The U.S. presidential election has come to a close, and Wall Street isn’t opposed to the administration change. Last week saw the S&P 500 notch its second-best performance during an election week on record, even as Trump’s chances of getting re-elected became slimer and slimer.
Weighing in for Oppenheimer, Chief Investment Strategist John Stoltzfus noted, “What appears clear so far is that the equity markets are not averse to a change of administration stateside at least so long as the Republicans maintain control over the Senate. Checks and balances ‘on the Hill’ have been known to be important to investors over the course of history. The present in our view is no exception.”
There is, however, some uncertainty surrounding the Senate, with the two runoff elections for seats in Georgia scheduled for January 5, only 15 days before Inauguration Day. That said, Stoltzfus points out that continued better-than-expected Q3 results from S&P 500-listed companies, economic data tied to job gains and a sharp decline in the unemployment rate have also been helping to prop stocks up.
Taking Stoltzfus’ outlook into consideration, we wanted to take a closer look at three stocks earning a round of applause from Oppenheimer, with the firm’s analysts forecasting over 100% upside potential for each. Using TipRanks’ database, we learned that the rest of the Street is in agreement, as all three boast a “Strong Buy” analyst consensus.
Strongbridge Biopharma (SBBP)
First up we have Strongbridge Biopharma, which is focused on developing therapies for rare diseases with significant unmet needs. Ahead of a key regulatory filing, Oppenheimer believes that SBBP’s $2.12 share price reflects an attractive entry point.
Representing the firm, analyst Hartaj Singh points out that investor focus has landed squarely on Recorlev, the company’s investigational cortisol synthesis inhibitor, in Cushing’s syndrome. The company is gearing up to file an NDA for the therapy in Q1 2021, and the analyst is optimistic about its potential approval.
In the LOGICS study, the therapy met its primary endpoint, with SBBP reporting the number of cases of a loss of mean urinary free cortisol (mUFC) response was 54.5% higher among patients who withdrew to placebo versus those who remained on Recorlev. Additionally, there was a rapid reversibility of the Recorlev treatment benefits on cholesterol following the switch to placebo given the 8-week time frame.
Meanwhile, in the SONICS study, a significant benefit on mUFC normalization was observed in 30% of the patients and several cardiovascular secondary measures. It should also be noted that none of the 44 patients who were randomized discontinued due to adverse events.
“Post-LOGICS, we continue to view Recorlev as a differentiated treatment for Cushing’s, both compared to off-label ketoconazole and the branded treatment landscape. Management reiterated its confidence in the drug’s positioning, based on market research with payors and physicians. Given LOGICS reaffirming the clinical benefit profile observed in SONICS, we are encouraged by its potential to become a mainstay treatment for the disease,” Singh explained.
What’s more, management is not anticipating an AdComm meeting, and Singh thinks speculation on labeling both from a safety and efficacy perspective may increase prior to the potential PDUFA decision. To this end, he expects more visibility as the NDA filing and acceptance gets closer.
Adding to the good news, the launch of Keveyis, the company’s FDA-approved treatment for hyperkalemic, hypokalemic and related variants of Primary Periodic Paralysis (an ultra-rare neuromuscular disorder), is progressing well despite the COVID-19 pandemic, according to Singh.
“With quarterly sales of ~$8.0 million, above our estimate of ~$7.8 million, the growing trajectory of the launch has been encouraging, with additional room for long-term growth highlighted by management. We anticipate more credit could be ascribed to these efforts, following additional updates from life-cycle management strategies,” the analyst commented.
To this end, Singh rates SBBP shares an Outperform (i.e. Buy) along with a $7 price target. What’s in it for investors? Upside potential of 233%. (To watch Singh’s track record, click here)
All in all, other analysts echo Singh’s sentiment. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $8, the upside potential comes in at 272%. (See SBBP stock analysis on TipRanks)
Molecular Templates (MTEM)
Molecular Templates works to bring the next generation of immunotoxins called engineered toxin bodies (ETBs), which are a novel class of therapeutics with unique biology and a differentiated mechanism of action, to market. Although one of its trials was put on a partial clinical hold, Oppenheimer still believes its long-term growth narrative is strong.
The Phase 2 monotherapy trial evaluating lead candidate MT-3724, an ETB that targets CD20 (a B-cell marker that is expressed in 90 percent of B-cell non-Hodgkin’s lymphoma (NHL)), was placed on partial clinical hold on November 4 following a treatment-related fatality. Management pointed to capillary leak syndrome (CLS) as the cause of the patient death. MT-3724 is being evaluated in three ongoing Phase 2 trials, one monotherapy and two combination.
