BioBucks Newsletter
FDA cleared a new arrhythmia nasal spray as gene therapy safety questions resurfaced.
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Upfront Briefing
Monday came in hot: Sobi agreed to buy Arthrosi Therapeutics for $950M upfront to bulk up in gout with a Phase 3 asset.
On the regulatory front, Milestone finally got FDA approval for Cardamyst (a nasal spray emergency option for a form of arrhythmia). Meanwhile, a child’s sudden death in a gene therapy trial put the sector’s risk calculus back on the front page.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,827.9 |
(1.1%) |
16.1% |
| Nasdaq 100 |
25,200.3 |
(1.9%) |
19.9% |
| Russell 2000 |
2,551.7 |
(1.5%) |
14.4% |
| XBI (Biotech) |
123.1 |
0.1% |
36.7% |
| NBI (Biotech) |
5,711.0 |
(0.3%) |
32.5% |
| Clinical Trials ETF (BBC) |
40.0 |
(0.2%) |
66.9% |
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Biotech held up better than the broader tape: XBI eked out a gain while the S&P 500 sold off.
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Nasdaq led the downside (vs S&P 500) in a mostly red session.
The Big 3
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1
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Sobi acquires Arthrosi Therapeutics for $950M upfront
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Sobi has acquired Arthrosi Therapeutics in a deal worth $950 million upfront, aiming to strengthen its position in the gout treatment market with a Phase 3 asset.
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Why it matters:
A $950M upfront tag for a private, late-stage gout asset reinforces how much value pharma is putting on de-risked, specialty medicines — and resets the comps for other kidney/cardiometabolic players circling Ph3 programs.
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Source:
Endpoints
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2
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FDA approves Milestone's Cardamyst nasal spray for arrhythmia
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An at-home, on-demand option for this arrhythmia could shift care away from the ER and IV drugs, expanding the treatment market and giving Milestone a beachhead product in a cardiology niche that’s been device- and procedure-heavy.
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Why it matters:
Milestone Pharmaceuticals secures FDA approval for its nasal spray, Cardamyst, offering a new emergency treatment option for a form of heart arrhythmia.
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Source:
Endpoints
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3
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Child's death raises gene therapy research concerns
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A child's sudden death in a gene therapy trial for neurological disorders highlights the inherent risks and challenges within this promising but complex field.
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Why it matters:
A pediatric death in a neuro gene therapy study will sharpen FDA and IRB scrutiny on high-dose CNS programs, potentially slowing timelines, raising development costs, and forcing sponsors to rethink how they communicate risk to families and investors.
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Source:
STAT
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Everything Else that broke
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Sanofi updates on tolebrutinib for multiple sclerosis. — PR
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FDA considers black box warning for COVID-19 vaccines. — BioSpace
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Arcus, Gilead end TIGIT cancer drug program after failure. — BioPharma Dive
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EMA recommends rejecting Anavex's Alzheimer’s drug. — Endpoints
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FDA expands Amgen's Uplizna label for myasthenia gravis. — BioSpace
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New gonorrhea treatments from GSK, Innoviva approved. — Fierce Pharma
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EMA's CHMP backs new medicines from Hansoh, Cytokinetics. — BioCentury
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Europe proposes shortening drug exclusivity period. — STAT
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GSK's long-acting asthma med depemokimab endorsed by CHMP. — Fierce Pharma
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Novartis breaks ground on NC manufacturing hub. — PR
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Centessa Pharmaceuticals announces CEO transition. — Endpoints
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Tiziana Life Sciences to dose first patient in Alzheimer’s trial. — PR
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Mineralys' lorundrostat trial recognized by JAMA. — PR
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EMA recommends higher Wegovy dose for obesity. — PR
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Predictive Oncology rebrands to Axe Compute, enters AI. — PR
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NANOBIOTIX to join CAC Mid 60 and SBF 120 indices. — PR
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argenx updates on efgartigimod studies for thyroid eye disease. — PR
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FDA's 'conundrum' with drugs failing confirmatory trials. — BioSpace
Deal Flow
M&A / BD&L
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Sobi acquires Arthrosi Therapeutics for $950M upfront. — Endpoints
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GSK spins out bioelectronic tech VC fund. — Endpoints
VC / Private Financings
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Impulse Dynamics secures $158M for heart failure implant. — Fierce Biotech
IPOs / Follow-Ons
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Tenaya targets $60M offering after heart disease updates. — Endpoints
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Biopharma public equity raises nearly $4.5B in a week. — BioCentury
Academic Corner - Cancer screening must become more precise — Nature Medicine argues that early-detection studies need to evolve and integrate multimodal data to better identify high-risk individuals. — Nature Medicine
- Betting on β-catenin inhibitors in oncology — A Nature Reviews Drug Discovery piece surveys emerging approaches to dial down overactive WNT–β-catenin signaling using stabilized peptides, condensate modulators and degraders. — Nature RDD
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See you on tomorrow’s tape
-- BioBucks
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