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Friday, February 3, 2023

Biden administration seeks to 'toughen' school nutrition standards

 

School meals for millions of children in the United States would include less sugar, more whole grains, and lower sodium under new standards proposed by the Biden administration on Friday.

Agriculture Secretary Tom Vilsack said the updated standards, to be rolled out over the next several years, were essential to tackling health concerns like childhood obesity.

"This is a national security imperative. It's a healthcare imperative for our children. It's an equity issue. It's an educational achievement issue. And it's an economic competitiveness issue," he said in a livestreamed event announcing the standards.

Under the proposed standards, by fall 2024, 80% of the grains provided by schools would need to be whole grain. By fall 2025, there would be limits for high-sugar products like cereals and yogurts, added sugar in flavored milks, and sodium. Future years would see additional limits on added sugar and sodium.

Some school nutrition directors worry the stricter guidelines will force schools to scale back menus, inadvertently pushing students to less healthy food choices.

"Most districts allow students to leave campus. They'll be hitting the convenience stores, the fast-food restaurants," said Michael Gasper, nutrition services supervisor for the School District of Holmen, Wisconsin. "Nutrition is only nutrition if they eat it."

School meal programs continue to struggle with inflated food prices and labor shortages, making new regulations difficult to implement, Gasper added.

The debate over school nutrition has spanned several administrations. The Obama administration hiked standards, requiring schools to serve fruits and vegetables daily and offer more whole grains. Under the Trump administration, some of those requirements were rolled back.

The Food Research & Action Center, a leading nutrition and hunger group, cheered Friday's announcement.

"These proposed evidence-based standards will make for a healthier school day," said FRAC President Luis Guardia in a statement.

Dairy industry advocates pushed back on the potential limits to flavored milk in schools.

"While we are pleased that this proposed rule continues to make dairy central to child nutrition, we are concerned with USDA's ongoing efforts to propose limitations to milk and dairy in school meals," said Michael Dykes, chief executive of the International Dairy Foods Association.

About 30 million students eat school lunches and 15 million eat school breakfasts each year, according to Department of Agriculture data.

The Biden administration committed to updating school meal nutrition standards as part of its strategy laid out at a conference on hunger last year.

https://www.marketscreener.com/news/latest/Biden-administration-seeks-to-toughen-school-nutrition-standards--42893487/

Gilead spells out allogeneic cell therapy doubts

 Slow progress with allogeneic cell therapies has prompted understandable scepticism, but the bluntness of Gilead’s opinions on these approaches is still notable. These were delivered by Christi Shaw, head of the group's Kite business, on a media call alongside Gilead’s earnings yesterday: she said it would be “be quite a while, if ever” before off-the-shelf cell therapies caught up with autologous offerings. Harnessing a person’s own cells will remain the mainstay of therapies in the future, she said, thanks to improvements in efficacy and manufacturing, particularly as products move into earlier treatment lines. Deals with Arcellx and Tmunity were examples of Gilead “doubling down” on autologous cell therapy, although the “door is open” to new approaches. The backdrop here is Yescarta, whose sales have picked up pace largely thanks to a second-line lymphoma label. Whether the highly complex Car-T space can become a profitable is still an open question, however. While manufacturing times are improving, bottlenecks elsewhere are still preventing these therapies from reaching their potential. Perhaps Gilead has decided that its efforts are better focused on improving what it already has. Over to the allogeneic players, like Allogene, Crispr, Precision and Caribou, to sort out the durability problem. 


https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/gilead-spells-out-allogeneic-cell-therapy-doubts

WW sales ($m)Finally taking off? Yescarta global salesWW sales ($m)Q1 2018Q2 2018Q3 2018Q4 2018Q1 2019Q2 2019Q3 2019Q4 2019Q1 2020Q2 2020Q3 2020Q4 2020Q1 2021Q2 2021Q3 2021Q4 2021Q1 2022Q2 2022Q3 2022Q4 20220100200300400Evaluate Pharma and Gilead

Sanofi backs away from AstraZeneca, argenx and more, stopping phase 3 trial of $3.7B drug

 The fight for the myasthenia gravis market has become too hot for Sanofi to handle. After reviewing the competitive landscape, the Big Pharma has decided to stop a phase 3 clinical trial of a drug candidate it acquired in its $3.7 billion takeover of Principia Biopharma.

