Biotech Stock Roundup: Regeneron's Eylea Stumbles, Geron Up on …
Last week, earnings remained in focus with several companies reporting their third quarter results. While AbbVie’s (ABBV – Analyst Report) results remained strong with the company raising its outlook, companies like Regeneron (REGN – Analyst Report) and Aegerion (AEGR – Analyst Report) narrowed their sales outlooks for their key products.
Among all this, Geron (GERN – Analyst Report) made it to the headlines with the FDA lifting its full clinical hold in connection with the company’s pipeline candidate, imetelstat.
Recap of the Week’s Most Important Stories
1. AbbVie’s third quarter results were strong despite the genericization of the company’s lipid franchise. Humira remained the growth driver with its performance being driven by several factors like continued market growth resulting from increasing penetration across therapeutic categories and geographies, broader label and approval for new indications. AbbVie has an important regulatory event coming up – a decision regarding the approval status of its hepatitis C virus (HCV) combination treatment should be out shortly (Read more: AbbVie Q3 Earnings Top on Humira Sales, Boosts Outlook).
2. Regeneron saw its shares losing 5.8% shortly after the release of third quarter results. Investors were disappointed to see the company lower the top end of its U.S. revenue guidance for eye drug, Eylea. Regeneron is currently working on strengthening the Eylea franchise and is evaluating the blockbuster drug in combination with other antibodies. Meanwhile, late-stage pipeline candidates (alirocumab – PCSK9 inhibitor – regulatory filing expected by year end, sarilumab – rheumatoid arthritis – phase III with regulatory filing expected by year end 2015 and dupilumab – atopic dermatitis – phase III) are garnering a lot of interest among investors (Read more: Regeneron Q3 Earnings Up Y/Y, Narrows Eylea Guidance).
3. Another company that disappointed with a lowered sales outlook is Aegerion. Aegerion cut its 2014 outlook for its cholesterol drug, Juxtapid, reflecting higher patient dropout rates and lower-than-expected U.S. prescription growth rates. Aegerion’s 2015 revenue outlook also lagged growth expectations significantly. Moreover, the market scenario will change significantly next year if PCSK9 inhibitors like Amgen’s (AMGN – Analyst Report) evolocumab and Sanofi (SNY – Analyst Report)/Regeneron’s alirocumab gain approval and enter the market next year (Read more: Aegerion Q3 Loss Wider than Expected, 2014 View Lowered).
4. Geron’s sole pipeline candidate, imetelstat, is back on track with the FDA lifting the full clinical hold on an investigational new drug (IND) application filed by the company. Shares shot up 25.6% on the positive development. Geron can now go ahead with its plans to initiate a multi-center phase II study in myelofibrosis in the first half of 2015 (Read more: Geron Q3 Loss Wider, Shares Up on Removal of Clinical Hold).
5. Amgen’s experimental ovarian cancer treatment, trebananib, failed to meet the secondary endpoint of overall survival in a late-stage study. Although trebananib had achieved the primary endpoint of the study, overall survival is an important criterion for gaining FDA approval. Moreover, the rate of discontinuation due to adverse events was much higher in the trebananib arm compared to the control arm (20% versus 7%). Trebananib is currently in a couple more phase III studies – while results from one of these studies should be out later this quarter, the other study data should be available next year.
Performance
Last week, Amgen was the biggest gainer among the major biotechs with share price increasing 2.05%. Meanwhile, Regeneron lost the most last week (down 6.41%) reflecting concerns regarding the growth prospects of its eye drug, Eylea.
Vertex (VRTX – Analyst Report) recorded the highest gain (66.79%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was down 0.19% over the last five trading days (See the last biotech stock roundup here: Beat & Raise Quarter for Amgen, Celgene, Alexion, Biogen).
Company
Last Week
Last 6 Months
AMGN
2.05%
43.20%
BIIB
1.27%
11.03%
GILD
-3.29%
37.44%
CELG
0.05%
45.56%
REGN
-6.41%
24.55%
ALXN
-0.47%
19.79%
VRTX
0.03%
66.79%
What’s Next in the Biotech World?
Several small and mid-sized biotech companies will be reporting third quarter results in the next few days.
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Biotech Stock Roundup: Regeneron's Eylea Stumbles, Geron Up on …
