Upfront Briefing
Merck spent three years and presumably a small fortune arguing that Medicare price negotiation is unconstitutional, and on Monday a DC judge said no. AstraZeneca got the same answer in Maryland five days earlier. Six manufacturers already struck out at the Supreme Court in May. At some point the litigation line item stops being a hedge and starts being a subscription. Elsewhere the FDA giveth and taketh: Roche and Lilly cleared the first blood test that can both rule amyloid in and rule it out, which is rather more useful to the Leqembi and Kisunla salesforces than another conference poster. Regenxbio, meanwhile, found five spinal surprises it wasn't looking for and lost a quarter of its market cap. Cardiology desks, start packing — ESC opens in Munich on Friday.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,652.9 |
(0.3%) |
11.8% |
| Nasdaq 100 |
29,023.2 |
(1.0%) |
15.1% |
| Russell 2000 |
2,995.1 |
(0.8%) |
20.7% |
| Healthcare (XLV) |
174.7 |
0.0% |
12.3% |
| Biotech (XBI) |
164.2 |
(0.9%) |
35.1% |
| Nasdaq Biotech (NBI) |
7,248.1 |
(0.5%) |
27.0% |
| Clinical Trials (BBC) |
54.1 |
(0.6%) |
43.8% |
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- Biotech underperformed with XBI off 0.9% against a fractionally green XLV. Regenxbio fell 23% on a second clinical hold for RGX-121, partly offset by Capricor rising as much as 16% on its three-month PDUFA extension.
- The broad tape finished mixed rather than red — the Dow added 0.3% while the Nasdaq 100 gave up 1.0% on a semiconductor unwind (Micron (5.8%), AMD (3%), Broadcom (2%)) after a weekend report that Nvidia will raise AI server pricing; Treasury Secretary Bessent's "Operation Economic Outcast" Iran sanctions package landed mid-afternoon, with Nvidia earnings and Chair Warsh's Jackson Hole remarks on Friday keeping positioning light.
- Market data: U.S. cash close Monday, 24 August 2026.
The Big 3
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1
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Merck loses its IRA case as the courts run out of road
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- Judge Colleen Kollar-Kotelly of the DC district court rejected Merck's constitutional challenge to Medicare drug price negotiation on Monday, three years after it was filed; a Maryland federal court dismissed AstraZeneca's separate suit five days earlier.
- Why it matters: Negotiated prices went live in January, the Supreme Court turned away six manufacturers in May, and Merck has now lost the case it filed three years ago. Teva's partial win last week is the only crack in the wall, and it is procedural. Underwrite the haircut rather than a reversal: for IRA-exposed franchises the live question is the size of the Medicare cut and how fast it bleeds into commercial contracts. The asymmetry driving capital allocation is unchanged — small molecules face selection at nine years post-approval versus thirteen for biologics, which keeps depressing small-molecule NPV and tilting large-cap BD&L toward biologics. AbbVie's Botox suit is the next test.
- Source: Endpoints
- More: Fierce Pharma
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2
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Regenxbio's Hunter gene therapy draws a second hold, shares off 23%
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- FDA placed RGX-121 on clinical hold after asymptomatic nodules or cystic masses turned up on spine MRIs in five CAMPSIITE participants dosed three to six years ago; Regenxbio no longer expects to resubmit the BLA in the near term, and RGNX fell 23%.
- Why it matters: FDA halted RGX-121 in January over a CNS tumor in the sister RGX-111 program, rejected the BLA in February demanding a new controlled study, then reversed in June and agreed to review a resubmission on existing data under accelerated approval. A Q3 refiling was the plan three weeks ago; there is no filing date now. Regenxbio found these lesions through the expanded MRI monitoring it added after January, and spine MRIs aren't standard in Hunter syndrome, so the background rate is unknown. That's the uncomfortable read for every CNS-directed AAV program: look harder, find more, explain less. With $240.9M in cash, solvency isn't the issue — the timeline is.
- Source: Endpoints
- More: BioPharma Dive; Fierce Biotech; BioSpace
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3
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Roche and Lilly clear the first rule-in, rule-out Alzheimer's blood test
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- FDA granted 510(k) clearance to Roche's Elecsys pTau217 plasma test, developed with Eli Lilly, for adults 55 and over presenting with cognitive decline — the first single-biomarker blood test cleared to both rule in and rule out amyloid pathology using identical cutoffs in primary care and specialty neurology. Results return as positive, intermediate or negative.
