Despite hitting the endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. is having a tough go of it at midday as the price of its stock (NASDAQ:AGLE) plunged 33%. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The data also revealed a sustained plasma arginine reduction and a positive trend in gross motor function measure Part E, an assessment of participants mobility that includes the ability to walk, run and jump. Pegzilarginase is a recombinant human enzyme for degrading arginine.

Recordati poised to acquire Eusa Pharma for about $817.5M

Milan-based Recordati SpA has proposed acquiring the global specialty pharma Eusa Pharma Ltd. for about €724 million (US$817.5 million) net of around €26 million in debt Eusa held at June 30. The deal "represents an excellent opportunity to further expand and reinforce our portfolio in a new and underserved therapeutic area, rare and niche oncology, with high potential growth products and will provide a platform for potential further future expansion in these areas," said Recordati's chairman, Andrea Recordati. The closing of the transaction is subject to regulatory clearances and is expected to take place in the first half of 2022.

Isofol stock drops 27% as PFS reporting issue emerges in phase III cancer trial

Shares in Isofol Medical AB dropped by as much as 31% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan. Isofol CEO Ulf Jungnelius described the issue as “a statistical storm in a teacup,” but some investors obviously took a different view. The Gothenburg, Sweden-based company said it may delay reporting of top-line data from the Agent head-to-head study, which is pitting arfolitixorin plus standard of care against leucovorin plus standard of care in first-line patients with non-resectable disease.

Prices for state covered drugs in China to be slashed by an average of 61.7%

Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List (NDRL). The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. The 2021 NDRL includes 1,486 drugs, 1,374 Chinese medicines and 892 Chinese-medicine products, all of which can be reimbursed.

Adcom could be a hard sell for Reata

The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc. (NASDAQ:RETA), of Plano, Texas. After closing at $78.69 Friday, Reata dropped to as low as $48.40 Monday before reclaiming a bit of that loss. The document that triggered the fall focuses on Reata’s bardoxolone methyl, an oral Nrf2 activator under FDA review to slow the progression of chronic kidney disease caused by Alport syndrome (AS). Even though Reata’s phase III trial met its endpoints, “the FDA review team does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure,” according to that document.

Immune imprinting may be key to future SARS-CoV-2 vaccine development

LONDON – New research shows the extent to which an individual’s immune response to the SARS-CoV-2 virus is affected by which variants they are initially exposed to, a finding that has consequences for attempts to update vaccines against emerging variants of concern. “Exposure to different spike proteins can result in reduced or enhanced responses to variants further down the line,” said Rosemary Boyton, professor of immunology and respiratory medicine at Imperial College London. “This has important implications for future-proofing vaccine design and dosing strategies,” she said.

Beigene’s siltuximab gets China nod for multicentric Castleman disease, as firm preps $3.5B STAR Market listing

Beigene Ltd.’s Sylvant (siltuximab for injection) has received marketing approval from China’s NMPA for the treatment of patients with multicentric Castleman disease (MCD), including HIV-negative and human herpes virus-8 (HHV-8)-negative. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing.

Viagra, cataract surgery associated with lower risk of Alzheimer’s disease

Far from the Groundhog Day spectacle of amyloid-targeting antibodies that do little to nothing for patients in trial after trial, researchers have reported success in reducing the risk of Alzheimer’s disease (AD) in unexpected ways. Researchers at the Cleveland Clinic Foundation have discovered that a Viagra prescription was associated with a roughly 70% reduced risk of being diagnosed with AD. And investigators from the University of Washington reported that in the prospective Adult Changes in Thought study, a long-term study into risk and protective factors for dementia, persons who underwent cataract surgery reduced their risk of AD by 30%, an effect that lasted for 10 years after surgery.

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