SVB Leerink Sees Over 600% Upside For Selecta

 

• SVB Leerink initiated Selecta Biosciences Inc 
  SELB+13.1%+ Free Alerts
   coverage with an Outperform rating and a price target of $7.
• The analysts view ImmTOR's approach to mitigate ADAs as de-risked by early clinical data from SEL-212 and believe that the ability to tame the immune response bodes well for ImmTOR's clinical potential in combination with gene and autoimmune therapies. 
• SVB sees near-term upside potential with lead candidate SEL-212 for chronic refractory gout. Pivotal trial data readout is expected in 1Q 2023.
• The analyst also notes its gene therapy SEL-302 for methylmalonic acidemia (MMA) with Phase 1 trial expected to start in 2H 2022, with data expected to be reported on a patient-by-patient basis. 
• Although shares are currently trading <$1/share, analysts see a low risk of de-listing based on the upcoming catalysts and surrounding rules. 
• "In our view, SELB represents an attractive buying opportunity for investors looking for an undervalued name with a low EV, de-risked late-stage clinical candidate, near-term news flow, and de-risked platform technology that supports long-term upside potential." SVB writes.

https://www.benzinga.com/analyst-ratings/analyst-color/22/06/27573199/svb-leerink-sees-over-600-upside-for-this-penny-biotech-stock

The ‘Open Secret’ on Getting a Safe Abortion Before Roe v. Wade

If the Supreme Court overturns Roe v. Wade, will psychiatrists resume their pre-Roe role as arbiters of abortion access? The law once compelled psychiatrists and pregnant women to perform dishonest rituals to get abortions. Will psychiatrists once again need to be complicit post-Roe?

Before Roe v. Wade, a number of states allowed abortions if doctors could certify that the mother’s health, not solely her life, was at serious risk. A great number of those certifications were granted by psychiatrists, some of them by the professors who taught me as a resident in the mid-1980s in Connecticut.

Through the 1940s and 1950s, medicine advanced to the point where health problems like heart disease and tuberculosis were generally no longer considered to be indications for therapeutic abortion. As a result, psychiatric justification became the primary rationale for therapeutic abortion before Roe.

Certainly, psychiatrists had — and still have — an important clinical role in the care of pregnant women. We care for those who are currently psychotic or deeply depressed and those whose past pregnancies triggered postpartum psychosis or depression. Fortunately, with the help of mental health professionals, mentally ill women have long been able to progress successfully through nine months and deliver healthy babies.

Before Roe, psychiatrists were asked to consult on women with severe anxiety and depression who were requesting abortions. It was an “‘open secret,’” Dr. Richard A. Schwartz of the Cleveland Clinic observed in 1972, the year before Roe was decided, “that a woman can obtain a safe abortion in a licensed hospital if she can find a psychiatrist who will say she might commit suicide.”

To accommodate such women, psychiatrists used a combination of empathy and civil disobedience to declare them at risk unless they were allowed to terminate their pregnancies. Requests to psychiatrists to evaluate women for abortion increased in the decades before Roe. According to “Modern Clinical Psychiatry,” a popular medical textbook published in 1968, “the number of abortions performed on the recommendation of psychiatrists increased rapidly in the past two decades.” At a convention of the American Medical Association, researchers presented data on two Buffalo hospitals where the proportion of therapeutic abortions approved for mental health reasons rose from 13 percent in 1943 to 87.5 percent in 1963.

In 1967, California became one of three states to authorize abortion when, among other indications, a pregnancy seriously endangered a woman’s physical or mental health. (Colorado was first, North Carolina second.) Before the passage of the act, the California Penal Code made it a felony to perform an abortion on a woman for any reason unless necessary to preserve her life.

Leon Marder, at the time an associate professor of psychiatry at the University of Southern California, described the workings of a committee that weighed abortion requests at the Los Angeles County-University of Southern California Medical Center. At first, a woman’s request for an abortion would be seriously considered only on psychiatric grounds if she was “overtly psychotic or highly suicidal.”

This high bar was consistent with the state’s Therapeutic Abortion Act of 1967, which authorized abortions when there was a “substantial risk” that pregnancy would “gravely impair” mental health.