- Why it matters: Diagnosis has been a bottleneck on anti-amyloid uptake. Leqembi and Kisunla launches have been throttled by PET capacity and lumbar punctures; a plasma assay that rules amyloid in and out on the same cutoffs in primary care moves the funnel upstream to the GP. Scale is the differentiator over Fujirebio's Lumipulse, cleared last year: this runs natively on 4,500 cobas analyzers already installed, with Quest and Labcorp both signed up to distribute. Read it through to Lilly and Eisai/Biogen on volume, and to Quest and Labcorp on menu. Roche didn't disclose pricing, and reimbursement is the open question — a 510(k) clearance is not a coverage determination.
- Source: Fierce Biotech
- More: Roche; CNN
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Everything Else that broke
- FDA pushed Capricor's deramiocel decision in Duchenne from August 22 to November 22, accepting 24-month HOPE-3 extension data and a refined upper-limb indication as a major amendment; CAPR rose as much as 16% after a 9–3 adcomm vote against in July. — Fierce Biotech
- ESC Congress opens Friday in Munich (Aug 28–31), with Cytokinetics' ACACIA-HCM Hot Line on aficamten in non-obstructive HCM, AstraZeneca/Ionis' Wainua miss and Novartis' pacibekitug the names to watch. — Endpoints
- Leqembi Iqlik, the once-weekly subcutaneous autoinjector for initiating anti-amyloid therapy, is now commercially available in the US — the late-August launch Eisai and Biogen guided to when FDA cleared it in July. — GlobeNewswire
- Erasca won FDA Fast Track for pan-RAS molecular glue ERAS-0015 in metastatic pancreatic adenocarcinoma, following the Phase 1 activity in 2L+ KRAS G12X disease it raised $550M against in July. — GlobeNewswire
- FDA approved J&J's Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia in patients 12 and over — the first therapy ever cleared in the indication — on the Phase 2/3 ENERGY trial, which hit durable hemoglobin response with roughly 1 g/dL mean improvement by week one. — BioSpace
- Qiagen named Jonathan M. Pratt chief executive, ending a nine-month search at the molecular diagnostics group. — Fierce Biotech
- Bausch + Lomb will push its dual-action dry eye drop into Phase 3 despite a Phase 2 miss. — Fierce Biotech
- Spruce Biosciences said FDA feedback supports a planned Q4 filing for tildacerfont in congenital adrenal hyperplasia. — Fierce Biotech
- Massachusetts biopharma jobs fell 3.1% in 2025, with R&D roles down 3.9%. — BioSpace
- MassBio says seed and Series A funding are splitting into two very different stories. — BioPharma Dive
- Cellares will cut 100 jobs after a large pharma customer terminated a contract. — BioPharma Dive
- Astellas dosed the first Phase 3 patient for ASP2138 in CLDN18.2-positive gastric and GEJ cancer. — PR
- Antengene won Australia clearance to start Phase 1 testing of ATG-201 in autoimmune disease. — PR
- Senhwa completed Phase 1b expansion enrollment for pidnarulex, with a CSR due in Q1 2027. — PR
- MHRA ordered NGPod devices quarantined and disposed as the product exits the UK market. — MHRA
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Lexicon (LXRX) earned a third $10M milestone from Novo Nordisk on a Phase 1 development trigger for LX9851, the first-in-class oral non-incretin obesity candidate Novo licensed in 2024 — the second non-incretin obesity payment to cross the tape this week. — PR
VC / Private Financings
- No notable private financings in the last 24 hours.
IPOs / Follow-Ons
- Arbutus (ABUS) commenced a US$230M modified Dutch auction tender for its own shares at $5.00–5.75, funded from cash on hand and open until September 29 — a biotech buying stock back rather than selling it, which is not the direction of travel for the sector. — PR
Academic Corner - Adaptive model-guided protein evolution with sparse data optimizes compact eukaryotic genome editors. — Nature Biotech
- Towards precision psychiatry: initial foundations and future directions. — Nature RDD
- Targeting CDKs in the RNAPII transcription cycle. — Nature RDD
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