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The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.
Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc.
MRNA,
and Pfizer Inc.
PFE,
-BioNTech
BNTX,
should become available later this week.
“We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”
The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.
The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.
The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines.
The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.
Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.
Under the Bridge Access program, CVS Health Corp.
CVS,
will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc.
WBA,
will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.
Their shared hippie spirit brought them together over a vegan potluck dinner, but the prospect of years in federal prison for allegedly stealing millions from a mentally-ill Malibu doctor, has driven a wedge between them.
A federal fraud prosecution against a pair of yoga gurus accused of siphoning cash from Dr. Mark Sawusch’s $60 million fortune took a significant turn at the end of August when one pleaded guilty and agreed to testify against the other, her ex-boyfriend, according to court documents and people familiar with the matter.
Anna Moore’s guilty plea before a federal judge in Los Angeles on Aug. 28 represents a serious legal challenge to her longtime partner, Anthony Flores, who faces decades behind bars if convicted in the case. Flores pleaded not guilty after his arrest in January.
Details of Moore’s agreement with federal prosecutors remain under seal, but people familiar with the matter say her ultimate sentence in the case will largely be determined after her level of cooperation is evaluated. A sentencing hearing for Moore was set for Nov. 6.
“We are aware of Ms. Moore’s decision to plead guilty. Obviously this changes Mr. Flores’ legal situation in the case, and we are currently reviewing our options,” Flores’ attorney Ambrosio Rodriguez said.
Messages left with Moore’s attorney weren’t immediately returned. A spokesman for the U.S attorney’s office for the central district of California declined to comment.
The tragic end to Sawusch’s life began on June 23, 2017, when the brilliant, but troubled, ophthalmologist met Flores and Moore in a chance encounter at a vegan ice cream parlor in Venice Beach, Calif.
Flores, who went by Anton David, was a guru-esque figure with long, flowing hair and a beard. He worked as a hair stylist on film shoots. Moore, a pixie-like blond, was an actress and singer. The couple had met years earlier at a vegan potluck dinner and had fallen in love over what they described as a shared hippie spirit. Together, they ran a yoga center in Fresno, Calif., while going back-and-forth to L.A.
Their spiritual vibe cast a spell on Sawusch, who had just days earlier been released from a mental health facility, where he had been committed after suffering a breakdown, court filings said. Within a week, Flores and Moore had moved into Sawusch’s multi-million dollar beachfront home in Malibu, Calif., federal prosecutors said.
Over the next year, the pair gained increasingly firm control over the doctor’s life and finances, with Flores establishing power of attorney over Sawusch’s vast fortune while plying him with a steady diet of marijuana and LSD as he also underwent experimental ketamine treatments for his bipolar disorder that left him addled, investigators said.
Sawusch later died in May 2018 of a lethal mixture of ketamine and alcohol, according to a coroner’s report. The Los Angeles County medical examiner’s office ruled the death an accident.
In her guilty plea, Moore said she was not immediately aware of the scope of Flores’ alleged efforts to steal the doctor’s money, but admitted that following Sawusch’s death she participated in a later effort in probate court to keep the stolen money. Prosecutors have alleged that this was a separate fraud.
When Sawusch’s family sought to take control of his estate, they discovered that almost $3 million had been transferred from his accounts to ones controlled by Flores in the days before and after the doctor’s death, federal prosecutors said.
Sawusch’s family launched a civil lawsuit against the yogi couple and convinced a California state judge to issue a restraining order freezing Flores’ and Moores’ accounts, and order they return the money. Instead, federal prosecutors say, the two engaged in a second fraud by making false claims in probate court that Sawusch had verbally told them he would give them a third of his fortune plus his Malibu beach house.
The couple claimed that the doctor had given them the money in return for them taking care of him and as part of an effort to protect his fortune from his family, from whom he was estranged. The family said those claims were untrue and that the pair had kept Sawusch isolated from his friends and family.
Eventually, the couple returned around $2 million of the doctor’s money, but around $1 million remained unaccounted for, according to federal prosecutors.
Flores and Moore broke up during the pandemic after nearly a decade together. Moore moved to Mexico while Flores remained in Fresno, where he was arrested in late January. Moore was arrested at George Bush Intercontinental Airport in Houston upon her return to the U.S. around the same time. Both have been held without bail since.
Read the series:
Part 4: Money, mania and LSD: A Malibu doctor’s tragic final weeks under yoga gurus’ sway
By Adria Calatayud
Nestle said it has sold its Palforzia peanut-allergy treatment business to biopharmaceutical company Stallergenes Greer.
