Optimism is on the rise, and investors are wondering if stocks are heading towards recovery territory. So, what does this mean for one industry that has largely outperformed the broader market amid the pandemic?
Just in time for summer, J.P. Morgan strategists looked at the biotech sector’s average summertime performance over the last 19 years, versus the S&P 500, to gain insights regarding what the next few months have in store for the space. Contrary to popular belief, the biotech indexes, NBI and IBB, bested the S&P 500 during the summer season in 12 out of 19 years, including 7 of the last 10.
Not to mention for the 11 years that the NBI was up going into summer, the space rounded out the year in the green 8 times. While COVID-19 could impact summer results, historically, this could bode well for the NBI, which is up 11.7% year-to-date.
Bearing this in mind, focus has narrowed in on the biotech space. That said, seasoned veterans of the Street know that these names come with a significant amount of risk due to the industry’s nature. For biotech companies, indicators like data readouts or regulatory verdicts are used to gauge the health of long-term growth narratives rather than financial results, and thus, any update can act as a catalyst capable of sending shares in either direction.
Acknowledging the risk involved, we used TipRanks’ database to take a closer look at three biotech stocks currently trading for under $5 apiece ahead of upcoming catalysts. All three tickers boast massive upside potential and have earned overwhelmingly bullish support from analysts, enough so to score a “Strong Buy” consensus rating.
Working on a cutting-edge anti-fungal asset, oral and IV ibrexafungerp (SCY-078), SCYNEXIS hopes to address the unmet medical needs of patients with difficult-to-treat and life-threatening fungal infections. With the candidate’s NDA submission slated for Q3 2020, several members of the Street believe that at $0.75 per share, investors should pull the trigger.
In a recent update, SCYX announced positive results from both the VANISH-306 trial and the FURI study, which are evaluating ibrexafungerp in vulvovaginal candidiasis (VVC) and severe fungal infections, respectively.
Marking the successful completion of the VANISH program, VANISH-306 saw the therapy demonstrate superior rates of resolution of symptoms at day 10, which was the test of cure, compared to the placebo.
Weighing in for Ladenburg, analyst Michael Higgins argues that because it has been 20 years since the only drug, Diflucan (fluconazole, “FLU”), was approved to treat VVC, the market should be very open to a new solution.
Higgins added, “In acute VVC, we believe ibrexa’s mid-70% rate of efficacy at day 25 will impress physicians when pared to FLU’s mid-50% rate (per its label)… And finally, we believe ibrexa has a key, >one-year lead, over any competitor and its one-day regimen (300mg BID) to secure its leading position among any branded competitor.”
Looking at the second interim efficacy analysis of the Phase 3 open-label FURI study, the data also impressed. In-line with the first interim readout in January 2019, 17 out of 21 additional patients, who had untreatable, refractory fungal infections, also experienced a complete or partial response, or even stable disease.
Higgins points out that two FURI abstracts will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference this year. “The FURI abstracts show that Candida glabrata is the most common fungi among FURI’s refractory patients. More important, is that ibrexa successfully treated the C. glabrata infections, as this is a pathogen that is becoming more common and is currently highly resistant to azoles,” he commented.
All of this combined with its two additional studies of ibrexafungerp that could give the asset even more commercial opportunities prompted Higgins to remain squarely in the bull camp.
To this end, the analyst reiterates a Buy rating and $5 price target, indicating 575% upside potential from current levels. (To watch Higgins’ track record, click here)
Do other analysts agree with Higgins? As it turns out, they do. With 100% Street support, or 5 Buy ratings to be exact, the message is clear: SCYX is a Strong Buy. At $4.40, the average price target puts the upside potential at 494%. (See SCYNEXIS stock analysis on TipRanks)
With the goal of providing effective solutions for autoimmune, inflammatory and fibrotic diseases as well as immuno-oncology, Kadmon develops and commercializes innovative therapies. Currently going for $4.44 apiece, the analyst community thinks the share price reflects an attractive entry point.
On May 21, the company updated investors on its pivotal ROCKstar study of KD025 (belumosudil) in chronic graft-versus-host disease (cGHVD), releasing data from the study's primary analysis at six months post-enrollment completion. This data revealed that response rates got even deeper compared to the data from the interim analysis at two months post-enrollment completion, with ORR rates between 73-74% in the 200mg QD and BID arms, versus 64-67% as of the last update.
Commenting on the results for Cantor, analyst Eliana Merle said, “Importantly, we think the safety profile continues to look strong with no increased rate or risk of infections reported by the investigators, which we think will be a major commercial differentiator. From a stock perspective, although we think investors expected this data to be positive and for the response rates to improve with time, we think this strong update could serve as a clearing event for shares ahead of potential near-term commercial opportunity (NDA filing guided for 4Q20).”
