- Arcutis reports quarterly earnings of 32 cents per share which beat the analyst consensus estimate of losses of 73 cents.
- Quarterly sales clock in at $49.57 million, beating the analyst consensus estimate of $14.68 million by 237.66%.
Tuesday, May 14, 2024
Arcutis Biotherapeutics Stock Climbs After Blockbuster Q1
Inovio started at Overweight by Stephens
Stephens initiated coverage on INOVIO Pharmaceuticals Inc
, noting the company’s diversified clinical pipeline of therapeutic and vaccine candidates, which the company is looking to advance eight additional clinical-stage candidates.
The analyst writes that the FDA considered lead program INO-3107 Phase 1/2 clinical trials sufficient for the Accelerated Approval Program.
If approved, INO-3107 could be the first non-surgical treatment for recurrent respiratory papillomatosis (RRP).
RRP is a rare chronic disease caused by the human papillomavirus. In RRP, wart-like tumors grow on and around vocal cords.
FDA marketing application submission for INO-3107 is on track for the second half of 2024.
The analyst initiated coverage with an Overweight rating with a price target of $20.
Stephens says INOVIO’s proprietary technology and approach involves developing and administering DNA plasmids into affected cells to restore normal functionality.
The DNA Medicines pipeline also has early clinical stage programs ongoing for head and neck squamous cell carcinoma, glioblastoma, and as an Ebola vaccine booster.
“We view the efficiencies implemented by the leadership team will translate over to more “high-percentage shots-on-goal” to de-risk the platform technology,” Stephens writes.
The analyst also writes, “New leadership and strategic reorganizations align focus to lead programs and operational efficiencies.”
Activist Jana Partners built position in QuidelOrtho in Q1: sources
Activist investor Jana Partners built a new stake in U.S. diagnostics company QuidelOrtho during the first quarter, sources familiar with the hedge fund’s position told Reuters.
It is unclear whether the hedge fund will seek changes at the company, which makes the popular QuickVue COVID-19 test for home use, and it could not be determined how large Jana’s stake is.
The company’s stock price, which had already been trading up roughly 1%, extended gains to roughly 10% before wiping away some of the increase. Trading closed at $44.18, up 4.92%.
A representative for Jana declined to comment and a representative for QuidelOrtho did not respond to a request for comment.
By building the position however, the hedge fund is signaling its interest in the company and that it has already committed significant resources to what could become an activist campaign.
The stake could be revealed publicly when Jana makes its 13F filing, which requires fund managers to detail their ownership in publicly traded U.S. companies for a given three-month period.
QuidelOrtho currently has a market valuation of roughly $2.8 billion and its stock price has tumbled more than 50% in the last 52 weeks. Since January the stock price has dropped 44%.
Biden's new China tariff wall faces leakage via Mexico, Vietnam
The Biden administration's new tariffs on Chinese electric vehicles and other strategic sectors aim to protect the future of U.S. manufacturing, but they will likely accelerate a shift of Chinese production to Mexico, Vietnam and elsewhere to avoid them.
U.S. officials and trade experts say that without strong efforts to cut off transshipped or lightly processed Chinese goods from Mexico and other countries, China's underpriced excess production will still find its way into U.S. markets.
"The new tariffs might keep out imports from China but it is likely that much of those imports could be rerouted through countries not subject to the tariffs," said Eswar Prasad, trade policy professor at Cornell University and a former China director at the International Monetary Fund.
Mexico and Vietnam, in particular, have benefited from escalating U.S.-China trade tensions due to their lower costs and proximity, Prasad said, adding that they both need to avoid Washington's "ire" while reaping new manufacturing investments.
Mexico, for one, has overtaken China as the top source of imports into the U.S., with more than $115 billion of goods originating from there in the first three months of 2024 versus less than $100 billion from China.
With that surge, concerns have grown about Mexico becoming a transshipment hub for Chinese goods to skirt U.S. tariffs, due to increasing U.S. imports of steel products from Mexico and Chinese EV maker BYD scouting out locations for a Mexican factory that could potentially supply the U.S. market. Reuters reported last month that U.S. officials have pressured Mexico to refuse investment incentives to Chinese automakers.
Punitive duties on Chinese EVs will soon be quadrupled to more than 100% under President Joe Biden's new tariff hikes on high-technology imports from China. The action also includes a doubling of duties on semiconductors and solar cells to 50% this year and new 25% tariffs on Chinese critical battery minerals, Chinese graphite and EV battery magnets over the next two years.
