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3 “Strong Buy” Pharmaceutical Stocks With Major Catalysts Approaching

3 "Strong Buy" Pharmaceutical Stocks With Major Catalysts Approaching

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Even during economic downturns, one fact remains resolute: pharma stocks represent the ultimate risk/reward plays. Out on Wall Street, the sector has become known for its high volatility. How did it earn this reputation? It comes down to the nature of the industry itself.

Unlike companies in other areas of the market, pharma stocks depend less on earnings results, and more on clinical data and regulatory decisions. As the latter determine the trajectory of these stocks, a single piece of good news can act as a catalyst that sends shares skyrocketing.

That being said, shares can plummet just as easily should a company publish lackluster data or if approvals don’t come through. For this reason, in-depth due diligence is necessary before pulling the trigger on a name in this sector.

Today, we’ll look at three pharma stocks recommended by Sumant Kulkarni, a top-rated analyst from Canaccord. Kulkarni believes these three tickers could be propelled higher by upcoming clinical trial results that could be huge catalysts for each one.

Indeed, according to TipRanks’ database, each ticker scores a “Strong Buy” consensus rating from the rest of the Street and boasts substantial upside potential.

Zynerba Pharmaceuticals (ZYNE)

Focused on developing transdermally-delivered cannabinoid therapeutics, Zynerba Pharmaceuticals wants to improve the lives of patients suffering from neuropsychiatric conditions like Fragile X syndrome (FXS), Autism Spectrum Disorder (ASD), 22q and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).

On the heels of its recent positive data readout and more potential catalysts ahead, Kulkarni believes ZYNE's $5.50 share price looks like a steal.

On May 27, ZYNE released data from its Phase 2 open-label BRIGHT trial studying Zygel (ZYN002), a transdermal synthetic cannabidiol gel, in ASD. Even though it’s still early, the data indicated that the asset could serve as an add-on treatment to the standard of care for the behavioral symptoms associated with the condition.

Expounding on this, Kulkarni noted, “Specifically, Zygel ‘hit’ on all five sub-scales of the Aberrant Behavior Checklist - Community (ABC-C), and also on the Parent-Rated Anxiety Scale - ASD (PRAS-ASD), while retaining the relatively-benign safety/tolerability profile seen so far.”  

While certainly promising, focus remains primarily on the data readout for the double-blind, placebo-controlled, CONNECT-FX pivotal trial evaluating Zygel in FXS, which is slated for later this month.

“Our view is there is limited read-through from today's ASD data to FXS, but we are encouraged Zygel appears to have activity on scales associated with social parameters. Our stock thesis is unchanged in that FXS has no approved products and trial data remain difficult to call, but we believe ZYNE presents significant opportunity for risk-tolerant investors going into the FXS data set,” Kulkarni commented.

If that wasn’t enough, Kulkarni points to several other possible catalysts on the horizon. The verdict from ZYNE’s discussions with the FDA regarding Zygel’s DEE pivotal program is set to come in the next few weeks, with top-line results from the Phase 2 open-label INSPIRE study for Zygel in 22q coming the following quarter.

To this end, Kulkarni rates ZYNE a Buy along with an $18 price target. This target implies shares could more than double in the next year. (To watch Kulkarni’s track record, click here)   

Like Kulkarni, other analysts also take a bullish approach. ZYNE’s Strong Buy consensus rating breaks down into 6 Buys and zero Holds or Sells. Given the $19.17 average price target, the upside potential lands at 249%. (See Zynerba stock analysis on TipRanks)

BioXcel Therapeutics (BTAI)

Next up we have BioXcel Therapeutics, which uses artificial intelligence (AI) to develop cutting-edge medicines across neuroscience and immuno-oncology. With two major potential catalysts in the near-term, it’s no wonder Wall Street focus has locked in on this name.

On June 11, the company revealed that the first patient had been enrolled in RELEASE, its Phase 1b/2 trial assessing the use of BXCL501, a sublingual dexmedetomidine film, in treating opioid withdrawal symptoms.

