Amgen’s Humira Competitor Gets Preliminary FDA Approval
An FDA panel ruled late Tuesday that Amgen’s cheaper alternative to AbbVie’s blockbuster arthritis drug Humira can move forward to the next step of potential FDA approval.
According to estimates, Humira brought in some $15 billion in revenue in 2015. Amgen’s biosimilar to that drug, called ABP 501, could now be in line to eat a significant portion of that total. The drug could come to market by March 2017, assuming the FDA makes a final approval.
Amgen, Inc. (AMGN) shares posted modest gains in premarket trading Wednesday, while AbbVie Inc (ABBV) shares plunged around 1%.
Teva Raises Guidance Amid Allergan Takeover
Global pharma giant Teva Pharmaceutical late Tuesday raised its quarterly earnings guidance, as its planned acquisition of Allergan’s generics unit appears to be progressing nicely.
Israel-based TEVA now expects Q2 earnings of $1.19 to $1.22 per share, up from $1.16 to $1.20 previously. It also boosted revenue guidance to a range of $4.9 billion to $5 billion compared with a prior range of $4.7 billion to $4.9 billion. Teva also noted it would provide full-year guidance through 2019 on Wednesday.
Teva Pharmaceutical Industries Ltd (TEVA) shares jumped more than 3% in premarket trading Wednesday.
Angiodynamics Profit and Revenue Beat Estimates
Medical diagnostics maker Angiodynamics on Wednesday posted better-than-expected quarterly earnings results. Fiscal Q4 profit was $0.19 per share, easily beating analyst estimates of $0.16. Revenue of $93.40 million also beat expectations of $88.41 million.
AngioDynamics, Inc. (ANGO) shares rose 3.5% in premarket trading Wednesday.
Big Bounce for Biotech ETFs — More Gains in Store?
After hitting a new 52-week low of $240.03 in late June, the iShares NASDAQ Biotechnology Index (IBB) has since bounced by over $32, or +13%. Comparatively, the SPDR S&P 500 ETF Trust (SPY) has gained about 7% in the same period.
Are Biotechs poised to continue to outperform the wider markets, or is this just another dead-cat bounce for a beleaguered sector? You can bet investors and money managers will continue to monitor the newsflow in coming weeks and months to find out.