Ahead of this key catalyst, Merle estimates that peak sales could reach $500 million, versus $700 million cap, with this large market opportunity potentially causing interest levels among market watchers to spike.
The good news kept on coming. KDMN also announced that it plans on submitting the NDA under the FDA's pilot Real-Time Oncology Review (RTOR) program. Even though Merle notes that it’s unclear exactly how this will impact review timelines, she believes it makes 2021 approval likely.
As the candidate has also received breakthrough designation, the deal is sealed for Merle. Along with a Buy rating, she reiterated a $10 price target. This target conveys her confidence in KDMN’s ability to soar 125% in the next twelve months. (To watch Merle’s track record, click here)
What does the rest of the Street think about KDMN? It turns out that other analysts also have high hopes. Only Buy ratings have been received in the last three months, 4 to be exact, so the consensus rating is a Strong Buy. More aggressive than Merle’s, the $13 average price target suggests 194% upside potential. (See Kadmon stock analysis on TipRanks)
Primarily focused on developing treatments for disorders of the ear that disrupt hearing, balance and connection, Otonomy wants to improve the lives of people impacted by the debilitating effects of these conditions. While COVID-19 has weighed on the company, some analysts believe that at $2.56, its share price presents investors with a unique buying opportunity.
Given the significant pandemic-induced slowdowns, OTIC was forced to withdraw trial timelines. That being said, H.C. Wainwright’s Oren Livnat remains optimistic based on the strength of Otividex, its sustained exposure dexamethasone intratympanic (IT) injection for Meniere’s disease (MD).
It should be noted that the candidate previously had one positive European Phase 3 study (AVERTS-2) but failed in one U.S. Phase 3 study (AVERTS-1), with the company currently conducting a third global study. Originally, the data readout for the study was expected to come by the end of Q3, but now Livnat predicts a one-quarter delay.
“We have no reason to think the integrity of the study is compromised as the primary endpoint was always collected via daily telephone diaries (not visits), and compliance apparently remains high. We remain optimistic that the final Phase 3 will replicate successful results seen in AVERTS-2 and the earlier Phase 2b... bolstered by more careful site selection and patient screening, not advertising, and improved communication and training to limit placebo response. Assuming a manageable delay, assuming success, we project 2022 launch and peak of $300 million sales for this underserved condition with no approved therapies,” Livnat explained.
On top of this, management stated it hopes to release top-line results from the Phase 1/2 of OTO-313 (IT gacyclidine) in tinnitus and that it has resumed the enrollment for the Phase 1/2 program evaluating OTO-413 (IT BDNF) in cochlear synaptopathic speech-in-noise hearing loss.
Also exciting, Livnat highlights the fact that OTIC and its partner, Applied Genetic Technologies, presented preclinical results for their AAV-based gene therapy for congenital hearing loss associated with GJB2 deficiency, with the data demonstrating that novel capsids are generating targeted gene expression in support cells throughout the cochlea. For at least twelve-weeks after one injection, no signs of cellular toxicity were witnessed.
Based on all of the above, it’s no wonder Livnat reiterated his bullish call. Given the $8 price target, shares could skyrocket 213% in the next twelve months. (To watch Livnat’s track record, click here)
Turning now to the rest of the Street, other analysts also like what they’re seeing. 3 Buys and no Holds or Sells have been assigned in the last three months, making the consensus rating a Strong Buy. Additionally, the $8 average price target matches Livnat’s. (See Otonomy stock analysis on TipRanks)
To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
We’ve added 60% to national debt since 2018. Germany - a country with major economic woes - added ‘just’ 32%.
Maybe it will never matter. Maybe MMT is real. Maybe we just cancel or inflate it out. Maybe career real estate borrowers or career politicians aren’t the answer.
I have no idea. Only time will tell. But it’s going to be fascinating to watch it play out.
He is right: it will be fascinating, and the latest budget deficit data simply confirmed that the day of reckoning will come very soon, certainly sooner than the two years that One River's Eric Peters predicted this weekend for the coming "US debt sustainability crisis."
According to the US Treasury, in February, the US collected $271 billion in various tax receipts, and spent $567 billion, more than double what it collected.
The two charts below show the divergence in US tax receipts which have flatlined (on a trailing 6M basis) since the covid pandemic in 2020 (with occasional stimmy-driven surges)...
... and spending which is about 50% higher compared to where it was in 2020.
The end result is that in February, the budget deficit rose to $296.3 billion, up 12.9% from a year prior, and the second highest February deficit on record.
And the punchline: on a cumulative basis, the budget deficit in fiscal 2024 which began on October 1, 2023 is now $828 billion, the second largest cumulative deficit through February on record, surpassed only by the peak covid year of 2021.
