carrying the mutation.
Tue, Feb. 17, 9:14 AM
Mon, Jan. 19, 5:38 PM
- The FDA grants Fast Track status to privately-held Marathon Pharmaceuticals' corticosteroid MP-104 (deflazacort) for the treatment of Duchenne Muscular Dystrophy (DMD).
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- DMD-related tickers: (NASDAQ:SRPT) (NASDAQ:PTCT) (NYSE:PFE) (NASDAQ:RNA) (OTCQB:MRNA) (NASDAQ:ROSG)
Dec. 23, 2014, 10:20 AM
- PTC Therapeutics (PTCT -4.4%) commences its rolling New Drug Application (NDA) submission for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The company expects to finalize the application in Q4 2015 following the completion of the confirmatory Phase 3 trial.
- DMD-related tickers: (PFE -2.2%)(SRPT -4.2%)(RNA -0.2%)(OTCQB:MRNA)(ROSG +0.4%)
Dec. 17, 2014, 10:10 AM
- Pfizer (PFE +0.2%) initiates a Phase 2 clinical trial assessing its investigational compound, PF-06252616, in boys with Duchenne Muscular Dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. It occurs in ~1 in 3,500 male births worldwide.
- The study will evaluate the safety, tolerability and efficacy of PF-06252616 in boys aged 6 to <10 years old diagnosed with DMD regardless of genotype.
- The FDA designated PF-06252616 an Orphan Drug in July 2012 and Fast Track in November 2012.
- DMD-related tickers: (SRPT +4.1%)(RNA +0.1%)(PTCT +1.6%)(OTCQB:MRNA +5.8%)(ROSG +0.4%)
- Previously: Catabasis Pharmaceuticals' CAT-1004 tagged an Orphan Drug for DMD (Nov. 24, 2014)
Nov. 24, 2014, 12:15 PM
- The FDA designates privately-held Catabasis Pharmaceuticals' investigational NF-kB inhibitor, CAT-1004, an Orphan Drug for the treatment of Duchenne muscular dystrophy (DMD).
- NF-kB is a key mediator of cellular injury. Evidence suggests that activated NF-kB contributes to the underlying pathology of DMD.
- In a Phase 1 trial, CAT-1004 was well-tolerated and demonstrated a significant reduction of activated NF-kB. The company plans to proceed to Phase 2 development in 1H 2015.
- Among the benefits of Orphan Drug designation is a seven-year period of market exclusivity if approved.
- DMD-related tickers: (SRPT +7.6%)(RNA +63.3%)(BMRN +1.7%)(PTCT +3.4%)(OTCQB:MRNA -3.3%)(ROSG +0.8%)
Oct. 16, 2014, 3:37 PM
- Prosensa Holding N.V. (RNA +5.5%) commences its NDA submission process with the FDA for drisapersen for the treatment of Duchenne muscular dystrophy (DMD). The agency will review the application on a rolling basis as stipulated under Fast Track. It also designated drisapersen an Orphan Drug in June 2013.
- DMD-related tickers: (SRPT +7.1%)(PTCT +1.3%)(ROSG +8%)(OTCQB:MRNA)
Sep. 17, 2014, 5:36 PM
Sep. 17, 2014, 4:56 PM
- Rosetta Genomics (ROSG +9.5%) 1H results: Revenues: $0.6M (+187.0%); Operating Expenses: $7.0M (+9.3%); Net Loss: ($7.2M) (-14.2%); Loss Per Share: ($0.66) (+7.0%); Quick Assets: $19.7M (-19.3%).
- Cash guidance: cash required to fund operations through 2014: $14M - 15M (includes $7.5M consumed in 1H). The company believes its existing cash and projected revenues will be sufficient to fund operations into 2016.
Aug. 18, 2014, 1:03 PM
Jul. 10, 2014, 9:56 AM
- The USPTO issues a Notice of Allowance for Rosetta Genomics' (ROSG +0.8%) patent application 13/977,797 entitled "Compositions and Methods for Treatment of Ovarian Cancer." The patent relates to the inhibition of miR-210 for the treatment of ovarian cancer.
- The patent, when issued, will be the company's 33rd in the U.S. It has 27 patent applications pending.
Jun. 26, 2014, 9:56 AM
- Rosetta Genomics (ROSG +8.7%) receives a Notice of Allowance from the USPTO for its patent application entitled "Compositions and Methods for Prognosis and Treatment of Prostate Cancer." The patent (No. 13/390,995) claims cover the expression of miR-205 as an indicator of good prognosis and relates to methods and kits for prognosis of prostate cancer.
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