Sanofi takes up option on Adagene biospecific and invests $25M, shielding partner from runway risk

 Sanofi has doubled down on its partnership with Adagene, investing $25 million in the biotech, taking up its option on a third program and agreeing to sponsor a trial of its partner’s lead candidate.

Adagene gave Sanofi rights to two antibody candidates in 2022 in return for $17.5 million upfront. The agreement, which is worth up to $625 million per program in milestones, secured Sanofi options on two additional Adagene prospects. Sanofi has taken up its option on one of the two drug candidates. Neither party has disclosed the size of the option fee paid by Sanofi. 

The discovery program picked up by Sanofi is advancing a bispecific antibody against undisclosed targets. Adagene said it has applied its masking technology and antibody engineering expertise to the program. 

The masking technology shields binding domains until antibodies reach the tumor microenvironment. Tying antibody activation to the conditions in the microenvironment could minimize on-target, off-tumor toxicity in healthy tissues, enabling the use of higher, more effective doses without causing safety and tolerability problems. 

Multiple other biotechs have developed rival shielding technologies, but the clinical data on the programs have been mixed. CytomX Therapeutics, Janux Therapeutics and Zymeworks are among the companies trying to extend the therapeutic window through conditional activation. 

Adagene shared phase 1b/2 data on its lead program in May, linking the use of its CTLA-4 candidate in combination with Merck & Co.’s Keytruda to median overall survival of 19.4 months. CTLA-4 has been an area of focus for masking technology. Bristol Myers Squibb, the company behind CTLA-4 drug Yervoy, has a pact with CytomX but dropped a program last year.

Sanofi is supporting Adagene’s muzastotug CTLA-4 program by making a $25 million investment that will support a phase 2 trial and by sponsoring another study. The Sanofi-sponsored phase 1/2 trial will test muzastotug in combination with other anticancer therapies in more than 100 advanced solid tumor patients. Adagene still owns worldwide commercial rights to muzastotug.

The investment extends Adagene’s cash runway from late 2026 into 2027. 

https://www.fiercebiotech.com/biotech/sanofi-takes-option-adagene-biospecific-and-invests-25m-shielding-partner-runway-risk

DOGE’s overhaul of SEC targets SPAC and private fund rules

 The Department of Government Efficiency (DOGE) is pushing the U.S. Securities and Exchange Commission (SEC) to ease regulations on blank-check companies and private investment funds, according to a Reuters report on Tuesday.

DOGE officials have recently requested meetings with SEC staff to discuss relaxing what some companies view as burdensome regulations. The discussions have focused on potentially reworking rules adopted during the Biden administration last year that govern Special Purpose Acquisition Companies (SPACs) and requirements for private investment advisers to confidentially report more data to regulators.

This regulatory rollback effort is part of President Donald Trump’s broader initiative to reduce government oversight to stimulate economic growth.

The report indicates that DOGE’s involvement in policy development has created tension with some SEC officials, who have expressed concerns about a White House initiative influencing the work of what has traditionally been viewed as an independent agency.

White House spokesperson Taylor Rogers stated that DOGE was working with the SEC "to more efficiently maintain fair and orderly markets while protecting everyday investors." Rogers added that under Trump’s leadership, SEC Chairman Paul Atkins would ensure the United States remains "the best and most secure place in the world to invest and do business."

https://finance.yahoo.com/news/doge-overhaul-sec-targets-spac-104551523.html

PetMeds Faces Internal Audit Probe As Whistleblower Reports Revenue Recognition Issues

PetMed Express (NASDAQ: PETS), operating as PetMeds and parent company of PetCareRx, announced it will be unable to file its Form 10-K for FY 2025 within the extension period ending July 1, 2025. The delay is due to an ongoing investigation initiated by the Audit Committee following anonymous whistleblower reports.

The whistleblower complaints concern three main issues: revenue recognition timing for certain autoship orders in Q4 2025 that led to customer complaints, a $50 coupon promotion's impact on new customer KPIs, and concerns about the company's culture and control environment. The Audit Committee has engaged external legal counsel and advisors to investigate these matters.

Despite the ongoing investigation, PetMed Express states that based on current evidence, they do not expect the investigation to materially impact their previously announced preliminary Q4 and FY 2025 financial results or previously filed financial statements.

[ "Company does not expect material impact on previously announced financial results", "External legal counsel and advisors engaged for thorough investigation", "Company has established whistleblower reporting system in place" ]

https://www.stocktitan.net/news/PETS/pet-med-express-inc-provides-update-on-status-of-fourth-quarter-and-4f18sjpk8cw4.html

RFK Jr. brings in team to 'revolutionize' US vaccine injury compensation program

 After taking aim at the United States’ vaccine safety reporting system earlier this year, Robert F. Kennedy Jr. has added a federal vaccine injury compensation program to his list of immunization bugbears. And this time around, the HHS Secretary says he already has a team working on a potential overhaul.

