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Tuesday, October 31, 2023
Investor urges Staar Surgical Asia spinoff
Investment firm Anatole Investment Management called on STAAR Surgical Company to consider spinning off its Asia or China business, arguing the standalone China business could be worth as much as $5 billion, according to its letter to the company.
Hong Kong-based Anatole, which owns roughly 4.2% of the Monrovia, California headquartered company's shares, said STAAR is undervalued and not reaching its "huge growth potential."
STAAR designs, makes and sells lenses that can be implanted during eye surgeries.
Since February, STAAR's stock price has dropped nearly 50%. It closed at $41.82 on Tuesday.
Pointing to a large market in China and research that suggests female patients are willing to pay more for brand and product quality, the investment firm wrote that management should raise prices and streamline the sales process.
Most importantly, the investment firm urged STAAR to hire investment bankers or corporate finance advisers to consider spinning off the Asia business, which it said makes up close to 80% of total sales.
"We suggest that the company consider spinning off its Asia or China business and listing it on one of the Asian exchanges," Anatole wrote in the Oct. 20 letter to STAAR's board. "STAAR’s China business alone is worth $5 billion in our estimation."
The letter has not been reported.
STAAR has a market capitalization of $2 billion.
The letter was posted on Anatole's website. Anatole did not respond to emails or calls for comment.
A STAAR spokesman said that the company has responded to Anatole's letter.
"We welcome and appreciate input from our shareholders and our management team and board regularly review opportunities to maximize value for all shareholders, so we are open-minded as to best paths to achieve this objective," the STAAR spokesperson said.
Asian investors are closer to the company's core market and would have a better understanding of the business's value, Anatole said. "The spin-off would result in a change of the investor base, thereby helping to narrow the gap between STAAR's intrinsic value and its market value," the letter said.
https://finance.yahoo.com/news/investor-urges-staar-surgical-spin-204026104.html
FDA panel says Vertex/CRISPR to assess safety risks of gene therapy in follow-up study
A panel of advisers to the U.S. health regulator said on Tuesday Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval.
If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy.
The inherited red-blood-cell disorder causes the cells to become sickle-shaped due to abnormal levels of hemoglobin in the body. A vaso-occlusive crisis occurs when sickled red blood cells block blood flow to the point that tissues become deprived of oxygen and causes pain.
The panel members said the 15-year follow up will help generate data from real-time monitoring of the therapy, which uses the new gene editing CRISPR technology.
Staff reviewers to the U.S. Food and Drug Administration said the new type of technology raised concerns about the "off target", or unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about the therapy's efficacy.
The therapy, exagamglogene autotemcel or exa-cel, met the main goal of a late-stage study. Patients who were treated with the therapy were free from severe vaso-occlusive crisis for 12 months from the infusion of exa-cel. "With regards to off target analysis we want to be careful to not let the perfect be the enemy of the good," said Dr. Scot Wolfe, professor at the department of molecular, cell and cancer biology at UMass Chan Medical School.
Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator's nod by Dec. 8.
"It was made pretty clear that any theoretical off-target editing concerns do not outweigh the benefits of drug approval," said Salim Syed, analyst at Mizuho.
https://finance.yahoo.com/news/fda-panel-says-vertex-crispr-222610620.html
Why the US offshore wind industry is in the doldrums
Energy giants BP and Norway's Equinor have booked hundreds of millions of dollars worth of impairments on their U.S. offshore wind power portfolios in recent days, the latest examples of a renewable energy industry in turmoil.
Danish energy company Orsted, the world's largest offshore wind farm developer and a big player in the U.S., said in late August it may see
$2.3 billion
in U.S. impairments due to supply delays, high interest rates and a lack of new tax credits. It will report third quarter earnings on Wednesday.
The companies are among several energy firms trying to build new offshore wind farms in the U.S., but feeling pain, raising questions about the future of fleet of projects that U.S. President Joe Biden hopes can help fight climate change.
Biden’s administration wants the U.S. to deploy 30,000 megawatts (MW) of offshore wind by 2030 from a mere 41 MW now, a key part of his plan to decarbonize the power sector and revitalize domestic manufacturing, and has passed lucrative subsidies aimed at helping companies do that.
But even with regulatory rules and subsidies in place, developers are facing a whole new set of headwinds.
Here is what they are:
INFLATION
The U.S. offshore wind industry has developed much more slowly than in Europe because it took years for the states and federal government to provide subsidies and draw up rules and regulations, slowing leasing and permitting.
However, as government policies started to line up in the industry's favor in recent years, offshore wind developers unveiled a host of new project proposals, mostly off the U.S. East Coast.
