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Friday, May 10, 2024

'FDA Preparing For Possible Bird Flu Spread Among Humans: Commissioner'

 by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Food and Drug Administration (FDA) is preparing for a scenario in which the highly pathogenic avian influenza starts spreading among humans, the agency’s commissioner said on May 8.

This virus, like all viruses, is mutating. We need to continue to prepare for the possibility that it might jump to humans,” Dr. Robert Califf, the commissioner, told senators during a hearing in Washington.

The influenza, also known as the bird flu or H5N1, has recently started spreading among cattle and other species. One person in Texas has had a confirmed case this year.

So far, genetic sequencing and other data indicate that influenza poses little risk to people, and there are no signs that the flu is transmitting from person-to-person, according to U.S. officials. But they are working on getting treatments, tests, and vaccines ready in case that changes.

We’ve been busy getting prepared for if the virus does mutate in a way that jumps into humans on a larger level,” Dr. Califf told the Senate Appropriations Committee’s Agriculture Appropriations Subcommittee.

The patient in Texas primarily experienced one symptom: inflamed eyes. Neither the patient nor many of the cows that have been infected have suffered respiratory symptoms. H5N1 commonly infects the respiratory tracts of birds.

“The real worry is that it will jump to the human lungs, where, when that has happened in other parts of the world for brief outbreaks, the mortality rates have been 25 percent,” Dr. Califf said. The worry is based in part on how viruses typically mutate, such as in the case of COVID-19.

From 2003 to April 1, 2024, 889 cases of H5N1 have been confirmed across the globe, according to the World Health Organization (WHO). Of the patients, 52 percent have died.

WHO chief scientist Jeremy Farrar said recently that H5N1 has developed into a “global zoonotic animal pandemic” and that scientists are concerned that the virus could evolve to spread among humans.

Tedros Ghebreyesus, the director-general of the organization, said Wednesday that “the virus does not show signs of having adapted to spread among humans, but more surveillance is needed.”

Many experts consulted by the U.S. government are concerned about the jump of the influenza to cattle and other species and how cattle intermingle with pigs, chickens, and humans on farms, according to Dr. Califf. A May 3 study from U.S. and Danish researchers said testing of tissues from cattle indicated the animals could serve as a “mixing vessel” for avian influenza because receptors from chickens, ducks, and humans were expressed in the cows.

While the risk is still low, “if we institute the countermeasures now and reduce the spread of the virus now, then we’re much less likely to see a mutation that jumps to humans for which we’re ill-prepared,” Dr. Califf added.

Current U.S. rules mandate testing of some cattle before being moved to another state. The guidance includes advising workers on farms to wear protective equipment when dealing with animals that may be or are sick with the bird flu.

The FDA is focusing in part on ensuring the country’s milk supply is safe to drink. The agency and its partners have tested samples of milk from grocery stores. Although some samples tested positive, no live virus has been detected, meaning the milk supply is safe, according to the agency.

Test results from beef have also found beef is safe, according to the U.S. Department of Agriculture.

The agency has confirmed H5N1 infections in 36 herds across nine states, including Colorado, Kansas, and Michigan. Data from affected cows indicate H5N1 began circulating in cattle in late 2023, according to a preprint paper from the department.

About 70 farm workers are being monitored in Colorado, officials said in a briefing this week, but none have displayed symptoms as of yet.

https://www.zerohedge.com/medical/fda-preparing-possible-bird-flu-spread-among-humans-commissioner

ICE Expected To Roll Out ID Program For Illegal Immigrants This Summer

 Immigration and Customs Enforcement (ICE) is planning to roll out a controversial ID card pilot program for illegal immigrants being released into the US, with the stated objective of 'modernizing the documentation process for removal proceedings,' Fox News reports.

Images show the ICE Secure Docket Card program. (Fox News)

First reported in 2022, the 'Secure Docket Card' pilot program is expected to begin this summer with around 10,000 cards in a limited rollout at three or four locations in the US. The agency claims that the program is "pre-decisional" and subject to change. According to the report, Houston and Atlanta are two potential locations.

Officials claim that the program will "modernize documentation provided to some noncitizens" but it will not be an official form of federal ID.

Images show the ICE Secure Docket Card program. (Fox News)

"While the specifics of the card and pilot are under development, it is important to note the secure card will not be an official form of federal identification," the agency said. "The secure card will indicate it is for use by DHS agencies and would be provided only after national security background checks have been performed."

When illegal immigrants cross the border and are released into the interior, they are often given a number of paper documents depending on their status and situation. ICE says that such documents pose a security risk and can be lost and degraded, and the new program will make the agency more efficient.

It would also allow for an easier verification of identity through DHS systems via officials. -Fox News

"Moving to a secure card will save the agency millions, free up resources and ensure information is quickly accessible to DHS officials while reducing the agency’s FOIA backlog," a spokesperson told the outlet. "For provisionally released noncitizens, the digital modernization will provide ongoing access to important immigration documents through the secure card and connected portal."

