Cross Country Healthcare (CCRN) has terminated its merger agreement with Aya Holdings after failing to extend the deal beyond the December 3, 2025, deadline. Aya is required to pay a $20 million termination fee to Cross Country. The merger was delayed due to an FTC Hart-Scott-Rodino review, impacted by a 43-day government shutdown. The review's completion was pushed to December 30, 2025, beyond the merger's termination date. Following the news, CCRN shares plummeted 19.6% on Thursday.
Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.
The final minutes from uniQure’s pre–biologics license application meeting with the FDA are in, and they confirm the company’s and analysts’ suspicions—it’s going to be a longer regulatory road to market than anticipated for the company’s Huntington’s disease gene therapy.
The final minutes are “consistent” with a previous update on Nov. 3. At that time, five weeks after reporting highly positive three-year data from a pivotal trial of AMT-130, uniQure shared initial feedback from this meeting, revealing that the FDA “no longer agrees” that data from its Phase I/II trials would be “adequate to provide the primary evidence in support of a BLA submission.”
In uniQure’s press release on Thursday, the company added that the agency “conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission.” UniQure is “carefully” evaluating this feedback and intends to “urgently” seek a follow-up meeting with the FDA, to take place during the first quarter of 2026.
UniQure’s stock, which fell to just over $26 on Nov. 3 from the previous closing price of $67.49, was down to just under $23 as of this writing.
Investors had not been expecting a speedy reversal of the November guidance, according to Stifel analysts.
“As time has passed since the 11/3 announcement, we think investors’ optimism has waned around a quick reversal at FDA,” they wrote in a note to investors Thursday morning.
“As we see it, there are still many scenarios on the table here,” the analysts continued, ranging from, “(1) an unfortunately challenging path forward for AMT-130--i.e. need an outright new study, to (2) some sort of compromise, i.e. more patients followed for longer, to (3) even a FDA reversal, perhaps helped by political/external pressure.”
The past four months have been a rollercoaster ride for uniQure—and for patients with Huntington’s, a genetic, neurodegenerative disease.
On Sept. 24, uniQure reported three-year data from a pivotal Phase I/II trial AMT-130, showing that the gene therapy slowed disease progression by 75%, beating analyst expectations. Plans were underway to file a biologics license application (BLA) in the first quarter of 2026, and uniQure’s shares soared 248%.
But thatwas followed by the FDA’s feedback in November—a seeming reversal of position as uniQure had previously aligned with the agency on the protocols and statistical analyses used in its trials—specifically, comparing AMT-130 to a natural history external control, according to uniQure’s announcement.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
“We still view the agency’s change in guidance as very surprising given the numerous interactions uniQure has had with the FDA since its November 2024 meeting,” William Blair analysts wrote in a note to investors on Thursday. They added that uniQure’s trial design aligns with the FDA’s recent publication of a plausible mechanism pathway for personalized therapies, as well as draft guidance on gene therapies for small populations, “which specifically stipulates that external controls may be an appropriate option in certain contexts.”
If approved, AMT-130 would be the first genetic treatment for Huntington’s disease.
Edwards Lifesciences Corporation (NYSE:EW) provided financial guidance for 2026 and reaffirmed its 2025 outlook during its annual investor conference, according to a company statement.
The medical device company projects 2026 constant currency sales growth of 8% to 10%, with total sales expected to reach $6.4 billion to $6.8 billion. The company forecasts adjusted earnings per share of $2.80 to $2.95 for 2026, representing approximately 11% growth at the midpoint.
Edwards reaffirmed its previously increased 2025 total company constant currency sales growth guidance at the high end of 9% to 10%, with earnings per share of $2.56 to $2.62.
For 2026, the company expects its transcatheter aortic valve replacement (TAVR) segment to generate sales of $4.6 billion to $4.9 billion, representing 6% to 8% constant currency growth. The transcatheter mitral and tricuspid therapies (TMTT) division is projected to achieve sales of $740 million to $780 million, with growth of 35% to 45%. Surgical segment sales are expected to reach $1.05 billion to $1.13 billion with mid-single digit growth.
The company anticipates adjusted operating margin expansion of approximately 100 basis points at the midpoint for 2026, with margins projected at 28% to 29%. Adjusted gross profit margin is expected to be 78% to 79%.
"As we enter 2026, we are poised for sustainable growth and long-term value creation," said Bernard Zovighian, Edwards' chief executive officer. "For the more than 20 million structural heart patients worldwide, we are continuing to bring novel and differentiated innovations and world-class evidence to transform care."
