New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 28, 2014
04:55 EDTALDR, ALDR, ALDR, ALDR, ALDR, ALDR, CNDO, CNDO, CNDO, CNDO, CNDO, CNDO, ISIS, ISIS, ISIS, ISIS, ISIS, ISIS, PTCT, PTCT, PTCT, PTCT, PTCT, PTCT, OPXA, OPXA, OPXA, OPXA, OPXA, OPXA, SRPT, SRPT, SRPT, SRPT, SRPT, SRPT, XNPT, XNPT, XNPT, XNPT, XNPT, XNPT, SNY, SNY, SNY, SNY, SNY, SNY, BIIB, BIIB, BIIB, BIIB, BIIB, BIIB, SYN, SYN, SYN, SYN, SYN, SYN, CYTK, CYTK, CYTK, CYTK, CYTK, CYTKAmerican Academy of Neurology to hold annual meeting
66th Annual Meeting of the AAN is being held in Philadelphia on April 26-May 3.
News For CYTK;SYN;BIIB;SNY;XNPT;SRPT;OPXA;PTCT;ISIS;CNDO;ALDR From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 >>
August 25, 2015
08:01 EDTPTCTPTC Therapeutics initiated with a Buy at Citi
Subscribe for More Information
07:40 EDTSYNSynthetic Biologics initiated with a Buy at BTIG
Target $5.
August 24, 2015
15:44 EDTPTCTOptions with increasing implied volatility
Subscribe for More Information
13:54 EDTSRPTFly Watch: Sarepta upgraded ahead of FDA deadline on DMD drug
The 60-day FDA review period for Sarepta's (SRPT) rolling NDA submission for its Duchenne muscular dystrophy drug eteplirsen ends tomorrow, Tuesday, August 25. Piper Jaffray is among research firms taking a bullish stance on the stock ahead of tomorrow's deadline. BACKGROUND: Eteplirsen is an "exon skipping" treatment that attempts to bypass genetic mutations to allow improved functioning of the affected gene. On August 21, Sarepta announced that the FDA granted a rare pediatric disease designation for eteplirsen, in addition to its previous orphan designation and fast track status. Piper Jaffray's Edward Tenthoff noted today that the drug could see a February 2016 PDUFA date, potentially yielding "blockbuster sales" for the company. Importantly, BioMarin's (BMRN) drisapersen is slightly ahead of eteplirsen's approval process with a December 27 PDUFA date, posing a potential competitive risk for Sarepta. PDUFA dates are FDA deadlines for approving new drugs, normally coming within 6 or 10 months of an NDA acceptance depending on the drug's priority status. ANALYST TAKE: Tenthoff stated in note to investors this morning that he expects the Food and Drug Administration to accept the New Drug Application for Sarepta's eteplirsen at the end of its 60-day review period tomorrow. Additionally, Tenthoff sees a joint advisory committee for eteplirsen and the similar drisapersen from BioMarin on November 23-24. On May 19, Sarepta said it held pre-NDA meetings with the FDA, and Piper Jaffray said it believes the company has now met all of the agency's information requests. The analyst upgraded Sarepta to Overweight from Neutral and hiked his price target to $48 from $28 and now values eteplirsen at $1.3B, up from $919M previously. PRICE ACTION: Shares of Sarepta Therapeutics are up roughly 1% in intraday trading to $34.21. The stock jumped about 60% on May 20 after the company announced its mid-year NDA plans for eteplirsen. BioMarin shares, meanwhile, are down 2% to $123.59 this afternoon.
10:12 EDTPTCTOptions with increasing implied volatility
Subscribe for More Information
09:45 EDTSRPTOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
06:50 EDTSRPTSarepta upgraded to Overweight from Neutral at Piper Jaffray
Subscribe for More Information
August 21, 2015
10:36 EDTPTCT, SRPTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
09:38 EDTBIIBUBS global healthcare analysts hold an analyst/industry conference call
Subscribe for More Information
08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
Subscribe for More Information
August 20, 2015
16:24 EDTBIIBBiogen reports 8.1% passive stake in Applied Genetic
Subscribe for More Information
11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
11:33 EDTSNYLeerink major pharmaceuticals analyst holds an analyst/industry conference call
Subscribe for More Information
August 19, 2015
17:46 EDTBIIBApplied Genetic says Biogen collaboration effective, equity investment closed
Subscribe for More Information
09:17 EDTPTCT, SRPT'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTPTCT, SRPTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
Subscribe for More Information
August 18, 2015
08:21 EDTBIIBBiogen long-term outlook still positive, says RBC Capital
Subscribe for More Information
07:05 EDTBIIBBiogen, ALS Association, Columbia collaborate to drive understanding of ALS
Biogen, the ALS Association and Columbia University Medical Center announced a new collaboration to better understand the differences and commonalities in the ALS disease process and how genes influence the clinical features of the disease. The project, "Genomic Translation for ALS Clinical care", will involve a combination of next generation genetic sequencing and detailed clinical phenotyping in 1500 people with ALS. The goal of the project is to provide a basis for the development of precision medicine, or more individually tailored therapies for ALS. "We want to bring genomics right to the point of care in ALS where instead of focusing on retrospective DNA samples with limited clinical information, we focus on patients who are under active clinical management," said ALS Association Chief Scientist Lucie Bruijn, Ph.D., M.B.A. "By focusing on patients seen by participating ALS clinics, this project will allow investigators to ask how different genetic causes of ALS translate into different clinical consequences."
August 17, 2015
07:03 EDTBIIBBiogen: Clinical data supports long-term safety, efficacy of Alprolix
New clinical data support the long-term safety and efficacy of ALPROLIX in people with severe hemophilia B treated for up to two years, Biogen announced. Participants in the Phase 3, open-label extension study, B-YOND, maintained low bleeding rates with one to two week prophylaxis regimens, according to data from an interim analysis. Investigators presented these interim results for the first time at the 67th Annual Meeting for the National Hemophilia Foundation in Dallas. B-YOND is a multi-year study for people with severe hemophilia B who completed the Phase 3 pivotal B-LONG or Kids B-LONG studies. In this interim analysis, the median time on ALPROLIX during B-YOND was 27.6 months for adults and adolescents, and 47.7 weeks for children under age 12. The study's primary endpoint is inhibitor development, and no inhibitors have been reported to-date. There were three prophylactic dosing options for adult, adolescent, and pediatric participants in the B-YOND trial - weekly, individualized, and modified prophylaxis. An episodic treatment arm was also available for adult and adolescent patients.
06:22 EDTSRPTPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).
1 | 2 >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use