Weighing in on the implications of this development, Kulkarni said, “This on-time start means BXCL501 will move into a sub-chronic dosing setting vs. acute/rescue therapy for agitation where it is farther along in development. This move also ties into BTAI's strategy to build a broader/leading franchise around agitation, which is an approach that we continue to view as smart. We also remain impressed by management's ability to hit stated timelines, and look forward to RELEASE top-line data in 1Q21.”

Speaking to the opportunity in this indication, there’s already a significant unmet need, and COVID-19 could potentially make the situation worse for many patients. As a result, Kulkarni projects a 2023 launch and unadjusted peak sales of $472 million in 2030.

However, before this, data on the candidate’s use in treating agitation caused by other conditions is expected. Kulkarni is looking forward to the data readout for the Phase 3 SERENITY trial of BXCL501 in agitation in schizophrenia and bipolar disorder this July as well as the results from the Phase 1b/2 TRANQUILITY trial in dementia-induced agitation in mid-2020.

Calling the above readouts “two key catalysts”, Kulkarni noted, “We continue to believe SERENITY data will come before TRANQUILITY, and like the risk-reward for the stock going into these events based on solid Phase 1b/2 data in schizophrenia, and proof-of-concept data in dementia.” The analyst added, “We model a probability of approval estimate of 75% for agitation in schizophrenia/bipolar disorder and our 2030E peak unadjusted sales are $313 million. We model 65% probability of approval in agitation in dementia, and our 2030E unadjusted peak sales are $584 million.”

All of the above combined with other possible catalysts involving BXCL501 and BTAI’s other candidate, BXCL701, slated for 2H20 prompted Kulkarni to keep a Buy recommendation and $71 price target on the stock. Should the target be met, a twelve-month gain of 34% could be in store.

All in all, other analysts are on the same page. 4 Buys and no Holds or Sells add up to a Strong Buy consensus rating. Based on the $89 average price target, which is more aggressive than Kulkarni’s, the upside potential comes in at 68%. (See BioXcel stock analysis on TipRanks)

Intra-Cellular Therapies (ITCI)

Founded on Nobel-prize winning research that uncovered how therapies impact the inner-workings of cells in the body, Intra-Cellular Therapies hopes to address the unmet needs of patients battling complex psychiatric and neurologic diseases. Ahead of an important possible catalyst, Kulkarni thinks ITCI is “significantly undervalued”.

It should be noted that its most recent quarter saw the company achieve a major milestone as its recently-approved Caplyta product, lumateperone, for schizophrenia, was launched. Only on the market since March 23, the asset generated just under $1 million in sales, with Kulkarni calling for $1.1 million. This is impressive as the estimate wasn’t updated after the onset of the COVID-19 pandemic.

“Given the current environment, we get the sense that ITCI has been nimble enough to adapt well and has also made good progress with payers... We continue to believe Caplyta could generate meaningful sales in schizophrenia, and at these levels we are BUYERS on this opportunity alone.” Kulkarni explained.

Also noteworthy for Kulkarni, though, is the publication of data from the Phase 3 global adjunct trial for lumateperone in bipolar depression, which is set to come in mid-20. Additionally, the analyst points out that ITCI should provide updates regarding its discussions with the FDA on this indication.

“That said, we also like the stock going into the mid-20 Phase 3 data for lumateperone in bipolar depression, which represents greater unmet need and is a potentially larger market opportunity with fewer approved products,” Kulkarni stated. The analyst added, “Recall that in 1Q20, ITCI started another monotherapy Phase 3 trial (global) with results expected in 2H21. ITCI, however, expects to send in a supplemental new drug application (sNDA) for bipolar depression in late-2020. With a successful global monotherapy trial and a U.S. trial with mixed results, we believe ITCI has a solid shot at a potential approval in this indication.”

The good news didn’t end there. Kulkarni believes that the possible upside drivers extend beyond lumateperone, with Phase 1/2 data for ITI-214 in heart failure expected in the next few weeks.