But wait there's more: because in a world where the US is spending more than twice what it is collecting, the endgame is clear: debt collapse, and while it won't be tomorrow, or the week after, it is coming... and it's also why the US is now selling $1 trillion in debt every 100 days just to keep operating (and absorbing all those millions of illegal immigrants who will keep voting democrat to preserve the socialist system of the US, so beloved by the Soros clan).
... having already surpassed total US defense spending and soon to surpass total health spending and, finally all social security spending, the largest spending category of all, which means that US debt will now rise exponentially higher until the inevitable moment when the US dollar loses its reserve status and it all comes crashing down.
We conclude with another observation by CNBC's Brian Sullivan, who quotes an email by a DC strategist...
.. which lays out the proposed Biden budget as follows:
The budget deficit will growth another $16 TRILLION over next 10 years. Thats *with* the proposed massive tax hikes.
Without them the deficit will grow $19 trillion.
That's why you will hear the "deficit is being reduced by $3 trillion" over the decade.
No family budget or business could exist with this kind of math.
Of course, in the long run, neither can the US... and since neither party will ever cut the spending which everyone by now is so addicted to, the best anyone can do is start planning for the endgame.
Former Project Veritas & O’Keefe Media Group operative and Pfizer formulation analyst scientist Justin Leslie revealed previously unpublished recordings showing Pfizer’s top vaccine researchers discussing major concerns surrounding COVID-19 vaccines. Leslie delivered these recordings to Veritas in late 2021, but they were never published:
Principal scientist at Pfizer, Kanwall Gill in 2021:
“We had no idea how it’s going to look like. MRNA vaccines have been there for 50 years, but nothing went to clinical trial because MRNA have been known to have side effects.”
Featured in Leslie’s footage is Kanwal Gill, a principal scientist at Pfizer. Gill was weary of MRNA technology given its long research history yet lack of approved commercial products. She called the vaccines “sneaky,” suggesting latent side effects could emerge in time.
Gill goes on to illustrate how the vaccine formulation process was dramatically rushed under the FDA’s Emergency Use Authorization and adds that profit incentives likely played a role:
Pfizer's principal scientist in 2021:
“It takes 10 year for a vaccine to come out. It takes years of observations... we are doing everything at the same time."
"It’s going to affect my heart, and I’m going to die. And nobody’s talking about that."
Leslie recorded another colleague, Pfizer’s pharmaceutical formulation scientist Ramin Darvari, who raised the since-validated concern that repeat booster intake could damage the cardiovascular system:
Pfizer's pharmaceutical formulation scientist, Ramin Darvari, in 2021:
“They’re engineering it specifically for me to take the next one, so increasing my consumption."
“It’s going to affect my heart, and I’m going to die. And nobody’s talking about that.”
None of these claims will be shocking to hear in 2024, but it is telling that high-level Pfizer researchers were discussing these topics in private while the company assured the public of “no serious safety concerns” upon the jab’s release:
Vaccine for Children is a Different Formulation
Leslie sent me a little-known FDA-Pfizer conference — a 7-hour Zoom meeting published in tandem with the approval of the vaccine for 5 – 11 year-olds — during which Pfizer’s vice presidents of vaccine research and development, Nicholas Warne and William Gruber, discussed a last-minute change to the vaccine’s “buffer” — from “PBS” to “Tris” — to improve its shelf life. For about 30 seconds of these 7 hours, Gruber acknowledged that the new formula was NOT the one used in clinical trials (emphasis mine):
“The studies were done using the same volume… but contained the PBS buffer. We obviously had extensive consultations with the FDA and it was determined that the clinical studies were not required because, again, the LNP and the MRNA are the same and the behavior — in terms of reactogenicity and efficacy — are expected to be the same.”
According to Leslie, the tweaked “buffer” dramatically changed the temperature needed for storage: “Before they changed this last step of the formulation, the formula was to be kept at -80 degrees Celsius. After they changed the last step, we kept them at 2 to 8 degrees celsius,” Leslie told me.
The claims are backed up in the referenced video presentation:
I’m no vaccinologist but an 80-degree temperature delta — and a 5x shelf-life in a warmer climate — seems like a significant change that might warrant clinical trials before commercial release.
Despite this information technically being public, there has been virtually no media scrutiny or even coverage — and in fact, most were told the vaccine for children was the same formula but just a smaller dose — which is perhaps due to a combination of the information being buried within a 7-hour jargon-filled presentation and our media being totally dysfunctional.
Bohemian Grove?
Leslie’s 2-hour long documentary on his experience at both Pfizer and O’Keefe’s companies concludes on an interesting note: James O’Keefe attended an outing at the Bohemian Grove.
