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  • TOP STORY: Intercept rises on new acquisition rumors

    Hepatology company Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $25.93 (28%) to $120.22 on Friday after media reports again said the company was exploring a sale. The company declined to comment on the rumors.On …

    Published on 2/12/2016
  • TOP STORY: McConnell schedules vote on Califf confirmation

    U.S. Senate Majority Leader Mitch McConnell (R-Ky.) has set in motion a procedure that could lead to a vote to confirm Robert Califf as FDA commissioner. On Thursday, McConnell scheduled a vote for Feb. 22 on a cloture …

    Published on 2/11/2016
  • TOP STORY: AbbVie plans NDA for endometriosis therapy

    AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the co-primary endpoints in the Phase III M12-671 trial to treat moderate-to-severe endometriosis-associated pain. The trial was the second of two identically designed…

    Published on 2/10/2016
  • TOP STORY: FDA panel backs first biosimilar mAb

    FDA's Arthritis Advisory Committee voted 21-3 to support approval of CT-P13 from Celltrion Inc. (KOSDAQ:068270), a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ), to treat seven of the eight …

    Published on 2/9/2016
  • TOP STORY: FDA moves eteplirsen PDUFA date

    FDA extended to May 26 from Feb. 26 the PDUFA date for eteplirsen (AVI-4658) from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. Sarepta fell $1.48 (12%)…

    Published on 2/8/2016
  • TOP STORY: FDA review: Remicade biosimilar extrapolation "reasonable"

    On Friday, FDA posted briefing documents ahead of the Feb. 9 meeting of its Arthritis Advisory Committee to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for its CT-P13, a biosimilar of Remicade infliximab from …

    Published on 2/5/2016
  • TOP STORY: FDA trying to ease Califf's pain

    On Thursday, FDA released new policies on opioids in an unsuccessful effort to wipe away opposition in the U.S. Senate to Robert Califf's confirmation as FDA commissioner. Califf, who is deputy commissioner for medical …

    Published on 2/4/2016
  • TOP STORY: BeiGene, Editas rise after IPOs

    Cancer play BeiGene Ltd. (NASDAQ:BGNE) and gene editing company Editas Medicine Inc. (NASDAQ:EDIT) each posted double-digit gains in their first day of trading on Wednesday after pricing IPOs late Tuesday.BeiGene gained…

    Published on 2/3/2016
  • TOP STORY: Editas prices IPO

    Gene editing company Editas Medicine Inc. (NASDAQ:EDIT) raised $94.4 million in an IPO through the sale of 5.9 million shares at $16, the low end of its previously proposed range. Underwriters were Morgan Stanley, …

    Published on 2/2/2016
  • TOP STORY: U.K. authority allows gene editing in human embryos

    The Francis Crick Institute said the U.K.'s Human Fertilisation & Embryology Authority (HFEA) approved an application to use gene editing techniques in human embryos. Crick said research could begin in "the next few …

    Published on 2/1/2016
  • TOP STORY: Modest rally ends rough week for biotechs

    Biotech stocks ended a difficult earnings week with a modest rally Friday. The BioCentury 100 index gained 75.39 (1.6%) to 4,814.53, with gainers outnumbering decliners 77-22. For the week, the index was off 338.96, or …

    Published on 1/29/2016
  • TOP STORY: Amgen raises 2016 guidance

    Amgen Inc. (NASDAQ:AMGN) reported 4Q15 earnings Thursday and raised its 2016 revenue and adjusted EPS guidance. The company now expects $22-$22.5 billion in revenue this year, up from $21.7-$22.3 billion, and expects …

    Published on 1/28/2016
  • TOP STORY: Biogen bounces on 4Q beat

    Biogen Inc. (NASDAQ:BIIB) gained $13.39 to $273.26 on Wednesday after reporting 4Q15 and full year financial results that beat estimates, including increased quarterly sales of multiple sclerosis drug Tecfidera dimethyl…