It should come as no surprise, then, that Kulkarni stayed with the bulls. In addition to keeping a Buy rating on the stock, the analyst maintained a $70 price target, which brings the upside potential to 215%.

Do other analysts agree with Kulkarni? As it turns out, they do. Only Buy ratings, 3 to be exact, have been received in the last three months, so the consensus rating is a Strong Buy. At $47.67, the average price target indicates 115% upside potential. (See Intra-Cellular stock-price forecast on TipRanks)

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

The post 3 "Strong Buy" Pharmaceutical Stocks With Major Catalysts Approaching appeared first on TipRanks Financial Blog.

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Survey Shows Declining Concerns Among Americans About COVID-19

Survey Shows Declining Concerns Among Americans About COVID-19

A new survey reveals that only 20% of Americans view covid-19 as "a major threat"…

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Survey Shows Declining Concerns Among Americans About COVID-19

A new survey reveals that only 20% of Americans view covid-19 as "a major threat" to the health of the US population - a sharp decline from a high of 67% in July 2020.

(SARMDY/Shutterstock)

What's more, the Pew Research Center survey conducted from Feb. 7 to Feb. 11 showed that just 10% of Americans are concerned that they will  catch the disease and require hospitalization.

"This data represents a low ebb of public concern about the virus that reached its height in the summer and fall of 2020, when as many as two-thirds of Americans viewed COVID-19 as a major threat to public health," reads the report, which was published March 7.

According to the survey, half of the participants understand the significance of researchers and healthcare providers in understanding and treating long COVID - however 27% of participants consider this issue less important, while 22% of Americans are unaware of long COVID.

What's more, while Democrats were far more worried than Republicans in the past, that gap has narrowed significantly.

"In the pandemic’s first year, Democrats were routinely about 40 points more likely than Republicans to view the coronavirus as a major threat to the health of the U.S. population. This gap has waned as overall levels of concern have fallen," reads the report.

More via the Epoch Times;

The survey found that three in ten Democrats under 50 have received an updated COVID-19 vaccine, compared with 66 percent of Democrats ages 65 and older.

Moreover, 66 percent of Democrats ages 65 and older have received the updated COVID-19 vaccine, while only 24 percent of Republicans ages 65 and older have done so.

“This 42-point partisan gap is much wider now than at other points since the start of the outbreak. For instance, in August 2021, 93 percent of older Democrats and 78 percent of older Republicans said they had received all the shots needed to be fully vaccinated (a 15-point gap),” it noted.

COVID-19 No Longer an Emergency

The U.S. Centers for Disease Control and Prevention (CDC) recently issued its updated recommendations for the virus, which no longer require people to stay home for five days after testing positive for COVID-19.

The updated guidance recommends that people who contracted a respiratory virus stay home, and they can resume normal activities when their symptoms improve overall and their fever subsides for 24 hours without medication.

“We still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses, this includes vaccination, treatment, and staying home when we get sick,” CDC director Dr. Mandy Cohen said in a statement.

The CDC said that while the virus remains a threat, it is now less likely to cause severe illness because of widespread immunity and improved tools to prevent and treat the disease.

Importantly, states and countries that have already adjusted recommended isolation times have not seen increased hospitalizations or deaths related to COVID-19,” it stated.

The federal government suspended its free at-home COVID-19 test program on March 8, according to a website set up by the government, following a decrease in COVID-19-related hospitalizations.

According to the CDC, hospitalization rates for COVID-19 and influenza diseases remain “elevated” but are decreasing in some parts of the United States.

Tyler Durden Sun, 03/10/2024 - 22:45

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Rand Paul Teases Senate GOP Leader Run – Musk Says “I Would Support”

Rand Paul Teases Senate GOP Leader Run – Musk Says "I Would Support"

Republican Kentucky Senator Rand Paul on Friday hinted that he may jump…

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Rand Paul Teases Senate GOP Leader Run - Musk Says "I Would Support"

Republican Kentucky Senator Rand Paul on Friday hinted that he may jump into the race to become the next Senate GOP leader, and Elon Musk was quick to support the idea. Republicans must find a successor for periodically malfunctioning Mitch McConnell, who recently announced he'll step down in November, though intending to keep his Senate seat until his term ends in January 2027, when he'd be within weeks of turning 86. 