But hospital officials soon realized that few cases met this narrow criterion, and the committee had to decline many applications. As some of those women resorted to self-induced abortion or underground surgeries, Dr. Marder said, the committee broadened eligibility to women who displayed a “disorder of thinking, feeling or behavior producing a breakdown in living so that the individual cannot deal with reality or cannot function.”

That created its own tension as psychiatrists struggled to discern whether a woman’s stated intent to kill herself was truthful. With many doctors reflexively discounting suicide threats, a desperate woman could become insistent during the psychiatric assessment. “The patient may consciously exaggerate all of her symptoms and frequently can be considered manipulative and malingering,” Dr. Marder noted. Any hope of conducting a careful assessment, one San Francisco psychiatrist commented, was “compromised from the outset.”

As more states liberalized their abortion statutes between 1967 and 1973 — 13 states extended exceptions to circumstances including the health of the woman and four states repealed abortion bans — psychiatrists increasingly faced painful dilemmas, among them the vast discrepancy in access to abortion. Middle- and upper-class women in psychoanalysis, those who knew the “right words” with which to request an abortion (which, according to a 1967 article about abortion in New York City was “if I have this baby I’ll kill myself”) and those with means to pay a psychiatrist to evaluate them in the first place had a clear advantage in obtaining approval for abortions.

Compounding the problem, psychiatrists did not have a strong database on which to draw to determine whether a pregnancy was likely to constitute a threat to the life and mental health of a given woman. (Even now, that remains true.)

The approval process placed psychiatrists in an ethically tenuous position. Though a 1969 survey of psychiatrists found that 79.5 percent (71.7 percent without qualification, and 7.8 percent with qualification) believed that abortion should “be available to any woman capable of giving legal consent,” some were uneasy about rubber-stamping permission for women who were not seriously mentally ill or truly suicidal.

Others committed small acts of rebellion, stretching boundaries. “I recommended abortion for all,” recalled Dr. H. Steven Moffic in a recent Psychiatric Times article. “My mental health analysis at the time was not only about the mental health of the would-be mothers, but their upcoming children if abortion was not done.”

The hypocrisy grated on some. One psychiatrist rued in The New England Journal of Medicine in 1969 that humanitarian rationales for abortion could “masquerade under psychiatric labels.” Yet others lamented the arbitrariness of approval, noting that the psychiatrist’s “anxieties concerning humanitarian, social, economic, and religious considerations rather than any definite psychiatric criteria play a definite role in his objections or consent.”

However ambivalent or decisive they felt, psychiatrists engaged in a formalized, sometimes cynical, ritual to provide women with safe care. Dr. Alan F. Guttmacher, a former president of Planned Parenthood, wrote that more than 85 percent of the abortions performed at Mt. Sinai Hospital in the mid-fifties (when he chaired the OB-GYN department) “at least bent the law, if they did not fracture it.”

In the year before the Roe decision, maternal mental health was the most common indication for a hospital abortion, accounting for more than 85 percent of all cases in the 12 states that reported the stated reason for abortion, according to the government’s abortion surveillance annual summary.

The Roe decision rescued psychiatry from these quandaries. It spared a woman the demeaning ordeal of lying about her mental health and the prospect of being branded “manipulative and malingering” should her deception fail or if she was interviewed by an unsympathetic or a conflicted doctor.

Today, as the nation appears to be moving toward a post-Roe world, we do not fully know what kind of patchwork of restrictions will be applied in different states. The governor of Oklahoma, Kevin Stitt, has already signed a bill whose wording seems emphatically designed to remove psychiatry from the picture. The state’s new ban on abortion excepts a life-threatening “medical emergency” arising from a “physical disorder, physical illness, or physical injury, including a life-endangering physical condition caused by or arising from pregnancy itself.”

Presumably, some states will have a mental health exception to their abortion statutes, but there is only a spotty network of psychiatrists to meet potential need. According to a 2015 estimate based on data from the Bureau of Labor Statistics, there are 76 percent more psychologists or psychiatrists per capita in blue states than in red states. Roughly 60 percent of counties in the United States — including 80 percent of rural counties — do not have a single psychiatrist practicing there, based on a 2017 report. Most of us are in the Northeast and some counties along the West Coast.

