Axogen traded lower after the company guided for revenue growth that is cooler than expected for fiscal 2024.
https://www.marketwatch.com/story/axogen-shares-fall-13-on-lukewarm-2024-outlook-0f6ed9aa
Tuesday, March 5, 2024
Dialysis providers gain as investors focus on cardiac benefits after Ozempic's latest data
Shares of dialysis services providers jumped between 3% and 12% on Tuesday as latest data from Novo Nordisk's hugely popular diabetes drug Ozempic indicated a less-than-expected effect in chronic kidney disease patients.
Investors, concerned after the interim data in October, are betting that most of the benefits of GLP-1 drugs such as Ozempic are related to cardiac events "rather than a game-changing extension in kidney disease progression, which the market has been worried about", said Morningstar analyst Julie Utterback.
The potential for GLP-1 drugs such as Ozempic and Wegovy to treat health problems beyond diabetes and obesity has also hit shares in bariatric surgery providers, food firms and glucose-monitoring device makers.
Colorado-based DaVita rose 8%, while the U.S.-listed shares of rival Fresenius Medical were up 12.3% in morning trade. Baxter International, which provides dialysis operations through its kidney care unit, gained 2.5%. DaVita and Baxter are among the top percentage gainers on the S&P 500 Healthcare index.
The late-stage data showed Ozempic delayed progression of chronic kidney disease in diabetes patients and cut the risk of major cardiac events and death by 24%, which analysts said fell short of some investors' expectations.
DaVita and German rival Fresenius have downplayed concerns over GLP-1 drugs shrinking the market for kidney care.
Citi analyst Joanne Wuensch attributed the rise in kidney care stocks to high investor expectations from the study, after it was stopped almost a year ahead of schedule as an interim analysis had shown that the treatment would succeed.
The full results from the trial, expected later this year, "will prove to be the real test for dialysis stocks", said Wuensch.
U.S.-listed shares of the Danish drugmaker Novo Nordisk fell 1.7%. The stock has gained more than 20% so far this year on surging demand for its highly effective diabetes and weight-loss drugs.
https://finance.yahoo.com/news/dialysis-firms-gain-ozempic-kidney-145019920.html
'Biden task force to crack down on 'unfair and illegal pricing' amid rising inflation'
President Joe Biden on Tuesday will launch a new task force to take on “unfair and illegal” corporate pricing, which Biden sees as a major reason why consumers are not yet feeling the impact of cooling inflation rates and a strong economy.
The task force will be jointly led by the Federal Trade Commission and the Department of Justice, two agencies at the forefront of the Biden administration’s aggressive regulatory agenda over the past three years.
“We’re excited to be co-chairing the president’s new Strike Force on Unfair and Illegal Pricing, which builds on the FTC’s far-reaching work to promote competition and tackle unlawful business practices that are inflating costs for Americans,” FTC Chair Lina Khan told reporters on a call Monday.
Assistant Attorney General for Antitrust Jonathan Kanter will co-chair the strike force along with Khan.
“Here at the Justice Department, we are confronting some of the world’s most powerful corporations so that we can improve the lives of American families, Kanter said on the call.
On Tuesday afternoon, Biden will convene the sixth formal meeting of the White House Competition Council, a group of top official throughout the administration who are tasked with rooting out anti-competitive practices across a wide range of industries.
“Over the last year supply chains have returned to normal and inflation has come down,” said National Economic Council Director Lael Brainard on the call. “Some corporations aren’t passing those savings on to consumers...President Biden is fed up with corporate practices that unfairly raise costs for consumers and he’s taking action.”
In advance of the council meeting, the Consumer Financial Protection Bureau will release a final rule to cut credit card late fees. The Agriculture Department will also release finalized protections for farmers against potentially discriminatory processing practices.
The announcements and the meeting are part of Biden’s ongoing crusade against corporate pricing practices that he claims are unfair. The White House believes they contribute directly to the public perception that the economy is doing poorly, despite data that objectively shows a strong U.S. economy.
“The competition council and its members have worked to bring down costs and everything from hearing aids to asthma inhalers to Epi pens to air travel, ” said Brainard.
Still, questions remain about precisely what actions regulators have the legal authority to take to address companies that exercise their pricing power more aggressively than others.
“There are dozens of statutes on the book across all of these agencies that can, in certain situations, be brought to bear where high prices are harming consumers,” a senior administration official said on the Monday call. “And it depends on how and when.”
Biden has pointed to what he says is “price gouging” and “shrinkflation” as two examples of corporate pricing strategies that keep profits high, even when wholesale and transportation costs drop.