Two small projects came into operation - Orsted's five-turbine Block Island wind farm off Rhode Island and the first two test turbines of U.S. energy firm Dominion Energy's Coastal Virginia Offshore Wind off Virginia.
Then came a hitch.
The COVID-19 pandemic gummed up supply chains and increased the cost of equipment and labor, making new projects far more expensive than initially projected.
FDA targeting ‘candy-like’ drugs that risk accidental overdose in kids
The Food and Drug Administration is beginning a crackdown on drugs and supplements that often appear to be gummies, vitamins or candy as more kids are accidentally ingesting and overdosing on them because of their appearance.
From 2012 to 2021, there was a 530% increase in kids consuming melatonin — an over-the-counter sleep aid commonly sold in gummy form — according to the Centers for Disease Control and Prevention.
“Alternatives to conventional solid oral tablets are becoming more prevalent in the nonprescription drug space as manufacturers seek to make drugs more palatable for consumers,” the FDA wrote online ahead of a meeting on better identifying “candy-like” drugs.
“Many of these products are easily confused with candy and non-drug products, resulting in misuse and inadvertent overdose, particularly among young children.”
“I’ve heard of situations where babysitters didn’t know which are the gummies or which are the medications,” said Doyon, who attended the meeting, according to NBC News.
Cleveland Clinic pediatrician Dr. Gina Robinson, who was not involved with the event, also said the issue commonly stems from people thinking that herbal supplements and vitamins do not pose a risk.
“Because things are natural or because things aren’t prescription medications doesn’t mean that there can’t be some complications or dangers involved with using them,” she said.
Another expert outside of the FDA panel, Johns Hopkins pediatrician Dr. Rachel Dawkins, also put out a stern warning to parents to never call vitamins candy to children.
“When I was a kid, my brother ate all of the Flintstones vitamins because he thought they were candy,” she said. “Poison control was very helpful, and he was just fine … But why risk letting kids think they are candy?”
Another issue: as drug makers have aimed to make some substances much more palatable, it’s causing kids to treat them as if they are a snack as well.
“Children will get into anything, and children will especially get into anything that tastes or looks like candy,” added Dr. Theresa Michele, who is in charge of the FDA’s office of nonprescription drugs.
Dr. Christopher Hoyte, medical director of the Rocky Mountain Poison & Drug Center, urged the creation of a straightforward definition for candy-like medications as a uniform term does not currently exist.
Pediatric pharmacist and Rutgers professor Rachel Meyers is preaching that “we need to get rid of the idea” of medicine going down like Skittles in order to take it.
Drug makers, like Senopsys president Jeffrey Worthington, are recommending the removal of appealing colors and shapes.
“I think there are lots of things I can point to in a gummy that I would rather not see in a drug product,” he said. “Things like rings and worms, cartoon characters and a lot of the iconography that aligns with gummies and other dietary supplements.”
Multivitamins that contain iron are of noteworthy risk to children, as they can potentially cause toxic symptoms, according to the Missouri Poison Center.
“Most prenatal vitamins, some adult vitamins, and many children’s chewable tablets likely contain iron,” the agency reports.
Research from 2006 also targeted candy-like vitamins.
It found that some vitamins — notably chewables — can be tied to Vitamin A toxicity in children when too many are consumed.
https://nypost.com/2023/10/31/lifestyle/fda-targeting-candy-like-drugs-that-risk-overdose-in-kids/
US sending 300 more troops to the Middle East as Israel escalates airstrikes
Pentagon press secretary Brig. Gen. Pat Ryder announced Tuesday that the U.S. will be sending an additional 300 troops to the Middle East.
These soldiers reportedly specialize in communications and explosive ordinance disposal.
In addition, Ryder said that attacks on U.S. military bases in Syria and Iraq have risen to 27 — 16 on bases in Iraq and 11 in Syria.
The announcement comes shortly after the IDF confirmed the death of a senior Hamas commander responsible for all military operations in the northern Gaza Strip.
Ibrahim Biari and several other terrorists were killed in an airstrike with Hamas claiming 50 civilians died, the Times of Israel reports.
Surmodics Launches Med Device Coating Tech for Range of Complex Devices
SurModics, Inc., (NASDAQ: SRDX), the global leader in medical device coating technologies, announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside™ hydrophilic coatings.
Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neurovascular applications, as well as improve crossing for challenging coronary lesions or chronic total occlusions.