Myasthenia gravis, a rare long-term condition that causes muscle weakness, has emerged as a focus for several drug developers in recent years. Alexion, now part of AstraZeneca, won approval for Soliris in the indication in 2017 before following up with an OK for Ultomiris last year. In between those approvals, argenx secured the green light to sell Vyvgart in the U.S.

UCB has filed for approval of two molecules, zilucoplan and rozanolixizumab, in the indication. Johnson & Johnson is following close behind, with the phase 3 trial of its challenger nipocalimab scheduled to get to primary completion by the end of the year.

The throng of companies targeting the indication has caused Sanofi to bow out. The French pharma began a phase 3 trial of tolebrutinib, the BTK inhibitor it acquired in the Principia buyout, in myasthenia gravis at the end of 2021. However, last summer, cases of drug-induced liver injury led Sanofi to pause enrollment in the study and in its phase 3 multiple sclerosis program.

At the time, Sanofi outlined plans to get the FDA partial clinical hold lifted in the fourth quarter but has now decided to walk away from myasthenia gravis while continuing to advance tolebrutinib in multiple sclerosis. In a full-year earnings document this morning, Sanofi said it reached the decision after a “careful evaluation of the emerging competitive treatment landscape.”

Even before the partial clinical hold, Sanofi faced the prospect of being late to the party. The phase 3 trial had a primary completion date of November 2024, suggesting Sanofi would have faced a fight to win a share of a market already served by drugs from argenx, AstraZeneca, J&J and UCB.

The decision leaves Sanofi looking to multiple sclerosis for a return on its $3.7 billion Principia bet. A phase 3 trial in non-relapsing secondary progressive multiple sclerosis hit its recruitment target late last year. Sanofi is continuing to recruit patients for its primary progressive multiple sclerosis trial outside of the U.S.

https://www.fiercebiotech.com/biotech/sanofi-backs-down-fight-astrazeneca-argenx-and-more-stopping-phase-3-trial-37b-drug

Immuneering cut to Underweight from Equal Weight by Morgan Stanley

 Target to $5 from $12

https://finviz.com/quote.ashx?t=IMRX&ty=c&ta=1&p=d

Why Twist Sank

 Shares of Twist Bioscience (TWST -17.18%) were sinking 17.5% as of 11:18 a.m. ET on Friday. The steep decline came after the synthetic DNA maker announced its fiscal 2023 first-quarter results.

Twist reported Q1 revenue of $54.2 million, up 29% year over year. This revenue total narrowly beat the consensus Wall Street estimate of $54.1 million.

The company posted a net loss in the first quarter of $41.8 million, or $0.74 per share. This result reflected improvement from the net loss of $45.6 million, or $0.91 per share, in the prior-year period. It also was much better than the average analysts' estimate of a net loss of $1.13 per share in Q1.

With these better-than-expected results, why is the life sciences stock falling so much? Twist provided disappointing guidance. The company expects Q2 revenue of $56.5 million, well under the consensus view of $61.9 million.

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NASDAQ: TWST

Twist Bioscience
Today's Change
(-17.18%) -$5.31
Current Price
$25.59
 TWST

KEY DATA POINTS

Market Cap
$2B
Day's Range
$23.81 - $26.18
52wk Range
$21.78 - $66.15
Volume
2,209,005
Avg Vol
1,024,317
Gross Margin
41.38%
Dividend Yield
N/A


There's a good argument to be made that Twist's guidance wasn't bad enough to justify its stock decline. The company still expects full-year fiscal 2023 revenue of between $261 million and $269 million, which are the same numbers it gave in November 2022. Wall Street's average revenue estimate for fiscal 2023 is $265.5 million -- smack dab in the middle of Twist's guidance range.However, after the great first quarter, analysts hoped that Twist would increase its guidance. That didn't happen, so the stock fell.


It's best to have a long-term perspective with any stock. That's especially true, though, with one like Twist Bioscience that could have tremendous future growth prospects.

One big development to look forward to later this year is the early-access product offering for the company's latest DNA data storage chip. Twist could have massive market potential over the long run with storing data in DNA.

https://www.fool.com/investing/2023/02/03/why-twist-bioscience-stock-is-sinking-today/

Neurocrine upped to Overweight from Equal Weight by Morgan Staney

 Target to $130 from $120

https://finviz.com/quote.ashx?t=NBIX&ty=c&ta=1&p=d

Repare cut to Equal Weight from Overweight by Morgan Stanley

 Target to $15 from $28

https://finviz.com/quote.ashx?t=RPTX&ty=c&ta=1&p=d