BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | May 6, 2019
Company News

May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx

FDA accepts Esperion NDAs for LDL-C-lowering indications  Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe...
BC Week In Review | Mar 8, 2019
Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
BC Extra | Mar 1, 2019
Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BioCentury | Oct 6, 2018
Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
BioCentury | Jun 30, 2018
Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
BC Week In Review | May 25, 2018
Clinical News

FDA approves BioMarin's phenylketonuria drug

FDA approved Palynziq pegvaliase-pqpz from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat phenylketonuria (PKU) in patients who have uncontrolled blood phenylalanine levels on current treatment. The company expects to launch the drug by the end of...
BC Extra | May 24, 2018
Company News

FDA approves BioMarin's phenylketonuria drug

FDA approved Palynziq pegvaliase-pqpz from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat phenylketonuria (PKU) in patients who have uncontrolled blood phenylalanine levels on current treatment. The company expects to launch the drug by the end of...
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