Telepsychiatry and licensing reciprocity laws could allow out-of-state psychiatrists to conduct assessments and thus compensate for their skewed national distribution. This, too, will depend on the restrictiveness of the state in which the woman lives, especially if criminal liability is extended to those advising women or coordinating with the physician who would terminate the pregnancy.

I live in Washington, D.C., which will surely take a liberal approach. But if called upon to evaluate a woman seeking an abortion, I would apply an expansive definition of mental health. Where state law limited its definition of “mental health,” I would follow the law.

Dr. Sally Satel is a visiting professor of psychiatry at Columbia and a senior fellow at the American Enterprise Institute.

https://www.nytimes.com/2022/06/04/opinion/sunday/psychiatrists-abortion-roe.html

Big-government interference caused the baby formula crisis

 The Biden administration is getting hammered for the baby formula shortage — and deservedly so. A whistleblower notified the Food and Drug Administration in October of unsanitary conditions at a baby formula factory, but the FDA did not shutter the plant until February, and the president took no steps to address the crisis — such as easing import rules — until May. That is inexcusable.

But that plodding response is not the main reason parents across the country are scrambling to find formula for their babies. Neither are pandemic-related supply-chain issues. The reason is big-government interference, which has distorted the baby formula market and produced the Soviet-style shortages we are experiencing today.

The shuttering of a single baby formula plant should not lead to bare shelves. Other food production facilities sometimes fail health inspections, but halting production at one factory does not send the entire country into crisis. That’s because we have multiple companies producing everything we eat — from meat, to vegetables, to processed foods — which means when something happens at one factory, other producers can step in to make up for shortfalls.

Not so with baby formula. Just two manufacturers — Abbott and Reckitt, the makers of Similac and Enfamil, respectively — are responsible for almost 80 percent of baby formula production in the United States; they have shared a virtual duopoly since the 1950s. Why? Because, as the Wall Street Journal reports, baby formula is so tightly regulated that it is nearly impossible for new entrants to break into the market.

The FDA treats baby formula like a pharmaceutical product instead of food for infants. Clinical studies and other requirements cost millions of dollars before a company can bring a product online, and the FDA subjects producers to pharmaceutical-grade regulation and inspection. Case in point: ByHeart is the first new formula manufacturer approved by the FDA in more than 15 years. To win approval, it had to raise $190 million to cover the cost of research and development, clinical growth studies, and a host of other FDA requirements. It took the company more than five years jumping over government hurdles to open its first manufacturing plant, which finally began production this year.

This is absurd. Except in the case of specialty formula for infants with certain medical conditions, baby formula is not a pharmaceutical product. It’s food. Formula generally contains purified cow’s milk, whey or soybeans for protein; vegetable oils for fat; lactose for carbohydrates; and a mix of vitamins and minerals. That’s it.

No other food is regulated that way — including baby food. As every parent knows, at six months of age, babies start transitioning from formula to pureed fruits, vegetables, oatmeal and meat. Unlike baby formula, baby food is produced by many companies — from Beech-Nut to Earth’s Best, Gerber, Yumi, Heinz, Nature’s One, Happy Family and Plum Organics. So why is it okay to give 6-month-old infants food that is subject only to basic health and safety guidelines, but the food we give them in the first six months of their lives is regulated like a vaccine?

If a single baby food plant shut down, we wouldn’t see parents struggling to feed their children; other companies would happily step in and make up for lost production. But thanks to the federal government, the shutdown of a single Abbott plant, responsible for one-fifth of all U.S. baby formula production, has left us with bare shelves and with almost no competitors ready to step in to fill the gap.

It gets worse. Government also distorts the baby formula market through the Women, Infants, and Children supplemental nutrition program. According to the Wall Street Journal, WIC “has deepened the hold that major manufacturers such as Abbott have over formula sales” resulting in “a marketplace with little competition and little flexibility.” Under WIC, each state grants exclusive contracts to a single manufacturer in exchange for discounts. Only the winning manufacturer’s product can be bought with the government vouchers issued to lower-income parents. This also increases sales to non-WIC consumers, because stores in each state tend to primarily stock the WIC-approved brand — giving the government-chosen company a near-monopoly in that state.

