Thu, Aug. 4, 4:47 PM
Tue, Jun. 28, 12:46 PM
Mon, May 9, 4:46 PM
Thu, Mar. 10, 4:19 PM
- Dicerna Pharmaceuticals (NASDAQ:DRNA): Q4 EPS of -$0.76 beats by $0.08.
Dec. 16, 2015, 4:26 PM
Nov. 10, 2015, 4:19 PM
- Dicerna Pharmaceuticals (NASDAQ:DRNA): Q3 EPS of -$0.82 beats by $0.02.
Sep. 8, 2015, 10:40 AM
- Based on encouraging preclinical data, Alnylam Pharmaceuticals (ALNY +2.2%) plans to initiate a Phase 1 clinical trial in early 2016 to investigate its RNAi therapeutic, ALN-GO1, for the treatment of primary hyperoxaluria type 1 (PH1), an ultra-rare liver disorder characterized by the overproduction of oxalate which leads to the accumulation of calcium oxalate kidney stones, irreparable kidney damage and end stage renal disease by the age of 30. It affects less than 1,000 Americans. There are no approved therapies for the condition.
- ALN-GO1 targets the enzyme glycolate oxidase, referred to as hydroxyacid oxidase 1 (HAO1). In animal models, ALN-GO1 silenced up to 99% of the HAO1 mRNA and reduced up to 98% of mean urinary oxalate.
- Dicerna Pharmaceuticals (DRNA +2.7%) is also developing a similar candidate, DCR-PH1. Its Phase 1 study should commence in the next few months.
- Previously: Dicerna Pharma submits IND for DCR-PH1 for the treatment of rare liver disorder (Sept. 2)
Sep. 2, 2015, 8:21 AM
- Dicerna Pharmaceuticals (NASDAQ:DRNA) submits an Investigational New Drug (IND) application to the FDA seeking clearance to initiate clinical studies of DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1), a rare inherited liver disorder that is characterized by excess production of oxalate which eventually damages the kidneys and other organs. It affects less than 1,000 Americans. There are no approved therapies for the condition.
- DCR-PH1 targets and destroys the messenger RNA produced by HAO1, a gene that plays a key role in the development of PH1.
- The company will be able to initiate a Phase 1 clinical trial after 30 days, unless the FDA imposes a clinical hold.
Aug. 6, 2015, 4:39 PM
- The European Medicines Agency grants Orphan Drug status for Dicerna Pharmaceuticals' (NASDAQ:DRNA) DCR-PH1, its candidate for the treatment of primary hyperoxaluria type 1 (PH1), a rare inherited disorder for which there are no approved therapies.
- PH1 is recessive which means that it only appears in people with both copies of mutations in the AGXT gene. It is characterized by the liver's overproduction of oxalate (oxalic acid). In the kidneys, excess oxalate combines with calcium to form calcium oxalate, the main component in kidney stones. Deposits of calcium oxalate can lead to kidney damage/failure and injury to other organs. Primary hyperoxaluria is caused by a deficiency in an enzyme that normally prevents the buildup of oxalate, called alanine-glyoxylate aminotransferase or AGXT. It's rare, occurring in only 1 - 3 people per million.
- DCR-PH1's mechanism of action is disabling the messenger RNA that encodes glycolate oxidase (GO), the liver enzyme that is involved in the breakdown of hydroxyproline, a component of collagen. Hydroxyproline plays a key role in the buildup of excess oxalate. The production of oxalate is reduced by preventing liver cells from making GO.
- Among the benefit of Orphan Drug status in the EU is a ten-year period of market exclusivity for the indication, if approved.
Aug. 6, 2015, 4:31 PM
- Dicerna Pharmaceuticals (NASDAQ:DRNA): Q2 EPS of -$0.72 beats by $0.06.
- Revenue of $0.18M
Jun. 29, 2015, 12:45 PM
Jun. 11, 2015, 8:10 AM
- Responding to Alnylam's (NASDAQ:ALNY) lawsuit accusing it of misappropriating trade secrets, Dicerna Pharmaceuticals (NASDAQ:DRNA) says the case is without merit and it will vigorously defend itself in the matter.
- The company says that earlier this year Alnylam was concerned about certain aspects of Dicerna's GalNAc delivery technologies. Dicerna conducted an internal investigation and confirmed that no Merck/Alnylam confidential information had been used, a finding that it communicated to Alnylam. It also says that many of the insinuations in Alnylam's complaint are either false or based on unfounded speculation.
- Previously: Alnylam sues Dicerna Pharma over trade secrets (June 10)
Jun. 10, 2015, 5:38 PM
Jun. 10, 2015, 4:35 PM
- Alnylam Pharmaceuticals (NASDAQ:ALNY) files a lawsuit in Massachusetts against Dicerna Pharmaceuticals (NASDAQ:DRNA) accusing it of misappropriating trade secrets Alnylam acquired via its buyout of Sirna Therapeutics from Merck in January 2014.
- The suit accuses Dicerna of obtaining its trade secrets by hiring six scientists from Merck who were involved in RNAi work, despite each of them signing a confidentiality agreement. It alleges that Dicerna's subsequent product candidates and delivery technologies are "strikingly similar" to Sirna's/Merck's. It also alleges that certain scientists hired by Dicerna were seen taking material out of the Merck facility prior to their departure.
Jun. 5, 2015, 5:37 PM
May 29, 2015, 12:38 PM
- Prothena (PRTA +11.7%) initiated with Buy rating and $58 (53% upside) price target by UBS.
- Dicerna Pharmaceuticals (DRNA +3%) initiated with Buy rating and $25 (47% upside) price target by Jefferies.
- Incyte (INCY +2.4%) initiated with Buy rating and $126 (14% upside) price target by Bank of America.
- Morgan Stanley resumes coverage of AbbVie (ABBV -0.7%) with an Equal Weight rating and $72 (7% upside) price target.
- Sorrento Therapeutics (SRNE +1.9%) initiated with Buy rating and $17 (21% upside) price target by Brean Capital.
- Aldeyra Therapeutics (ALDX -1.9%) initiated with Buy rating with $13 (86% upside) price target by Janney Capital.
- Diplomat Pharmacy (DPLO +2.1%) initiated with Outperform rating and $43 (10% upside) price target by Raymond James.