Preside hydrophilic coatings are specifically formulated to meet the challenge of achieving the right balance of enhanced lubricity (reduction in friction) and excellent coating durability (resulting in low particulates) for the next-generation of Neurovascular, Coronary and Peripheral vascular devices. Surmodics’ Preside hydrophilic coatings allow customers to leverage their existing coating processes resulting in easy implementation in a manufacturing environment.
https://www.biospace.com/article/releases/surmodics-announces-launch-of-preside-medical-device-coating-technology-providing-industry-leading-lubricity-and-durability-to-a-broader-range-of-complex-device-applications/
Pfizer Continues COVID Cliff in Q3 with First Quarterly Loss Since 2019
Pfizer reported third-quarter financial results Tuesday, pulling in $13.2 billion in revenues, a 42% drop compared to the prior-year period and the first quarterly loss since 2019.
Third-quarter revenues for antiviral treatment Paxlovid dropped 97% operationally compared with the prior-year period, while COVID-19 vaccine Comirnaty revenues declined 70% in the quarter.
However, Pfizer’s non-COVID products grew 10% operationally. Sales of its other vaccines, such as Prevnar 13 and 20 for pneumococcal conjugate vaccination, brought in over $1.8 billion in the third quarter while its RSV vaccine Abrysvo pulled in $375 million.
“We are encouraged by the strong performance of Pfizer’s non-COVID products in the third quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands,” CEO Albert Bourla said in a statement.
Pfizer CFO David Denton noted in the release that new product launches will meet the company’s non-COVID growth target of 6% to 8% for the full year, as it makes some changes to bring in cash. Earlier this month, the company announced a cost-cutting initiative—which includes layoffs—as the company looks to generate around $3.5 billion in savings.
Pfizer’s cost-cutting actions include the closing of a facility in Peapack, New Jersey—which will go into effect in early 2024—a company spokesperson told BioSpace, adding that “a vast majority” of employees will be shifted to other facilities. The Triad Business Journal reported last week that two Pfizer manufacturing locations in Durham and Morrisville, North Carolina, will be closing. Fierce Pharma also noted layoffs occurring in Colorado in early October.
Pfizer and BioNTech are still focused on mRNA-based vaccines, presenting data last week from a Phase I/II trial for a combination vaccine for both the flu and COVID-19. While Pfizer gave no specific numbers, the trial had shown that the combination vaccine has a “safety profile consistent with the safety profile of the companies’ COVID-19 vaccine and reached Geometric Mean Titer (GMT) ratios needed for regulatory approval.
A Phase III trial for the vaccine will begin “in the coming months” but Pfizer gave no exact start date.
“We are encouraged by these early results in our Phase I/II study of our combination vaccine candidates against influenza and COVID-19,” Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said in a statement. “This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world.”
Bourla also noted that the $43 billion acquisition of Seagen is moving ahead, as the deal received antitrust clearance from the European Commission earlier this month. He said it’s a regulatory decision that “confirms our view that the transaction is pro-competitive, reflective of our complementary portfolios and good for patients.”
The Federal Trade Commission in July 2023 requested additional information on the Seagen buyout as part of the agency’s review of the acquisition.
Judge Blocks Biden Administration From Damaging Razor Wire Along US–Mexico Border
by Zachary Stieber via The Epoch Times (emphasis ours),
The Biden administration must stop cutting and otherwise damaging razor wire that Texas has placed along the U.S.–Mexico border, a federal judge ruled on Oct. 30.
U.S. officials mustn't remove the wire or tamper with it, U.S. District Judge Alia Moses said as she entered a temporary restraining order.
The exception is in cases of medical emergencies that would "most likely" result in serious bodily injury or death to a person, provided no "live-saving apparatus" is available, Judge Moses, an appointee of former President George W. Bush, wrote in her ruling.
The U.S. Department of Homeland Security (DHS), which includes border agents, told news outlets it doesn't comment on pending litigation but would comply with the order.
"Generally speaking, Border Patrol agents have a responsibility under federal law to take those who have crossed onto U.S. soil without authorization into custody for processing," the agency said.
Texas Gov. Greg Abbott, a Republican, called the ruling "another win for Texas and our historic border mission."
The wire was put into place as the governor's effort, called Operation Lone Star, to strengthen border security.
"Biden created this crisis and has tried to block us at every turn. Attorney General Paxton and I are pushing back," Mr. Abbott wrote on X.
Texas Attorney General Ken Paxton, another Republican, sued the Biden administration earlier in October for tampering with the barriers.
The temporary order is in place until Nov. 13, unless the court extends it.
The government is prohibited from removing the wire, concealing it, offering it to another person, selling it, and tampering with it.
A hearing on the bid from Texas for a preliminary injunction is scheduled for Nov. 7.
