Several major biotech companies like Biogen (BIIB – Analyst Report), AbbVie (ABBV – Analyst Report), Celgene and Gilead reported second quarter results over the last five trading days. Biogen has been grabbing headlines for the wrong reasons – although the company’s earnings were better-than-expected, revenues missed expectations.
With the company saying that it is cutting its outlook based on revised expectations for its oral multiple sclerosis (MS) treatment, shares were down significantly. Another major bit of news last week was the approval of the first PCSK9 inhibitor in the U.S.
Recap of the Week’s Most Important Stories
1. Companies like Biogen, AbbVie, Celgene and Gilead reported second quarter results over the last week. Although Biogen and AbbVie’s earnings surpassed expectations, both companies missed revenue estimates. Biogen’s shares were down significantly with the company cutting its 2015 outlook based on revised expectations for its oral MS treatment, Tecfidera (Read more: Biogen Tops Q2 Earnings, Cuts View on Tecfidera Issues).
Meanwhile, sales of AbbVie’s Humira fell short of expectations (Read more: AbbVie Tops Earnings, Misses on Revenues, Maintains View). The company attributed Humira’s weak international sales to the timing of shipments and negative currency movement and said that Remicade biosimilars did not impact ex-U.S. Humira sales. Celgene’s second quarter results were in-line with expectations (Read more: Celgene Q2 Earnings & Revenues In Line, Keeps View). Gilead’s earnings and revenues were both above expectations.
2. Regeneron (REGN – Analyst Report) and partner Sanofi are the first to gain approval for a PCSK9 inhibitor in the U.S. The FDA approved their cholesterol treatment, Praluent, late last week. As far as EU approval is concerned, the CHMP has voted in favor of approving the treatment. However, Amgen’s (AMGN – Analyst Report) PCSK9 inhibitor, Repatha, has already been approved in the EU.
Meanwhile, Regeneron and Sanofi are the latest to join the immuno-oncology brigade with the companies entering into a new agreement. The agreement will see Sanofi making a $640 million upfront payment to Regeneron and a major part of the initial expenses will be funded by Sanofi.
3. Amgen gained FDA approval for a label expansion of its cancer treatment, Kyprolis. With this approval, Kyprolis can now be used in combination with Revlimid and dexamethasone (KRd) in multiple myeloma patients who have received one to three prior lines of therapy.
Data from the ASPIRE study had shown that patients treated in the KRd arm lived 50% longer (8.7 months) without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone (Rd) alone. Median progression-free survival (PFS) was 26.3 months versus 17.6 months
4. XOMA (XOMA – Snapshot Report) suffered a major setback with the company’s lead pipeline candidate, gevokizumab, failing in a phase III study in patients with Behçet’s disease uveitis. Shares plunged 77.3% on the news (Read more: XOMA Crashes after Gevokizumab Misses Primary Endpoint).
5. Sunesis’ shares plunged more than 70% with the company announcing that the FDA has advised it to not go ahead with a regulatory filing for its experimental leukemia treatment, vosaroxin, without providing additional clinical evidence. Based on feedback from the EU, Sunesis is currently going to focus on submitting a regulatory application in the EU.
Over the last five trading days, Biogen recorded a decline of 21.87% while Amgen was the highest gainer (5.52%) among the major biotechs. Biogen lost 8.90% over the last six months with Regeneron being the highest gainer (35.4%) during this period.
Last 6 Months
The NASDAQ Biotechnology Index declined 3.25% over the last five trading days (See the last biotech stock roundup here: Amgen PCSK9 Inhibitor First to Gain Approval, Exelixis Up on Positive Data).
What’s Next in the Biotech World?
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