    Published on 1/27/2016
  • TOP STORY: J&J rises after issuing 2016 guidance

    Johnson & Johnson (NYSE:JNJ) gained $4.78 to $101.18 on Tuesday after reporting earnings and issuing 2016 guidance. The company expects adjusted EPS this year of $6.43-$6.58, exceeding a consensus estimate of $6.38.On a…

    Published on 1/26/2016
  • TOP STORY: OncoMed sinks after tarextumab futility analysis

    OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) lost $7.53 (43%) to $10.04 on Monday, shedding $226.7 million in market cap after it said an independent DSMB said tarextumab (OMP-59R5) was unlikely to meet the primary …

    Published on 1/25/2016
  • TOP STORY: Japan approves Repatha

    Amgen Inc. (NASDAQ:AMGN) said the Japanese Ministry of Health, Labour and Welfare (MHLW) approved lipid-lowering drug Repatha evolocumab, making it the first anti-PCSK9 mAb approved in the country.The drug received …

    Published on 1/22/2016
  • TOP STORY: Alkermes sinks on Phase III depression data

    Alkermes plc (NASDAQ:ALKS) fell $26.73 (44%) to $33.69 on Thursday, losing more than $4 billion in market cap, after its ALKS 5461 missed the primary endpoint of change from baseline in Montgomery-Asberg Depression …

    Published on 1/21/2016
  • TOP STORY: Zafgen jumps on beloranib Prader-Willi data

    Zafgen Inc. (NASDAQ:ZFGN) jumped $4.42 (79%) to $10.04 on Wednesday after it said subcutaneous beloranib (ZGN-440) met the co-primary endpoints of significantly reducing both body weight and hyperphagia-related …

    Published on 1/20/2016
  • TOP STORY: Acorda adds to PD portfolio with Biotie takeout

    Acorda Therapeutics Inc. (NASDAQ:ACOR) will acquire Biotie Therapies Corp. (HSE:BTH1V; NASDAQ:BITI) for about $363 million in cash. The deal gives Acorda two clinical stage programs for Parkinson's disease, including …

    Published on 1/19/2016
  • TOP STORY: Sarepta plummets on FDA briefing documents

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) fell $17.35 (55%) to $14.28 on Friday after FDA released briefing documents that raised questions about the data package for the company's eteplirsen (AVI-4658) to treat Duchenne …

    Published on 1/15/2016
  • TOP STORY: FDA rejects BioMarin's Kyndrisa

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA issued a complete response letter for an NDA for Kyndrisa drisapersen to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. According to the company…

    Published on 1/14/2016
  • TOP STORY: Biotech falls to 18-month low

    Biotech stocks were hammered on Wednesday, resuming a selloff that has depressed indices in the early days of 2016. The BioCentury 100 index dipped 298.68 (6%) to 5,121.17 on Wednesday, with decliners outnumbering …

    Published on 1/13/2016
  • TOP STORY: Senate committee endorses Califf

    The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee voted Tuesday to approve Robert Califf as FDA commissioner. Chairman Lamar Alexander (R-Tenn.) ordered a voice vote and there were no dissenters. …

    Published on 1/12/2016
  • TOP STORY: Shire, Baxalta to merge

    Shire plc (LSE:SHP; NASDAQ:SHPG) and Baxalta Inc. (NYSE:BXLT) said they would combine in a cash and stock deal in which Baxalta shareholders will receive $18 cash and 0.1482 Shire ADSs per Baxalta share. The companies …

    Published on 1/11/2016
  • TOP STORY: Thermo Fisher acquiring Affymetrix

    Life sciences supplier Thermo Fisher Scientific Inc. (NYSE:TMO) said after market close Friday it will acquire tools company Affymetrix Inc. (NASDAQ:AFFX) for $14 per share, or about $1.3 billion in cash. The price …

    Published on 1/8/2016

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