Development
Newron Pharma's evenamide faces FDA enrollment hold after patient death
Newron Pharmaceuticals said the US Food and Drug Administration has placed a clinical hold on new patient enrollment at US sites in its Phase III ENIGMA-TRS...
Pfizer's elranatamab meets Phase III primary endpoint in relapsed or refractory multiple myeloma
Pfizer (NYSE: PFE) reported that elranatamab (Elrexfio) met its primary endpoint in the Phase III MagnetisMM-5 trial, demonstrating a statistically...
AbbVie's Rinvoq beats Humira in Phase IIIb/IV rheumatoid arthritis trial
AbbVie (NYSE: ABBV) reported that upadacitinib beat adalimumab on the primary endpoint of a Phase IIIb/IV head-to-head trial in rheumatoid arthritis...
Mirum Pharmaceuticals' brelovitug meets primary endpoint in Phase IIb chronic hepatitis delta virus trial
Mirum Pharmaceuticals (Nasdaq: MIRM) reported that brelovitug met its primary endpoint in the Phase IIb portion of the AZURE-1 study in chronic hepatitis...
Erasca's ERAS-0015 shows strong early efficacy in KRAS-mutant solid tumors
Erasca reported preliminary Phase I dose-escalation data for ERAS-0015, its oral pan-RAS molecular glue, in patients with RAS-mutant solid tumors, with...
Taiho's first ADC enters clinic with Araris platform, targeting CD79b in non-Hodgkin lymphoma
Taiho Oncology and Araris Biotech AG have announced that the FDA has completed its Investigational New Drug review for ARC-02, a CD79b-targeting...
Janux discontinues EGFR-targeted TRACTr JANX008 after insufficient patient responses
Janux Therapeutics (San Diego, USA) announced the discontinuation of its JANX008 clinical development program, an EGFR-targeted Tumor Activated T Cell...
Oruka Therapeutics' ORKA-001 achieves 63.5% complete skin clearance in plaque psoriasis trial
Oruka Therapeutics reported Week 16 interim results from the EVERLAST-A Phase 2a trial of ORKA-001, a half-life extended IL-23p19 monoclonal antibody, in...
Compass Therapeutics' tovecimig meets progression-free survival endpoint in Phase II/III biliary tract cancer trial
Compass Therapeutics (Nasdaq: CMPX) reported that tovecimig, its DLL4/VEGF-A bispecific antibody, met the key secondary endpoint of progression-free...
Alltrna puts engineered tRNA therapeutic into first-in-human study
Alltrna, a Cambridge, Massachusetts-based Flagship Pioneering company, has received approval from Australia's Therapeutic Goods Administration to initiate a...
Veradermics' oral minoxidil meets endpoints in Phase II/III male pattern hair loss trial
Veradermics (NYSE: MANE) reported that its extended-release oral minoxidil tablet, VDPHL01, met all primary and key secondary endpoints in a Phase II/III...
Kyowa Kirin, Kura initiate Japanese Phase II for ziftomenib in relapsed/refractory NPM1-mutated AML
Kyowa Kirin and Kura Oncology have initiated a Japanese Phase II registration-directed trial of ziftomenib in adult patients with relapsed/refractory...
Repertoire Immune Medicines' RPTR-1-201 enters first clinical trial for advanced solid tumors
Repertoire Immune Medicines announced that the first participant has been dosed in a Phase I/II trial of RPTR-1-201, a TCR bispecific therapy designed to...
Connect Biopharma's rademikibart advances Phase II asthma and COPD exacerbation trials
Connect Biopharma (Nasdaq: CNTB) reported that an independent Data Monitoring Committee has reviewed interim efficacy data from its Phase 2 Seabreeze STAT...
Janux Therapeutics' masked bispecific T cell engager enters Phase I for mCRPC
Janux Therapeutics, the San Diego-based NASDAQ-listed biopharmaceutical company (ticker: JANX), has initiated a first-in-human Phase I clinical trial of...
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