Last week, bright pink lights lit up the White House — and other monuments across the country — to mark the start of Breast Cancer Awareness Month. Over the last few months, survivors and supporters of those with childhood cancer rallied for the same level of national attention. And early in September, over 700 cancer patients and survivors lobbied U.S. legislators for increased funding. One key point in their efforts: Several of the drugs used to treat deadly forms of cancer are many decades old.
For investors, these sociopolitical movements translate into the rise and fall of biotech stocks. Companies emerge, ready to tackle the problems of old drugs. In doing so, they capture massive attention and sometimes shoot high. And cancer drugs aren’t the only ones capturing this great demand. Plenty of current biotech companies have risen to address a host of rare diseases in hopes of launching a new — or potentially even the first — treatment on the market.
But as much as the world is personally betting on a cure for cancer, the unfortunate reality is that not all promising biotech solutions pan out. This means these stocks are particularly volatile — and hinge heavily on approval from the U.S. Food and Drug Administration. So what does this mean? While it’s a high risk, high reward space, following headlines of FDA approvals and positive trial results can really pay off.
These ten biotech companies are all currently stocks to buy, thanks to their robust drug pipelines and encouraging FDA news.
Biotech Stocks to Buy: Seattle Genetics (SGEN)
Seattle Genetics (NASDAQ:SGEN) has been a long-time darling in the biotech space. It is the industry leader in antibody-drug conjugates (ADC), which unlike other cancer treatments, aim to spare non-targeted cells. In traditional chemotherapy, cancer drugs are known for having more damaging effects because they kill healthy cells in addition to ones mutated by cancer.
The company started 2019 with a bang, thanks to great news regarding Adcetris, its most famous drug. Already available in 65 countries, Adcetris treats Hodgkin Lymphoma, which is a form of cancer targeting the body’s immune system. Results from a Phase 3 clinical trial show that when combined with other chemo drugs, Adcetris improved rates of patient survival, reducing the risk of death by as much as 34%.
Plus, SGEN has other promising drugs in its pipeline. The stock is up 52% year-to-date, and rising higher after recent news. In a partnership with Astellas Pharma (OTCMKTS:ALPMY), Seattle Genetics received priority review status from the FDA for enfortumab vedotin. SGEN and Astellas are investigating enfortumab vedotin as a treatment for urothelial cancer. What does this mean? The FDA extends Breakthrough Therapy designation to drugs that are intended to treat serious conditions and are likely to be much more effective over other existing treatments.
And when a company receives Breakthrough Therapy designation, its stock usually pops.
Just the other day, Seattle Genetics announced that when patients received enfortumab vedotin in combination with Merck’s (NYSE:MRK) Keytruda, the objective response rate was 71%. Investors can anticipate a final ruling from the FDA in March 2020 — so make sure to keep SGEN stock on your radar.
Celgene (NASDAQ:CELG) is another biotech legend, and it’s up 57% year-to-date. While SGEN has Adcetris, Celgene has Revlimid, which is approved for the treatment of multiple myeloma (a cancer in plasma cells) and forms of anemia. Although Revlimid hasn’t been the cash generator CELG needed in 2019, the company is still on a roll.
News that Bristol-Myers Squibb (NYSE:BMY) would acquire Celgene dominated headlines at the start of the year, but the future of that acquisition remains unclear. BMY is in talks with the U.S. Federal Trade Commission to negotiate the planned $74 billion deal — to be the largest in the pharmaceutical industry. But Celgene isn’t stuck in a rut waiting.
In August, the FDA approved Inrebic — making it the first new drug in over a decade to treat myelofibrosis. Myelofibrosis is a rare form of cancer in the bone marrow.
“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” Mays Cancer Center Director Ruben Mesa, M.D. said in a press statement. “There has not been a new treatment approved for this disease in nearly a decade. With INREBIC, physicians and patients now have another option available for myelofibrosis.”
There are still more reasons to put Celgene on your “buy” list. In mid-September, the company announced promising results from its investigational drug CC-486. Intended to treat acute myeloid leukemia, the drug was found to have a statistically significant impact on survival rates during a Phase 3 study. CELG will submit regulatory paperwork for the drug’s approval in early 2020.
In just under 30 years, Incyte (NASDAQ:INCY) has developed a robust pipeline of cancer-fighting drugs. And with news of new drugs on the market, INCY stock is up over 20% year-to-date.
In May, the FDA approved Jakafi for the treatment of graft-versus-host disease (GVHD), which can occur any time after a transplant. Incyte’s Jakafi is the only FDA-approved drug for the rare disease. Prior to that news, Jakafi was FDA-approved to treat forms of blood cancer, including polycythemia vera and myelofibrosis.
