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3 “Strong Buy” Biotech Stocks Ahead of FDA Verdicts

support@smarteranalyst.com (Ben Mahaney)

Most biotech stocks have been under pressure recently, but as we approach the end of the year, many analysts are quite bullish as to what is next for these stocks.

While the biotech industry carries substantial risk based on the fact that any negative event such as disappointing results from a clinical study can trigger a drop in share prices, analysts argue that a few stocks in this space are set to heal the market flu ahead of their upcoming FDA advisory committee (AdCom) meetings.

During an AdCom, both the company and agency will give presentations, with patients often getting a chance to speak as well. A vote will then take place to decide if a drug gets an approval recommendation. This recommendation can help determine whether or not a drug receives final FDA approval, with a positive AdCom outcome acting as a catalyst that can cause shares to skyrocket.

We wanted to take a closer look at 3 biotech stocks poised to soar ahead of their upcoming FDA AdCom meetings. Each boasts almost 100% upside potential as well as significant support from the Street with a “Strong Buy” analyst consensus, based on TipRanks’ Stock Screener.

With that in mind, let’s dive in:

Aimmune Stock Is Looking for a Turnaround

Aimmune Therapeutics (AIMT) develops treatments to help protect people with food allergies by potentially reducing the risk of allergic reactions, thus making accidental exposures to allergens less dangerous.

Going into its September 13 AdCom for its primary drug AR101, the company’s long-term growth narrative appears healthy. As Food Allergy Research & Education states that 32 million Americans have food allergies, including 5.6 million children under age 18, there’s a large market available for AIMT.

While shares are down 18% year-to-date, the panel is expected to put AIMT back on an upward trajectory assuming all goes according to plan.

AIMT is on track in terms of its timeline. A regulatory decision for AR101 should be announced in January 2020 but could come before. This means that the company would be able to launch the drug at the beginning of Q4 2019.

Adding to the good news, AIMT’s management stated that it would be initiating its P2 AR201 trial for egg allergies. Investors could also get an update regarding its AR301 program for walnut allergies by the end of 2019.

5-star Piper Jaffray Christopher Raymond commented: “With all eyes ahead to September, we continue to like the setup and remain buyer.” As a result, he reiterated his Buy rating and $60 price target. Raymond’s price target demonstrates his confidence in AIMT’s potential to surge 207% over the next twelve months. (To watch Raymond’s track record, click here)

“As investors are well aware, the AR101 AdCom is scheduled for Sept 13th, an event that we think could help reverse the stock’s downward trend if things go well. With this in mind, we’ve looked beyond the compelling data package and instead focused on factors affecting how the meeting may go, digging deeper on APAC panelists’ views on OIT, and becoming more comfortable that FDA understands that allergen immunotherapies cause allergic reactions during patient desensitization (per sublingual immunotherapy commentary). Though the small minority of (vocal) naysayers might continue to debate the risk/reward of OIT, we feel very comfortable that FDA understands this point well,” Raymond wrote.

Wall Street is on the same page. AIMT boasts a ‘Strong Buy’ analyst consensus as well as a $51 average price target, suggesting 158% upside potential. (See AIMT’s price targets and analyst ratings on TipRanks)

Agile Therapeutics Shares Can Soar ~250%

Agile Therapeutics (AGRX) is working to fulfill the unmet healthcare needs of women globally. Its current product candidates were developed to provide a contraceptive method for women that don’t want to commit to a longer-acting method or take a daily pill.

With the U.S. contraceptive market expected to grow from $7.6 billion in 2017 to reach $11.6 billion by 2025 according to a Grand View Research report, AGRX stands to reap the benefits.

The FDA announced at the end of June that an AdCom would take place for lead candidate Twirla, its once-weekly transdermal low-dose combination hormonal contraceptive (CHC) patch, on October 30. This news had investors excited as the AdCom will fall closely before AGRX’s November 16 Prescription Drug User Fee Act (PDUFA), the date that the FDA will reveal is if it has approved the treatment. Some have interpreted this timing to mean that the FDA may already have draft labeling ready.

4-star H.C. Wainwright analyst, Oren Livnat, argues that the FDA wants to “tease out labeling issues regarding lower CHC efficacy in obese subjects, an issue that has long been ripe for discussion”. However, he thinks the Twirla SECURE Phase 3 trial was “the most robust CHC trial ever”, especially regarding AGRX’s inclusion of a significant number of obese patients.

“We can’t predict the final labeling, if approved, but we maintain our current projection of $300M peak sales with just 2.6% market share, or approximately 50% of transdermal share,” he explained.

Based on all of the above factors, the four-star analyst reiterated his Buy rating and $4 price target, implying 251% upside. (To watch Livnat’s track record, click here)

Livnat is not the only fan of this healthcare company on Wall Street, as TipRanks analytics exhibit AGRX as a Strong Buy. Based on 4 analysts polled in the last 3 months, all 4 rate Agile stock a Buy. The 12-month average price target stands at $3.50, marking a 207% upside from where the stock is currently trading. (See AGRX’s price targets and analyst ratings on TipRanks)

Amarin Has What It Takes to Score Crucial FDA approval

Amarin’s (AMRN) primary drug, Vascepa, is a purified fish oil derivative and has already been approved by the FDA as an EPA treatment to lower triglycerides without increasing bad cholesterol levels.

Investors were not as happy to hear that the FDA would be holding an AdCom for Vascepa on November 14. The AdCom is related to its pending supplemental new drug application (sNDA) for expansion of Vascepa labeling based on its ability to reduce the risk of major adverse cardiovascular events from the REDUCE-IT study. Management stated that the AdCom meeting will most likely extend the original PDUFA date from September 28 to the end of December.

That being said, the American Heart Association (AHA) published an update on August 20 to its 2002 scientific statement for omega-3 fatty acids for reducing triglycerides in patients with hypertriglyceridemia, with the update working in Vascepa’s favor. While this wasn’t a formal change to guidelines, it is a step in the right direction.

The points from the AHA update noted that a wealth of evidence including epidemiological and genetic studies suggest the treatment of triglycerides is valid method to reduce cardiovascular disease. The AHA also highlighted the fact that over-the-counter fish oil agents should not be used for pharmacological treatment for patients, which bodes well for AMRN.

Despite some negative investor sentiment, Jeffries’ Michael Yee remains confident in AMRN’s long-term growth narrative. “Scripts continue to grow every week despite no label change and we think 2020 numbers are too low. In our view, we think the totality of AMRN’s data support approval,” he explained.

As a result, the four-star analyst reiterated his Buy rating and $30 price target. He believes share prices could gain 86% over the next twelve months. (To watch Yee’s track record, click here)

The Street appears to mirror Yee’s sentiment. With 7 Buy ratings and no Holds or Sells assigned in the last three months, AMRN has a ‘Strong Buy’ analyst consensus. Its $32 average price target suggests 96% upside potential. (See AMRN’s price targets and analyst ratings on TipRanks)

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