Target tp $3.50 from $2.25
Tuesday, May 28, 2024
'Elanco: FDA Completes Review of Methane-Reducing Feed Ingredient for Dairy Industry'
- Food and Drug Administration confirms Bovaer meets safety and efficacy requirements
- Elanco expects product launch and added carbon credit value to producers beginning in the third quarter
- Elanco announces agreement with dsm-firmenich to expand distribution of Bovaer across North America, adding both the Canada and Mexico markets
Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has completed its comprehensive, multi-year review of Bovaer® (3-NOP), a first-in-class methane-reducing feed ingredient, and determined the product meets safety and efficacy requirements for use in lactating dairy cattle.
[Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction.
Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd)
Novo blames US health system after criticism over Wegovy price
Novo Nordisk said it retains about 60% of the list price of its popular diabetes and obesity drugs - Ozempic and Wegovy - after rebates and fees paid to middlemen in the United States, according to a Bloomberg report on Tuesday.
The Danish drugmaker's comments, made in a letter to Senator Bernie Sanders on Friday, come amid an ongoing investigation by a U.S. Senate committee into the higher prices of the drugs in the United States compared to other countries.
Novo Nordisk did not immediately respond to a Reuters request for comment.
The company argued in the letter to Senator Sanders, who has been pressing to lower the cost of Wegovy, that the focus on the list price of the drugs was misplaced because a part of it is paid to middlemen in the complex US health care system, Bloomberg said in its report on Tuesday.
The drugs belong to a class of treatments known as GLP-1s, which help regulate blood sugar and cause the stomach to empty more slowly. Analysts estimate the market for these drugs could be about $150 billion by the early 2030s as their use expands beyond obesity and diabetes and supply constraints ease.
A 2 milligram dose of Ozempic carries a list price of $935.77 in the United States, while Wegovy has a list price of $1,349.02 per package, according to the drugmaker's website.
Novo said "under current market conditions, the company expects that net prices will continue to decline for both Ozempic and Wegovy," according to the report.
https://www.yahoo.com/news/novo-blames-us-health-system-115915965.html
Travere gains on Novartis data, Calliditas buyout
Travere Therapeutics (TVTX) stock rose after Novartis (NVS) posted data for a rival kidney disease drug, while Calliditas (CALT) drew buyout interest.
https://seekingalpha.com/news/4110827-travere-stock-gains-novartis-data-calliditas-buyout
NATO's Newest Member OKs Ukraine Using Its Weapons To Strike Deep In Russian Territory
Calls are growing for escalation in Ukraine, with EU foreign policy chief Josep Borrell on Tuesday joining in the chorus of Western leaders urging allowing Kiev to attack Russian territory with West-supplied weaponry.
Borrell said that Ukraine has a right to strike back: "According with the law of war, it is perfectly possible and there is no contradiction," he said in a meeting with European Union defense ministers. Sweden agrees with him.
"I could retaliate or I could fight against the one who fights against me from his territory," Borrell said, adding: "You have to balance the risk of escalation and the need for Ukrainians to defend."
So far Washington, which has recently supplied the US Army's ATACMS with a max range of 190 miles, has not officially overturned its prohibition on using American missiles for strikes inside Ukraine. Germany has also been reluctant to change policies.
Borrell's fresh remarks come soon on the heels of NATO Secretary-General Jens Stoltenberg saying in a weekend interview with The Economist that "The time has come for allies to consider whether they should lift some of the restrictions they have imposed on weapons donated to Ukraine."
"To deny Ukraine the possibility of using these weapons against legitimate military targets on Russian territory makes it very hard for them to defend themselves," Stoltenberg had explained.
Meanwhile, NATO's newest member is also joining the crowd, jumping on the bandwagon in favor of strikes on Russian territory:
Sweden has permitted Ukraine to use its donated military weapons to strike deep into Russia — a bold move seen as an attempt to influence other nations to do the same.
Kyiv has long called for greater freedom to hit targets in Russia by lifting the restrictions imposed by Western nations on their donated weapons.
The country's Defense Minister Pal Jonson said Ukraine is up against an "unprovoked and illegal war of aggression" by Russia and thus it has a right to defend itself by any necessary means.
