AllSci News

Basilea secures USD 30m BARDA tranche to advance fosmanogepix Phase III trials
Switzerland-based Basilea Pharmaceutica Ltd (SIX: BSLN) announced a USD 30 million non-dilutive funding tranche from the Biomedical Advanced Research and...

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...

CORE launches with a portfolio licensed from Eisai plus USD 21m in financing
Boston-based CORE Biomedicine has secured exclusive global rights to a portfolio of preclinical oncology programs from Japan-based Eisai Co., Ltd. (TYO:...

FDA AdCom briefing raises broad efficacy concerns over Replimune's melanoma BLA
The US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee convenes on July 30 to publicly deliberate on Replimune's (Nasdaq: REPL) BLA 125827 for...

Claris Bio raises USD 118m to advance first-ever pharmacologic therapy for limbal stem cell deficiency
Jersey City, New Jersey-based Claris Biotherapeutics, Inc. has closed a USD 118 million Series B financing to advance CSB-001 (oremepermin alfa ophthalmic...

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...

Promatix advances EGFR × EphA2 cis-bispecific ADC with Innovate UK funding
UK-based Promatix Biosciences has received a non-dilutive Innovate UK Biomedical Catalyst grant to advance PBS293-exatecan, its lead EGFR × EphA2...

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...

AbelZeta wins FDA clearance for registrational Phase II study of lupus nephritis CAR-T
Rockville, Maryland-based AbelZeta Pharma has received US FDA clearance to proceed with a multi-center registrational Phase II trial of C-CAR168, an...

Yarrow completes reverse merger with VYNE, enters Phase II with TSHR antibody
New Haven, Connecticut-based Yarrow Bioscience, Inc. (Nasdaq: YARW) has closed its reverse merger with VYNE Therapeutics and simultaneously initiated dosing...

Harbour Bio pairs Harbour Mice platform with Sinopharm to develop biologics across oncology and inflammation
HBM Holdings Limited (HKEX: 02142) has entered a strategic collaboration with China National Pharmaceutical Group Co., Ltd. (Sinopharm) to establish a joint...

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...
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