But two months into the election year, the narrative of a strong economy may finally be taking hold with voters who have so far not given Biden credit for the economy’s soft landing. Instead, they have blamed him for the post-pandemic elevated cost of living.
Four new polls released over the weekend pointed to signs of growing economic optimism among respondents.
Nonetheless, the polls still showed Biden trailing his likely November opponent, twice-impeached former President Donald Trump, in a head-to-head hypothetical general election contest.
https://www.yahoo.com/news/biden-launch-task-force-crack-154747556.html
'Updated COVID-19 shot expected to come this fall: CDC'
Americans should expect yet another update of the COVID-19 vaccine this fall at about the same time as flu shots are available, the top U.S. public health official said Monday.
Researchers are working on selecting a strain for the upcoming version, and will probably wait until May to pick one to target with vaccines, Centers for Disease Control and Prevention Director Mandy Cohen said in an interview at Bloomberg’s offices in Washington.
Cohen took the helm at the CDC in July, just weeks after the U.S. ended the emergency declaration that gave the agency special powers to address the COVID crisis. As COVID death rates and hospitalizations quickly recede, the focus remains on making sure that vulnerable Americans continue to get vaccine protection, Cohen said.
“Folks should anticipate that when they get their flu shot, they’ll get an updated COVID shot as well,” Cohen said in the interview.
Children’s recommendations
CDC is unlikely to pull back on its COVID vaccine recommendations for children, Cohen said, even though the virus broadly impacts kids less than in the past. Young children, along with the elderly, still make up a large proportion of those hospitalized for the disease, she said.
“We want to make sure we’re still protecting our kids from COVID and the flu,” she said in the interview.
With concerns about the virus abating, the CDC issued updated guidance Friday, saying that people with COVID whose symptoms are improving and have been fever-free for 24 hours without medication can return to work, school or other public places. The recommendation puts the pandemic virus alongside influenza and RSV that aren’t considered national emergencies, though they can be lethal in some vulnerable people.
“It bows to reality,” said Bill Hanage, a professor at Harvard University School of Public Health. “Very few people are actually observing those isolation polices and moreover, some people might not be willing to take a test if they need to isolate.”
The CDC guidance scraps the earlier recommendation for five days of isolation following a positive test, mirroring public health policies in Oregon and California, where strict isolation periods for COVID infections were recently abandoned. At least nine states have already amended their COVID policies since the CDC issued its guidance Friday, while officials in other states said they’re reviewing the new recommendations.
Maternal mortality
“I am happy to see the CDC guidance that harmonizes the approach and gives people concrete information of what they can do everyday,” said Dean Sidelinger, Oregon’s state epidemiologist. The state was the first to remove the five-day isolation guideline after finding it wasn’t slowing community spread, he said.
The CDC also recommended last week that people 65 years and older get a second dose of the latest version of the COVID vaccine, which was made available last fall. Only 39% of adults 65 years and older have received the first dose of the 2023-24 annual vaccine, according to the CDC.
While tweaking the response to the coronavirus, Cohen is now focusing on longstanding functions such as bolstering state and local health infrastructure and responding to crises like the epidemic of opioid-related deaths. Cohen also said the agency will expand its collection of data on maternal mortality to all 50 states.
Access to care for pregnancy-related conditions has been called into question after the U.S. Supreme Court’s 2022 Dobbs decision that eliminated access to abortion in some states. About half of the annual 6.1 million U.S. pregnancies are unintended, and advocates continue to tussle over access to birth control.
“We definitely continue to track data,” showing the impact of the Dobbs decision, Cohen said, “but I don’t think yet we’re at that place where we can compare pre and post.”
Akari, Peak to Merge
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, and Peak Bio Inc. (OTC: PKBO), a clinical-stage biopharmaceutical company focused on developing therapeutics in areas of inflammation and oncology announce a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX.
Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages. An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations.
Fresenius Med Sells Dialysis Clinics in Brazil, Colombia, Chile, Ecuador
Divestment of assets includes four separate country transactions to DaVita Inc. for USD 300 million
Transactions further reduce the Company`s clinic footprint in Latin America, following the exit from Argentina at the end of 2023
Expected to close throughout 2024
Proceeds to be used to reduce debt
Regenxbio NEW POSITIVE INITIAL EFFICACY DATA FROM DUCHENNE TRIAL
- New three-month assessment in first patient at dose level 2 demonstrates robust microdystrophin expression
- Patient aged 12 years at dosing had expression level at 75.7% of control
- Early evidence of strength and motor function improvement observed
- On track to initiate pivotal trial in second half of 2024
- Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigator
REGENXBIO will host a webcast Tuesday, March 5 at 8:30 a.m. ET. The live webcast can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.
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