Damaging the Wire
Mr. Paxton said in his complaint that U.S. Customs and Border Protection (CBP) agents were damaging the wire to allow thousands of illegal immigrants to enter Texas.
"Federal agents not only cut Texas’s concertina wire, but also attach ropes or cables from the back of pickup trucks to ease aliens’ ability to illegally climb up the riverbank into Texas. And they regularly cut new openings in the wire fence, sometimes immediately after Texas officers have placed new wire to plug up gaps in fencing barriers," Mr. Paxton said.
Several days later, Texas officials asked for the temporary restraining order, pointing to how federal agents had used a forklift on Oct. 26 to hold up some of the wire so that a group of hundreds of immigrants could cross the border.
"This brazen escalation by defendants is an affront not only to Texas, but also to this court, which already had pending before it a motion for a preliminary injunction," the officials said. "This court should immediately grant a temporary restraining order to enjoin defendants from continuing to damage, destroy, or otherwise meddle with Texas’s concertina wire fence until the court can rule on the state’s preliminary-injunction motion. Alternatively, this court could simply grant a preliminary injunction in light of defendants’ willful misconduct."
In a notice to the court on Oct. 28, the officials said federal agents damaged another portion of the fence. Texas Military Department officer Roberto Ortiz Diaz attested to witnessing federal agents using a forklift to flatten the fence, letting dozens of illegal immigrants into Texas.
"While the operator was flattening the concertina wire, I observed no medical emergencies among the migrant[s] crossing the river, and I am not aware of any reason for [CBP] agents to flatten the concertina wire other than to allow an easier entry path for migrants arriving in the United States," Mr. Diaz said.
Federal officials hadn't yet responded to the various filings as of press time.
Likely to Succeed
Judge Moses said Texas was likely to succeed in its claim that federal officials violated a law that prevents people from trespassing to interfere with a person's property.
Texas has established that it owns the wires, she said. And multiple officials have said that they witnessed federal officials tamper with the barriers.
"Third and finally, the plaintiff established that the defendants lacked permission to interfere with the wires," she said.
Judge Moses said that because she determined that Texas was likely to succeed in one of its claims, she need not analyze its other claims.
The other claims include illegally exercising dominion over another's private property and acting in excess of statutory jurisdiction.
The case is Texas v. U.S. Department of Homeland Security et al. It's being heard in the U.S. District Court for the Western District of Texas.
Waystar delays IPO until December or 2024
Healthcare software company Waystar, which was set to launch its initial public offering roadshow to pitch investors this week, has now delayed it until December at the earliest, the Wall Street Journal reported on Tuesday.
The company will likely wait till 2024, the Journal's report added, citing people familiar with the matter.
Waystar declined to comment on the report, when contacted by Reuters.
Reuters reported in August that Waystar was eyeing an IPO that could value the company as much as $8 billion, including debt.
Waystar made its IPO filing public in October after confidentially filing it in August, joining a wave of new listings that followed a months-long dry spell wrought by high interest rates and fears of a recession.
https://www.nasdaq.com/articles/waystar-delays-ipo-until-december-or-2024-wsj
Protein interaction causing rare but deadly vaccine-related clotting
A mechanism that led some patients to experience cases of deadly clotting following some types of Covid-19 vaccination has been identified in new research.
In a paper published in Blood, scientists from the University of Birmingham funded by the National Institute for Health and Care Research and the British Heart Foundation have been able to identify how deadly blood clots, in the disease known as Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT), occur.
Previous studies have shown that patients with VITT produce antibodies that stick to a protein called Platelet factor 4 (PF4) to create a large cluster of molecules called an immune complex. Following the development of a complex, platelets and cells of the immune system causing clotting and inflammation are activated, but the precise nature of what PF4 does in this event was unknown.
In this latest study, the team used blood taken from healthy donors, as well as serum and plasma from patients with VITT, and have been able to learn for the first time how PF4 was directly involved in the activation of platelets and resulted in thrombotic events. By sticking to a receptor called c-Mpl on the surface of platelets, PF4 triggered the production of the small cells known to cause clotting.
Dr Pip Nicolson, Associate Clinical Professor in Cardiovascular Medicine at the University of Birmingham and senior author of the study said: "The major advances seen in vaccine development during the global Covid-19 pandemic were thrown into sharp relief following the tragic, rare cases of vaccine-induced immune thrombosis. While there were alternative vaccines available to continue to provide protection against the coronavirus in some countries around the world, understanding the mechanisms behind these cases is critical to ensuring that the technology for delivering vaccines can be used with confidence in the future."
