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Stock Market & Financial Investment News

News Breaks
January 31, 2014
11:36 EDTCWH, JNJ, MYGN, BMRNOptions with increasing implied volatility: BMRN CWH MYGN JNJ
News For BMRN;CWH;MYGN;JNJ From The Last 14 Days
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July 2, 2015
13:59 EDTBMRNNHS to wait on NICE to make call on PTC Therapeutics, BioMarin drugs
NHS England has set out its planned investment decisions for certain specialized services as part of its annual commissioning round. NHS England has agreed with the recommendations from CPAG that final funding decisions on the following two treatments should be made after NICE has concluded its Highly Specialized Technology Appraisal process: BioMarin Pharmaceutical's (BMRN) Vimizim for Morquio A Syndrome and PTC Therapeutics' (PTCT) Translarna for Duchenne muscular dystrophy. The decisions on those two drugs came among 39 proposed new investments that the group said were "carefully considered against the principles NHS England follows when making investment decisions." Reference Link
July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 29, 2015
12:53 EDTBMRNSarepta NDA submission for eteplirsen done ahead of schedule, says Piper Jaffray
Piper Jaffray noted that Sarepta (SRPT) completed its rolling NDA submission for eteplirsen ahead of schedule and the firm believes that concurrent advisory committee meetings for its DMD drug and BioMarin's (BMRN) drisapersen could take place this fall. The firm has a Neutral rating and $20 price target on Sarepta and Overweight rating and $147 target on BioMarin.
08:36 EDTBMRNBioMarin announces FDA acceptance of drisapersen NDA
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June 25, 2015
16:03 EDTBMRNBioMarin announces EMA validates MAA for drisapersen for treatment of DMD
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June 23, 2015
07:49 EDTBMRNPTC Therapeutics risk lowered by symposium, says Oppenheimer
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07:25 EDTBMRNPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 19, 2015
10:28 EDTBMRNBioMarin slips after Baird breaks from pack with downgrade
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10:00 EDTBMRNOn The Fly: Analyst Downgrade Summary
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06:33 EDTBMRNBioMarin downgraded to Neutral from Outperform at Baird
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