"As long as the military actions comply with the laws of war, Sweden stands behind international law and Ukraine’s right to defend itself," Jonson said while discussing the question of Swedish weapons in Ukraine. Despite being relatively small in size, the Scandinavian country is the world's ninth biggest donor of defense aid to Ukraine. The US of course tops the list.
Today Markets Switch To "T+1" Settlement: Here's All You Need To Know
In a witty turn of the phrase, Bloomberg writes today that "the US stock market is finally as fast as it was about a hundred years ago" and it's true: it's been about one century since share trades in New York settled in a single day, as they will from Tuesday under new SEC rules.
The change, which cuts in half the time it takes to complete every transaction, us also occurring in Canadian and Mexican markets starting Monday; For some investors, one-day settlement cycles may mean greater convenience. For others, T+1 may require closer attention to how shorter settlement times could affect one's investment, trading, or tax decisions. It also means that settlement will still take about 24 hours longer than any single crypto transaction, all of which settle instantly and securely courtesy of the blockchain.
That's right: even in this age of instant communication and live financial data, investors still had to wait at least two days to take ownership of the stocks they purchase or to receive payment for the stocks they sell. That’s about to change. Starting today, May 28, US trades will “settle” (complete the exchange of dollars for stock) in one day rather than two.
US banks, brokers and investors have been forced to review all of their post-trade technologies and procedures to ensure they are ready for the new pace of stock trading. The change poses a special challenge to investors outside the US who need to buy dollars as part of their stock trades.
The switch to the system known as T+1, abandoned in the previous era as volumes became unwieldy, is intended to reduce risk in the financial system. Yet there are worries about potential teething issues, including that international investors may struggle to source dollars on time, global funds will move at different speeds to their assets, and everyone will have less time to fix errors.
While the hope is that everything will run smoothly, even the SEC warned last week the transition may lead to a “short-term uptick in settlement fails and challenges to a small segment of market participants.” The finance world’s main industry group, the Securities Industry and Financial Markets Association, has instigated what it calls the T+1 Command Center to identify problems and coordinate a response.
Courtesy of Bloomberg, here is a useful primer on where the change comes from, and what it will mean for markets.
1. Background
Stock trades before the computer age involved the physical exchange of stock certificates, which often took five days or more. That became a problem in the late 1960s as the stock market finally climbed its way back to its 1929 peak. As public participation in the stock market increased, trading volume skyrocketed to 12 million shares a day in 1970 from 3 million a day in 1960. With the industry’s growth prospects threatened by a “paperwork crisis,” the New York Stock Exchange created a central clearinghouse that would hold the millions of certificates owned by its member firms. That set the stage for transactions to become computer-automated.
2. How did the clearinghouse speed up stock settlements?
Transferring ownership among members of the clearinghouse required only a “book entry,” eliminating the need to physically transfer shares. The Securities and Exchange Commission has been gradually shortening the settlement cycle since the early 1990s, from five days to the current “T+2,” where the T stands for the “trade” or “transaction” date. The shift to T+1 means retail and institutional investors will get the proceeds of their transactions in a matter of hours.
3. What’s behind the change to T+1?
The “meme stock” trading frenzy in early 2021 highlighted the need to update the market infrastructure that transmits and settles stock trades. As amateur traders prompted by social media postings bought up shares of inexpensive stocks like GameStop Corp. and Bed Bath & Beyond Inc., operators of retail trading platforms like Robinhood Financial Inc. had to post collateral for those trades during the two days it took to settle them. As the prices rose along with the stocks’ volume and volatility, Robinhood started to restrict the purchasing of those stocks to ensure it had enough capital to cover the collateral. That drew loud rebukes from retail traders and scrutiny from regulators and members of Congress.
4. Why the need for collateral?
Brokers are required to post collateral, also known as margin, in a fund held by the Depository Trust & Clearing Corp. — the modern Wall Street clearinghouse for stock trades. This way, both sides of a trade are protected if one party defaults, or fails to hold up its commitment.