This is a toxic marriage of big government and big business to crowd out competition. First government raises prices through overregulation and a lack of free-market competition, and then it justifies mass government purchases from single manufacturers by arguing these are necessary to negotiate discounts. The discounts would not be necessary if there were more producers of baby formula competing for the business of American parents. Then store shelves would be filled with as much cheap baby formula as there is banana puree.

What is the solution? Stop treating formula like a pharmaceutical product, except in specialty cases. Eliminate the barriers to entry that allow 80 percent of the market to be dominated by two manufacturers. Treat baby formula like baby food, with common-sense measures to make sure that factories are clean and products are safe. If we did that, then American parents would not have to worry about the Biden administration’s incompetent response to this crisis — because it would have never have happened in the first place.

Marc Thiessen writes a twice-weekly column for The Post on foreign and domestic policy. He is a fellow at the American Enterprise Institute, and the former chief speechwriter for President George W. Bush.

https://www.washingtonpost.com/opinions/2022/06/02/solve-baby-formula-crisis-regulate-as-food-not-pharmaceuticals/

White House Keeps Stoking Covid Fears

 ‘I’ve been a huge advocate of keeping schools fully open to in person education since October of 2020,” Ashish Jha, the White House’s Covid response coordinator, tweeted last week. “Still am.” So why is Dr. Jha engaged in scare-mongering about the danger of Covid to children?

In a May 30 tweet, Dr. Jha asserted that Covid is “a far greater threat to kids than the flu is.” He linked to an article by Harvard Medical School instructor Jeremy Faust,

which claims that Covid killed more than 600 children in 2021, whereas the flu kills “an average” of only 120 children annually. But Dr. Faust’s data are severely skewed, for three reasons.

First, while flu is seldom tested, everyone admitted to a hospital for any reason gets a Covid test. Between October 2018 and September 2019, 1.4 million flu tests were reported to public-health and clinical labs. As of May 31, 2022, there had been 897 million PCR tests for Covid.

Second, evidence from audits of death certificates found that 35% of all pediatric deaths in 2020 “had co-occurring diagnosis codes that could not be plausibly categorized as either a chain-of-event or significant contributing condition,” according to a study published by the Centers for Disease Control and Prevention. Put another way, in at least 35% of pediatric “Covid deaths,” Covid couldn’t have been the cause.

Third, Dr. Faust relies on a figure for confirmed flu deaths that is well-known to underestimate actual flu deaths by an order of magnitude. Correcting for the lack of flu testing, the National Center for Immunization and Respiratory Diseases estimated 1,261 pediatric flu deaths in the 2012-13 season rather than the 142 that Dr. Faust reported.

For the White House to amplify a false message of high Covid risk for children undermines public health and erodes public confidence. It foments an erroneous assessment of risk and is the kind of misinformation that leads to more school closings as well as burdensome mask and quarantine mandates.

There are far greater risks to children than Covid. Since March 2020, more than 1,000 kids have died with Covid (an average of around 38 a month), according to the CDC. In the same period more than 1,400 children died from drug- and alcohol-related causes.

The biggest risk to children comes from disruptions in their schooling. We will be cleaning up the school-closing mess for years, and fomenting baseless fear only makes the task harder.

Dr. Jay Bhattacharya is a professor of health policy at Stanford and a founding fellow at the Academy for Science and Freedom.

https://vigourtimes.com/the-white-house-keeps-stoking-covid-fears/

Lilly Flirts With Buy Point On 'Flawless' Update For Diabetes-Turned-Obesity Drug

 Eli Lilly (LLY) delivered a promising update for its experimental obesity treatment over the weekend, leading LLY stock to rise Monday.

In the final-phase study, patients who took Lilly's tirzepatide for 72 weeks lost 35-52 pounds — or 16%-22.5% of their body weight — depending on the dose. Further, treatment with tirzepatide led to improvements in other cardio-metabolic factors, like lipids and blood pressure.