“We just brought in a guy this week who’s going to be revolutionizing the Vaccine Injury Compensation Program,” Kennedy said during an interview with Tucker Carlson on Monday. 

Kennedy rebuked the no-fault system underpinning the National Vaccine Injury Compensation Program (NVICP), which was established in 1988 through the National Childhood Vaccine Injury Act of 1986. The program was designed as a spike in lawsuits against vaccine companies threatened to cause vaccine shortages and disease resurgences, according to a Human Resources & Services Administration fact page on the program.

“No matter how reckless that company is, no matter how toxic the product, no matter how egregious your injury, you cannot sue them,” Kennedy said of the program in its current form.

Under the NVICP framework (PDF) today, a vaccine injury petition must be filed within three years of the first symptom of the alleged injury, or within two years of death and four years after the first symptom of an alleged injury that resulted in death. If compensation is awarded, claimants receive a payout through a trust fund that is kept afloat via surcharges on recommended vaccines, rather than from vaccine makers themselves.

Only vaccines that have been recommended for routine administration to kids and pregnant women by the Centers for Disease Control and Prevention (CDC) are included in NVCIP. The program doesn’t include COVID-19 vaccine-related injuries, though similar claims for COVID shots can still be submitted through the U.S.’ Countermeasures Injury Compensation Program (CICP).

Despite the ability to submit COVID-19 vaccine claims through CICP, Kennedy stressed during his interview that he wants to expand NVCIP “so that COVID vaccine injured people can be compensated.” The HHS secretary also expressed a desire to extend the program’s current statute of limitations beyond its current three years.

Kennedy says he “brought in a team” this week to work on potential changes to the compensation program.

A spokesperson for the HHS did not immediately respond to Fierce Pharma’s request for comment on Kennedy’s statements and plans. The HHS secretary’s ability to make sweeping changes to NVCIP without congressional action is unclear, STAT News pointed out.

Nevertheless, Kennedy has already successfully wielded his influence over U.S. vaccine policy in his new role, despite reported pledges during his confirmation hearing to leave vaccine recommendations alone.

Perhaps most notably, Kennedy last month fired all 17 former sitting members of the CDC’s Advisory Committee on Immunization Practices over conflict-of-interest allegations, replacing them with handpicked—and at times controversial—new members who met last week to issue recommendations on a number of shots.

Kennedy’s ACIP struck an immediate blow to established vaccine policy, recommending against the use of flu shots that use the mercury-containing preservative thimerosal.

Thimerosal has long been a target of anti-vaccine activists who’ve linked the ingredient to the development of autism, though multiple studies, including one by the CDC itself, have debunked that link.

In reference to the ACIP purge last month, Kennedy told Carlson that the CDC panel was little more than a “sock puppet for the industry that it was supposed to regulate.”

Kennedy also used the pulpit on Carlson’s show to level criticism against the HHS’ Vaccine Adverse Event Reporting System (VAERS) and re-up his pledge to make sweeping changes to the system.

“We’re going to absolutely change VAERS and we’re going to create—either within VAERS or supplementary to VAERS—a system that actually works,” Kennedy said.

As in previous interviews and speeches, Kennedy linked the abundance of recommended pediatric vaccines to the prevalence of conditions like diabetes, rheumatoid arthritis, attention-deficit/hyperactivity disorder (ADHD) and autism in the U.S.

“That’s a lot of vaccines for a kid, and each one of those is designed to permanently alter your immune system, and so we have now this epidemic of immune dysregulation in our country,” he said. “And there’s no way to rule out vaccines as one of the key culprits.”

Apart from last week’s thimerosal vote, Kennedy’s new-look ACIP has also proposed new subcommittees to examine the cumulative effect of childhood vaccine schedules and to assess shots that haven’t been subject to review in more than seven years. 

https://www.fiercepharma.com/pharma/rfk-jr-takes-aim-nvicp-bringing-new-team-revolutionize-vaccine-injury-compensation-program

AstraZeneca stock rises amid reports CEO favors US listing move

 AstraZeneca PLC (NASDAQ:AZN) ADRs rose 2.2% following a Times report that CEO Sir Pascal Soriot has privately expressed interest in moving the company’s stock market listing to the United States.

According to The Times, citing sources familiar with his thinking, Soriot has discussed his preference for relocating the FTSE 100 company’s listing on multiple occasions and has even considered moving AstraZeneca’s domicile. However, such a move would likely face resistance from parts of the board and the British government, which reportedly has not been informed of these discussions.

Soriot, who has led the pharmaceutical giant since 2012, has publicly voiced concerns about Europe falling behind the US and China in developing innovative medicines. These two markets represent AstraZeneca’s largest revenue sources globally.