So far, the announced field consists of two quintessential establishment types: John Cornyn of Texas and John Thune of South Dakota. While John Barrasso's name had been thrown around as one of "The Three Johns" considered top contenders, the Wyoming senator on Tuesday said he'll instead seek the number two slot as party whip. 

Paul used X to tease his potential bid for the position which -- if the GOP takes back the upper chamber in November -- could graduate from Minority Leader to Majority Leader. He started by telling his 5.1 million followers he'd had lots of people asking him about his interest in running...

...then followed up with a poll in which he predictably annihilated Cornyn and Thune, taking a 96% share as of Friday night, with the other two below 2% each. 

Elon Musk was quick to back the idea of Paul as GOP leader, while daring Cornyn and Thune to follow Paul's lead by throwing their names out for consideration by the Twitter-verse X-verse. 

Paul has been a stalwart opponent of security-state mass surveillance, foreign interventionism -- to include shoveling billions of dollars into the proxy war in Ukraine -- and out-of-control spending in general. He demonstrated the latter passion on the Senate floor this week as he ridiculed the latest kick-the-can spending package:   

In February, Paul used Senate rules to force his colleagues into a grueling Super Bowl weekend of votes, as he worked to derail a $95 billion foreign aid bill. "I think we should stay here as long as it takes,” said Paul. “If it takes a week or a month, I’ll force them to stay here to discuss why they think the border of Ukraine is more important than the US border.”

Don't expect a Majority Leader Paul to ditch the filibuster -- he's been a hardy user of the legislative delay tactic. In 2013, he spoke for 13 hours to fight the nomination of John Brennan as CIA director. In 2015, he orated for 10-and-a-half-hours to oppose extension of the Patriot Act

Rand Paul amid his 10 1/2 hour filibuster in 2015

Among the general public, Paul is probably best known as Capitol Hill's chief tormentor of Dr. Anthony Fauci, who was director of the National Institute of Allergy and Infectious Disease during the Covid-19 pandemic. Paul says the evidence indicates the virus emerged from China's Wuhan Institute of Virology. He's accused Fauci and other members of the US government public health apparatus of evading questions about their funding of the Chinese lab's "gain of function" research, which takes natural viruses and morphs them into something more dangerous. Paul has pointedly said that Fauci committed perjury in congressional hearings and that he belongs in jail "without question."   

Musk is neither the only nor the first noteworthy figure to back Paul for party leader. Just hours after McConnell announced his upcoming step-down from leadership, independent 2024 presidential candidate Robert F. Kennedy, Jr voiced his support: 

In a testament to the extent to which the establishment recoils at the libertarian-minded Paul, mainstream media outlets -- which have been quick to report on other developments in the majority leader race -- pretended not to notice that Paul had signaled his interest in the job. More than 24 hours after Paul's test-the-waters tweet-fest began, not a single major outlet had brought it to the attention of their audience. 

That may be his strongest endorsement yet. 

Tyler Durden Sun, 03/10/2024 - 20:25

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The Great Replacement Loophole: Illegal Immigrants Score 5-Year Work Benefit While “Waiting” For Deporation, Asylum

The Great Replacement Loophole: Illegal Immigrants Score 5-Year Work Benefit While "Waiting" For Deporation, Asylum

Over the past several…

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The Great Replacement Loophole: Illegal Immigrants Score 5-Year Work Benefit While "Waiting" For Deporation, Asylum

Over the past several months we've pointed out that there has  been zero job creation for native-born workers since the summer of 2018...

... and that since Joe Biden was sworn into office, most of the post-pandemic job gains the administration continuously brags about have gone foreign-born (read immigrants, mostly illegal ones) workers.

