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Galleri Caught the Cancers. The Trial Design Let Everyone Down.
Grail's Galleri blood test detected cancers at seven times the rate of standard screening across 142,000 NHS patients, catching nearly 74% of the 12 deadliest types while holding false positives to just 0.4%. Over half were found early. The stock still cratered 47% after hours because the trial missed its primary endpoint, which awkwardly lumped Stage III and IV diagnoses together. But dig into the secondary data and a different picture emerges: Stage IV diagnoses on their own actually dropped, meaning Galleri appears to be catching the cancers most likely to kill you before they become untreatable. The test worked. The measuring stick was broken.
Why it matters: This result is going to force a reckoning across cancer screening. If bundling Stage III and IV into one endpoint can mask the detection of lethal cancers before they become untreatable, then regulators, payers, and trial designers all need to seriously reconsider what success means for multi-cancer screening tools.
Read more →Clinical and Regulatory
An Oral Breast Cancer Drug That Cut Progression 62% Just Scored Its FDA Date
Roche's giredestrant earned FDA filing acceptance with a December 18, 2026 decision date after cutting progression or death by 62% in ESR1-mutated breast cancer. It would be the third oral SERD, a class that blocks estrogen receptor signaling, but its combo potential with everolimus could carve out real differentiation from rivals at Menarini and Lilly.
Read more →The First Drug in an Entirely New Class of Myeloma Treatment Is Months Away
Iberdomide just landed priority review with an August 17 decision date, putting it on track to become the first cereblon E3 ligase modulator approved for myeloma. Think of it as a mechanistic upgrade to lenalidomide. The filing leans on biomarker-driven endpoints from the Phase 3 EXCALIBER-RRMM trial, reflecting FDA's growing comfort with that approach in blood cancers.
Read more →81% Remission at Three Years Makes TREMFYA a Durability Machine
At week 140, 80.8% of patients on J&J's guselkumab maintained clinical remission in ulcerative colitis, and 87.5% of those in remission at week 44 held it through three full years. Even more impressive: the drug worked in patients who had already failed other biologics and JAK inhibitors, the toughest crowd in gastroenterology.
Read more →One Brain Tumor Four Years Later Just Froze Two Gene Therapy Programs
A single brain tumor reported four years after dosing with Regenxbio's RGX-111 for Hurler syndrome triggered FDA clinical holds on that program and the related RGX-121 for Hunter syndrome. No proven link exists and the safety record across 30-plus patients over seven years is clean, but the FDA isn't taking chances. Every gene therapy developer should be paying attention.
Read more →Deals and Financing
$100M Bet on a Virus Engineered to Kill Prostate Cancer
RTW Investments is backing Candel Therapeutics' oncolytic virus therapy CAN-2409 with $100M in royalty funding after it showed a 14.5% relative improvement in disease-free survival for localized prostate cancer. The deal hinges on FDA approval following a planned Q4 2026 filing, with tiered single-digit royalties offering a blueprint for small biotechs to fund launches without crushing dilution.
Read more →Recursion's CFO Sold Stock Near the 12-Month Low. Earnings Drop Tuesday.
Recursion's CFO unloaded 13,426 shares at $3.08, barely above the AI drug discovery firm's 12-month low of $2.98, while major backers including NVIDIA head for the exits. Q4 earnings land February 25 with a consensus $0.28 per-share loss expected. The timing raises fresh questions about the platform-to-product translation story.
Read more →Science and Discovery
This Oral Crohn's Drug Showed Results in One Week. Biologics Take a Month.
Abivax's obefazimod delivered symptomatic response by week one and remission by week two in Crohn's disease, dramatically faster than the four-to-eight-week timeline typical of biologics. Preclinical data also showed 50-to-90% reductions in fibrosis markers, meaning it could tackle both inflammation and the scar tissue that eventually sends patients to surgery. Safety looked comparable to placebo.
Read more →Zero Responses in 30 Patients: Another NKG2D Program Goes Down
Not a single objective response across 30 patients forced Novartis to kill its QEQ278 program targeting NKG2D ligands. Twenty-six patients discontinued due to disease progression. Similar flameouts at Nkarta and Astellas suggest this pathway might simply be a dead end in solid tumors. Novartis cut six Phase 1 oncology programs total while adding two new ones.
Read more →14 Months and One Patient Later, Ionis Walked Away from Alzheimer's
After 14 months and exactly one enrolled patient, Ionis abandoned its antisense trial targeting APP in adults with Down syndrome, a population where up to 90% develop dementia but can't use approved anti-amyloid therapies due to bleeding risk. Eli Lilly plans to test donanemab in roughly 60 Down syndrome patients starting August 2026, but this withdrawal shows how brutally hard rare disease enrollment remains.
Read more →Policy and Market Dynamics
The Supreme Court Just Took Pharma Tariffs Off the President's Desk
In a 6-3 ruling, the Supreme Court struck down using IEEPA for broad tariffs, ruling only Congress can levy duties. For pharma, that kills IEEPA-based tariffs on active ingredients and finished drugs. But Section 232 duties on raw materials and manufacturing inputs survive, leaving real cost uncertainty for biotechs reliant on imported components.
Read more →Daiichi Sankyo Hired the Architect of 15 Novartis Approvals to Run R&D
John Tsai, who oversaw 15 global drug approvals at Novartis spanning gene therapy and radioligand therapy, is joining Daiichi Sankyo as Global Head of R&D. The hire signals the company wants to diversify beyond the antibody-drug conjugate franchise that fueled its recent rise, with expansion targets across oncology, cardiovascular, and kidney disease.
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