Regulatory Science

Rose Hill and Control Z sign LOI for psilocybin PTSD therapy

The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
Biologics

Amplia Therapeutics publishes narmafotinib pancreatic cancer preprint

A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
Digital Health

Glucotrack and Lōkahi Therapeutics complete reverse merger

Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
Regulatory Science
Biologics

60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
Biologics
Regulatory Science

AB2 Bio gets $30m as Nippon Shinyaku takes U.S. Tadekinig rights

Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Biologics

Anika Therapeutics raises 2026 guidance after record Q2 revenue

The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
Biologics

Atavistik Bio joins Cure HHT network as Harmony-HHT trial opens

Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Biologics

FDA approves Pluvicto for hormone-sensitive prostate cancer

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Biologics

Leads Biolabs completes enrolment in Phase II BTC study of opamtistomig

The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO

Moleculin AML trial holds 37% blinded CRc in venetoclax-failed patients

Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Biologics

Novo Nordisk ZEUS trial fails to cut cardiovascular events

Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Bioprocessing
Biotech

ProLogium secures $50m PIPE ahead of SPAC listing on Nasdaq

The Taiwan-based solid-state battery maker has locked in $50m from existing shareholders to support its SPAC merger with TDAC and fund its French
The Taiwan-based solid-state battery maker has locked in $50m from existing shareholders to support its SPAC merger with TDAC and fund its French
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