And while the left might find this data almost as verboten as FBI crime statistics - as it directly supports the so-called "great replacement theory" we're not supposed to discuss - it also coincides with record numbers of illegal crossings into the United States under Biden.

In short, the Biden administration opened the floodgates, 10 million illegal immigrants poured into the country, and most of the post-pandemic "jobs recovery" went to foreign-born workers, of which illegal immigrants represent the largest chunk.

Asylum seekers from Venezuela await work permits on June 28, 2023 (via the Chicago Tribune)

'But Tyler, illegal immigrants can't possibly work in the United States whilst awaiting their asylum hearings,' one might hear from the peanut gallery. On the contrary: ever since Biden reversed a key aspect of Trump's labor policies, all illegal immigrants - even those awaiting deportation proceedings - have been given carte blanche to work while awaiting said proceedings for up to five years...

... something which even Elon Musk was shocked to learn.

Which leads us to another question: recall that the primary concern for the Biden admin for much of 2022 and 2023 was soaring prices, i.e., relentless inflation in general, and rising wages in particular, which in turn prompted even Goldman to admit two years ago that the diabolical wage-price spiral had been unleashed in the US (diabolical, because nothing absent a major economic shock, read recession or depression, can short-circuit it once it is in place).

Well, there is one other thing that can break the wage-price spiral loop: a flood of ultra-cheap illegal immigrant workers. But don't take our word for it: here is Fed Chair Jerome Powell himself during his February 60 Minutes interview:

PELLEY: Why was immigration important?

POWELL: Because, you know, immigrants come in, and they tend to work at a rate that is at or above that for non-immigrants. Immigrants who come to the country tend to be in the workforce at a slightly higher level than native Americans do. But that's largely because of the age difference. They tend to skew younger.

PELLEY: Why is immigration so important to the economy?

POWELL: Well, first of all, immigration policy is not the Fed's job. The immigration policy of the United States is really important and really much under discussion right now, and that's none of our business. We don't set immigration policy. We don't comment on it.

I will say, over time, though, the U.S. economy has benefited from immigration. And, frankly, just in the last, year a big part of the story of the labor market coming back into better balance is immigration returning to levels that were more typical of the pre-pandemic era.

PELLEY: The country needed the workers.

POWELL: It did. And so, that's what's been happening.

Translation: Immigrants work hard, and Americans are lazy. But much more importantly, since illegal immigrants will work for any pay, and since Biden's Department of Homeland Security, via its Citizenship and Immigration Services Agency, has made it so illegal immigrants can work in the US perfectly legally for up to 5 years (if not more), one can argue that the flood of illegals through the southern border has been the primary reason why inflation - or rather mostly wage inflation, that all too critical component of the wage-price spiral  - has moderated in in the past year, when the US labor market suddenly found itself flooded with millions of perfectly eligible workers, who just also happen to be illegal immigrants and thus have zero wage bargaining options.

None of this is to suggest that the relentless flood of immigrants into the US is not also driven by voting and census concerns - something Elon Musk has been pounding the table on in recent weeks, and has gone so far to call it "the biggest corruption of American democracy in the 21st century", but in retrospect, one can also argue that the only modest success the Biden admin has had in the past year - namely bringing inflation down from a torrid 9% annual rate to "only" 3% - has also been due to the millions of illegals he's imported into the country.

We would be remiss if we didn't also note that this so often carries catastrophic short-term consequences for the social fabric of the country (the Laken Riley fiasco being only the latest example), not to mention the far more dire long-term consequences for the future of the US - chief among them the trillions of dollars in debt the US will need to incur to pay for all those new illegal immigrants Democrat voters and low-paid workers. This is on top of the labor revolution that will kick in once AI leads to mass layoffs among high-paying, white-collar jobs, after which all those newly laid off native-born workers hoping to trade down to lower paying (if available) jobs will discover that hardened criminals from Honduras or Guatemala have already taken them, all thanks to Joe Biden.

Tyler Durden Sun, 03/10/2024 - 19:15

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