Thanks to this success, InvestorPlace’s James Brumley included INCY stock as one of the best stocks to buy for August and September. And analysts from Oppenheimer and Nomura recently reiterated “buy” calls for Incyte stock, with price targets of $100 and $110, respectively. That’s as much as 27% upside from its current price.
“But, with double-digit sales growth expected this year and next thanks to strong interest in its relatively young cancer drug Jakafi, the odds of a breakout are a little too good to ignore,” Brumley wrote.
I have to agree with Brumley. Make sure to keep INCY stock on your radar.
One of the most exciting things about Novartis (NYSE:NVS) is the fact that NVS markets a wide range of products — as many as 100 drugs in the U.S. Its drugs treat conditions from chronic migraines to psoriasis to ADHD. Oh, and it has a handful of cancer-fighting names in there, too.
Like Seattle Genetics, Novartis recently was granted FDA Breakthrough Therapy designation for capmatinib, a drug designed to treat non-small cell lung cancer (NSCLC). NSCLC refers to a specific subset of rare lung cancers that are considered to be very aggressive. There is currently no approved treatment for these conditions on the market.
There are two things to note here. To start, Incyte has actually been licensing capmatinib to Novartis since 2009. While Novartis definitely stands to gain, INCY could also see as much as $500 million in future royalties. NVS plans to file regulatory paperwork sometime this quarter, so NVS stock is a great name to watch. This process is often associated with stock price rallies — and NVS is already up 12% year-to-date against broader industry declines.
However, the second thing to note is that competition is fierce. Many biotech companies are trying to be the first to release a treatment for NSCLC. Merck’s Keytruda (referenced above) is also a competitor in the space.
So while the future with capmatinib is uncertain, there is still a lot to like about Novartis. The company recently announced a partnership with Microsoft (NASDAQ:MSFT). The two plan to use artificial intelligence to streamline Novartis’ business practices and to tailor personalized treatments for patients. It’s no secret that artificial intelligence is hot in the investing world right now, so this could be a big boost to the NVS stock price.
Although it doesn’t have the largest year-to-date gains on this list of biotech stocks to buy, MRK stock is still up 10% since the beginning of the year. Merck leads its peers in bringing the most FDA-approved new drugs to the market, whether through internal development or external licensing agreements.
The week of Sept. 20 brought Novartis positive FDA news on two fronts. Merck’s Keytruda is sometimes referred to as a “miracle cancer drug.” It is already approved for a lengthy list of cancers, and MRK is awaiting approval to expand its reach. Most recently, the FDA granted accelerated approval for the use of Keytruda in combination with Lenvima (another of Merck’s medicines) to treat advanced endometrial cancer. There are currently very few other treatment options for women with advanced-stage endometrial cancers on the market.
Late September’s second positive announcement came in for one of Merck’s investigational vaccines, V920. The FDA accepted the biologics license application for the vaccine, which is a request to introduce the drug into interstate markets. A decision on V920, developed to treat the Ebola Zaire disease, should come Mar. 14, 2020.
A sure strength with MRK stock is that it features both well-received cancer treatments and up-and-coming investigational medicines. Also in the pipeline are treatments for HIV, schizophrenia and pancreatic cancer.
Axsome Therapeutics (AXSM)
Axsome Therapeutics (NASDAQ:AXSM) has soared high as a breakout biotech stock this year, up 740% year-to-date. In January 2019, AXSM stock traded for just over $2. Now shares are near $18.30. According to TipRanks, Axsome Therapeutics is a “strong buy” with an average 12-month price target of $34.33. That’s 87% upside from here.
So what happened to set AXSM stock off running? One of Axsome Therapeutics’ four investigational drugs, AXS-05, received Breakthrough Therapy designation in March 2019. Although the company has no approved drugs on the market, it is exciting investors with its potential. AXS-05 received fast track designation to explore its use in treating treatment-resistant depression and agitation in Alzheimer’s.
The company is also studying its use in supporting smoking cessation and in treating major depressive disorder.
In recognition of the company’s massive year-to-date gains, AXSM was also added to the Russell 2000 and Russell 3000 indices in July 2019.
Unlike some of the other names on this list, Axsome Therapeutics reflects the high-risk, high-reward side of biotech stocks. Because it lacks currently approved drugs, a lot is riding on its investigational therapies. While AXS-05 is promising thus far, investors should be cautious with this stock to buy.
Horizon Therapeutics (HZNP)
Horizon Therapeutics (NASDAQ:HZNP) is undergoing a major strategy shift. Previously, much of the company’s focus was on anti-inflammatory and antacid drugs. But these treatments for more common maladies limited HZNP’s pricing power.
