BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

BioMarin's hemophilia gene therapy gets Priority Review  BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) could become the first company to have a hemophilia gene therapy approved in the U.S. FDA accepted and granted Priority Review to a BLA...
BC Extra | Oct 29, 2019
Company News

Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

Galapagos, MorphoSys, Novartis discontinue atopic dermatitis program  With an interim analysis indicating futility of the Phase II IGUANA trial, MorphoSys AG (Xetra:MOR; NASDAQ:MOR), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) and Novartis AG (NYSE:NVS; SIX:NOVN) terminated development of...
BC Extra | Oct 4, 2019
Financial News

Oct. 4 Financial Quick Takes: Innovent raises $300M in Hong Kong's first biotech follow-on; plus Oyster Point, Heron, Molecular Assemblies and Geneoscopy

Innovent brings in first follow-on of HKEX's biotech chapter  A year after going public on the Hong Kong stock exchange, Innovent Biologics Inc. (HKEX:1801) raised HK$2.4 billion ($299.8 million) through the sale of 97 million...
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 1, 2019
Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
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...
BC Week In Review | Jan 4, 2019
Clinical News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
BC Extra | Dec 31, 2018
Company News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
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

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...
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