Friday, June 26, 2026
CHMP negative opinion on Yartemlea (narsoplimab) for TA-TMA hits OMER
CHMP negative opinion on Yartemlea (narsoplimab) for TA-TMA drives OMER -16% premarket drop
- EMA's CHMP issued negative opinion on Yartemlea for transplant-associated thrombotic microangiopathy after June 22-25 meeting
- Drug already FDA-approved and launched in US (Jan 2026) with strong early sales, but EU rejection is major setback
- Negative opinion also covered other meds but directly hits Omeros' lead asset European prospects
- Mid-2026 EMA decision had been anticipated; this follows positive US launch momentum and J-code reimbursement
- Stock closed at $10.72 on June 25; plummeted to ~$8.97-$8.50 range in premarket on high volume
- Company had reported Q1 net income boosted by launch and Novo partnership; no immediate US impact
- Analysts previously maintained buy ratings with high price targets tied to global expansion
Obesity is rising fastest in young adults in England
Around a third of adults in England are now living with obesity, and new cases are rising most quickly in younger adults, according to an analysis of electronic health records (EHRs) for more than 54 million people.
Researchers used EHRs from NHS England to look at obesity trends between 2019 and 2025, and have concluded that rates of obesity have shot up since the pandemic, while the gap in rates between affluent and disadvantaged groups is widening. Obesity is now more common than high blood pressure in the UK.
"We're also seeing large disparities across the country: the percentage of adults affected by obesity in northeast England is six times higher than in central London," said study co-lead Robert Fletcher of the Department of Public Health and Primary Care at Cambridge University. "Differences on this scale are rarely seen in other areas of public health."
Rates of new obesity cases were 35% higher for people with the highest socioeconomic deprivation – those with the lowest incomes, highest unemployment, and poorest housing – compared with people at the other end of the scale.
The difference was even more stark among women, where new cases of obesity were 54% higher among the most deprived, and most apparent in Asian women, where the difference was found to be 94%. Meanwhile, 48% of people living in northeast England are affected by obesity, compared to 8.5% in central London.
The team found that rates of new obesity cases rose by almost 20% in those aged 30-39, and by 16% in those aged 20-29, while rates fell among adults aged 60-79, according to the results of the study, which has been published in The Lancet Diabetes & Endocrinology.
The rise in new cases among young adults of childbearing age is especially concerning, according to Fletcher, given that obesity raises the risk of diabetes, heart disease, and cancer.
"Beyond the implications for their own long-term health, obesity is associated with infertility, adverse pregnancy outcomes, and child obesity, which may perpetuate intergenerational cycles of health inequality," he added.
GLP-1 impact uncertain, for now
While the data period overlaps with the roll-out of GLP-1 agonist weight-loss drugs, such as Novo Nordisk's Ozempic/Wegovy (semaglutide) and Eli Lilly's Mounjaro (tirzepatide), the study did not examine their impact. However, there was no clear effect on obesity in the data that could be attributed to these medicines, according to Fletcher.
"The drugs on their own are unlikely to be the answer," he said. "At present, the majority are privately prescribed and the jabs are expensive, which poses a barrier for people from disadvantaged backgrounds. We need deep-seated change to the many social and economic factors that drive obesity in the first place."
That sentiment was echoed by co-author Naveed Sattar, professor of cardiometabolic medicine at the University of Glasgow and chair of the UK's Obesity Health Care Goals Programme.
"Obesity is not primarily about willpower. [This] new, powerful data indicate[s] that those most at risk frequently reside in the most obesogenic environments and likely have the least agency to withstand such environments," he said.
"To achieve lasting change, the UK must expand access to new treatments faster, but also fundamentally reshape food and activity environments so that healthier choices occur with minimal conscious effort. Failure to act will drive further rises in multimorbidity and human suffering, with profound consequences for the NHS and the wider economy."
https://pharmaphorum.com/news/obesity-rising-fastest-young-adults-england
Euro regulators urge revoking Amgen’s EU marketing authorization for its vasculitis drug Tavneos.
European medicines regulators recommend revoking Amgen’s EU marketing authorization for its vasculitis drug Tavneos.
FDA accepts Replimune resubmitted BLA for RP1 plus nivolumab in advanced melanoma
FDA accepts Replimune resubmitted BLA for RP1 plus nivolumab in advanced melanoma as a complete Class 1 response, sets Aug 2 2026 action date
- FDA plans an advisory committee meeting in late July to review the RP1 BLA resubmission.
Otsuka’s drug eases symptom burden, anxiety in ADHD as FDA verdict nears
The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
Otsuka Pharmaceuticals’ investigational treatment for attention-deficit/hyperactivity disorder significantly reduced overall symptoms and feelings of anxiety in a Phase 3b study, beefing up the company’s case for the drug as an FDA decision looms.
At eight weeks, patients on Otsuka’s candidate, dubbed centanafadine, showed a 5.87-point improvement over placebo in ADHD symptom burden, as measured by a semi-structured interview tool. This effect was statistically significant, the company said in a Thursday release.
Moreover, Otsuka noted that statistical separation between centanafadine and placebo started as early as the first week and persisted through the rest of the follow-up period.
Centanafadine also significantly lowered anxiety symptoms, as measured by a separate scale, with a 1.92-point advantage in patients receiving the investigational drug. Otsuka said centanafadine also met other secondary outcomes, though it did not elaborate further. The company plans to present a more detailed analysis of the study at an upcoming scientific conference.
Designed to be taken orally, centanafadine is a triple reuptake inhibitor, preventing the reabsorption of norepinephrine, dopamine and serotonin into cells after they transmit a neuronal message. That way, these neurotransmitters stay in the synapse and continue signaling for longer than they would otherwise.
The drug is currently under FDA review for ADHD, with a target action date of July 24. Data from Thursday’s readout were not part of Otsuka’s regulatory submission.
Thursday’s positive data for centanafadine add to biopharma’s recent clinical and regulatory wins across the neuropsychiatric space. In February, the FDA signed off on Vanda Pharmaceuticals’ Bysanti for first-line treatment of schizophrenia and manic or mixed episodes in patients with bipolar I disorder.
Then, last week, an independent study found that the dopamine agonist pramipexole could help patients with mood disorders feel pleasure—an outcome that Jefferies said in a May 15 note “instills confidence” in Alto Neuroscience’s ALTO-207 for treatment-resistant depression. ALTO-207 is a fixed-dose combination of pramipexole with antiemetic ondansetron. The drug is in mid-stage development, with data expected later this year.
But not all has gone smoothly for the neuropsych field. In April, Newron Pharmaceuticals disclosed a patient death in a late-stage study of its oral glutamate modulator evenamide for treatment-resistant schizophrenia, prompting the FDA to put the trial under a clinical hold. Earlier this month, Neumora Therapeutics decided to scrap its oral drug candidate navacaprant after disappointing results in two Phase 3 studies.