"We believe tirzepatide's (effectiveness) on weight loss is unmatched by other pharmacological treatments and, as further emphasized in the accompanying New England Journal of Medicine editorial, the tirzepatide data 'could have major ramification for people with obesity,' " Mizuho Securities analyst Vamil Divan said in a report.

On today's stock market, LLY stock advanced 0.6% to 303.36. Earlier, shares jumped as much as 4.4%.

LLY Stock: Massive Weight Loss

Tirzepatide already sells under the brand name Mounjaro as a treatment for type 2 diabetes. But Lilly is hoping to also launch it as a weight-loss drug, a proposition that's now prodding LLY stock. This would put it on Novo Nordisk's (NVO) path. The Danish company sells semaglutide, in several formulations, for diabetes and obesity.

Lilly tested three doses of tirzepatide in weight loss. At the low dose, 89% of patients lost at least 5% of their body weight vs. 96% of patients at the middle and high doses. In comparison, 28% of placebo recipients hit the same bar. One analyst called the update "flawless."

At the highest dose, nearly 40% of patients lost at least one-quarter of their weight. Additionally, patients taking tirzepatide lost three times more fat than lean muscle.

The results pushed LLY stock closer to a buy point. Shares broke out of a flat base with an entry at 314.10 on May 27, but slipped back below that mark late last month. Now, Lilly stock is making a fresh run at a breakout, according to MarketSmith.com.

Testing Across Multiple Diseases

Lilly is also testing tirzepatide across various obesity-related conditions, including heart failure, and nonalcoholic steatohepatitis. The company also hopes tirzepatide can lower the risk of heart attacks, stroke and other cardiovascular conditions.

Mizuho's Divan expects tirzepatide to capture more than $14 billion in 2030 sales.

"Our enthusiasm on tirzepatide remains a key driver of our bullish view on Lilly shares," he said.

He has a buy rating and 356 price target on LLY stock.

https://www.investors.com/news/technology/lly-stock-pops-on-flawless-update-for-diabetes-turned-obesity-treatment/

NetScientific Says FDA Granted PDS0101 Cancer Treatment Fast Track

 NetScientific PLC said Monday that the U.S. Food and Drug Administration has granted its PDS0101 cancer treatment a Fast Track designation in combination with Merck & Co.'s Keytruda therapy.

The London-listed life-sciences, technology, investment and commercialization company said its portfolio company PDS Biotechnology Corp. was granted the designation for the treatment of recurrent or metastatic head and neck cancer.

The company said the designation program is intended to help develop and expedite the review of drug candidate applications that can potentially treat serious or life-threatening conditions.

"The FDA fast track designation of PDS0101 provides recognition that the drug fills an unmet need in a serious condition, with the purpose to get a drug to patients faster. The board therefore considers this a significant milestone and value inflection point for PDS," Chief Executive Ilian Iliev said.

https://www.marketscreener.com/quote/stock/NETSCIENTIFIC-PLC-14285587/news/NetScientific-Says-FDA-Granted-PDS0101-Cancer-Treatment-Fast-Track-Designation-40647706/

Becton Dickinson to Buy Parata Systems for $1.53 B

 Becton Dickinson & Co. on Monday said it agreed to buy Parata Systems, a provider of pharmacy automation solutions, from private-equity firm Frazier Healthcare Partners, for about $1.53 billion.

Franklin Lakes, N.J., medical-technology company Becton Dickinson said the deal, which it expects to complete by the end of March 2023, expands its portfolio to a new area of the high-growth pharmacy automation space.

Becton Dickinson said Parata, which generated revenue of about $220 million for the 12 months ended March 31, offers solutions to pharmacies to reduce costs, enhance patient safety and improve the patient experience.

Healthcare-focused Frazier, which has raised more than $7.1 billion in total capital since its inception in 1991, acquired Parata in 2018.

https://www.marketscreener.com/quote/stock/BECTON-DICKINSON-AND-COM-11801/news/Becton-Dickinson-to-Buy-Parata-Systems-for-1-53-Billion-40650412/