The CEO is reportedly "deeply frustrated" with the UK’s operating environment, particularly regarding restrictions on new medicine approvals by the National Institute for Health and Care Excellence (Nice). Specific concerns include approval challenges for drugs and pricing constraints under the NHS sales rebate scheme.

As Britain’s most valuable public company, any potential move by AstraZeneca would represent a significant shift in the UK corporate landscape. The company has become a cornerstone of the British pharmaceutical industry under Soriot’s leadership over the past decade.

https://finance.yahoo.com/news/astrazeneca-stock-rises-amid-reports-151224791.html

'Proposed Medicare payment cut for home health could scuttle UnitedHealth/Amedisys deal'

 A Raymond James analyst is warning that a just proposed 6.4% cut in Medicare payments to home health care agencies in 2026 introduced by the Trump administration could be a "death knell" for UnitedHealth Group's (NYSE:UNH) planned acquisition of Amedisys (NASDAQ:AMED).

That deal, worth ~$3.3B, has already had a rocky road to completion as the Department of Justice has voiced opposition unless remedies are made.

The 6.4% cut in 2026 equates to ~$1.1B.

Out of the 6.4%, ~4% of that is to account for Medicare's move to ramp up a value-based payment model known as Patient-Driven Groupings Model in which payments are based on patient characteristics and care needs, instead of the number of therapy services provided.

In addition, the administration's proposal includes a separate payment cut of 5%. CMS stated this is to recoup retrospective overpayments from 2020 through 2024.

"While AMED has worked through prior rate updates relatively well, this update is orders of magnitude worse than previous years," Raymond James John Ransom, who rates Amedisys at market perform, wrote. 

He added that while a final rule is usually not as severe as a proposed rule, the cut for 2026 is "by far the deepest cut yet."

"We wonder if this could mean the AMED/UNH deal is off given it has faced a two-year legal battle with the Department of Justice, and the deal is currently set to go to mediation in August. We wonder if UNH would be willing to walk away given their current situation and to avoid more heartache with regulators."

RBC Capital Markets' Ben Hendrix projects significant pushback to the rule "and renewed legislative efforts later this year to address the disparity between CMS and industry budget neutrality expectations."

Enhabit (NYSE:EHAB) is so far the hardest-hit home health stock, down ~18% in Tuesday morning trading. Pennant Group (NASDAQ:PNTG), BrightSpring Health Services (NASDAQ:BTSG), and Aveanna Healthcare (NASDAQ:AVAH) are also off significantly. 

https://www.msn.com/en-us/health/other/proposed-medicare-payment-cut-for-home-health-could-scuttle-unitedhealthamedisys-deal/ar-AA1HLNfy

Concentra acquires IGM Biosciences, continuing M&A streak with struggling biotechs

 Concentra Biosciences continues to scavenge for struggling biotechs, this time picking up antibody biotech IGM Biosciences for $1.25 per share.

IGM’s board has approved the acquisition by Tang Capital Partners’ Concentra, and the deal is expected to close in August, according to a July 1 release. 

Concentra has tacked on a contingent value right that will provide IGM with any net cash from the deal once it exceeds $82 million plus 80% of proceeds received from the biotech’s pipeline candidates and intellectual property that occurs within a year of closing.

The deal closing depends on IGM having at least $82 million available in cash among other customary closing conditions, according to the release.

California-based IGM set out to develop a new class of antibody medicines with its engineered IgM therapeutic candidates. The biotech has been around for almost 30 years, operating under the name Palingen until 2010.

But the company hit dire straits in early May, when Sanofi scrapped a collaboration and effectively terminated the biotech’s last program in the process. In response, IGM laid off 80% of its staff and closed most of its lab and office spaces.

The dissolved deal with Sanofi was just one of many roadblocks the biotech faced over the last few years. In late 2023, the company laid off 22% of its workforce and then underwent a further restructuring in September 2024. The biotech started 2025 by axing its last two internal drug candidates and reducing its head count by 73%, meaning the company’s pipeline consisted solely of the Sanofi-shared programs.

Most recently, IGM received written notice from Nasdaq indicating that the biotech failed to meet the $50 million minimum market value for the company's publicly held shares, according to a June 6 Securities and Exchange Commission document. IGM has 180 calendar days, or until Dec. 3, to regain compliance, according to the filing.

Enter Concentra, the increasingly busy company that’s already scooped up at least three other struggling biotechs this year. Just this June, Concentra announced plans to acquire Elevation Oncology after buying Kronos Bio and Allakos.

Not all of Concentra's recent M&A efforts have succeeded, though. In response to the company’s advances, two biotechs enacted "poison pill" defenses in March to keep Concentra away. One of them, Acelyrin, chose to merge with another biotech rather than sell itself.

https://www.fiercebiotech.com/biotech/concentra-acquires-igm-biosciences-continuing-ma-streak-struggling-biotechs