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What’s in Today’s Brief? (May 18th Preview)
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Regulatory – Medicare drug pricing legal fight ends
The U.S. Supreme Court declined to hear multiple biopharma challenges to the Inflation Reduction Act’s Medicare drug price negotiation program, dealing another blow to the brand-drug industry’s legal campaign. The petitions covered AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Novartis and Novo Nordisk, according to court order summaries. The decision follows losses in lower courts and comes as companies argue the negotiated-price framework infringes on investment-backed patent rights and reduces market pricing. The Supreme Court’s refusal to take up the cases effectively keeps the IRA negotiation structure intact. For manufacturers with meaningful Medicare Part D exposure, the ruling narrows the pathway for litigation-based relief and increases pressure to plan commercial strategies around IRA-linked pricing trajectories.
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FDA approval – First-in-class aldosterone synthase inhibitor expands hypertension options
The FDA approved AstraZeneca’s Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor intended for patients with hypertension not adequately controlled on other therapies. FDA clearance follows results from the Phase 3 BaxHTN study, which met primary and secondary endpoints. The approval adds a new mechanism for clinicians targeting aldosterone-driven pathways and positions AstraZeneca for continued revenue growth as other cardiometabolic assets face patent cliffs. The label supports use in combination with other antihypertensives. A close competitive watch is now on Mineralys Therapeutics, whose aldosterone synthase inhibitor lorundrostat has a December 2026 PDUFA date, potentially setting up a near-term second wave of approvals in the same class.
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Oncology – LAG-3 inhibitor fianlimab stumbles again in late-stage cancer
Regeneron’s LAG-3 inhibitor fianlimab missed a late-stage mark in melanoma, failing to significantly outperform Keytruda (pembrolizumab) in a Phase 3 setting in untreated patients with unresectable locally advanced or metastatic disease. The readout compounds recent clinical setbacks for the LAG-3 class and intensifies scrutiny of combination strategies in this space. Separate from the clinical disappointment, Regeneron has been pivoting to new platform bets and partnering arrangements, underscoring how quickly late-stage outcomes can reshape capital allocation and pipeline prioritization. For investors and trial teams, the failed endpoint refocuses attention on biomarkers, patient selection, and the durability of benefit in LAG-3-centered approaches.
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Dealmaking – Regeneron and Parabilis expand into peptide platform ADC-like strategy
Regeneron struck a collaboration with Parabilis Medicines to pursue new drugs across five undisclosed targets using Parabilis’ Helicon peptide platform. The structure includes $125 million upfront plus up to about $2.2 billion in potential milestone payments and tiered royalties. The deal follows recent setbacks for Regeneron’s own immuno-oncology pipeline, and it signals a shift toward more target-access and delivery-focused modality development. For Parabilis, the financing and milestone pathway provides continued runway while it translates Helicon into oncology candidates. Because the targets remain undisclosed, the near-term value for both companies hinges on target validation and how Helicon-derived drugs perform in preclinical-to-clinical progression.
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Diagnostics – cfDNA lung cancer screening tool lifts uptake in real-world trial
Delfi Diagnostics reported interim clinical-utility results for its FirstLook Lung cfDNA liquid-biopsy assay presented at the American Thoracic Society International Conference. In the cluster-randomized FIRSTLUNG trial across 28 clinics in Colorado, Florida and North Carolina, use of the blood test increased overall lung cancer screening by nearly threefold. Among nearly 3,000 patients who were behind on screening, FirstLook Lung showed about 80% sensitivity, 56% specificity and a negative predictive value of 99.8%. The company also reported a 1.5-fold rise in low-dose CT screening, with many cancers detected at stage I. Delfi said the test’s access through outpatient workflows can address under-screening and that it has submitted results to a peer-reviewed journal. The company also estimated that a 3% increase in annual screening uptake over five years could prevent slightly more than 3,000 deaths in a simulated population of 15 million.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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