The biotechnology space is an exciting one with incredible potential for investors. Moreover, due to the fact that several catalysts take place from the time a new discovery is made to the time a new drug is ready to be commercialized, the potential for big gains in value over a relatively short period of time is very real.
One strategy that many have found success with in the biotech investing space is making moves around catalysts. This involves looking for companies with data readouts, PDUFA dates, and other upcoming releases that will likely move the needle for the stock. By getting involved before these events take place, investors are able to take advantage of the growth that takes place as a result of them.
With that said, here are 5 biotechnology stocks that have near-term catalysts ahead...
#1: Sanofi (NASDAQ: SNY): Two PDUFA Dates In The Next Two Weeks
PDUFA dates are some of the most tracked dates in the biotech investing community, and for good reason. These are the deadline dates for the FDA to make decisions with regard to the approval or denial of New Drug Applications, Biologics License Applications, and supplemental applications aimed at label expansions for already approved drugs and biologics.
Sanofi, a large player in the biotechnology space, has two PDUFA dates coming over the next two weeks. First and foremost, the company has a supplemental Biologics License Application in with the FDA under a partnership with Regeneron Pharmaceuticals (NASDAQ: REGN).
The treatment the application surrounds is known as Praluent, a drug that was originally approved by the FDA in 2015. The drug is currently approved in the United States as a second-line option for patients with high cholesterol who have not responded well to diet and statin treatment.
Through the supplemental Biologics License Application, the company is hoping to expand the label for the drug to be indicated as an option to reduce risk of recurrent ischemic cardiovascular events in patients who had a previous acute coronary syndrome and who were receiving high-intensity statin therapy. With strong data suggesting positive efficacy, there is a high likelihood of approval.
The second coming catalyst for the company is yet another PDUFA date, scheduled for May 1, 2019. On this day, the FDA will make their decision surrounding the potential approval of Dengvaxia. If approved, the vaccine will be the only approved vaccine as an option to reduce risk of dengue.
Dengue is a condition most commonly seen in the tropics as it is transferred through mosquitoes. The condition causes sudden fever accompanied by joint pain. Considering that Dengvaxia may be the only approved vaccine for this indication, it could prove to be an overwhelmingly valuable product.
With multiple PDUFA dates coming that are just weeks away, now may be the perfect time to start diving into Sanofi.
#2: Cellectar Biosciences (NASDAQ: CLRB): 2019 Is Packed With Data Readouts
Cellectar Biosciences is a relatively small player in the biotechnology space. However, this clinical-stage company has catalysts ahead that could pack a big punch. The company’s claim to fame is CLR 131, a treatment that is currently under development for various types of cancer.
In fact, Cellectar Biosciences is currently on the back end of multiple clinical studies. The first is a Phase 2 study that was initiated in 2017. In the study, Cellectar is assessing the safety and efficacy of CLR 131 as a potential treatment option for multiple myeloma and other hematologic malignancies with unmet clinical need.
Through the Phase 2 study, Cellectar plans to prove that patients receiving the treatment achieve a clinical benefit response. Additional endpoints include progression free survival improvement, median overall survival improvement and other markers of efficacy.
The study received approximately 50% funding through a $2 million National Cancer Institute Fast-Track Small Business Innovation Research Grant. As we are on the tail end of the clinical study, it is expected that the study will reach completion soon. This will likely prove to be a positive catalyst.
Moreover, shortly after the completion of the study, we can expect other catalysts including the interim data readout, final data read out, and potential meetings with the FDA.
Cellectar Biosciences also has an ongoing Phase 1 study that is expected to be completed relatively soon. The study is a standard three-by-three dose escalation safety study in patients with relapse or refractory multiple myeloma. Through the study, the company is assessing the safety and tolerability portfolio of CLR 131 at increasing doses.
The most recent data reported in the Phase 1 trial was provided in early January. The data proved to be overwhelmingly positive, showing not only safety and tolerability, but strong early efficacy results, suggesting that there is more positive news ahead.
Like the Phase 2 trial, the Phase 1 clinical trial of CLR 131 has the potential to yield multiple catalysts. In fact, I believe that the company will experience at least 5 more catalytic events surrounding CLR 131 by the end of 2019, making the stock one to watch.