The program is expected to face serious opposition from Republicans and conservatives who have criticized the Biden administration for regular releases of illegal immigrants.

"Just in time for the election, the Biden administration is quietly legitimizing a government-sanctioned invasion of our nation," said RJ Hauman, president of the National Immigration Center for Enforcement (NICE) and a visiting fellow at The Heritage Foundation, in a statement to Fox News Digital.

"Providing illegal aliens with identification will undoubtedly lead to obtaining other documents, benefits and rights — or create an entirely new identity. After all, most who cross the border have no identification information in their possession. So, how do we even know who they are?"

On Wednesday, Republicans moved forward with legislation that would require a citizenship question on the census in order to prevent noncitizens from being counted.

https://www.zerohedge.com/political/ice-expected-roll-out-id-program-illegal-immigrants-summer

Progyny’s stock plunges as demand for IVF treatments drops after Alabama ruling

 Fertility-treatment company misses first-quarter revenue estimates, provides downbeat second-quarter outlook and cuts full-year view

Shares of Progyny Inc. were headed for a record selloff Friday after the fertility-services company said the Supreme Court of Alabama's February ruling regarding in vitro fertilization seemed to scare off some potential customers.

The increased customer caution led to lower-than-expected first-quarter revenue and prompted the company to provide a downbeat outlook for the current quarter and cut its full-year outlook.

The stock (PGNY) plunged 23.5% in morning trading, putting it on track for the lowest close since October 2020. The selloff was set to surpass the current record one-day decline of 18.8%, suffered on Feb. 25, 2021.

Chief Executive Peter Anevski explained on the post-earnings call with analysts late Thursday that the quarter started on the same track as last year, with strong demand.

"However, unlike last year, we began to see the ramp in member activity leveling off slightly in March, coinciding with the national conversations about women's access to reproductive healthcare sparked by the Alabama Supreme Court ruling," Anevski said, according to an AlphaSense transcript.

The Alabama court ruled in mid-February that embryos created and frozen during IVF procedures were legally considered children, meaning the destruction of the embryos, even if accidental, can lead to prosecution.

Since then, Alabama has passed legislation to protect access to IVF procedures, but concerns remain about potential consequences, especially in states with more restrictive abortion laws.

Anevski said he can't be certain why people decide not to pursue IVF procedures, "as no one contacts us to say why they're not doing something," but he said that after looking at activity by client, industry and region, one noticeable pattern emerged.

"The modest dip in activity that we saw across the country was more pronounced in the states with the most restrictive laws for women's reproductive healthcare, suggesting that a relatively small number of members were proceeding with a greater degree of caution before commencing their fertility journey," Anevski said.

KeyBanc analyst Scott Schoenhaus followed by downgrading Progyny's stock to sector weight from overweight. He is now the only analyst, out of the 10 surveyed by FactSet who cover the company, that isn't bullish.

He said his previous bullish stance had been based expectations of sustained, healthy growth, but he is now "more weary" of the company's visibility into revenue, utilization and customer behavior.

"We would look to return to a more positive outlook on shares if we do see an improvement in underlying utilization and the ability for management to have better visibility into customer trends and ultimately its business," Schoenhaus wrote in a note to clients.

The company reported late Thursday first-quarter revenue of $278.1 million, up 7.6% from the same period a year ago but below the FactSet consensus of $289.4 million.

Fertility benefit services revenue rose 8% to $169.8 million, and pharmacy benefit services revenue grew 7% to $108.3 million.

For the second quarter, the company said it expects revenue of $300 million to $310 million, below the current FactSet consensus of $321.4 million, which has declined from the estimate of $335.8 million as of the end of April.

For the full year, the company cut its revenue guidance to $1.23 billion-$1.27 billion, from the range provided in late February of $1.285 billion-$1.315 billion.

The company also reported first-quarter net income that slipped to $16.9 million, or 17 cents a share, from $17.7 million, or 18 cents a share, in the same period a year ago.

On the bright side, excluding nonrecurring items, adjusted earnings per share of 39 cents beat the FactSet consensus of 35 cents.

The company said it expects adjusted EPS for the second quarter of 39 cents to 41 cents, compared with the current FactSet consensus of 41 cents, and raised full-year guidance to $1.61-$1.68 from $1.54-$1.59.

https://www.morningstar.com/news/marketwatch/20240510227/progynys-stock-plunges-as-demand-for-ivf-treatments-drops-after-alabama-ruling

Biden administration won’t conclude Israel violated terms of US weapons agreement: report

 A soon-to-be-released Biden administration report does not conclude that Israel has violated the terms for its use of US weapons, according to three people who have been briefed on the matter.

The report is expected to be sharply critical of Israel even though it didn’t conclude that Israel violated terms of US-Israel weapons agreements, according to one US official.