The tariffs are designed to protect new domestic manufacturing sectors that the Biden administration is trying to develop with hundreds of billions of dollars in tax incentives and grants.
'FACT PATTERN' TROUBLING
U.S. Trade Representative Katherine Tai told reporters she was concerned about Mexico's trade relationship with China and to "stay tuned" on future separate efforts to head off tariff evasion problems.
"The fact pattern that's developing is one that is of serious concern to us, and that at USTR, we are looking at all of our tools to see how we can address the problem," Tai said.
Biden issues veto threat over ‘misguided’ GOP bill on weapons to Israel
The White House said Tuesday that President Biden would veto a House GOP bill intended to pressure him to send weapons to Israel, calling it a “misguided reaction to a deliberate distortion of the Administration’s approach to Israel.”
The pushback comes ahead of an expected vote this week on the Israel Security Assistance Support Act. GOP lawmakers introduced the bill after Biden warned he would withhold certain offensive weapons for Israel if its forces invaded Rafah in Gaza.
But the White House cautioned that the legislation “would undermine the President’s ability to execute an effective foreign policy.”
“This bill could raise serious concerns about infringement on the President’s authorities under Article II of the Constitution, including his duties as Commander-in-Chief and Chief Executive and his power to conduct foreign relations,” the White House said in a statement of administration policy.
“The President has been clear: we will always ensure Israel has what it needs to defend itself. Our commitment to Israel is ironclad,” the White House added.
The U.S. already paused a shipment of bombs to Israel earlier this month over concerns of a looming full-scale invasion of Rafah. Officials said the large bombs were withheld because of the damage they could cause in high-density areas.
Biden warned in a CNN interview last week that he would stop supplying Israel with offensive weapons such as bombs and artillery shells if Israeli forces launched an invasion of Rafah, where about a million refugees have settled after fleeing the fighting in northern Gaza. He said the U.S. would continue to supply defensive materials, such as missiles for the Iron Dome, regardless of Israel’s actions.
The House bill urges the “expeditious delivery” of defense articles and services to Israel, condemns the Biden administration’s decision to pause shipments to Israel and reaffirms Israel’s right to self-defense.
It also calls for funds for the secretaries of Defense and State and the National Security Council to be withheld until defense articles are delivered to Israel.
White House press secretary Karine Jean-Pierre said Monday that the administration “strongly” opposed the bill, and that the White House planned “to spend every last cent appropriated consistent with legal obligations, including in the recent … national security supplemental that was just passed.”
In late April, Biden signed a national security package that included $61 billion in aid for Ukraine in its war against Russia and $15 billion in military aid for Israel, which has been fighting Hamas after the group killed more than 1,100 Israelis in attacks last October.
More copies of ribosomal DNA may mean higher risks of developing disease
Ribosomal DNA (rDNA) is present in hundreds of copies in the genome, but has not previously been part of genetic analyses. A new study of 500,000 individuals indicates that people who have more copies of rDNA are more likely to develop inflammation and diseases during their lifetimes.
Standard genetic analysis techniques have not studied areas of the human genome that are repetitive, such as ribosomal DNA (rDNA), a fundamental part of the molecular mechanism which makes proteins in cells.
A new study, led by Vardhman Rakyan and Francisco Rodriguez-Algarra from Queen Mary University of London's Blizard Institute in collaboration with David Evans from the University of Queensland's Institute for Molecular Bioscience, has discovered that genetic disposition to disease can be found in these previously understudied areas of the genome.
The results, published in Cell Genomics, suggest that wider genome analysis could bring opportunities for preventative diagnostics, novel therapeutics, and greater insight into the mechanism of different human diseases.
In this study, samples from 500,000 individuals in the UK Biobank project were analyzed. Researchers used new whole genome sequencing (WGS) techniques to identify differences in numbers of copies of rDNA in each sample, and compared them with other health metrics and medical records.
The researchers found that the number of copies of rDNA in an individual showed strong statistical association with well-established markers of systemic inflammation—such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII). These statistically significant associations were seen in the genomes of individuals of different ethnicities, suggesting a common indicator for risks of future disease.
rDNA copy number was also linked with an individual's kidney function within the sample of individuals of European ancestry. A similar effect was seen in samples from other ancestries, but further research using larger sample sizes will be needed to confirm this connection.
