The pharmaceutical industry is changing rapidly. While several companies race to find effective approaches to treat some of the most stubborn conditions, not only are outcomes improving for patients, investment opportunities are arising.
As treatments go through the development process, study initiations, data readouts, and regulatory filings have the potential to lead to significant movements in value. So, it’s a good idea to follow the companies that have these types of events ahead. Below are several pharmaceutical-focused companies that have multiple catalystic events on the horizon.
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AbbVie (ABBV): An Immunology Play With An Oncology Kicker
AbbVie is best known for its work in immunology with the world’s top-selling drug, Humira. Humira is indicated to treat a wide range of autoimmune diseases, but it’s not the only trick under the company’s sleeve.
In fact, AbbVie is quickly becoming a big player in the oncology space. The number 2 product at the company, known as Imbruvica, is quickly becoming a major success. Last year, the drug indicated for the treatment of B-cell cancers, including lymphoma, chronic lymphocytic leukemia, and other cancer types, generated around $3.6 billion. Moving forward, AbbVie expects the drug to peak with annual sales around $7 billion.
Not to mention, the company has yet another rising star with a drug by the brand name Venclexta. At the moment, Venclexta is approved for the treatment of chronic lymphocytic leukemia as well as acute myeloid leukemia.
Also, it looks like the company is placing quite a bit of focus on opportunities in oncology. In fact, if you take a look at the company’s pipeline, you’ll see that several early-stage oncology programs have been added to the fray. Moreover, the company is working in early-to-late stage clinical trials to expand the indications for its currently approved oncology treatments.
With a proven ability to bring products through the development process and into approval combined with strong marketing abilities, AbbVie represents a strong opportunity as is. Bringing in the company’s newly centered focus in oncology combined with several clinical programs that will likely generate strong catalysts ahead, and this stock is one that’s hard to ignore!
Hemispherx Biopharma (HEB): Ampligen Could Become A Blockbuster!
Hemispherx Biopharma is a relatively small biotechnology company, just starting to get its feet wet in commercial stages. Nonetheless, while the company is small, it could have seriously explosive potential.
The company has several oncology-focused clinical programs that are showing incredible promise. Its flagship product candidate, known as Ampligen is currently being assessed across multiple tumor types including ovarian, colorectal and breast cancers as well as renal cell carcinoma and melanoma.
The approach that Hemispherx Biopharma took with Ampligen is interesting. Instead of using harmful drugs to combat cancer, Ampligen has the potential to modulate the tumor micro-environment enabling the body’s own immune system to attack cancer cells. Ultimately, it is expected that this unique approach may enhance responses from immune blockade inhibitor drugs (checkpoint inhibitors).
However, the potential of Ampligen goes beyond its targeted cancer indications. In fact, it is the only drug with double-blind, placebo-controlled clinical trial data demonstrating efficacy in ME/CFS. As a result, the drug has won regulatory approval for the indication in Argentina, becoming the first to do so.
It’s also worth mentioning that Hemispherx Biopharma is no one trick pony. In fact, the company is the developer of the Alferon N Injection, the only naturally occurring alferon on the market today. Indicated for the treatment of genital HPV in both the United States and Argentina, this treatment comes with tremendous long-run market potential.
With a commercial launch on the horizon and multiple clinical trials underway, the coming months, and possibly years, are likely to be riddled with catalystic events from Hemispherx Biopharma. Moreover, the company has been outspoken about its active search to find a partner for its Phase 3 study of Ampligen. Should a partner be announced, this could prove to be yet another large catalyst. All in all, with so many potential market moving releases ahead, Hemispherx Biopharma is a stock that’s well worth watching.
Exelixis (EXEL): A Key Approval And More To Follow
Exelixis is a commercial-stage biotechnology company that has made a splash with its bread-and-butter drug known as Cabometyx. The treatment was first approved by the FDA in April of 2016. At the time, it was indicated as a second-line treatment for patients with renal cell carcinoma. In fact, Cabometyx was the only drug that showed statistical significance in the improvement of objective response rate, progression-free survival, and median overall survival in its target patient population.
Since the original approval of the treatment in 2016, Exelixis has seen multiple label expansions. In fact, in 2017, the label on the drug was expanded to include first-line treatment for advanced RCC patients after data showed the drug to be more effective than Bristol-Myers Squibb’s (BMY) Opdivo.