The Swiss consumer-goods company said Monday that it will receive milestone payments and royalties from Stallergenes Greer. The deal was closed upon signing, Nestle said.
The sale allows Nestle’s health-science operations to focus on its core strengths and key growth drivers, the unit’s Chief Executive Greg Behar said.
Nestle last year said that it would conduct a strategic review of Palforzia after a slower-than-expected adoption by patients and healthcare professionals.
Write to Adria Calatayud at adria.calatayud@dowjones.com
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Johnson & Johnson
plans to maintain its quarterly dividend at $1.19 a share even after separating its
Kenvue
over-the-counter drug and pers…
By David Sachs
Roche said Friday that its Alecensa drug demonstrated the ability to reduce recurrence of lung cancer for patients in the early stage of the disease.
The Swiss pharmaceutical company said the results, from a Phase 3 study of 257 people which compared the treatment with platinum-based chemotherapy, met its primary goal of disease-free survival in people with early-stage non-small cell lung cancer. About half of people with this type of lung cancer experience a recurrence of the disease after surgery, Roche said.
Roche said that it found no unexpected safety issues and will submit the data to global health authorities.
Write to David Sachs at david.sachs@wsj.com
Johnson & Johnson
on Wednesday issued new financial guidance after spinning out the consumer-health company
Kenvue
While its earnings and sales projections were lowered on an absolute basis, the company is maintaining its dividend and expects to increase its revenue at a faster pace.
Johnson & Johnson
$35 billion exchange offer for
Kenvue
that expired last Friday was substantially oversubscribed. The result is that participating J&J holders will be able to convert only a fraction of their shares for Kenvue stock.
By Adria Calatayud
Novartis said the planned spinoff of its Sandoz generic pharmaceuticals and biosimilars business is expected to occur on or around Oct. 4.
The Swiss pharmaceutical giant said Friday that the separation will take place through a proposed distribution of Sandoz shares to its existing shareholders. Novartis shareholders will get one Sandoz shares for every five Novartis shares held and one Sandoz American depositary receipts–or ADRs–for every five Novartis ADRs, the company said.
Novartis had previously said it expected the spinoff to happen early in the fourth quarter.
The Sandoz spinoff remains subject to approval by Novartis’s shareholders. Novartis has scheduled an extraordinary general meeting for Sept. 15 to vote on the proposed distribution of Sandoz shares and a reduction in its own share capital in connection with the spinoff, it said.
Following the separation, Sandoz would be listed in SIX Swiss Exchange, with an ADR program in the U.S., Novartis said.
Write to Adria Calatayud at adria.calatayud@dowjones.com
Johnson and Johnson
$40 billion exchange offer for shares in
Kenvue
is likely to generate strong interest from the healthcare company’s shareholders, resulting in participants being able to swap only a portion of their J&J stock.
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By Joe Hoppe
Exor and Royal Philips jointly said that they have entered a relationship agreement, with Exor picking up a 15% stake in Philips for an undisclosed sum, but worth around 2.58 billion euros ($2.82 billion).
Investment company Exor, which holds stakes in a number of companies such as car makers Ferrari and Stellantis, said Monday that its investment is fully supportive of Dutch health-technology company Philips’ leadership, strategy and value creation potential, and gives it the ability to nominate one member to Philips’ supervisory board.
As of Friday’s closing, Philips had a market cap of around EUR17.18 billion.
Exor said it was committed to being a long-term minority investor, and while it doesn’t plan to buy more shares in Philips in the short-term, over time the agreement allows for Exor to increase its participation to a maximum limit of 20% of Philips’ outstanding share capital.
“Exor’s investment in Philips, their long-term outlook and increased focus on healthcare and technology, fit well with our strategy and substantial value creation potential,” Philips Chief Executive Roy Jakobs said.
Write to Joe Hoppe at joseph.hoppe@wsj.com
Home Depot, Target, Cisco, Deere, Walmart, and More Stocks to Watch This Week
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SolarEdge Technologies
was falling sharply Wednesday after issuing disappointing third-quarter guidance, the latest solar company to do so.
Pfizer Stock Gains After Earnings Beat. Revenue and Outlook Aren’t So Good.
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The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms.
Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.
The…
That’s a notion that has long fueled hope for many of the more than 40% of Americans who are considered obese — and fueled criticism by those who advocate for wider weight acceptance. Soon, it may be a reality.
