The “dog days” of summer are here, but it’s just as busy as ever on the Street. As earnings results continue to roll in, investors will be watching for any update on the next economic stimulus package along with the non-farm payroll report slated for release this Friday. Against this backdrop, plenty of questions remain, weighing on the minds of both institutional and private investors.
In a recent note to clients, Oppenheimer’s Chief Investment Strategist John Stoltzfus addresses these concerns. When it comes to stocks’ disconnected state, he writes that the market tends to focus on the future, with it betting on a successful outcome based on the stimulus policy already put in place. But will this highly accommodative monetary policy eventually cause inflation?
“We do not expect high levels of inflation to result from the extraordinary stimulus and monetary policy taken to deal with the Covid-19 pandemic. Federal Reserve vigilance against inflation (as well as vigilance by central banks around the world) is likely to be able to suitably address any flare up of inflation,” Stoltzfus commented.
Bearing this in mind, we took a closer look at three stocks backed by the analysts at Oppenheimer, the third best-performing research firm, according to TipRanks. Running the tickers through TipRanks’ database, we learned Oppenheimer sees at least 120% upside potential in store for each, and all three have earned a “Strong Buy” consensus rating from the rest of the Street.
Durect Corporation (DRRX)
Developing innovative therapies based on its endogenous epigenetic regulator program, Durect believes it could potentially transform the treatment of acute organ injury and chronic liver diseases. As one of its candidates has delivered encouraging results, Oppenheimer sees an opportunity to get in on the action.
Firm analyst Francois Brisebois recently told clients, “After several years of promising results, we believe DRRX's endogenous small molecule epigenetic regulator DUR-928 has finally found its home in the treatment of Alcoholic Hepatitis (AH). Given a high level of mortality (26% 1-month rate) and no viable treatment options, we believe DUR-928's fairly early robust Phase 2a efficacy and safety data could have it attacking this ~ $3 billion market opportunity with peak penetration as early as 2025.”
Digging a bit deeper into this Phase 2a data, along with a robust safety profile, the trial showed that the therapy was able to rapidly reduce bilirubin, a marker of AH. In addition, there was a 100% response to treatment from the Lille score (mortality predictor tool) in 30mg and 90mg dosages and reduction in MELD (AH severity). Going forward, AH Phase 2b is set to begin in 2H20.
“Given the potential to receive Breakthrough Therapy Designation (BTD) for treating a life-threatening condition with a substantial improvement over available therapies (mainly corticosteroids), launch could happen ahead of anticipation. Additionally, market exclusivity and pricing could be greater if Orphan Drug Designation (ODD) is awarded based on ~117,000 annual hospitalizations,” Brisebois added.
Plenty of other catalysts are still ahead, in Brisebois’ opinion. DUR-928 is being evaluated in hospitalized COVID-19 patients with acute liver or kidney injury in a Phase 2 study and Phase 1b NASH data could be released during an upcoming conference. It should also be noted that it’s a “waiting game” for Posimir’s PDUFA, with the analyst considering “any related weakness as a buying opportunity.”
All of the above makes Brisebois optimistic about DRRX’s long-term growth prospects. As a result, the analyst continues to assign an Outperform rating and $7 price target to the stock. Should his thesis play out, a potential twelve-month gain of 202% could be in the cards. (To watch Brisebois’ track record, click here)
Brisebois’ colleagues are also pounding the table on DRRX. Only Buy ratings, 4, in fact, have been issued in the last three months, so the consensus rating is a Strong Buy. At $6, the average price target implies shares could climb 156% higher in the next year. (See DRRX stock analysis on TipRanks)
Avadel Pharmaceuticals (AVDL)
Hoping to address overlooked and unmet medical needs, Avadel Pharmaceuticals wants to provide solutions through its patient-focused and cutting-edge products. With Oppenheimer stating its asset has “disruptive potential in a proven blockbuster market,” the firm believes it might be time to snap up shares.
According to analyst Francois Brisebois, who also covers DRRX, AVDL is primarily focused on FT218, a once-nightly sodium oxybate designed for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. He goes so far as to call the candidate the company’s “first, second and third priorities,” noting that it recently sold its Hospital Drug Portfolio “to avoid distractions.”
