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Thursday, March 20, 2025

Abeona Pz-cel Regulatory Update and Commercial Launch Plans

 Abeona Therapeutics reported its full year 2024 financial results and provided updates on pz-cel regulatory progress. The FDA's priority review of pz-cel BLA is advancing with a PDUFA date of April 29, 2025, with the company targeting first patient treatment in Q3 2025 if approved.

Financial highlights include cash position of $98.1 million as of December 31, 2024, up from $52.6 million year-over-year. The company reported a net loss of $63.7 million ($1.55 per share) compared to $54.2 million ($2.53 per share) in 2023. R&D expenses increased to $34.4 million from $31.1 million, while G&A expenses rose to $29.9 million from $19.0 million.

The company has secured additional facility space in Cleveland for manufacturing expansion and obtained two patents extending protection for pz-cel treatment to 2037 and transport system to 2040. Current cash runway is expected to fund operations into 2026.

Abeona Therapeutics' financial results and regulatory update signal a pivotal moment for the company as it approaches the potential commercialization of pz-cel for RDEB. The FDA review is progressing on schedule with a PDUFA date of April 29, 2025, and the receipt of draft labeling suggests the review is in advanced stages.

The company reported $98.1 million in cash and investments at year-end 2024, a 86.5% increase from $52.6 million in 2023, providing runway into 2026. This strengthened cash position should adequately support commercialization efforts if pz-cel receives approval. However, financial metrics show increasing expenditures, with R&D expenses rising to $34.4 million from $31.1 million and G&A expenses climbing significantly to $29.9 million from $19.0 million. The 57.4% increase in G&A spending reflects substantial investment in commercial infrastructure ahead of potential launch.

Net losses widened to $63.7 million ($1.55 per share) from $54.2 million ($2.53 per share) year-over-year. While the increased loss warrants attention, it represents expected pre-launch investments rather than operational deterioration.

Beyond financial metrics, the company has secured patent protection for pz-cel until 2037/2040, enhancing long-term value prospects. Additionally, Abeona may receive a Priority Review Voucher upon approval, which could be monetized for $100+ million based on recent PRV transactions, potentially extending cash runway significantly beyond current projections.

https://www.stocktitan.net/news/ABEO/abeona-therapeutics-reports-full-year-2024-financial-results-z9itxlf3gnwi.html

Southwest US grid operator expanding into the west

 Energy regulators on Thursday approved the Southwest Power Pool (NASDAQ:POOL) to expand its territory and become the first regional U.S. grid to operate in both the western and eastern interconnections of the country’s electrical system, SPP said.


SPP is one of seven regional transmission operators that manage the physical flow of electricity and the markets that facilitate that movement, and those RTOs sometimes compete with each other for territory and members.

SPP, which runs the bulk electric grid and wholesale power market across 14 western and Midwest states, will expand its reach to encompass all or parts of 17 states under the agreement unanimously signed off on by the U.S. Federal Energy Regulatory Commission, SPP said in a statement.


Seven power providers that currently intersect with the SPP market on a limited basis will get the ability to participate in the broader market, transmission planning and other grid services beginning in April 2026.

Those potential new members include Basin Electric Power Cooperative, Colorado Springs Utilities, Deseret Power Electric Cooperative, the Municipal Energy Agency of Nebraska (MEAN); Platte River Power Authority, Tri-State Generation and Transmission Association, and the Western Area Power Administration Colorado River Storage Project, Rocky Mountain and Upper Great Plains regions. 


"With the complexities of today’s energy industry and the regulations that define it, an adaptable electric grid with access to both local and regional resources is essential for managing customer costs and maintaining service reliability,” Colorado Springs Utilities Chief Executive Officer Travas Deal said in a statement.

https://www.investing.com/news/commodities-news/southwest-us-grid-operator-expanding-into-the-west-3940265

US offers $15M reward for team accused of smuggling drone tech to Iran

 The State Department is offering a $15 million reward for information linked to four Chinese nationals it says have helped the Islamic Revolutionary Guard Corps (IRGC) procure U.S. military equipment and drone technology.

