3 Top Biotech Stocks With Major Catalysts Approaching

Given the widespread market volatility, some investors are seeking refuge in more defensible stocks. However, this certainly doesn’t apply to every Wall Street observer. A select group remains ready to take on some risk, enticed by the possibility of massive returns. Where are they looking for these opportunities? The biotech industry.

The nature of the sector sets names up for impressive upside potential as only a few key indicators determine their prospects. So, a single piece of good news like positive trial data or a regulatory approval can act as a catalyst that sends shares through the roof. That being said, the opposite holds true, meaning that shares are in for a rapid drop should bad news be doled out.

Bearing this in mind, it can be challenging to differentiate between the tickers bound for greatness, and those poised for a slump. That’s where TipRanks comes in. With the help of the platform’s Stock Screener tool, we were able to zero in on 3 biotech stocks that have received substantial analyst support ahead of important upcoming catalysts. Should the outcome be favorable, each stands to notch some serious gains in the next year. Let’s get started.

DBV Technologies SA (DBVT)

DBV Technologies is using a new type of immunotherapy that could activate the immune system of patients through the skin to find more effective food allergy treatments. With this approach, the company has developed its proprietary Viaskin platform as a self-administered and non-invasive treatment option. With the platform’s AdCom meeting to discuss its use in patients with peanut allergies scheduled for May 15, DBVT has caught Wall Street’s attention.

SVB Leerink analyst Dae Gon Ha points out that both he and the company expected the AdCom announcement, and that the biotech has been getting ready for it for some time now. “We believe DBVT will be well prepared come May 15 and remain optimistic that the FDA will take a holistic approach evaluating the totality of the Viaskin Peanut data,” he commented. After the AdCom takes place, the PDUFA date is slated for August 5.

While some investors have been concerned about competition from Aimmune’s recently approved Palforzia therapy, Ha remains confident in DBVT. “In our view, given the prevalence of peanut allergy, this is unlikely a ‘winner take all’ market and depending on the needs of the pts. could accommodate both Palforzia and Viaskin Peanut, if not other approaches,” he explained.

Part of what sets DBVT apart is that the therapy was designed as a patch, making it convenient and easy to use for children and parents. Ha does acknowledge that desensitization takes longer to achieve with Viaskin than with Palforzia, but thinks “many parents would prefer to have an alternative to Palforzia, even though it may take longer to achieve roughly the same result, since it may be easier and safer to undertake, and desensitization can still be achieved before the child encounters allergens outside the home on their own.”

In line with his optimistic approach, the four-star analyst reiterated his Outperform call and $29 price target. Should the target be met, shares could be in for a whopping twelve-month gain of 201%. (To watch Ha’s track record, click here)

H.C. Wainwright analyst Andrew Fein seems to agree with Leerink. In a research note issued today, the analyst noted, “In considering the AdCom, we maintain Viaskin Peanut offers differentiation based on its safety profile and, in our view, sufficient efficacy to manage risk of accidental peanut exposure.” According to Fein, DBVT could be worth about 177% more than it’s currently selling for, and should hit $25 within the next 12 months. (To watch Fein’s track record, click here)

What does the rest of the Street have to say? With 100% Street support, or 3 Buy ratings to be exact, the message is clear: the stock is a Strong Buy. At $19, the average price target implies 111% upside potential. (See DBV Technologies stock analysis on TipRanks)

Zogenix (ZGNX)

Zogenix develops drug candidates that have the potential to improve the lives of patients with rare diseases. While the company has taken a beating recently, some members of the Street believe that ZGNX’s future is still bright.

Last week, the company announced that the PDUFA date for its Fintepla candidate will now be on June 25, three months later than previously expected. This was caused by the three month extension of the Fintepla NDA review after ZGNX provided additional efficacy data so the FDA could perform their own sensitivity analyses of its Phase 3 results. It should be noted that the review isn’t related to safety concerns and the FDA isn’t planning on holding an AdCom meeting. However, the Fintepla manufacturing site will be inspected.

Needham’s Serge Belanger notes that given past concerns related to the candidate’s safety and the Refuse-to-file (RTF) in 2019, the analyst understands why investors are concerned. That being said, he tells investors that the news isn’t necessarily a negative. “The FDA delay appears to be part of the regular review process rather than a specific Fintepla efficacy or safety issue. It’s possible FDA needed breathing room to meet its Priority Review timeline mandate. We see no negative read-thrus to Fintepla’s approvability or its potential to play a prominent role in DS patients,” he stated.

The situation wasn’t helped after it released Phase 3 trial data evaluating its Fintepla therapy in Lennox–Gastaut syndrome (LGS) patients. While the primary endpoints were met, the efficacy levels disappointed as they couldn’t match those produced in patients with Dravet syndrome (DS).

However, Belanger thinks that in spite of the result, Fintepla still has the potential to be an effective LGS treatment. He also points out that “the heterogeneity of LGS and wider patient age range (2-35) made it more difficult to deliver efficacy levels on par with those seen in DS patients.”

To this end, Belanger’s bullish thesis remains very much intact. Citing the recent weakness as presenting a unique buying opportunity, he maintained both his Buy recommendation as well as his $54 price target. This target leaves room for a potential twelve-month gain of 97%. (To watch Belanger’s track record, click here)

Looking at the consensus breakdown, it appears that other analysts also like what they are seeing. With 7 Buys compared to a single Hold, the word on the Street is that ZGNX is a Strong Buy. The $51.67 average price target brings the upside potential to 89%. (See Zogenix stock analysis on TipRanks)

Foamix Pharmaceuticals (FOMX)

Switching gears now, Foamix develops topical drugs for dermatological applications. Most of its products are designed as, you guessed it, foam. With one treatment, Amzeeq, already approved for acne treatment, analysts are keeping an eye on FOMX as the PDUFA data for another candidate approaches.

The company filed the sNDA for its papulopustular rosacea treatment, FMX-103, back in August, with the FDA’s approval decision being handed out on its June 3 PDUFA date. Part of the excitment surrounding the therapy is related to the size of the market. Even though the market opportunity is less than acne’s, there are 16 million people living with rosacea. Additionally, the lack of effective treatment options means that a majority of patients aren’t receiving treatment.

Weighing in on FOMX’s prospects for Cowen, analyst Ken Cacciatore thinks that the candidate’s potential as a treatment for inflammatory lesions as well as the erythema (redness) has been undervalued by Wall Street. “We do not believe that investors fully appreciate the potential of this asset that is targeting a market that has limited options that provide limited benefits,” he noted.

Cacciatore added, “Interestingly, our consultants have continued to indicate that FMX-103 has a very competitive efficacy and tolerability profile when compared to market-leading Oracea, which is oral doxycycline (and therefore systemic), and yet is a ~$350 million a year product. Taking our consultants’ commentary into account – and their view when compared to Oracea – we believe could yield another $250 million-plus product, with conservative penetration rates.”

On top of this, Cacciatore argues that with Amzeeq’s approval, a commercial platform will most likely be established. Should FMX-103 get the go ahead from the FDA, it can leverage the Amzeeq relationship building and commercial platform as it taregts the same clinician base. Based on the Cowen analyst’s estimates, this could drive combined sales of $500 million.

As a result, Cacciatore decided to stay with the bulls. Along with his Outperform rating, he kept the price target at $15, implying shares could skyrocket 356% in the next twelve months. (To watch Cacciatore’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 $15 average price target puts the upside potential at 352%. (See Foamix stock analysis on TipRanks)

To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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