Most recently, the treatment was approved by the FDA as an option for hepatocellular carcinoma. The approval came after positive data was produced through the Phase 3 Celestial trial.
Now, the company is working with Bristol-Myers Squibb on a combination treatment including Cabometyx as a first line option in RCC. The final readout from the trial should be coming soon, and if it’s positive, Exelixis could grab a strong portion of the first-line RCC market share.
Aside from Cabometyx, the company has 2 other approved therapies and several in clinical trials. Moreover, it is expected that by 2022, the company will be generating about $1.6 billion in annual sales. With that considered, not only do we have clinical and regulatory catalysts to look forward to, but investors can look forward to strengthening sales reports as the company continues to expand its efforts.
Intercept Pharmaceuticals (ICPT) Stock: Could Become The Sole Option In NASH
Intercept Pharmaceuticals has been interesting to watch. The stock has been trading on weakness as of late for two reasons. First and foremost, the company’s lead drug came with some safety concerns in a recent clinical study.
In particular, the highest dose of Ocaliva led to 9% of patients discontinuing the study due to severe itching. 51% of patients experienced itching. Of course, this led to the safety concerns mentioned above, putting some pressure on the stock.
Moreover, in May, the company announced the pricing of a public offering under which the company raised more than $400 million by diluting current investors. Nonetheless, recent weakness could prove to be an opportunity.
Let’s not forget, Ocalvia is already approved. The treatment was approved by the FDA as a treatment option for primary biliary cholangitis, also known as PBC. However, this indication isn’t a particularly valuable one. Expectations are that this indication could lead to peak sales of $300 million annually.
Nonetheless, Ocaliva could prove to be an overwhelmingly valuable asset. Back in February, the company announced positive clinical data from a pivotal Phase 3 trial of Ocaliva as a potential option for the treatment of NASH, an ailment that is currently met with no approved treatment options.
Although severe itching was a concern in the high-dose arm of the study, the fact that Ocaliva is already approved for the PBC indication could pave the way for a label expansion without safety concerns holding up the potential approval. Ocaliva generated a reduction in liver fibrosis in NASH patients, suggesting strong efficacy and increasing its chances of approval.
Moreover, the NASH market is a massive one. In fact, it is estimated that between 3% and 12% of adults in the United States live with this condition. With no treatment options currently available, the drug could quickly take the market by storm. In fact, Wall Street suggests that a NASH approval would mean about $2 billion in annual sales for Intercept.
All in all, Intercept Pharmaceuticals offers up an interesting opportunity. With regulatory updates and a potential approval around the figurative corner, there are several catalysts ahead. Moreover, should Ocaliva be approved as a treatment for NASH, the long-term potential of an investment here is incredible.
Vertex Pharmaceuticals (VRTX): Multiple Approved Treatments With More To Come
Finally, we have Vertex Pharmaceuticals. At the moment, the company has three treatments approved by the FDA that are indicated for patients with cystic fibrosis. However, cystic fibrosis isn’t the only indication that the company is focused on.
In fact, the company recently announced that it would be expanding its relationship with CRISPR Therapeutics for the development of potential treatments for auto-immune disorders. Also expanding on its work in auto-immune disorders, Vertex recently acquired Exonics Therapeutics.
Exonics Therapeutics is working to develop a gene therapy for Duchenne’s muscular dystrophy, the most common form of muscular dystrophy. Unfortunately, DMD is a very serious condition that is met with limited treatment options. Nonetheless, if Vertex Pharmaceuticals has its way, it will offer up the next big option in the space.
At the moment, the company is working on several clinical trials across five indications. In fact, the company has 13 ongoing clinical development programs with an additional 3 potential treatments in the research and development phases.
All in all, with its strong hold on the cystic fibrosis market, Vertex Pharmaceuticals offers up strength and stability. Moreover, with several potential treatment options under development, investors can look forward to several catalysts ahead. This is one that’s well worth paying attention to!
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The biotech industry is one that offers up opportunities on a regular basis. By following stocks with catalysts ahead, investors have the opportunity to see tremendous growth in value as these catalystic events hit. In my view, the stocks listed above fall perfectly into this category!
CNA Finance, parent company to Alpha Stock News, has a monetary relationship with Hemispherx Biopharma. Click here to learn more.