High-dose oral versions of the medication in the weight-loss drug Wegovy may work as well as the popular injections when it comes to paring pounds and improving health, according to final results of two studies released Sunday night. The potent tablets also appear to work for people with diabetes, who notoriously struggle to lose weight.
Drugmaker Novo Nordisk
NOVO.B,
plans to ask the U.S. Food and Drug Administration to approve the pills later this year.
“If you ask people a random question, ‘Would you rather take a pill or an injection?’ People overwhelmingly prefer a pill,” said Dr. Daniel Bessesen, chief of endocrinology at Denver Health, who treats patients with obesity but was not involved in the new research.
That’s assuming, Bessesen said, that both ways to take the medications are equally effective, available and affordable. “Those are the most important factors for people,” he said.
There have been other weight-loss pills on the market, but none that achieve the substantial reductions seen with injected drugs like Wegovy. People with obesity will be “thrilled” to have an oral option that’s as effective, said Dr. Katherine Saunders, clinical professor of medicine at Weill Cornell Health and co-founder of Intellihealth, a weight-loss center.
Novo Nordisk already sells Rybelsus, which is approved to treat diabetes and is an oral version of semaglutide, the same medication used in the diabetes drug Ozempic and Wegovy. It comes in doses up to 14 milligrams.
But results of two gold-standard trials released at the American Diabetes Association’s annual meeting looked at how doses of oral semaglutide as high as 25 milligrams and 50 milligrams worked to reduce weight and improve blood sugar and other health markers.
A 16-month study of about 1,600 people who were overweight or obese and already being treated for Type 2 diabetes found the high-dose daily pills lowered blood sugar significantly better than the standard dose of Rybelsus. From a baseline weight of 212 pounds, the higher doses also resulted in weight loss of between 15 and 20 pounds, compared to about 10 pounds on the lower dose.
Another 16-month study of more than 660 adults who had obesity or were overweight with at least one related disease — but not diabetes — found the 50-milligram daily pill helped people lose an average of about 15% of their body weight, or about 35 pounds, versus about 6 pounds with a dummy pill, or placebo.
That’s “notably consistent” with the weight loss spurred by weekly shots of the highest dose of Wegovy, the study authors said.
But there were side effects. About 80% of participants receiving any size dose of oral semaglutide experienced things like mild to moderate intestinal problems, such as nausea, constipation and diarrhea.
In the 50-milligram obesity trial, there was evidence of higher rates of benign tumors in people who took the drug versus a placebo. In addition, about 13% of those who took the drug had “altered skin sensation” such as tingling or extra sensitivity.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles. Plus, tablets would be more portable than injection pens and they don’t have to be stored in the refrigerator.
But the pills aren’t necessarily a better option for the hundreds of thousands of people already taking injectable versions such as Ozempic or Wegovy, said Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital.
“I don’t find significant hesitancy surrounding receiving an injection,” she said. “A lot of people like the ease of taking a medication once a week.”
In addition, she said, some patients may actually prefer shots to the new pills, which have to be taken 30 minutes before eating or drinking in the morning.
Paul Morer, 56, who works for a New Jersey hospital system, lost 85 pounds using Wegovy and hopes to lose 30 more. He said he would probably stick with the weekly injections, even if pills were available.
“I do it on Saturday morning. It’s part of my routine,” he said. “I don’t even feel the needle. It’s a non-issue.”
Some critics also worry that a pill will also put pressure on people who are obese to use it, fueling social stigma against people who can’t — or don’t want to — lose weight, said Tigress Osborn, chair of the National Association to Advance Fat Acceptance.
“There is no escape from the narrative that your body is wrong and it should change,” Osborn said.
Still, Novo Nordisk is banking on the popularity of a higher-dose pill to treat both diabetes and obesity. Sales of Rybelsus reached about $1.63 billion last year, more than double the 2021 figure.
Other companies are working on oral versions of drugs that work as well as Eli Lilly and Co.’s
LLY,
Mounjaro — an injectable diabetes drug expected to be approved for weight-loss soon. Lilly researchers reported promising mid-stage trial results for an oral pill called orforglipron to treat patients who are obese or overweight with and without diabetes.
Pfizer
PFE,
too, has released mid-stage results for dangulgipron, an oral drug for diabetes taken twice daily with food.
Novo Nordisk officials said it’s too early to say what the cost of the firm’s high-dose oral pills would be or how the company plans to guarantee adequate manufacturing capacity to meet to demand. Despite surging popularity, injectable doses of Wegovy will be in short supply until at least September, company officials said.
A nascent category of mental health treatments is getting a major cash infusion.