#3: Amarin Corporation (NASDAQ: AMRN): Vascepa Catalysts Could Be Game Changers
The next on the list, Amarin, is the maker of a fish oil drug known as Vascepa. The treatment is currently approved by the United States Food and Drug Administration to reduce triglyceride levels in adults when accompanied by a low-fat, low-cholesterol diet.
The company recently announced that it submitted an application to expand the label on Vascepa to the FDA. Should the FDA approve the application, the drug may soon be approved to reduce the risk of cardiovascular events in adults. While the PDUFA date for this application isn’t until early 2020, there are plenty of catalysts to look forward to between now and then.
First and foremost, before the FDA approves or rejects the label expansion, it is expected that the regulatory authority will organize an advisory committee that will vote on the approval or rejection of the label expansion. The vote from the advisory committee is likely to prove to be a catalyst.
Moreover, Amarin has benefited from other positive catalysts, and more of the same may be coming down the line soon. Some great examples of this include:
- The American Heart Association (AHA) announced that it no longer recommends using aspirin to control cardiovascular risk. With the label expansion application under review, this opens the door to a large potential audience for Vascepa, once approved.
- It was also recently announced that the American Diabetes Association (ADA) backed the use of Vascepa to control cardiovascular risk.
All of the positive news has stemmed from the company’s recent release of data from its REDUCE-IT trial. The data enrolled more than 900 patients and showed a reduction in cardiovascular events experienced by those taking Vascepa. The treatment also came with a favorable safety and tolerability profile.
With the buzz surrounding Vascepa, we could see more big names backing the drug. Moreover, with a coming FDA Advisory Committee vote and a decision expected in early 2020, Amarin stock is one that’s worth keeping an eye on.
#4: GW Pharmaceuticals (NASDAQ: GWPH)
GW Pharmaceuticals is a biotech play that also attracts interest from cannabis investors. That’s because the company uses the properties of cannabis to treat severe forms of epilepsy and other serious illnesses.
Back in July of last year, the United States FDA approved Epidiolex, a treatment developed by GW Pharmaceuticals for Lennox-Gastaut syndrome and Dravet syndrome. Both of these are rare, yet severe forms of epilepsy. This was a significant drug approval, as it represented the first cannabis-related treatment approved by the FDA to treat Epilepsy.
The next catalyst from GW Pharmaceuticals and its Epidiolex product will take place in early May. On May 7, 2019, the company will be presenting data from its Phase 3 study in Dravet syndrome at the American Academy of Neurology Annual Meeting. The poster that will be used in the presentation is embargoed until May 3, 2019. So, we’ll get the first look at the presentation early in May.
This is a significant catalyst, as the company will be presenting data in front of institutional investors, potential commercialization partners, and other key members of the investing and medical community. As a result, the company’s attendance could lead to more investor interest in the stock and physician interest in Epidiolex.
Moreover, with Epidiolex being a newly-approved treatment. Each update with regard to sales will likely prove to be a catalyst. So, keep an eye on GW Pharmaceuticals ahead as the stock is likely to lead to several opportunities.
#5: BioMarin Pharmaceutical (NASDAQ: BMRN)
Finally, we have BioMarin Pharmaceutical. The company already has multiple products on the market, and the next may be coming relatively soon. In fact, the company is expected to provide a clinical update on valoctocogene roxaparvovec, also known as BMN 270.
The treatment is currently being developed as an option for patients with Hemophilia A. In clinical studies, the treatment has been shown to lead to a 97% decrease in bleeding rate. It is expected that the company will release further data surrounding the treatment in May. Moreover, BioMarin Pharmaceutical is expected to submit a BLA filing to the FDA in the second half of 2019.
Both, the coming data release and the Biologic License Application filing have the potential to act as catalysts in the movement of BioMarin Pharmaceuticals. Not to mention, with a BLA on the horizon, other catalysts like the Advisory Committee vote and other communication between the FDA and BioMarin have the potential to lead to further excitement.
The company also has a strong pipeline with several clinical candidates under development. As a result, we can expect to see other catalysts related to the development of these treatments.
With clinical, regulatory, and commercial catalysts taking place often, the biotechnology space is an exciting one to invest in. Paying attention in times when catalysts are likely to take place is a strategy that can yield great returns. All of the stocks mentioned above, have multiple catalysts coming and, in my opinion, the potential to yield growth for investors!
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