5. What are the benefits of T+1?
The SEC has said that a shorter settlement window means lower odds that the buyer or seller might default before the transaction is completed. That translates to lower margin requirements for the broker and a lower risk that high volumes or volatility will force a broker to restrict trades. (US Treasuries and mutual funds already settle at T+1.)
6. What are the challenges for T+1 in the US?
The SEC has also said that T+1 could increase some operational risks. As the new rule was being finalized, SEC Commissioner Mark Uyeda said that speeding up settlements would mean less time for participants to address errors in the transaction process and for regulators to block the potential proceeds from frauds, among other challenges.
“Transition to a shorter settlement cycle may lead to a short-term uptick in settlement fails and challenges to a small segment of market participants,” SEC Chair Gary Gensler said in a written statement a week before the changeover.
7. How about outside the US?
The halving of the time it takes to settle equity transactions will put US stocks out of step with the $7.5-trillion-dollar-a-day global market for currency exchanges, which typically take two days to complete. Many overseas institutions trying to buy US assets will need to secure dollars in advance to ensure they have them in time to complete a transaction. Failure to do so might cause some purchases to fall through entirely. The European Fund and Asset Management Association, which represents firms managing €28.5 trillion, has warned that as much as $70 billion of daily currency trading could be at risk from a faster US settlement cycle.
Brokers and investors in Asia face a particular time crunch to be able to execute their trades by the US market close so they meet the industry’s 9 p.m. New York time deadline for trade “affirmation,” the last step before settlement. FX liquidity dries up in the US afternoon, when other markets are shut.
Some funds, such as Baillie Gifford, have chosen to move traders to the US. Others like Jupiter Asset Management are purchasing dollars in advance, while yet more will look to outsource their FX trading. All options come with costs. More than half of European financial companies with fewer than 10,000 staff are planning to either move people to North America or hire overnight staff, a survey sponsored by the DTCC found last year.
8. Why not T+0?
Gensler has said that modern technology could shorten the transaction process “to same-day settlement (T+0 or T+evening)”, especially if blockchain is used to enable instant settlement. That would further reduce the risk that one part or the other would default before settlement. But the Securities Industry and Financial Markets Association, the trade group known as Sifma, says that such a change would require expensive modifications to market operations. The group said T+0 could result in many more “failed trades” and fraud because there would be less time to fix incorrect settlement instructions or spot compliance problems.
9. What are banks doing to prepare for T+1?
Financial trade groups like the Investment Company Institute have said their industry is on track in preparing for the transition. Banks have drawn up transition plans to keep on top of any potential hiccups. They’re paying particular attention to a so-called double-settlement day on May 29 — when US trades from the old T+2 cycle will come due at the same time as the first batch of T+1 trades — and preparing for some of the world’s major indexes to rebalance their lineups at the end of the month, just days after the shift.
T+1 is also changing banks’ longer-term decisions: The securities services arm of Societe Generale SA, for example, is among non-US institutions extending the hours for some staff, while Citigroup Inc. is moving part of its team in Kuala Lumpur to a Tuesday-through-Saturday schedule instead of a typical Monday to Friday one to better align with the US trading week.
10. Are other countries making the change?
Yes. India is already on T+1, and regulators have approved a soft launch of same-day settlement in 25 stocks, as it attempts to lure back retail investors who’ve been shunning direct bets on shares in favor of more complex derivative products. China’s markets operate with a mix of same-day to T+2 settlement speeds. Canada and Mexico are poised to make the shift to T+1 in May. The UK plans to move to T+1 no later than the end of 2027. The US is also pressing the European Union to align with T+1, and the bloc’s financial regulation chief, Mairead McGuinness, has said the “question is no longer if, but how and when” the bloc will make the move. Australia is also weighing a move to T+1.
https://www.zerohedge.com/markets/today-markets-switch-t1-settlement-heres-all-you-need-know
CorMedix Inc. in Commercial Agreement With Top Tier Dialysis Provider
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin).
CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15th. The Company expects to begin commercialization in outpatient dialysis clinics in July. CorMedix is committed to building meaningful long-term relationships with dialysis providers that are dedicated to innovation and infection reduction. This agreement will allow for patients to have access to DefenCath at more than 500 dialysis facilities located nationally.
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