Development
Shape Therapeutics secures funding to advance one-time gene therapy for Parkinson's disease.
Seattle-based Shape Therapeutics has received a research grant from The Michael J. Fox Foundation for Parkinson's Research to fund IND-enabling studies of...
FDA clears registrational Phase II path for Cullinan's CLN-049 in relapsed/refractory AML
Cullinan Therapeutics (Nasdaq: CGEM) announced on July 28 that the FDA endorsed its Phase II development strategy for CLN-049, a FLT3×CD3 bispecific T cell...
Atea's hepatitis C combination meets non-inferiority bar, clears path to regulatory filing
Boston-based Atea Pharmaceuticals (Nasdaq: AVIR) reported positive topline results from its Phase III C-BEYOND trial on July 28, with the fixed-dose...
Altimmune's pemvidutide sees clear path forward in alcohol use disorder after strong Phase II
Gaithersburg, Maryland-based Altimmune, Inc. (Nasdaq: ALT) reported positive topline results from the RECLAIM study, a Phase II trial of pemvidutide in...
Treeline opens Phase I trial of TLN-499 plus venetoclax in BCL-2-dependent solid tumors
Treeline Biosciences, Inc. has registered a first-in-human Phase I clinical trial of TLN-499 in combination with venetoclax (Venclexta) in patients with...
ProMIS reports no ARIA-E in blinded six-month Alzheimer's trial update
ProMIS Neurosciences (Nasdaq: PMN) reported blinded six-month interim safety and biomarker data from its Phase Ib Alzheimer's disease trial on Monday, with...
ViiV's two-drug Dovato matches three-drug Biktarvy in first head-to-head HIV trial
ViiV Healthcare reported Week 48 data from the phase IIIb VOGUE study showing that dolutegravir/lamivudine (Dovato) met a non-inferiority endpoint against...
AstraZeneca's sonesitatug vedotin delivers first Phase III OS win for CLDN18.2 ADC in gastric cancer
AstraZeneca's sonesitatug vedotin (CMG901, AZD0901) has demonstrated a statistically significant and clinically meaningful overall survival benefit in...
MapLight's M1/M4 agonist aces Phase II schizophrenia trial
MapLight Therapeutics (Nasdaq: MPLT) reported positive topline results from its Phase II ZEPHYR trial of ML-007C-MA in adults with acute exacerbation of...
Gossamer reacquires seralutinib rights ahead of September NDA submission in PAH
Gossamer Bio (Nasdaq: GOSS) announced on July 27 that FDA meeting minutes from a mid-June Pre-NDA Type B meeting support a September 2026 NDA submission for...
InnoCare's oral TYK2 meets primary endpoint in Phase III psoriasis trial
InnoCare Pharma (HKEX: 09969; SSE: 688428) announced that fadeucravacitinib, its oral TYK2 inhibitor, met the primary endpoint with statistical significance...
Revagenix opens first clinical trial of LpxC inhibitor for Pseudomonas-driven bronchiectasis
San Francisco-based Revagenix, Inc. has dosed the first participant in a Phase I trial of Rev-56, an inhaled therapy targeting chronic Pseudomonas...
CAMP4 launches first-in-human trial of antisense therapy for SYNGAP1 disorder in Australia
Cambridge, Massachusetts-based CAMP4 Therapeutics Corporation (Nasdaq: CAMP) has received clearance from Australia's Therapeutic Goods Administration (TGA)...
Bio-Thera advances CD25-targeted ADC into first human trial for solid tumors.
Bio-Thera Solutions, Ltd. (SH: 688177), a Guangzhou, China-based commercial-stage pharmaceutical company, has dosed the first patient in a Phase I trial of...
Ultomiris misses Phase III endpoint in adult HSCT-TMA, leaving pediatric approval path intact
AstraZeneca (LSE/STO/NYSE: AZN) reported that ravulizumab (Ultomiris) failed to meet the primary endpoint in a Phase III placebo-controlled trial in adults...
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