The FDA is set to announce decisions in July 2026 on therapies for breast cancer, IgA nephropathy, multiple myeloma, ADHD, and wet AMD. This follows a June that saw several regulatory milestones, including the first new over-the-counter sunscreen active ingredient in over two decades with the approval of Bemotrizinol on June 9. The agency also cleared Dexcom's Stelo Glucose Biosensor System as the first OTC continuous glucose monitor for children on June 12, approved the first generic version of Xofluza for influenza on June 17, and authorized Orca Biosystem's Tregzi as the first regulatory T cell-based immunotherapy for chronic graft-versus-host disease on an unspecified date.
J&J Reaches $5.5 Billion Talc Settlement as Stock Climbs 18% in Three Months
Johnson & Johnson has agreed to a $5.5 billion settlement covering nearly all of its remaining talc litigation, a deal that requires participation by plaintiff firms representing at least 95% of the remaining claims before it becomes effective, with a first payment of up to $3 billion expected in 2027 and additional payments beginning in 2028. The agreement addresses roughly 76,000 lawsuits alleging that the company's talc-based baby powders contained asbestos and caused ovarian cancer. The news comes as JNJ stock has risen 18.3% in the past three months and 30.6% this year, against a 10.9% gain for the industry, supported by a raised 2026 outlook and Innovative Medicine segment sales up 6.2% on an organic basis in the first half of 2026 despite the loss of exclusivity of Stelara. That segment has now posted five consecutive quarters of sales above $15 billion, while J&J's newer cancer drugs Carvykti, Tecvayli, Talvey and Rybrevant/Lazcluze combined for $2.6 billion in first-half sales. MedTech grew more slowly, with second-quarter sales up 4.5% year over year to $8.93 billion, or 3.6% operationally, as Abiomed sales fell 2% and cardiovascular operational growth reached just 3.1%. J&J still targets around $100 billion in 2026 revenues, with $49.4 billion already booked in the first half, and the Zacks Consensus Estimate for 2026 earnings per share has edged up from $11.59 to $11.61 over the past 30 days.
Novartis Shares Plunge 10% as Del-desiran Fails Late-Stage Trial
Novartis shares fell about 10% after the company said its experimental drug del-desiran failed to meet its primary goal in a late-stage trial for myotonic dystrophy type 1, marking its third clinical setback in a week. The earlier failures involved the cardiovascular drug pelacarsen and a pause of eight trials of the cell therapy rap-cel following three patient deaths. The decline erased roughly 24 billion Swiss francs, or about $29.6 billion, in market value and put Novartis on pace for one of its worst trading days in company history. Barclays had estimated peak annual sales of about $3.1 billion for del-desiran and assigned the drug a 60% probability of success after positive mid-stage results, and the failure raises questions about the $12 billion Avidity acquisition that brought the drug into Novartis' pipeline. Management reaffirmed its full-year financial guidance and maintained its target for 5% to 6% compound annual sales growth from 2025 through 2030, while the company reported successful late-stage results for remibrutinib in multiple sclerosis and expects more data later this year.
GSK Buys Chimagen Trispecific T Cell-Engager for Multiple Myeloma
GSK agreed to acquire Chimagen's trispecific T cell-engager candidate for multiple myeloma, a drug asset the parties describe as a potential best in class trispecific T cell therapy. The deal expands GSK's blood cancer research portfolio and complements recent moves such as the Nuvalent acquisition that brought in Jideytro. Separately, GSK plans to close its German vaccine manufacturing site and consolidate production in Canada, with associated job reductions and supply chain changes. The key test will be whether GSK hits its stated timeline to move the trispecific T cell-engager into phase I trials in 2027, while advancing Jideytro's first line FDA submission planned for 2026. GSK is a £74.8b pharmaceuticals group that develops vaccines, specialty treatments and general medicines across major markets.
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