Liu Baoxia, Li Yongxin, Yung Yiu Wa and Zhong Yanlai are accused of facilitating the sale of U.S. goods to front companies based in China that would send the technology to Iran, according to a State Department release.

Iran would then transport products to the IRGC and its linked companies including Shiraz Electronics Industries and Rayan Roshd Afzar, which use U.S.-controlled technology to develop and manufacture unmanned aerial vehicles, arms and weapons systems, according to the State Department.

Manufactured products are then sold to governments and groups in allied countries such as Russia, Sudan and Yemen in violation of U.S. sanctions. 

Officials are now urging individuals with information about the illegal sale of technology to report information through their anonymous Tor Browser to receive a monetary reward.

https://thehill.com/policy/defense/5205621-us-15m-reward-drone-tech-china-iran/

Hawley to introduce legislation to curb court rulings against Trump agenda

 Sen. Josh Hawley (R-Mo.), a member of the Senate Judiciary Committee, says he will introduce legislation to curb what he says is a “dramatic abuse of judicial authority” by courts that have issued injunctions against President Trump’s agenda, including the deportation of alleged gang members.

“District Court judges have issued RECORD numbers of national injunctions against the Trump administration — a dramatic abuse of judicial authority. I will introduce legislation to stop this abuse for good,” Hawley posted on the social platform X.

Hawley issued the statement amid several ongoing court battles between the Trump administration and federal judges.

James Boasberg, the chief judge of the U.S. District Court for the District of Columbia, issued an order over the weekend halting the deportation of a group of Venezuelans, including alleged members of the Tren de Aragua gang, to El Salvador.

The Trump administration continued the deportation of the migrants after a stopover in Honduras despite a verbal and written order by Boasberg attempting to halt two deportation flights.

White House press secretary Karoline Leavitt told reporters that the judge “is essentially trying to say that the president doesn’t have the executive authority to deport foreign terrorists from our American soil,” calling it “an egregious abuse of the bench.”

Another federal judge Tuesday blocked Trump’s executive order banning transgender people from serving in the military.

On March 13,  federal judge ordered that the departments of Agriculture, Defense, Energy, Interior, Treasury and Veterans Affairs must immediately reinstate probationary employees who were fired.

Earlier this month, U.S. District Judge John McConnell ruled to extend an injunction against the Trump administration’s attempt to freeze payments for federal grants, writing that that the freeze “fundamentally undermines the distinct constitutional roles of each branch of our government.”

Hawley’s office said details about the legislation the Missouri senator intends to introduce will be announced at a later time.

https://thehill.com/homenews/senate/5205259-hawley-curbing-judicial-authority/

EU delays imposing first round of retaliatory tariffs against US until mid-April

 The European Union (EU) has delayed imposing its first retaliatory tariffs against the U.S. until mid-April, after President Donald Trump threatened a 25% tariff increase on all steel and aluminum imports earlier this month, according to Reuters. 

The countermeasures of around $28 billion on U.S. goods, including a 50% tariff on American whiskey, were originally set to phase in on April 1, with a second wave to hit on April 13.

However, the EU decided on Thursday to delay imposing all retaliatory tariffs until mid-April, Reuters reported.

The outlet said the delay will give the EU more time to negotiate with the U.S. and review products subject to the new tax.

"We are now considering to align the timing of the two sets of EU counter-measures so we can consult with member states on both lists simultaneously, and this would also give us extra time for negotiations with our American partners," European Trade Commissioner Maros Sefcovic said in a hearing at the European Parliament on Thursday, according to Reuters. 

American whiskey distillers praised the decision.

"This is a very positive development and gives U.S. distillers a glimmer of hope that a devastating 50% tariff on American whiskey can be averted," Distilled Spirits Council president and CEO Chris Swonger said in a statement. "Over the past three years that these EU tariffs have been suspended, American Whiskey exports to the EU have soared, supporting jobs at U.S. distilleries as well as local farms."

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"We urge the EU and U.S. to reach an agreement that will return and safeguard zero-for-zero tariffs for spirits trade, benefitting the spirits and hospitality sectors," Swonger said. "The spirits industry is a model for growth through fair and reciprocal trade at zero for zero tariffs."