Now, Horizon Therapeutics is marketing itself as a manufacturer of orphan drugs — therapies for rare diseases lacking effective treatments. Often these orphan drugs require federal support, but the biotech companies behind them have more control in setting their prices. The company is up 33% year-to-date, and is awaiting a decision regarding FDA approval for its first foray into the so-called orphan drug business.
September was a busy month for biotech stocks. The FDA accepted HZNP’s biologics license application for the investigational teprotumumab for the treatment of active thyroid eye disease (TED). The federal administration also granted the application Priority Review designation. If approved, teprotumumab would be the first treatment for active TED.
Active TED is a condition where inflammation is present in the eye muscles, eyelids and the eye’s fatty tissues. Approximately 1 million Americans are diagnosed with the condition each year, so FDA approval could significantly boost the company’s sales.
Y-mAbs Therapeutics (YMAB)
Y-mAbs Therapeutics (NASDAQ:YMAB) and the next name on this list of stocks to buy are both top holdings in the Loncar Cancer Immunotherapy ETF (NASDAQ:CNCR), along with Seattle Genetics. CNCR is an exchange-traded fund, designed around a specific set of cancer treatments.
“Immunotherapy is a transformational field within the biotechnology space that may have a foundational impact on cancer care,” the fund’s page reads. “… Our ETF seeks to support this important work and its positive impact on society.”
Compared to CNCR’s essentially flat performance, YMAB stock is up 33% since January. However, its current price near $25 is off its mid-September high above $31. Beyond the socially conscious investing thesis, Y-mAbs Therapeutics also has some exciting drugs in its pipeline.
In July 2019, Y-mAbs received Breakthrough Therapy designation for naxitamab after a meeting with the FDA. Because of this designation, the company will start to submit its biologics licensing materials on a rolling basis. Naxitamab is in clinical trials to determine its effectiveness in treating specific types of neuroblastoma, a type of cancer that predominantly affects children.
The company’s other drug in Phase 3 trials, omburtamab, is also a proposed treatment for neuroblastoma. In early phase trials it prolonged survival among high-risk patients.
Like Axsome Therapeutics, this is a high-risk, high-reward situation as investors wait to hear the FDA’s decision on the two potential neuroblastoma treatments. But with upside potential of 56%, its a stock to buy now.
The third-largest holding in the CNCR ETF, Zymeworks (NYSE:ZYME) is up almost 83% year-to-date. The Canadian biotech company has two drugs in clinical development and a handful of drugs in pre-clinical development.
Exciting news for the company came in May, when its biggest asset ZW25 received Breakthrough Therapy designation. This asset uses the company’s Azymetric platform, which essentially helps bind existing drugs or antigens (which connect antibodies) together. The ongoing clinical trials are studying the impact of ZW25 on gastric and breast cancers.
“Receipt of Fast Track designation from the FDA emphasizes the large unmet need of patients with these types of HER2-expressing cancers,” CEO Ali Tehrani said in a press release. “This designation is key to our objective of getting important new therapies to patients as quickly as possible.”
Also in the Zymeworks pipeline are drugs aimed at treating various types of tumors. Although this is another potentially volatile company, analysts at Raymond James just upgraded ZYME stock to a “strong buy,” noting that it appeared “born to run.” The firm set raised its price target to $40 — reflecting 66% upside from its current price near $24.
The last company on this list of stocks to buy, Genmab (NASDAQ:GMAB), went public just in July 2019. Its IPO raised $582 million, making it the second-largest biotech IPO in the U.S. It opened July 18 at $18.25 and now sits near $19.30.
Beyond its IPO buzz, it is also a biotech stock to watch because it is the largest holding in the iShares Genomics Immunology and Healthcare ETF (NYSEARCA:IDNA). According to the fund’s investment objective, IDNA supports investing in what will prove to be long-term drivers of the global economy.
Genmab has two products on the market: Darzalex and Arzerra. Darzalex treats forms of blood cancers, including multiple myeloma and leukemia as well as amyloidosis, a rare disease caused by abnormal protein buildup. Arzerra treats leukemia and multiple sclerosis. Arzerra is marketed through a partnership with Novartis.
In the pipeline, GMAB is researching treatments for cervical and ovarian cancers and Parkinson’s disease. Plus, it has partnered with Horizon Therapeutics in studying teprotumumab.
Since the company is relatively new to the public markets, it will be important to watch over the coming weeks. Genmab will report its financial information for the first nine months of 2019 on Nov. 6. Investors should pay close to attention to GMAB stock then. For now, the four analysts who cover it have it as a “strong buy” with an average price target of $23.50.
Sarah Smith is a web editor at InvestorPlace. As of this writing, she did not hold a position in any of the aforementioned securities.