AllSci News
Specialised Therapeutics’ Niktimvo wins second global approval in Australia for cGVHD
Singapore-based Specialised Therapeutics has announced that Australia’s Therapeutic Goods Administration (TGA) has approved Niktimvo (axatilimab) for the treatment of chronic graft-versus-host disease…
Ligand moving to terminate TR-Beta Program license with Viking Therapeutics over development breach
Ligand Pharmaceuticals (Nasdaq: LGND) has terminated its TR-Beta Program license with Viking Therapeutics (Nasdaq: VKTX), pulling rights to two small...
Celcuity's gedatolisib triplet beats alpelisib in Phase III breast cancer trial
Celcuity (Nasdaq: CELC) reported that gedatolisib combined with fulvestrant and palbociclib met the primary endpoint of the Phase III VIKTORIA-1 trial,...
UCB acquires Candid Therapeutics for USD 2.2b to expand T-cell engager immunology platform
Belgium-based UCB (Euronext Brussels: UCB) has agreed to acquire San Diego-based Candid Therapeutics in a transaction valued at up to USD 2.2 billion,...
FDA issues landmark approval for Arvinas, Pfizer PROTAC Veppanu in breast cancer
Arvinas announced US FDA approval of Veppanu (vepdegestrant), developed with partner Pfizer, for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic…
Seaport's Nasdaq IPO raises USD 254.9m
Seaport Therapeutics (Nasdaq: SPTX), a clinical-stage neuropsychiatric drug developer based in Boston, priced an upsized initial public offering of...
Scancell Holdings’ iSCIB1+ DNA immunotherapy gains FDA Fast Track for advanced melanoma
Scancell Holdings plc (LSE: SCLP), a clinical-stage biotechnology company headquartered in Oxford, United Kingdom, announced receipt of US FDA Fast Track Designation…
IDEAYA Biosciences initiates FDA submission for darovasertib plus crizotinib in metastatic uveal melanoma
IDEAYA Biosciences has initiated a New Drug Application (NDA) submission to the US FDA for darovasertib in combination with crizotinib, seeking approval in...
Corcept’s dazucorilant shows large survival signal in ALS despite Phase II primary endpoint miss
Corcept Therapeutics (Nasdaq: CORT) reported two-year overall survival data from its Phase 2 DAZALS study of dazucorilant in amyotrophic lateral sclerosis,...
FDA approves Axsome’s Auvelity for agitation associated with Alzheimer’s disease dementia
New York-based Axsome Therapeutics (Nasdaq: AXSM) announced that the US FDA has approved Auvelity (dextromethorphan HBr/bupropion HCl) for the treatment of agitation…
European Commission approves Rhythm’s Imcivree for acquired hypothalamic obesity treatment
Rhythm Pharmaceuticals announced that the European Commission has granted marketing authorization for Imcivree (setmelanotide) for the treatment of obesity and control of…
Summit’s ivonescimab heads toward November FDA decision as HARMONi-3 interim PFS misses threshold
Summit Therapeutics reported its Q1 2026 financial results on April 30, 2026, with the company's single asset, ivonescimab (SMT112), advancing toward a...
LEO Pharma bags Replay's HSV gene therapy platform for USD 50m upfront
Denmark-based LEO Pharma has entered into a definitive agreement to acquire San Diego-based Replay, a private gene therapy company, for USD 50 million...
FDA advisory committee votes against AstraZeneca's camizestrant combination for hormone receptor-positive advanced breast cancer
AstraZeneca's New Drug Application for camizestrant in combination with a CDK4/6 inhibitor encountered a setback on May 1, 2026, when the US FDA's Oncologic...
FDA advisory committee recommends AstraZeneca's Truqap for PTEN-deficient prostate cancer
AstraZeneca's Truqap (capivasertib) received a positive recommendation from the US FDA's Oncologic Drugs Advisory Committee (ODAC) for use in patients with...
The AllSci Brief
Systematic R&D and deal news. Daily.