2016 has not been a great year for biotech stocks which were under intense pressure with issues like increasing political and media focus on high price tags for drugs and the changing competitive scenario weighing on the sector.
While there has always been dissatisfaction about the high prices of drugs, the issue picked pace last year in September when Hillary Clinton tweeted about “price gouging”. Clinton’s tweet was in response to news regarding a huge price hike (about 5,000%) taken by Turing Pharmaceuticals for a drug (Daraprim) that was approved by the FDA way back in 1953.
Needless to say, this caused a major furor considering growing concerns regarding the pricing and affordability of prescription drugs. Since then, drug stocks, especially biotechs, have found themselves under the scanner for price hikes and the high costs of important treatments.
Although the sector did react favorably to the surprise win of Donald Trump in the Presidential election in Nov 2016, investors were in for a rude shock with the President-elect recently saying that he does not like price increases. The NASDAQ Biotechnology index is down 19.1% year-to-date (YTD).
Medical - Biomedical and Genetics Industry 5YR % Return
However, despite the immense pressure on the sector, there were some biotech stocks that bucked the trend and more than doubled in 2016. Here is a look at 4 such stocks.
CoLucid Pharmaceuticals, Inc. CLCD: Cambridge, MA-based CoLucid is working on the development a molecule for the acute treatment of migraine. The company’s pipeline candidates utilize a new mechanism of action that could address the unmet needs of migraine patients, including those with cardiovascular risk factors or stable cardiovascular disease and those who are dissatisfied with existing therapies.
CoLucid’s shares shot up in Sep 2016 with the company presenting positive data from a late-stage study on its lead pipeline candidate, lasmiditan. CoLucid’s shares are up 331.9% YTD.
Exelixis, Inc. EXEL: South San Francisco, CA-based Exelixis is focused on developing and commercializing small molecule therapies with the potential to improve the treatment of cancer. The company has had a phenomenal run in 2016 outperforming the Zacks categorized Medical/Biomedical Genetics industry by a huge margin. Exelixis’ shares are up 189.3% YTD compared to the industry decline of 25.4%.
Exelixis’ portfolio includes two products derived from cabozantinib -- Cabometyx tablets (treatment of advanced kidney cancer) and Cometriq capsules (treatment of certain forms of thyroid cancer). Another product, Cotellic, derived from cobimetinib, is marketed under a collaboration with Roche (for use in combination with Zelboraf to treat advanced melanoma).
Recently approved Cabometyx had a strong full quarter driven by METEOR data and commercial execution. The product already has a 19% share in the second line metastatic kidney cancer market and 35% of the third-line segment. A major catalyst for Exelixis would be approval for the first-line indication -- the company has already presented pretty impressive results in October for the first-line patient population and is looking to seek approval for this indication. The first-line patient population represents huge commercial potential.
Exelixis is evaluating Cabometyx in several studies for different types of cancer and has other candidates in its pipeline including CS-3150 (partnered with Daiichi Sankyo). The company has made significant progress towards its goal of becoming a profitable, fully integrated, commercial company. (Looking for the Best Stocks for 2017? Be among the first to see our Top Ten Stocks for 2017 portfolio here.)
TESARO, Inc. : Waltham, MA-based TESARO is another cancer-focused company that saw its shares soaring in 2016 on impressive data. TESARO’s shares shot up in Jun 2016 when the company presented impressive data on its PARP inhibitor, niraparib. YTD, TESARO’s shares are up a whopping 161.5%. The company is currently seeking FDA approval for niraparib for a certain type of ovarian cancer -- the agency has granted the drug priority review with a response expected by Jun 30, 2017. Importantly, the FDA does not expect to hold an advisory committee meeting for the candidate. PARP inhibitors are currently being considered to be the next major class of therapeutics in oncology and represent immense commercial potential.
Achaogen, Inc. AKAO: South San Francisco, CA-based Achaogen is another company that had a phenomenal run this year mainly due to positive data on its lead pipeline candidate. Shares are up 116.7% YTD with the stock receiving a major boost earlier this month when the company reported positive late-stage data on plazomicin. The candidate achieved the primary endpoint of non-inferiority (for the FDA) and superiority (for the European Medicines Agency - EMA) compared to meropenem in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Results from another phase III study showed a lower rate of mortality or serious disease-related complications for plazomicin compared with colistin therapy in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE). Achaogen intends to seek FDA approval for the treatment in the second half of 2017 and EMA approval in 2018.
While Exelixis, TESARO and Achaogen are all Zacks Rank #3 (Hold) stocks, CoLucid is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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