Blake Mycoskie, founder of the canvas-footwear phenomenon TOMS Shoes, has committed to giving $100 million to support psychedelic research and access, Mycoskie told MarketWatch in an exclusive interview. The money will help fund academic institutions investigating psychedelics’ potential to treat anxiety, depression, post-traumatic stress disorder and other mental-health issues, as well as nonprofits helping to connect patients in need with psychedelic treatments.
Traditional psychedelics include hallucinogens like LSD and psilocybin, or “magic” mushrooms–recently legalized in Oregon and Colorado. Other drugs that can alter mood and perception–such as ketamine and MDMA, also known as ecstasy–aren’t classical psychedelics but are broadly included in the research and policy discussions generating a surge of interest in this class of treatments. The U.S. Food and Drug Administration, for example, has granted psilocybin and MDMA “breakthrough therapy” status, a designation designed to expedite development and review of drugs for serious conditions, and could approve MDMA for treatment of PTSD as soon as next year.
Given the rapid developments in the field, ”we really need to get this right, and we really need to have these foundations and nonprofits funded properly,” therapists trained, and clinics open and running smoothly, Mycoskie said. “I felt a real sense of urgency,” he said, and asked his wealth manager, “what’s the most that I can give?”
The $100 million answer to that question amounts to about a quarter of Mycoskie’s net worth and marks a major milestone in psychedelics’ delicate image transformation. Shedding some of their dangerous-party-drug reputation, psychedelics are gaining attention from top pharmacologists, the scientific community, biotech companies and investors who see them as a critical part of the solution to America’s mental health crisis.
Mycoskie, 46, said his interest in psychedelics dates back to 2017, when a friend returning from a trip to Central America described his incredible experience with ayahuasca, a plant-based psychedelic brewed into a tea. As an entrepreneur under intense pressure to perform, Mycoskie said, he decided to try it for himself. The experience “cracked me open, and it connected me more to my faith in God, made me feel that we were all connected and everything was fine and perfect,” he said. “I came back just feeling like, wow, that was more powerful than any therapy I’d ever done.” He later tried MDMA-assisted therapy, he said, which also helped him process issues that traditional talk therapy had left unresolved.
Realizing how many people could benefit from similar treatments, Mycoskie started giving money to academic groups and the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit organization. He also got involved in last year’s Colorado ballot initiative, which legalized psilocybin and several other psychedelic substances, including ibogaine, which has shown potential to treat substance-use disorders. Mycoskie has already given about $10 million to psychedelic research and access, he said, and plans to give about $5 million annually for 18 more years.
Mycoskie was a bit squeamish at first, he acknowledges, about publicly backing research on drugs that are largely illegal. “Am I going to get held up at TSA every time I go through the airport?” he remembers thinking. The U.S. Drug Enforcement Administration categorizes LSD and MDMA alongside heroin as “schedule one” drugs, defined as “drugs with no currently accepted medical use and a high potential for abuse.” But with growing public awareness and acceptance of the drugs’ potential as mental-health treatments, he said, he felt emboldened to make a big public commitment, and “the research has caught up,” he said. “It’s important that people like myself put their name out there and their money out there to show that this really is a path forward,” he said.
Mycoskie’s $100 million commitment “is the biggest that we’ve ever seen in the psychedelics space,” said Joe Green, president of the Psychedelic Science Funders Collaborative, a nonprofit supporting philanthropy in the field, and a MAPS board member. Now that research has made great strides to support use of the medicines as mental-health treatments, that money can help ensure that “these actually come to the world in a safe and beneficial way,” Green said. With certain treatments legalized in Oregon and Colorado, for example, “the system requires licensed guides, facilitators, licensed service centers,” he said. “It’s not like cannabis medical–you won’t be able to take the mushrooms outside the service center.”
Mycoskie plans to publicize his pledge at the Multidisciplinary Association for Psychedelic Studies’ psychedelic science conference–billed as “the largest psychedelic conference in history”–this week in Denver. On the agenda: Sessions ranging from state policy and regulatory considerations to clinical trials of psilocybin- and MDMA-assisted therapy and “sex and psychedelics: weaving altered states for healing and pleasure.”
The news comes as lawmakers on both sides of the aisle are pushing for new funding for research into the use of psychedelics to treat PTSD in military service members as part of the fiscal year 2024 National Defense Authorization Act, which the House Armed Services Committee will consider Wednesday.
