Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector. A confirmatory trial, dubbed Origin 3, already is underway, with results expected in the third quarter of this year, putting a potential full approval in 2027. The accelerated nod was based on reduction in proteinuria, so regulators will be looking to see whether Trutakna slows kidney function decline over the long term, as assessed by estimated glomerular filtration rate.

Endocrinology becomes Vertex’s fifth pillar with $10B Crinetics buy

Representing the fourth largest biopharma M&A announced in 2026, Vertex Pharmaceuticals Inc. offered $85 per share in cash, or about $10 billion, to buy endocrine specialist Crinetics Pharmaceuticals Inc., adding the acromegaly drug Palsonify and a phase III asset, atumelnant, for congenital adrenocorticotropic hyperplasia. Together, the two products could bring upwards of $5 billion in peak sales to Vertex, which is adding endocrinology as its fifth commercial pillar, along with cystic fibrosis, hematology, pain and renal. Crinetics’ shares (NASDAQ:CRNX) climbed 99%, or $41.49, to $83.52 by midday July 6, while Vertex’s shares (NASDAQ:VRTX) traded downward by $3.36 to $526.55. Both boards unanimously approved the transaction, expected to close in the third quarter.

Tvardi skyrockets on phase I data; broader swath for STAT3?

Shares of Tvardi Therapeutics Inc. (NASDAQ:TVRD) were trading up 46%, or 93 cents, to sell at $2.94 on phase I results for TTI-109, the company’s next-generation STAT3 inhibitor, a phosphate prodrug of TTI-101 designed to improve delivery and tolerability while preserving the parent compound's mechanism of action. TTI-101 failed in phase II against idiopathic pulmonary fibrosis last October, when problematic gastrointestinal (GI) effects surfaced. With TTI-109, the latest study confirmed fast conversion, dose-proportional pharmacokinetics (exposures above the STAT3 inhibitory concentration 50 [IC50]), and – in an exploratory pharmacodynamic analysis – reductions of up to 60% in STAT3-driven immune cell populations across Th17, Tfh and B-cell subsets. Tvardi’s early stage win supports advancement into phase II exploration, the company said. Taking aim at the STAT3 target, which is well-validated in cancer, could mean the drug will work in GI as well as dermatologic indications.

EG427 raises $37.7M series C for HSV gene therapy in chronic bladder conditions

The gene therapy specialist formerly known as EG427 has a new name and fresh momentum, after closing a €33 million (US$37.7 million) series C that will further advance clinical development of the lead program in chronic neuro-urology indications. Now named Cyllene Therapeutics, the funding was raised on the back of data from the company’s phase Ib/ IIa trial of EG-110A, in which the 88% reduction in urinary incontinence episodes in patients with neurogenic bladder seen at week 12, was maintained at 24 weeks follow-up. Those data were published in February 2026 and since then there has been sustained efficacy for more than one year in the first 10 patients enrolled in the ongoing study, which is treating neurogenic detrusor overactivity caused by spinal cord injury.

Opus aligns with FDA on rare eye disease gene therapy trial

Opus Genetics Inc. has secured U.S. FDA alignment on an eight-patient phase III trial of its lead gene therapy, OPGx-LCA5, for an ultra-rare form of inherited childhood blindness. The FDA feedback further supported a potential BLA submission for the gene augmentation therapy based on efficacy data from the six-month primary endpoint, with 12-month durability data to be submitted during the review process. Opus CEO George Magrath said the feedback, rendered at the end of the company’s type B Rare Disease Evidence Principles meeting with the FDA, provided a “clear roadmap” for regulatory filing and potential approval.

340B reforms on the congressional table

After years of hearings, finger-pointing and litigation, the U.S. Congress finally seems to be getting serious about fixing the 340B prescription drug discount program, which today is the second largest federal drug program. In introducing a bipartisan proposal yesterday to modernize the program that was created in 1992 to help safety-net hospitals and clinics provide services to low-income patients, Rep. Scott Peters, D-Calif., said, "The Secure 340B Act closes the loopholes that have allowed the program to drift from its mission, stops the legal chaos that plagues the program today, and puts in place the kind of transparency and accountability that will keep 340B strong for decades to come." The House proposal comes a week after Sen. Bill Cassidy, R-La., released a discussion draft of his own comprehensive reform proposal, the 340B for Patients Act.

‘Target-high but uptake-defective’ state identified in ADC resistance

Separate research teams have reported new insights into resistance mechanisms to the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin, Astellas Pharma Inc./Pfizer Inc.), and possibly to ADCs more broadly. Urothelial cancer drug Padcev, which targets the cell adhesion molecule Nectin-4, was approved in 2019 and is currently one of Pfizer’s top 10 medicines and vaccines, generating $1.94 billion in 2025. Investigators from Sun Yat-sen University Cancer Center have reported that some cells expressing high levels of target protein were nevertheless resistant to Padcev due to the activity of the enzyme AKR1C1, which reduced endocytosis of the Padcev-bound Nectin-4 and increased its packaging into extracellular vesicles and export from cells.

Science fiction realized: BCI tech is here

After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care, what’s driving investor interest and the challenges ahead.

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