It should be noted that six patients (fatality patient and five treated in DLBCL monotherapy study) received the drug from the same batch, and the first five completed the study without evidence of CLS. Later PK analysis found peak drug exposure (Cmax) 3-4x expected levels in five out of six patients receiving the therapy from the lot. Management plans to investigate what caused the higher Cmax levels.
Oppenheimer’s Kevin DeGeeter told clients, “We would look to accumulate MTEM shares into any weakness based on expectation: 1) manufacturing batch inconsistency may have resulted in excess Cmax in limited number of patients providing clear path to remedy the problem, 2) limited read through on immunogenicity from MT-3724 (only product on first-gen ETB backbone) to other pipeline programs, and 3) guarded expectation for commercial opportunity of MT-3724 prior to clinical hold with market opportunity focused primarily on salvage patients.”
Even if the CLS is determined to be dose-related, the five-star analyst argues there may still be a path forward for MT-3724, as the monotherapy study is evaluating a dose of 50 µg/kg while combination studies are assessing a 10-25 µg/kg dose.
Reflecting another positive, the hold doesn’t impact studies for products on the second-generation ETB backbone, including MT-5111, TAK-169 and MT-6402. In addition, the company is set to provide a clinical update on CTX001, a potential treatment for sickle cell disease (SCD).
DeGeeter opined, “Our investment thesis is based, at least in part, on continued partnering of ETB platform to large biotechs for targets outside of MTEM’s core oncology focus. Despite the clinical hold on MT-3724, MTEM remains in active discussions with potential partners. We’d view additional partnering deals as validation of the platform’s overall safety profile.”
In line with his optimistic approach, DeGeeter rates MTEM an Outperform (i.e. Buy) along with a $20 price target. This figure indicates 123% upside potential from current levels. (To watch DeGeeter’s track record, click here)
Are other analysts in agreement? They are. Only Buy ratings, 3 to be exact, have been issued in the last three months. Therefore, the message is clear: MTEM is a Strong Buy. Given the $18.33 average price target, shares could soar 108% in the next year. (See MTEM stock analysis on TipRanks)
Provention Bio (PRVB)
At the forefront of the autoimmune disease space, Provention Bio is working to improve the lives of patients from all over the world. With the company making significant headway in its efforts to gain approval for one of its therapies, Oppenheimer thinks that now is the time to snap up shares.
On November 2, Provention Bio announced that the rolling submission of a BLA to the FDA for regulatory approval of teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals had been completed. The submission included chemistry, manufacturing and controls (CMC) and administrative information modules. Now, the FDA has 60 days to review the final submission to determine if the BLA is complete, and then, a PDUFA date will be set.
Writing for Oppenheimer, analyst Justin Kim points out that the BLA acceptance will be a key milestone for PRVB. “We believe the external validation and review of the application would reflect favorably on the significant efforts Provention has made towards completion of this filing, namely manufacturing scale-up. As a potential advisory committee meeting and regulatory decision offer subsequently greater validation, we have confidence into these events based on teplizumab’s established clinical profile.”
Going forward, Kim believes the therapy’s commercialization will become a central theme in 2021. Based on teplizumab’s 14-day infusion cycle, logistics and physician/patient reception of the modality, especially during the COVID-19 pandemic, are attracting major attention, according to the analyst.
Should the candidate ultimately be granted approval, screening and awareness work could reflect a significant tailwind, in Kim’s opinion. With it already having established meaningful relationships across key T1D advocacy groups and foundations, “Provention is well-positioned and connected to build momentum for screening and identification initiatives.” The analyst added, “While the hurdle to execute successfully is high, reward, in our view, would be commensurate.”
When it comes to the long-term opportunity, “the TN-10 population criteria” remains a key area of focus for Kim, as “these opportunities may not only expand the market opportunity for teplizumab but also significantly solidify its positioning the treatment paradigm.” He also mentions that re-dosing paradigms and adjunctive use post-transplant for teplizumab are other points of strength.
Summing it all up, Kim stated, “PRVB remains underappreciated in our universe, potentially given macro themes around COVID-19 and intensified focus on momentum names. However, as continued execution carries PRVB through successful regulatory, pre-commercial, and commercial milestones, we believe the shares could enter a period of significant re-rating.”
Everything that PRVB has going for it prompted Kim to leave his Outperform (i.e. Buy) rating as is. Along with the call, he keeps the price target at $29, suggesting 106% upside potential. (To watch Kim’s track record, click here)
Turning to the rest of the Street, the bulls have it on this one. With 4 Buys and no Holds or Sells assigned in the last three months, the word on the Street is that PRVB is a Strong Buy. At $28.75, the average price target implies 104% upside potential. (See PRVB stock analysis on TipRanks)
To find good ideas for 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.