Already, public companies like Atai Life Sciences
ATAI,
Compass Pathways
CMPS,
and Cybin
CYBN,
are developing therapies based on psychedelic substances. The psychedelic therapeutics market could be worth more than $8.3 billion by 2028, according to InsightAce Analytic. Even the federal government is throwing money at this niche, funding efforts to develop psychedelic mental-health treatments without the hallucinogenic side effects.
More than one in five U.S. adults live with a mental illness, according to the National Institute of Mental Health, and less than half of the roughly 58 million adults with any mental illness are receiving treatment. Suicide rates, which have been on a long upward trajectory, declined briefly between 2018 and 2020 before returning to peak levels in 2021, according to the Centers for Disease Control and Prevention. Nine out of 10 U.S. adults believe the country is suffering a mental health crisis, according to a survey last year by CNN and KFF, a health policy nonprofit. And commonly prescribed antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) don’t work well for many patients.
Courtesy of Nushama and Costas Picadas
Mental illness “is truly an epidemic, and we are losing the fight,” said Dylan Beynon, CEO and founder of Mindbloom, which offers a telehealth ketamine treatment program. While there are some existing solutions that are helping to bend the curve, he said, more research and educational support for providers and patients is needed, he said.
Indeed, some substantial hurdles still separate psychedelic mental-health treatments from many of the patients they might benefit, including a lack of insurance coverage for the currently legal treatments and debate over how to administer them safely. In the case of ketamine, for example, which is FDA-approved as an anesthetic and used off-label as a mental-health treatment, some providers favor in-person guided sessions while others, like Beynon, advocate for telehealth prescribing–a model that boomed during the pandemic.
Some experts have lately warned that the practice of psychedelic medicine may be getting ahead of the science. Given the growing public and commercial interest, “there is the risk that use of psychedelics for purported clinical goals may outpace evidence-based research and regulatory approval,” the American Psychiatric Association said last year in a position statement on psychedelic and “empathogenic” agents–a category that includes MDMA.
Mycoskie has also made some investments in the psychedelics space, although he said profits aren’t his motivation. He has invested in Mind Medicine Inc.
MNMD,
which says it is developing “psychedelic inspired medicines” that aim to treat the underlying causes of distress in the brain. And Mycoskie helped fund a public benefit corporation linked with MAPS, which is taking MDMA through the FDA approval process–an investment that will pay dividends when the treatment is commercialized, he said.
Providers currently offering ketamine treatments say they’re eager to expand into MDMA and other therapies in the category as soon as they’re legal. Mindbloom, for example, currently offers a ketamine treatment program that’s available through telehealth in several dozen states and aims to start offering MDMA-assisted therapy late next year after FDA approval is finalized, Beynon said. Psilocybin-assisted therapy could come a couple of years after that, he said.
Nushama, a New York City psychedelic wellness center that offers ketamine-based therapy, delivered through in-person IV infusions, also hopes to expand into MDMA when it’s approved, said co-founder Jay Godfrey.
Still on the horizon: New treatments that could produce psychedelic medicines’ mental-health benefits without the trip. University of North Carolina School of Medicine pharmacology professor Dr. Bryan Roth is leading an effort to create new medications for depression, anxiety and substance abuse that work similarly to psychedelics but without the hallucinogenic, disorienting side effects. His effort is backed by a $27-million grant from the Defense Advanced Research Projects Agency. Such treatments, Roth said, could help the many patients for whom such psychedelic effects are unappealing or ill-advised–such as military service members. “You would never want to give psilocybin or ketamine to somebody who has a gun,” Roth said.
Having worked with Vietnam veterans suffering from PTSD while training as a psychiatrist earlier in his career, Roth said, he’s keenly aware of the need for safe and effective treatments. “There was nothing we could give them for their symptoms,” he said. “The most we could do was give them medications to stop their ability to have dreams, so they wouldn’t have nightmares. That was basically it.”
Costas Picadas
Roth’s team has already developed compounds that have shown antidepressant effects without psychedelic side effects in mice, he said. The team is now working to find a clinical candidate suitable for testing in humans, he said.
Treatments that can help “break bad emotional or psychological patterns without scary, high-friction psychedelic experiences would be a great thing for patients, providers and the healthcare system,” said Mindbloom’s Beynon.
Much more remains to be done to reduce the stigma associated with psychedelics, experts say. It has been 52 years since President Richard Nixon declared drug abuse “public enemy number one,” and billions of dollars have been spent since then telling people that “these medicines are dangerous, that they’re addictive, and that they’ll fry your brains,” Godfrey said. “Undoing 52 years of propaganda is a heavy lift, but one thing I’m optimistic about is that the outcomes are starting to speak for themselves.”
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