Joe Biden
Biden’s admin will not conclude Israel violated US weapons agreement terms.REUTERS
Gaza
The memorandum is expected to be released Friday.Majdi Fathi/NurPhoto/Shutterstock

Two US officials and a third person briefed on the findings of the national security memorandum to be submitted by Secretary of State Antony Blinken to Congress discussed the matter before the report’s release. They spoke on condition of anonymity because the information was not yet public.

A senior Biden administration official said the memorandum is expected to be released later Friday, but declined to comment on the findings.

The Biden administration finding comes after seven months of airstrikes, ground fighting and aid restrictions in Gaza that have claimed the lives of nearly 35,000 Palestinians, mostly women and children.

A presidential directive agreed to by the White House under pressure from congressional Democrats and others forced the administration to deliver a first-of-its-kind public verdict on whether Israel is using US-provided bombs and other security support lawfully in its conflicts with Palestinians. Israel is the largest recipient of US military aid and America’s security partner for more than a half-century.

Axios first reported on the memorandum’s finding.

https://nypost.com/2024/05/10/us-news/biden-administration-wont-conclude-israel-violated-terms-of-us-weapons-agreement-report/

CareDx gains on Testing Services advances

 First Quarter 2024 Highlights

  • Reported first quarter revenue of $72.0 million.
  • Revenue for Testing Services of $53.8 million, an increase of 15% as compared to the fourth quarter 2023.
  • Grew testing services patients results for the third consecutive quarter to approximately 42,000, an increase of 6% as compared to the fourth quarter 2023.
  • Over 30 oral presentations, posters and two symposia highlighting CareDx’s scientific advancements in heart and lung transplantation presented at the International Society for Heart and Lung Transplantation (ISHLT).
  • SHORE data presented at ISHLT demonstrated that HeartCare® multimodal testing outperforms donor-derived cell-free DNA (dd-cfDNA) testing alone in identifying allograft rejection.
  • Expanded payer coverage by 14 million lives nationwide.
  • Reported first quarter revenue of $9.6 million for Patient and Digital Solutions and $8.6 million for Products, representing year-over-year growth of 12% and 25%, respectively.
  • Ended the quarter with cash, cash equivalents, and marketable securities of approximately $216 million, with no debt.

“We set a new baseline in our Testing Services business in the second half of 2023 and are back to delivering sequential growth. I am pleased with the team’s strong performance across all businesses this quarter,” said John W. Hanna, CareDx President and CEO. “CareDx is the leader in transplant patient care and our dedication to serving patients will continue to be our catalyst for growth.”

https://www.businesswire.com/news/home/20240509171418/en/

ADMA Biologics Analysts Increase Their Forecasts After Upbeat Results

 ADMA Biologics, Inc. 

+ Free Alerts
 reported better-than-expected first-quarter financial results and issued strong revenue guidance on Thursday.

ADMA Biologics posted GAAP earnings of 8 cents per share, beating market estimates of 5 cents per share. The company's quarterly sales came in at $81.875 million versus expectations of $77.275 million, according to data from Benzinga Pro.

“ADMA’s commercial success continues to unfold, and during the first quarter of 2024, we surpassed our financial expectations and delivered compounding earnings growth. The versatility and strength of our innovative business model has yet again provided for significant increases to both top- and bottom-line projections for 2024 and 2025,” said Adam Grossman, President, Chief Executive Officer and Interim Chief Financial Officer of ADMA. “We believe ASCENIV™’s record utilization coupled with BIVIGAM®’s deepening entrenchment in the expanding U.S. IG market are driving our commercial growth and further solidifying our position as a leader in specialty biologics. With an unwavering commitment to serving immune deficient patients, we believe we are poised for enduring growth within our target markets for years to come.”

ADMA Biologics said it sees FY24 revenue more than $355 million and FY25 revenue more than $410 million.

ADMA Biologics shares rose 1% to close at $6.93 on Thursday.

These analysts made changes to their price targets on ADMA Biologics following earnings announcement.

  • Mizuho raised the price target on ADMA Biologics from $10 to $12. Mizuho analyst Anthony Petrone maintained a Buy rating.
  • HC Wainwright & Co. increased the price target on ADMA Biologics from $7.5 to $10. HC Wainwright & Co. analyst Raghuram Selvaraju maintained a Buy rating.

iTeos results, update

  Belrestotug + dostarlimab exceeded pre-defined efficacy criteria for clinically relevant activity observed in an interim assessment of Phase 2 GALAXIES Lung-201

- Clinically meaningful tumor reduction observed at every belrestotug + dostarlimab dose vs monotherapy
- GSK to provide update on GALAXIES program at upcoming investor event in June
- RA Capital and Boxer Capital led $120 million registered direct offering at $17.50, representing a premium of approximately 44% to last close
- Pro forma cash and investment balance of $715 million as of March 31, 2024 expected to provide runway through 2027 across a number of impactful portfolio milestones