Looking at the pivotal Phase 3 REST-ON top-line data, Brisebois believes it “speaks for itself.” At the 9g dose, FT218 was able to produce a change from baseline in Maintenance of Wakefulness (MWT) of 10.82 minutes vs. 4.469 in placebo, in Clinical Global Impression-Improvement (CGI-I) of 72% vs. 31.6% and in Mean Weekly Cataplexy Attacks of -11.51 vs. -4.86, all three of the co-primary endpoints. “We were particularly impressed that the 6g and 7.5g doses also showed p<0.001 across all co-primary endpoints,” the analyst added.
The implication? “Following strong efficacy and safety data, we believe FT218 could significantly disrupt Jazz Pharmaceuticals' Xyrem (twice-nightly sodium oxybate), which reported FY19 sales of $1.6 billion,” Brisebois said.
While some investors have expressed concern regarding the company’s freedom to operate, Brisebois isn’t too worried. “We are comfortable with AVDL's freedom to operate path forward as we don't believe it will infringe on Xyrem's IP (REMS or DDI). Although FT218 does use the same drug substance, it consists of a substantially different drug product. The label should add more clarity,” he explained.
Additionally, management has made a significant effort to drive a turnaround. Brisebois points out that since CEO Greg Divis was appointed in June 2019, he has offered clear guidance on enrollment, which has led to huge gains in the share price. He also mentioned, “Dr. Jordan Dubow's appointment as CMO was key because of his important role in adjusting the original study design (data a year ahead of expectations). New CFO Thomas McHugh's commercial experience is crucial.”
Given everything that AVDL has going for it, it’s clear why Brisebois joined the bulls. In addition to initiating coverage with an Outperform rating, the analyst put a $19 price target on the stock. What does this mean for investors? Upside potential of 134% is at play.
Overall, the bulls take the lead on this one. Out of 5 total reviews published in the last three months, all 5 analysts rated the stock a Buy. Therefore, the message is clear: AVDL is a Strong Buy. The $18.40 average price target implies shares could skyrocket 126% in the next twelve months. (See Avadel stock analysis on TipRanks)
CymaBay Therapeutics (CBAY)
Last but not least we have CymaBay Therapeutics, which develops therapies designed to improve the lives of patients with liver and other chronic diseases. Given its impressive technology, Oppenheimer has high hopes.
Covering the stock for the firm, analyst Jay Olson points out that its seladelpar asset produced strong results in the ENHANCE Phase 3 study in PBC. As it was terminated early and there were only a small number of patients that reached 12 months, the primary endpoint was changed to 3 months. The revised primary composite and key secondary ALP normalization endpoints were both statistically significant at 10mg. “We believe these impressive efficacy results could set a new paradigm for physicians and patients as they strive to achieve ALP normalization,” the analyst commented.
Going into more detail, 30% of patients in the study had moderate-to-severe pruritus, and the pruritus levels were balanced and representative of high-risk PBC patients, in Olson’s opinion. Unlike Ocaliva, which has a warning for severe pruritus with management strategies that include temporary dosing interruption, seladelpar was able to generate a substantial improvement in pruritus.
Based on this promising data, CBAY could kick off a Phase 3 PBC study. “We expect CBAY to initiate this simplified Phase 3 PBC trial in 1Q21 with 12-month primary endpoint for pivotal data in 2023. The safety profile of seladelpar is similar to placebo and compares favorably to Ocaliva's which has a boxed warning for dosing in certain patients,” Olson stated.
When it comes to the NASH indication, Phase 2b 52-week biopsy data, which showed a solid reduction in fibrosis and NASH resolution, could support seladelpar’s progression to Phase 3. It should be noted that CBAY might seek a partner here.
With the company boasting a path forward in 2L PBC that could establish seladelpar as the standard of care, the deal is sealed for Olson. To this end, the analyst rates CBAY an Outperform (i.e. Buy) along with a $12 price target. This figure suggests 127.5% upside potential from current levels. (To watch Olson’s track record, click here)
Looking at the consensus breakdown, other analysts echo Olson’s sentiment. With 8 Buys compared to no Holds or Sells, the word on the Street is that CBAY is a Strong Buy. In addition, the $12 average price target is identical to the Oppenheimer analyst’s. (See CBAY stock analysis on TipRanks)
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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.