Leslie offers this photo of James’ Bohemian Grove “GATE” slip as evidence, left on his work desk atop a copy of his book, “American Muckraker”:
My thoughts on the Bohemian Grove: my good friend’s dad was its general manager for several decades. From what I have gathered through that connection, the Bohemian Grove is not some version of the Illuminati, at least not in the institutional sense.
Do powerful elites hangout there? Absolutely. Do they discuss their plans for the world while hanging out there? I’m sure it has happened. Do they have a weird ritual with a giant owl? Yep, Alex Jones showed that to the world.
My perspective is based on conversations with my friend and my belief that his father is not lying to him. I could be wrong and am open to evidence — like if boxer Ryan Garcia decides to produce evidence regarding his rape claims — and I do find it a bit strange the club would invite O’Keefe who is notorious for covertly filming, but Occam’s razor would lead me to believe the club is — as it was under my friend’s dad — run by boomer conservatives the extent of whose politics include disliking wokeness, immigration, and Biden (common subjects of O’Keefe’s work).
Therefore, I don’t find O’Keefe’s visit to the club indicative that he is some sort of Operation Mockingbird asset as Leslie tries to depict (however Mockingbird is a 100% legitimate conspiracy). I have also met James several times and even came close to joining OMG. While I disagreed with James on the significance of many of his stories — finding some to be overhyped and showy — I never doubted his conviction in them.
As for why Leslie’s story was squashed… all my sources told me it was to avoid jail time for Veritas executives.
Feel free to watch Leslie’s full documentary here and decide for yourself.
Fun fact — Justin Leslie was also the operative behind this mega-viral Project Veritas story where Pfizer’s director of R&D claimed the company was privately mutating COVID-19 behind closed doors:
BREAKING: @Pfizer Exploring "Mutating" COVID-19 Virus For New Vaccines
"Don't tell anyone this...There is a risk...have to be very controlled to make sure this virus you mutate doesn't create something...the way that the virus started in Wuhan, to be honest."#DirectedEvolutionpic.twitter.com/xaRvlD5qTo
“[…] our findings support the hypothesis that the intrauterine environment, particularly essential and non-essential metals, affect epigenetic aging biomarkers across the life course.”
Credit: 2024 Bozack et al.
“[…] our findings support the hypothesis that the intrauterine environment, particularly essential and non-essential metals, affect epigenetic aging biomarkers across the life course.”
BUFFALO, NY- March 12, 2024 – A new research paper was published inAging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 16, Issue 4, entitled, “Associations of prenatal one-carbon metabolism nutrients and metals with epigenetic aging biomarkers at birth and in childhood in a US cohort.”
Epigenetic gestational age acceleration (EGAA) at birth and epigenetic age acceleration (EAA) in childhood may be biomarkers of the intrauterine environment. In this new study, researchers Anne K. Bozack, Sheryl L. Rifas-Shiman, Andrea A. Baccarelli, Robert O. Wright, Diane R. Gold, Emily Oken, Marie-France Hivert, and Andres Cardenas from Stanford University School of Medicine, Harvard Medical School, Harvard T.H. Chan School of Public Health, Columbia University, and Icahn School of Medicine at Mount Sinai investigated the extent to which first-trimester folate, B12, 5 essential and 7 non-essential metals in maternal circulation are associated with EGAA and EAA in early life.
“[…] we hypothesized that OCM [one-carbon metabolism] nutrients and essential metals would be positively associated with EGAA and non-essential metals would be negatively associated with EGAA. We also investigated nonlinear associations and associations with mixtures of micronutrients and metals.”
Bohlin EGAA and Horvath pan-tissue and skin and blood EAA were calculated using DNA methylation measured in cord blood (N=351) and mid-childhood blood (N=326; median age = 7.7 years) in the Project Viva pre-birth cohort. A one standard deviation increase in individual essential metals (copper, manganese, and zinc) was associated with 0.94-1.2 weeks lower Horvath EAA at birth, and patterns of exposures identified by exploratory factor analysis suggested that a common source of essential metals was associated with Horvath EAA. The researchers also observed evidence of nonlinear associations of zinc with Bohlin EGAA, magnesium and lead with Horvath EAA, and cesium with skin and blood EAA at birth. Overall, associations at birth did not persist in mid-childhood; however, arsenic was associated with greater EAA at birth and in childhood.
“Prenatal metals, including essential metals and arsenic, are associated with epigenetic aging in early life, which might be associated with future health.”
Read the full paper: DOI:https://doi.org/10.18632/aging.205602
Corresponding Author: Andres Cardenas
Corresponding Email:andres.cardenas@stanford.edu
Keywords: epigenetic age acceleration, metals, folate, B12, prenatal exposures
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About Aging:
Launched in 2009, Aging publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways.
Please visit our website at www.Aging-US.com and connect with us:
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