Edwards outlined longer-term targets, including reaching approximately 10% average annual constant currency sales growth with earnings per share leverage. The company expects its TMTT business to reach $2 billion by 2030.
Goldman Sachs analyst Salveen Richter has upgraded Taysha Gene Therapies (TSHA) to a Buy rating, setting a price target of $11. This positive outlook is primarily driven by optimism regarding the company's progress in treating Rett syndrome. The analyst is confident that Taysha can achieve the crucial 33% response rate in the REVEAL study, which is necessary to meet the success criteria for this clinical trial. This development signifies a promising future for the company's therapeutic initiatives.
Moody’s Ratings cut Jersey City’s credit grade one step to A2 from A1, saying the rating reflected a financially “struggling city with a deteriorating liquidity profile.”
The Wednesday ratings report came a day after Jersey City elected Council Member James Solomon as its mayor. Solomon, who ran against former Governor James McGreevey, pledged to make the city more affordable and to curb corruption.
U.S. Secretary of Agriculture Brooke Rollins says she will be moving to stop federal funding to 21 non-compliant states that have refused to provide data from the Supplemental Nutrition Assistance Program (SNAP).
In February, the Trump administration had asked all states to provide their SNAP data to the federal government as part of the administration’s efforts to root out waste and fraud in the welfare program.
29 mostly Republican-led states provided the data and revealed 500,000 cases of duplicate benefits as well as 186,000 deceased individuals’ Social Security numbers in use.
But 21 mostly Democrat-led states, including California, Minnesota and New York, have dug in their heels and refused to provide the information, citing concerns over privacy.
Secretary Rollins told reporters that if a state refuses to share data on criminal use of SNAP benefits, “it won’t get a dollar of federal SNAP administrative funding.”
NO DATA, NO MONEY — it’s that simple.
If a state won’t share data on criminal use of SNAP benefits, it won’t get a dollar of federal SNAP administrative funding.
Let’s see which states stand for accountability and which are just protecting their bribery schemes. 🤔💸 pic.twitter.com/Y1UXXDOoao
Rollins said that cooperation is needed from all states in order to root out fraud in the SNAP program and that action is impending for those states that refuse to provide names and immigration status of aid recipients.
Speaking at a Cabinet meeting Tuesday, Rollins said, “We asked for all the states for the first time to turn over their data to the federal government to let the USDA partner with them to root out this fraud, to make sure that those who really need food stamps are getting them, but also to ensure that the American taxpayer is protected.”
Rollins accused former president Joe Biden of trying to “buy an election” by ramping up food stamp funding by 40% last year.
Roughly 42 million recipients currently use SNAP benefits to help buy their groceries, at an annual cost to taxpayers of nearly $100 billion a year.
Doctors have admitted to performing “non-standard” gender-affirming procedures on youngsters and sometimes base treatment purely on cosmetic goals — as they see a spike in patients seeking out “nonbinary” surgeries.
The medical professionals copped to sometimes even performing the life-altering procedures with little to no assessment of an individual’s mental health or gender identity, newly emerged videos obtained by The Free Press show.
The recordings, some of which have been made at closed-door medical conferences in the US within the last few years, captured clinicians openly discussing how they were trying to fulfill a patients’ desires — even if it means deviating from guidelines.
One doctor said requests for “nonbinary” procedures were “growing in number,” according to video obtained by The Free Press.megaflopp – stock.adobe.com
One social worker from Oregon once described how an 18-year-old high school graduate wanted to look like “a Barbie down there.”
Amy Penkin, a social worker with the Transgender Health Program at the Oregon Health & Science University, spoke of the case study at the 2021 conference of the US Professional Association for Transgender Health.
The patient, only identified as Sky, had indicated they were asexual, had no desire to have sex in the future and was hoping to have a procedure to remove “all erogenous tissue.”
Penkin went on to say that requests for “nonbinary” procedures were “growing in number.”
It wasn’t immediately clear what became of that specific patient.
At a separate World Professional Association for Transgender Health conference in 2022, one unidentified clinician from Utah sought advice after seeing nonbinary interventions at a “dramatically increased” rate.
The clinician noted, astonishingly, that she was drawn to the idea of providing patients with a “Pinterest board” of gender procedures that could be offered.
She acknowledged, too, that medical professionals were often making it up as they went, saying: “I feel like we’re all just winging it, you know? And which is okay, you’re winging it too. But maybe we can just, like, wing it together.”
The controversial videos emerged as the nationwide debate gender-affirming care rages on.
Since 2021, 28 states with Republican-controlled legislatures have adopted policies to ban or restrict gender-affirming care for minors.