After the EU first announced its countermeasures, Trump responded by threatening a 200% tariff on wine and other alcohol products from its European counterparts if the union were to proceed with its retaliatory tariffs.

"If this Tariff is not removed immediately, the U.S. will shortly place a 200% Tariff on all WINES, CHAMPAGNES, & ALCOHOLIC PRODUCTS COMING OUT OF FRANCE AND OTHER E.U. REPRESENTED COUNTRIES. This will be great for the Wine and Champagne businesses in the U.S.," Trump said in a post on Truth Social.

Prime Minister Micheal Martin of Ireland, a major whiskey exporter, said on Thursday that delaying countermeasures was a sensible decision and would allow Europe to "wisely and strategically respond," according to Reuters.

Sefcovic indicated that little progress has been made in de-escalating the global trade war, the outlet reported.

"I don't think that the U.S. thinking is in that direction," Sefcovic said about proposals to lower import duties. "And currently they believe that the best way to do this is through the tariff policy. I hope that one day we will get to this discussion, but currently we are clearly not there."

https://www.foxbusiness.com/economy/eu-delays-imposing-first-round-retaliatory-tariffs-against-us-until-mid-april

USPS Implements Refinements To Service Standards, Launches New Online Tools & Fact Sheet

 New tools and fact sheet offered to help customers determine expected delivery times

  • Refinements will occur in two phases: April 1 and July 1
  • Refinements estimated to save USPS at least $36 billion over 10 years

 The United States Postal Service is implementing refinements to service standards and has launched new online tools and a fact sheet to help customers prepare for the changes. These adjustments will affect First-Class Mail, Periodicals, Marketing Mail, Package Services (including Bound Printed Matter, Media Mail, and Library Mail), USPS Ground Advantage, Priority Mail, and Priority Mail Express.

The enhancements are estimated to save the Postal Service at least $36 billion over the next decade through reductions in transportation, mail and package processing and real estate costs. The service standards refinement will occur in two phases to ensure effective operational implementation: the first phase will begin April 1. The second phase will start July 1.

As part of the ongoing Delivering for America 10-year plan, USPS has already achieved $2.2 billion in annual transportation cost reductions by streamlining networks and optimizing air and surface options. Additionally, it has decreased work hours by 50 million — translating to $2.5 billion in annual savings, by enhancing plant productivity and closing unnecessary facilities. At the same time, the Postal Service has increased revenue by $3.5 billion annually by adapting product offerings amidst significant declines in First-Class Mail volume.

These newly enhanced service standards align with the Postal Service's operational goals and enable the organization to realize the projected savings while also:

  • Preserving the current service standard day ranges for First-Class Mail and USPS Ground Advantage, thus ensuring the standard First-Class Mail delivery time will not exceed 5 days.
  • Enhancing service predictability and reliability.
  • Offering 2-3-day turnaround service within regions and specific local areas.
  • Allowing flexibility in regional transportation schedules, which may extend service expectations by one day for mail collected at certain Post Offices, while overall improving delivery speeds for mail and packages between regions.

In preparation for these upcoming changes, USPS has developed user-friendly tools to assist customers in understanding expected delivery times for their mail.

Available now: 

  • Detailed file specifications for downloadable files with the new standards are available on PostalPro (Service Standards | PostalPro).
  • The service standards Application Programming Interface (API) has been updated to include a new presort indicator for First-Class Mail standards. API specs are available now on the USPS Developer Portal (https://developers.usps.com/)

Starting March 24:

  • Customers can look up service standards on usps.com for mailings from one ZIP Code to another on a particular mailing date. The search results will display the available mail classes along with the expected delivery dates for each.
  • A new interactive map will be available that will display service standards. Customers will be able to enter the ZIP Code they are mailing from along with the mail class to view the expected delivery time.

For additional information about the service standard changes, please go to:
https://about.usps.com/what/strategic-plans/delivering-for-america/details.htm#fcps
This information will be updated as needed to communicate any new information.

https://www.morningstar.com/news/pr-newswire/20250320dc46185/usps-is-enhancing-service-standards

Noncitizen Voting in U.S. Elections



Disputes about how America votes have raged since the 2020 pandemic-driven expansion of vote-by-mail.


