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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%
  • Biotech held up better than the broader tape: XBI eked out a gain while the S&P 500 sold off.
  • Nasdaq led the downside (vs S&P 500) in a mostly red session.

The Big 3

1
Sobi acquires Arthrosi Therapeutics for $950M upfront
  • 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.
  • 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.
  • Source: Endpoints
2
FDA approves Milestone's Cardamyst nasal spray for arrhythmia
  • 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.
  • 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.
  • Source: Endpoints
3
Child's death raises gene therapy research concerns
  • 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.
  • 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.
  • Source: STAT

Everything Else that broke

  • Sanofi updates on tolebrutinib for multiple sclerosis. — PR
  • FDA considers black box warning for COVID-19 vaccines. — BioSpace
  • Arcus, Gilead end TIGIT cancer drug program after failure. — BioPharma Dive
  • EMA recommends rejecting Anavex's Alzheimer’s drug. — Endpoints
  • FDA expands Amgen's Uplizna label for myasthenia gravis. — BioSpace
  • New gonorrhea treatments from GSK, Innoviva approved. — Fierce Pharma
  • EMA's CHMP backs new medicines from Hansoh, Cytokinetics. — BioCentury
  • Europe proposes shortening drug exclusivity period. — STAT
  • GSK's long-acting asthma med depemokimab endorsed by CHMP. — Fierce Pharma
  • Novartis breaks ground on NC manufacturing hub. — PR
  • Centessa Pharmaceuticals announces CEO transition. — Endpoints
  • Tiziana Life Sciences to dose first patient in Alzheimer’s trial. — PR
  • Mineralys' lorundrostat trial recognized by JAMA. — PR
  • EMA recommends higher Wegovy dose for obesity. — PR
  • Predictive Oncology rebrands to Axe Compute, enters AI. — PR
  • NANOBIOTIX to join CAC Mid 60 and SBF 120 indices. — PR
  • argenx updates on efgartigimod studies for thyroid eye disease. — PR
  • FDA's 'conundrum' with drugs failing confirmatory trials. — BioSpace

Deal Flow

M&A / BD&L

  • Sobi acquires Arthrosi Therapeutics for $950M upfront. — Endpoints
  • GSK spins out bioelectronic tech VC fund. — Endpoints

VC / Private Financings

  • Impulse Dynamics secures $158M for heart failure implant. — Fierce Biotech

IPOs / Follow-Ons

  • Tenaya targets $60M offering after heart disease updates. — Endpoints
  • 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
See you on tomorrow’s tape -- BioBucks

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