Professor Vardhman Rakyan, from the Genomics and Child Health in the Blizard Institute at Queen Mary, said, "Our research highlights the importance of analyzing the whole genome to better understand the factors impacting on our health. This study is also an example of how having access to large biobanks allows us to make unexpected discoveries, and provides new avenues for harnessing the power of genetics to understand human diseases."
Professor David Evans, from the University of Queensland's Institute for Molecular Bioscience, said, "Geneticists have long struggled to fully explain the genetic basis of many common complex traits and diseases. Our work suggests that at least part of this missing heritability resides in difficult to sequence regions of the genome such as those encoding ribosomal copy number variation."
More information: Ribosomal DNA Copy Number Variation Associates with Hematological Profiles and Renal Function in the UK Biobank, Cell Genomics (2024). DOI: 10.1016/j.xgen.2024.100562. www.cell.com/cell-genomics/ful … 2666-979X(24)00128-9
https://medicalxpress.com/news/2024-05-analysis-people-ribosomal-dna-higher.html
Virus that causes COVID-19 can penetrate blood-retinal-barrier and could damage vision
The blood-retinal barrier is designed to protect our vision from infections by preventing microbial pathogens from reaching the retina where they could trigger an inflammatory response with potential vision loss. But researchers at the University of Missouri School of Medicine have discovered the virus that causes COVID-19 can breach this protective retinal barrier with potential long-term consequences in the eye.
Pawan Kumar Singh, Ph.D., an assistant professor of ophthalmology, leads a team researching new ways to prevent and treat ocular infectious diseases. Using a humanized ACE2 mice model, the team found that SARS-CoV-2, the virus that causes COVID-19, can infect the inside of the eyes even when the virus doesn't enter the body through the surface of the eyes.
Instead, they found that when viruses enter the body through inhalation, it not only infects organs like lungs, but also reaches highly protected organs like eyes through the blood-retinal barrier by infecting the cells lining this barrier.
"This finding is important as we increase our understanding of the long-term effects of SARS-CoV-2 infection," said Singh. "Earlier, researchers were primarily focused on the ocular surface exposure of the virus. However, our findings reveal that SARS-CoV-2 not only reaches the eye during systemic infection but induces a hyperinflammatory response in the retina and causes cell death in the blood-retinal barrier. The longer viral remnants remain in the eye, the risk of damage to the retina and visual function increases."
Singh also discovered that extended presence of SARS-CoV-2 spike antigen can cause retinal microaneurysm, retinal artery and vein occlusion, and vascular leakage.
"For those who have been diagnosed with COVID-19, we recommend you ask your ophthalmologist to check for signs of pathological changes to the retina," Singh said. "Even those who were asymptomatic could suffer from damage in the eyes over time because of COVID-19 associated complications."
While viruses and bacteria have been found to breach the blood-retinal-barrier in immunocompromised people, this research is the first to suggest that the virus that causes COVID-19 could breach the barrier even in otherwise healthy individuals, leading to an infection that manifests inside the eye itself. Immunocompromised patients or those with hypertension or diabetes may experience worse outcomes if they remain undiagnosed for COVID-19 associated ocular symptoms.
"Now that we know the risk of COVID-19 to the retina, our goal is to better understand the cellular and molecular mechanisms of how this virus breaches the blood-retinal barrier and associated pathological consequences in hopes of informing development of therapies to prevent and treat COVID-19 induced eye complications before a patient's vision is compromised," Singh said.
This study, titled "SARS-CoV-2 infects cells lining the blood-retinal barrier and induces a hyperinflammatory immune response in the retina via systemic exposure," was recently published in PLOS Pathogens.
In addition to Singh, the research team from the University of Missouri School of Medicine included Vaishnavi Balendiran, MD, vitreoretinal surgery fellow; Monu Monu and Faraz Ahmad, post-doctoral fellows in the Department of Ophthalmology; and Rachel M. Olson, Ph.D., Chief Scientific Officer, Laboratory for Infectious Disease Research at the College of Veterinary Medicine.
More information: Monu Monu et al, SARS-CoV-2 infects cells lining the blood-retinal barrier and induces a hyperinflammatory immune response in the retina via systemic exposure, PLOS Pathogens (2024). DOI: 10.1371/journal.ppat.1012156
https://medicalxpress.com/news/2024-05-virus-covid-penetrate-blood-retinal.html
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