Development
LEO Pharma extends Adtralza into younger children with positive pediatric safety data
Denmark-based LEO Pharma A/S has reported positive results from the Phase II TRAPEDS-1 trial, a pediatric study evaluating tralokinumab (Adbry/Adtralza) in...
Hansoh's B7-H3 antibody-drug conjugate achieves first-ever Phase III overall survival win in small-cell lung cancer
Hansoh Pharma's ARTEMIS-008 has delivered what the field has not seen before: the first Phase III overall survival benefit for a B7-H3-targeted...
Bausch + Lomb's glaucoma neuroprotective candidate fails Phase II primary endpoint
Bausch + Lomb's BL1107 glaucoma Phase II trial failed to replicate earlier visual function signals in primary open-angle glaucoma, a setback that closes the...
Roche discontinues huntingtin-targeting antisense programs tominersen and RG6496 in Huntington's disease
Roche has announced the discontinuation of two Huntington's disease programs simultaneously: the Phase II GENERATION HD2 study of tominersen (RG6042), a...
Forte's becomes first to beat placebo in vitiligo with durable post-treatment gains
Dallas-based Forte Biosciences, Inc. (Nasdaq: FBRX) has reported statistically significant repigmentation data from a Phase Ib double-blind,...
Ipsen's Dysport becomes first botulinum toxin to beat placebo in episodic migraine Phase III trial
France-based Ipsen (Euronext: IPN; ADR: IPSEY) reported that abobotulinumtoxinA (Dysport) met primary endpoints in both the E-BEOND and C-BEOND Phase III...
Adlai Nortye pushes CEACAM5-targeted Pan-RAS(ON) ADC into first-in-human trial
Adlai Nortye Biopharma, a Taiwan-based oncology company, has initiated a first-in-human clinical trial of AN4035, a bispecific antibody designed to target...
AstraZeneca, Ionis report Phase III failure for eplontersen in ATTR-CM
AstraZeneca (NYSE: AZN) and Ionis Pharmaceuticals (Nasdaq: IONS) reported that eplontersen (Wainua) failed to meet the primary endpoint of the...
Seres' biotherapeutic resolves checkpoint inhibitor colitis without systemic immunosuppression
Cambridge, Massachusetts-based Seres Therapeutics (Nasdaq: MCRB) reported early clinical data suggesting that SER-155, its oral live biotherapeutic, may...
Xiaflex wins first-ever FDA approval pathway for plantar fibromatosis with Phase III success
Keenova Therapeutics has reported that collagenase clostridium histolyticum (Xiaflex) met its primary endpoint in a pivotal Phase III trial for plantar...
Merck ends Phase II Alzheimer's trial of MK-1167 after interim efficacy failure
Merck's Phase II MK-1167-008 trial evaluating MK-1167, an oral M1 muscarinic acetylcholine receptor positive allosteric modulator (M1 PAM), in mild to...
Compass Pathways' COMP360 becomes first classic psychedelic to prove durable six-month benefit in TRD
Compass Pathways plc (Nasdaq: CMPS) has reported 26-week data from its second Phase III trial of COMP360, a synthetic psilocybin formulation for...
Kailera's oral GLP-1 agonist HRS-7535 delivers weight loss but trails injectable rivals in obesity race
Kailera Therapeutics (Nasdaq: KLRA) reported positive topline data from two Hengrui Pharma-sponsored Phase III trials of HRS-7535, an oral small molecule...
Insilico's AI-designed TNIK inhibitor rentosertib advances to Phase III IPF trial
Insilico Medicine (HKEX: 3696) has initiated a Phase III clinical trial for rentosertib (formerly ISM001-055 / INS018055), its first-in-class oral TNIK...
Teva reports early vitiligo data for anti-IL-15 TEV-'408, advances into Phase IIb
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) reported Phase Ib data for TEV-'408, its internally discovered anti-IL-15 monoclonal antibody, and...
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