While mail balloting has continued to stir controversy, now noncitizen voting has taken center stage. Debate surrounding the issue will likely soon culminate as Congress prepares to consider the SAVE Act, which aims to block noncitizen registration and voting.

To some, the legislation is a solution in search of a problem. They say noncitizen voting is illegal in federal and state elections, that federal law requires most states include on their registration applications a sworn statement affirming citizenship, and that penalties for noncitizen voting are severe enough to deter it.

These arguments ignore the fact that America’s registration system lacks adequate defenses beyond deterrence, an applicant’s honesty, and noncitizens’ assumed disinterest in voting. These omissions are certainly intentional. One cannot dispute the reality that we are not equipped to screen out those noncitizens who – either wittingly or unwittingly – register to vote.

Our existing voter registration process largely relies on an honor system. There are simply no comprehensive federal standards for verifying citizenship – either by requiring that applicants provide proof of it at the front end or for officials to verify it using governmental databases on the backend. In fact, federal law undermines states who attempt to ensure only citizens register and gives a free pass to those whose policies enable it.

A chief culprit is the National Voter Registration Act (NVRA), also known as “Motor Voter,” an antiquated federal law that requires most states register individuals who visit the DMV and other government agencies. Congress drafted the NVRA so poorly that states interpret it to require their agencies offer voter registration to all customers, including those officials know or suspect are noncitizens.

Some states such as California, Illinois, and Oregon have also implemented a turbo-charged Motor Voter process that automatically registers those who appear in their state DMV databases. These systems have proven sloppy at best, and reckless at worst, allowing the automatic registration of thousands of noncitizens, proving that states have no reliable method of verifying the citizenship of would-be voters. Just recently, Oregon announced that more than 1,600 noncitizens were registered through automatic registration, and referred three to prosecutors for illegal voting. Even the traditional Motor Voter process in Pennsylvania resulted in the registration of 8,700 noncitizens over a several year period.

The NVRA does nothing to stop this. Worse, the Supreme Court has interpreted the law to severely restrict states from requesting proof of citizenship when voters register. Some, such as Arizona, have attempted to find workarounds, but it has been a challenge in practice. An important pending lawsuit will decide whether Arizona can maintain meaningful safeguards to ensure citizen-only voting or whether courts will read the NVRA and other federal laws to essentially foreclose those efforts.

Another federal law, the Help America Vote Act (HAVA), at least aims to require officials to verify registrants’ identity, but it too falls short. HAVA requires individuals to provide their Driver’s License number or last four Social Security digits when registering and that officials “match” it with information in DMV or Social Security Administration (SSA) databases. That may seem like a good start, but even though SSA and DMV have citizenship information on file, HAVA does not require either agency to provide it to election officials during the matching process.

And let’s face it, government agencies aren’t going to do much more than the legally required minimum. SSA does not provide citizenship information during the HAVA matching process and the only existing federal resource is the Department of Homeland Security’s “SAVE” database that a few states use to identify noncitizens. SAVE has major potential, but has limited current utility for various reasons, one being that officials must possess a specific identifying number issued to noncitizens in order to verify their citizenship status.

Some states’ DMVs do provide election officials with lists of noncitizens, but they are incomplete, and cooperation is uneven among the states. The NVRA turned DMVs into America’s main registration hubs, but they are reluctant participants and are typically uninterested in doing no more than what the law requires.

Naysayers will point to the serious criminal penalties for noncitizens registering and voting but cannot deny the very unserious safeguards preventing this from happening. It is imperative that federal policymakers fix the NVRA and HAVA and streamline access to federal and state records to empower election officials to ensure only eligible citizens can participate in our elections.

Justin Riemer is Senior Advisor and Counsel to Restoring Integrity and Trust in Elections (RITE) and a partner at First Street Law.

https://www.realclearworld.com/articles/2025/03/19/noncitizen_voting_in_us_elections_1098631.html