North America

The United States and Canada.
Biologics

Lycia Therapeutics raises $75m Series D for LYTAC pipeline

The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
Biologics
Regulatory Science

Capricor's DMD cell therapy Deramiocel heads to FDA advisory panel

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
Genomics
Regulatory Science

Taysha Gene Therapies presents TSHA-102 Rett data at IRSF 2026

Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
Biologics

Applied Biologics submits CAMPX Trial abstract to SAWC Fall 2026

Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
Biologics

AnaCardio Phase 1b/2a heart failure data published in The Lancet

AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
Biologics

Absci reports clean Phase 1 safety data for anti-PRLR antibody ABS-201

Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
Biologics

Phathom Pharmaceuticals completes enrolment in Phase 2 EoE trial

Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Regulatory Science

Agomab aligns with FDA on Phase 2b NOV-ERA design for FSCD

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Biologics

Lilly's $7.8bn Centessa acquisition cleared by English High Court

Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Regulatory Science

BridgeBio to present Phase 3 infigratinib achondroplasia data at ICCBH

BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
Biologics

Boehringer opens three Phase III trials in lung and NEC cancers

Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Regulatory Science

Nephros touts ultrafiltration tech as microplastic risk gains EPA focus

Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Biologics
Regulatory Science

ENA Respiratory secures two US patents for TLR2 agonist COPD programme

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Biologics

Medicenna secures new U.S. patents across IL-2, IL-4 and IL-13 platforms

Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Regulatory Science

Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104

Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.

FocalTherics partners with MellingMedical to bring HIFU to VA system

FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
Biologics
Genomics

Prime Medicine clears NZ hurdle for first in vivo Prime Editing trial

Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
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