Dr Richard Buka, Research Fellow in the Institute of Cardiovascular Sciences and co-lead author "As well as identifying a new way in which platelets are being activated in a potentially deadly manner in VITT, our research has also been able to find how this mechanism may lead to new drugs to protect against blood clots in VITT and blood clots in general."
Variations on a drug used to treat bone marrow cancers could be developed to protect VITT patients from deadly clotting, the research also found.
The team used ruxolitinib, a drug used to treat some types of blood cancer, to block the receptor being triggered by PF4 following the vaccine-induced event. Although they note that the current form of the drug is unsuitable for use in VITT patients, the team nevertheless identified that blocking the pathway through ruxolitinib slowed down platelet aggregation and demonstrates a potential future way to protect patients from blood clots.
Dr Samantha Montague, Research Fellow in the Institute of Cardiovascular Sciences at the University of Birmingham and co-lead author of the paper said: "It is gratifying that we have been able to identify a new, important biological mechanism through trying to thoroughly understand a new disease. This work helps us to understand more fundamental things about how blood clots form and may also be relevant in other related diseases that are more common.
"Our ongoing research funded by the British Heart Foundation is looking at how we can identify patients who may develop VITT, with a view that future vaccine programmes around the world can be delivered while understanding and managing the potential risk for those few at greatest risk."
Journal Reference:
- Richard John Buka, Samantha Jayne Montague, Luis A Moran, Eleyna M Martin, Alexandre Slater, Stephen P Watson, Phillip Lindsay Ross Nicolson. PF4 activates the c-Mpl-Jak2 pathway in platelets. Blood Journal, 2023; DOI: 10.1182/blood.2023020872
Biden and Jordan's king discussed increasing aid to civilians in Gaza-White House
U.S. President Joe Biden and Jordan's King Abdullah on Tuesday discussed their shared commitment to increasing aid to civilians in Gaza during the Israel-Hamas conflict, the White House said.
The two men also reiterated the importance of protecting civilian lives and that it was critical to ensure that Palestinians were not forcibly displaced from Gaza, the White House said
Engineering student arrested in ‘horrendous’ Cornell University anti-Jewish death threats
A 21-year-old student was arrested Tuesday for making “horrendous” anti-Jewish death threats at Cornell University that put the Ivy League campus on high alert over the weekend.
Patrick Dai, a junior majoring in engineering at the prestigious university, was named in a federal complaint charging him with posting threats to kill or injure another using interstate communications — which could land him in jail for up to five years.
The Pittsford, New York, native was formally charged just hours after New York State Police troopers identified a person of interest over the online threats to “bring an assault rifle to campus.”
The disturbing messages, which came days after “F–k Israel” graffiti was scrawled on sidewalks at the upstate Ithaca campus, were revealed by university officials Sunday.
“The genocidal fascist zionist regime will be destroyed,” said one of the messages posted to a public school forum. “Rape and kill all the jew women before they birth more jewish hitlers.”
Dai allegedly threatened to “shoot up 104 west,” a university dining hall that caters predominantly to Kosher diets, and to “slit the throat” of any Jewish men he came across.
Joel Malina, Cornell’s vice president for university relations, confirmed in a statement Tuesday that a Cornell student was in custody, but did not name Dai.
“We remain shocked by and condemn these horrific, antisemitic threats and believe they should be prosecuted to the full extent of the law. We know that our campus community will continue to support one another in the days ahead,” Malina said, adding that the school will maintain its “heightened security presence on campus.”
Dai was interrogated hours before his arrest after state police identified a “person of interest” in the disturbing case, Gov. Kathy Hochul revealed on X.
“When I met with Cornell students yesterday I promised them we would do everything possible to find the perpetrator,” she added.
“Public safety is my top priority and I’m committed to combatting hate and bias wherever it rears its ugly head.”
A rep for the New York State Police referred questions to campus cops.
Pro-Palestinian unrest has surged at the state’s college campuses in the wake of the surprise attacks on Israel by radical Hamas militants Oct. 7 — and the subsequent counteroffensive in the Gaza Strip by the Jewish nation.
More than 1,400 Israelis, nearly all civilians, were killed in the sneak attack earlier this month by the militants, with more than 200 others kidnapped, including some Americans.
On Tuesday, Hochul tapped Jonathan Lippman, a former chief judge of the New York Court of Appeals, to review the “policies and procedures related to antisemitism and discrimination at City University of New York campuses amid the unrest.
“The problem didn’t begin with the weeks following Oct. 7 attacks,” Hochul said in making the announcement. “It’s been growing on a number of campuses and seen most acutely in the City University of New York.
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