Pharminent · Daily Brief
September 18, 2026
Regulatory & Approvals
FDA approves Ultragenyx gene therapy Fayuvi for Sanfilippo syndrome type A
Ultragenyx Pharmaceutical received FDA approval for Fayuvi, a one-shot gene therapy priced at $3.9m, giving US patients with Sanfilippo syndrome type A their first FDA-approved therapy.
Pharmaphorum →$RARE
CHMP recommends 12 medicines including Novo’s haemophilia A drug Frehemgo
The EMA’s Committee for Medicinal Products for Human Use recommended 12 new medicines for approval at its 14-17 September 2026 meeting, including Novo Nordisk’s Frehemgo (denecimig) for prophylaxis in haemophilia A and SFL Pharmaceuticals’ Gevalka (ensartinib) for adult patients.
EMA →$NVO
Clinical Data
Xenon pauses phase 3 depression trials after psychosis events
Xenon Pharmaceuticals voluntarily stopped enrolling new patients in its phase 3 depression studies in response to reports of psychosis adverse events that were mostly mild or moderate.
Fierce Biotech →
Deals & Partnerships
Novo Nordisk enters $1.4bn oral macrocycle partnership with Orbis
Novo Nordisk has partnered with Orbis in a deal worth up to $1.4bn focused on oral macrocycles, compounds that sit between small molecules and biologics.
Pharmaceutical Technology →$NVO
Roche and Dualitas sign $1bn bispecific antibody research deal
Roche and Dualitas Therapeutics entered a research and licence agreement worth up to $1bn to develop bispecific antibodies for immunology and inflammation diseases.
Pharmaceutical Technology →$RHHBY
Business & Finance
Electra Therapeutics raises $350 million in upsized Nasdaq IPO
Inflammation-focused Electra Therapeutics brought in $350 million from an upsized Nasdaq listing, exceeding its own IPO expectations.
Fierce Biotech →
Bristol Myers Squibb drops Orum degrader-antibody conjugate after phase 1 data
Bristol Myers Squibb has axed the degrader-antibody conjugate it acquired from Orum Therapeutics for $100 million, walking away from the asset after reviewing phase 1 data.
Fierce Biotech →$BMY
UK committee chairs ask NAO to probe UK-US pharma deal
The chairs of six UK parliamentary committees have asked the National Audit Office to investigate the UK-US pharma deal and its impact on the NHS.
Pharmaphorum →
STAT reports FDA hiring bottleneck limits agency recruitment
STAT reported that the FDA lacks sufficient staff to process additional hiring, creating a bottleneck at the agency.
STAT →
Get the signal in your inbox
Sign up free →
Pharminent — Competitive Intelligence Suite · Tickers link to Yahoo Finance for reference only. Editorial framings are analysis, not investment advice. © 2026.