It’s been a turbulent few days for the biotech sector with the NASDAQ Biotechnology Index declining 5.46% over the last five trading days. A major part of this decline was recorded on Monday as the sector reacted to negative pipeline updates from companies like Amgen (AMGN – Analyst Report) and Celladon (CLDN – Snapshot Report). Meanwhile, Biogen’s (BIIB – Analyst Report) results were also a disappointment.
Recap of the Week’s Most Important Stories
1. Ahead of an FDA advisory panel meeting, the regulatory agency released briefing documents regarding Amgen’s experimental skin cancer treatment, talimogene laherparepvec. Some of the questions raised by the agency include the imbalance in drop-outs which could have created bias in favor of the talimogene laherparepvec arm, limited and difficult to quantify data supporting talimogene laherparepvec’s systemic effect as well as the lack of robust survival results.
The briefing documents also state that an accelerated approval pathway for talimogene laherparepvec is not feasible currently. Amgen’s shares were down 3.3% on the concerns raised in the briefing documents. The FDA’s advisory panels will be meeting today to discuss the talimogene laherparepvec regulatory filing.
2. Celladon saw its shares plunging 80.7% on disappointing data from a mid-stage study on its cardiovascular gene therapy agent Mydicar. The phase IIb CUPID2 study for advanced heart failure failed to meet its primary as well as secondary endpoints (Read more: Celladon’s Advanced Heart Failure Study Fails, Shares Crash).
3. Celgene (CELG – Analyst Report) announced that it will be acquiring privately held biotech company Quanticel Pharmaceuticals, Inc., in a deal worth up to $485 million (includes an upfront payment of $100 million and additional payments of $385 million on the achievement of research, development, and regulatory advances). This acquisition will give Celgene access to Quanticel’s proprietary platform for the single-cell genomic analysis of human cancer, as well as Quanticel’s lead cancer programs (Read more: Celgene to Buy Quanticel, Boost Pipeline Development).
4. Gilead (GILD – Analyst Report) presented data on Sovaldi-based regimens in chronic hepatitis C virus (HCV)-infected patients with certain genotypes at the annual meeting of the European Association for the Study of the Liver (The International Liver Congress 2015). The company also presented results on its other HCV treatment – Harvoni. Gilead reported high cure rates across a range of genotypes (Read more: Gilead and Bristol-Myers Reveal Positive Data on HCV Drugs).
5. Apart from updates on the development and regulatory front, the biotech sector saw quite a few big names like AbbVie (ABBV – Analyst Report), Biogen and Alexion reporting first quarter 2015 results over the last five trading days. While AbbVie surpassed expectations on the back of strong Humira sales (Read more: AbbVie Beats Earnings on Humira and HCV Sales, Ups View), both Alexion (Read more: Alexion Misses Q1 Earnings Estimates, Keeps 2015 Outlook) and Biogen (Read more: Biogen Misses on 1Q Earnings, Tecfidera Falls Short) fell short of earnings expectations.
Last 6 Months
Over the last five trading days, Regeneron was the only company among major biotechs to record a gain (up 0.67%). Biogen saw its shares declining 11.24% during this period reflecting concerns regarding oral multiple sclerosis treatment, Tecfidera’s growth prospects. Biogen, however, was the highest gainer (17.81%) over the last six months. Alexion lost 10.99% during this period. See the last biotech stock roundup here (Amgen Starts Earnings Season on Strong Note, Setbacks for Ampio & Athersys).
What’s Next in the Biotech World?
The FDA’s advisory panels will be meeting today to discuss the regulatory filing for Amgen’s talimogene laherparepvec. Meanwhile, companies like Vertex, (VRTX – Analyst Report) Gilead and Celgene will be reporting first quarter results later this week.
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