3 Healthcare Stocks With Huge FDA Decisions in January

In the stock market, sometimes all it takes is a single catalyst to propel shares to sky-high levels. This is especially common with healthcare stocks. While they carry significant risk, these names rely on only a few key milestones such as favorable trial data or attaining FDA approval, so a single dose of good news can have a big impact on share prices.

The latter is particularly important as drug or medical device approval from the regulatory agency can lead to sustainable revenues for a company. No wonder, then, that investor focus locks in on healthcare companies ahead of decisions from the FDA.

Bearing this in mind, we took a closer look at 3 healthcare stocks awaiting huge decisions from the FDA in January. TipRanks, a company that measures and tracks the performance of analysts, revealed that Wall Street sees each of these names as solid Buys. Here’s what we uncovered.

Durect Corporation (DRRX)  

Recognized for its expertise in both formulation and drug delivery, Durect focuses on developing novel treatments for chronic kidney disease as well as acute organ injury. Its lead candidate, DUR-928, is an orally bioavailable small molecule that’s part of the company’s Epigenetic Regulator program. Representing a new class of therapeutics, it could play a key role in cellular functions like lipid homeostasis, inflammation and cell survival.

That being said, the attention directed at DRRX is related to its POSIMIR candidate, designed to provide non-opioid pain relief after surgery. While still commonly used, opioids often have undesirable side effects and can be highly addictive. With 72 million surgical procedures performed each year in the U.S., there is a large unmet need for alternative forms of pain management.

On January 16, an AdCom meeting will take place to determine if the FDA will recommend POSIMIR approval for the post-surgical analgesia indication.

H.C. Wainwright analyst Ed Arce notes that his bullish thesis remains very much intact. He argues that the company’s submission of new data and re-analysis of the integrated summary of safety bode well for FDA approval.

“PERSIST was designed based on extensive consultation and feedback from the FDA, and DURECT has successfully compiled a safety database with over 260 patients in the study to sufficiently address the issues raised in the CRL…We believe POSIMIR’s data portfolio that was built upon efficacy data from two completed trials and safety data of all 16 completed trials, assembled under Dr. Simon’s guidance, is sufficient to support POSIMIR’s approval,” the analyst explained.

Based on this conclusion, the five-star analyst told investors that he is staying with the bulls, reiterating the Buy rating. At his $4 price target, shares could surge 23% in the coming twelve months. (To watch Arce’s track record, click here)

Cantor’s Eliana Merle set a more aggressive price target along with her Buy rating based on not only POSIMIR but also DUR-928’s potential as a treatment for Alcoholic hepatitis (AH), for which there is a huge opportunity. Should the $5 target be met, investors could see 53% upside. (To watch Merle’s track record, click here)

Judging from the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Over the last three months, only 2 analysts have reviewed the biopharma. Both of which, however, were bullish, making the consensus a Moderate Buy. On top of this, the $4.50 average price target puts the upside potential at 38%. (See Durect stock analysis on TipRanks)

Aimmune Therapeutics (AIMT)

Switching gears now, Aimmune takes aim at food allergies. The biopharma develops new treatments for people with potentially life-threatening food allergies. While shares are up 37% in 2019, investors want to know if AIMT has more fuel in the tank as it approaches the FDA decision for its lead candidate.

PALFORZIA (AR101), its oral immunotherapy (OIT) treatment of peanut allergy, could see an approval decision come in late January 2020 for its use in the U.S., with the EU approval outcome expected in the second half of the year. Back in September, the company got a piece of good news as the FDA’s Allergenic Products Advisory Committee (APAC) voted in favor of approval for the therapy’s use in pediatric patients with peanut allergies.

In addition to the vote of confidence from the panel, Wedbush’s Liana Moussatos sees a clear path to approval based on “robust efficacy and safety data to date.” Despite different regions of study, entry criteria, dosing periods and primary endpoints, both of the Phase 3 studies indicated consistent results. If that wasn’t promising enough, the analyst forecasts more than $1.5 billion in annual sales worldwide starting in 2023 if PALFORZIA is in fact approved. To this end, Moussatos left the Outperform rating and $79 price target unchanged. This conveys her confidence in AIMT’s ability to skyrocket 142% in the year ahead. (To watch Moussatos’ track record, click here)

Meanwhile, Christopher Raymond of Piper Jaffray cites a recent meeting with management as reason for his bullish approach. He came away with a much more optimistic take on PALFORZIA’s launch. “We are much more confident that Palforzia’s launch can meaningfully outperform expectations, both near- and long-term. Coupling this with the stock’s 30% short interest, we like the opportunity for meaningful upside into this drug’s late January expected approval and launch,” the five-star analyst noted. As a result, Raymond maintained both the bullish call and $60 price target. (To watch Raymond’s track record, click here)

Is the rest of the Street in agreement? As it turns out, the analyst consensus is more of a mixed bag. Split almost right down in the middle, 3 Buy ratings and 4 Holds were assigned in the last three months, giving AIMT Moderate Buy status. With a $44.14 average price target, the potential twelve-month gain comes in at 35%. (See Aimmune stock analysis on TipRanks)

Epizyme (EPZM)

Through the use of targeted epigenetic medicines, Epizyme is developing treatments for cancer and other serious diseases. Ahead of the January 23 PDUFA date for its primary product candidate, tazemetostat, all eyes are on the company.

Looking at the results of the AdCom that took place earlier this month, it’s clear why investors have been getting excited. The panel voted unanimously to support the approval of tazemetostat for use in epithelioid sarcoma. Even though there was some concern about an open-label single-arm study, the panelists were impressed by the duration of response for a small indication with high unmet need, its safety and tolerability profile, its efficacy in a second-line (2L) setting and the limited amount of available treatment options.

While the outcome doesn’t mean that final FDA approval is a sure thing, the Street is certainly buzzing. Since the AdCom vote, shares have climbed 24% higher, pushing EPZM’s 2019 rise to a whopping 267%.

Jeffries analyst Michael Yee believes the AdCom should ease concerns about a possible FDA rejection. “Bottom line: we think the outcome today partially de-risks EPZM’s follicular lymphoma program (NDA filing by YE:19) and should enable the company to transition to a commercial stage company by 2020,” he commented. With this in mind, Yee left the Buy rating and $21 price target as is. (To watch Yee’s track record, click here)

Like Yee, Morgan Stanley’s David Lebovitz has high hopes for EPZM, pointing out that the FDA usually adheres to the recommendations of its AdCom panels. This prompted the analyst to keep the Overweight rating and $24 price target, suggesting 11% upside potential. (To watch Lebovitz’s track record, click here)

Turning now to the rest of the Street, other analysts are on the same page. Based on the 6 Buy ratings vs no Holds or Sells, the Strong Buy consensus comes in just like the AdCom vote, unanimously. Given the recent uptick to the share price, the $20.33 average price target implies 10% downside. (See Epizyme stock analysis on TipRanks)


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