With third quarter earnings season winding down, the only major biotech company to report results over the last five trading days was Regeneron REGN. While some small and mid-sized biotechs are yet to report results, focus is back on pipeline and regulatory updates.
Recap of the Week’s Most Important Stories
Ionis Jumps on Study Data: Ionis’ IONS shares soared on positive interim data from a late-stage study on Spinraza, an investigational treatment being evaluated in collaboration with Biogen for spinal muscular atrophy (SMA). Ionis and Biogen said that Spinraza met the primary endpoint in the phase III CHERISH study for later-onset SMA. The results were statistically significant and clinically meaningful with a favorable safety profile and the study will be stopped early.
These are the second set of positive late-stage results to be presented by Biogen and Ionis on Spinraza and support the potential to use Spinraza across a wide range of SMA patients.
Spinraza is currently under FDA and EMA review with Biogen expecting a launch in the U.S. as early as the end of this year or the first quarter of 2017. While Ionis gained 18.4% on the interim results, Biogen’s shares were up 6.7%.
Regeneron Tops Q3 Earnings: Regeneron’s third quarter results were mixed with the company easily surpassing earnings expectations while falling short of revenue estimates. Flagship eye treatment, Eylea, continued to deliver in the U.S. while sales of PCSK9 inhibitor Praluent are yet to pick up. On the pipeline front, Regeneron is pursuing a diabetic retinopathy indication for Eylea while sarilumab (rheumatoid arthritis) got a complete response letter from the FDA due to manufacturing issues at partner Sanofi’s plant (Read more: Regeneron Beats on Q3 Earnings, Misses on Sales). Regeneron is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AbbVie Gets a Boost in Humira IPR Case: AbbVie ABBV got a boost in its efforts to protect Humira from biosimilars with the Patent Trial and Appeal Board (PTAB) denying Coherus Biosciences’ petition requesting an inter partes review (IPR) of the ‘166 patent. AbbVie is looking to delay the entry of Humira biosimilars and is in litigation with Amgen AMGN as well – Amgen gained FDA approval for Amjevita, its biosimilar version of Humira, in Sep 2016.
The Medicines Co. Stops MDCO-216 Development: The Medicines Company MDCO has decided to discontinue the development of its investigational cholesterol efflux promoter, MDCO-216. The company’s decision was based on top-line efficacy data from the MILANO-PILOT trial, which provided insufficient basis for further development of the candidate. With this decision, the company expects to free up substantial additional capital that can be used for the development of its PCSK9 synthesis inhibitor.
Performance
Medical – Biomedical and Genetics Industry Price Index
The NASDAQ Biotechnology Index gained 2.9% over the last five trading days. Among major biotech stocks, Alexion ALXN declined 6.6% while Regeneron was up 7%. Over the last six months, Alexion lost 16.8% while Biogen was up 9.4% (See the last biotech stock roundup here: Amgen Down on Enbrel Sales, Regeneron's Sarilumab Faces Delay).
What's Next in the Biotech World?
With third quarter earnings season drawing to a close, watch out for pipeline and regulatory updates. A response from the FDA regarding the approval status of Gilead’s GILD TAF for hepatitis B virus (HBV) should be out shortly.
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