Development
Pfizer's Seagen-acquired IB6 ADC fails primary survival test in advanced lung cancer
Pfizer (NYSE: PFE) reported that sigvotatug vedotin, an integrin beta-6 (IB6)-directed antibody-drug conjugate, failed to demonstrate a statistically...
Merck's tulisokibart becomes first anti-TL1A antibody to achieve Phase III remission in ulcerative colitis
Merck (NYSE: MRK) reported positive topline results from the Phase III ATLAS-UC Study 2, making tulisokibart (MK-7240) the first anti-TL1A monoclonal...
Novartis advances FAP theranostic platform with first-in-human imaging agent trial across six solid tumors
Novartis has initiated a first-in-human Phase I trial of [68Ga]Ga-DFC413 (JFI447), a gallium-68-labeled radioligand designed to image fibroblast activation...
Cancer Cell publication provides biological rationale for sac-TMT's Phase III push into first-line EGFR-mutant NSCLC
Translational research published in Cancer Cell this week offers a mechanistic rationale for one of the most strategically significant combination studies...
Exelixis reports split Phase III outcome for zanzalintinib ahead of FDA review
Exelixis, Inc. (Nasdaq: EXEL) reported that the final analysis of its second dual primary endpoint in the Phase III STELLAR-303 trial did not reach...
MoonLake reports best-in-class one-year HS data for sonelokimab
Switzerland-based MoonLake Immunotherapeutics (Nasdaq: MLTX) reported Week 52 data from its Phase III VELA-1 and VELA-2 trials showing that 67.2% of adults...
101 Therapeutics bypasses peer review to seek emergency evaluation of Ebola therapy candidate
Israel and New Jersey-based 101 Therapeutics Ltd. has released Phase II/III clinical data for 101-PGC-005, a macrophage-targeted dexamethasone prodrug,...
Immunomic launches first self-amplifying RNA vaccine trial in triple-negative breast cancer
Privately held Rockville, Maryland-based Immunomic Therapeutics, Inc. has initiated a first-in-human Phase I trial of ITI-5000, a self-amplifying RNA...
Mabwell's Nectin-4 ADC challenges Pfizer's Tivdak with 77% response rate in combination study
China-based Mabwell (688062.SH, 02493.HK) reported early-stage clinical data for its Nectin-4-targeting antibody-drug conjugate 9MW2821 (bulumtatug...
Novocure's glioblastoma expansion bid fails, leaving Optune's label unchanged
A Phase III trial failure that leaves Novocure's approved label intact but closes the door on a meaningful expansion opportunity — that is the central...
F2G, Shionogi's oral anti-fungal scores Phase III success against Gilead's AmBisome in invasive aspergillosis
Olorofim's Phase III non-inferiority win against Gilead's AmBisome (liposomal amphotericin B) in azole-refractory invasive aspergillosis reported by...
Verastem's RAF/MEK-FAK strategy shows encouraging survival signal in pancreatic cancer
Updated data from the RAMP 205 trial show that avutometinib plus defactinib, layered on top of gemcitabine and nab-paclitaxel, produced a 52% confirmed...
ScinnoHub launches Phase I study of RET inhibitor aimed at post-Retevmo/Gavreto resistance
China-based ScinnoHub Pharmaceutical Co., Ltd. has initiated a first-in-human Phase I trial of SNH-118110, an oral small-molecule RET inhibitor, in patients...
NMD Pharma reports functional gains for CIC-1 inhibitor in CMT despite Phase IIa endpoint miss
Functional improvements in hand grip strength and composite motor measures in Charcot-Marie-Tooth disease patients — sustained a week after treatment...
Akeso revives CD47 strategy in AML after strong Phase II showing for ligufalimab
A randomized, placebo-controlled Phase II trial of ligufalimab, a CD47-targeting antibody, has reported survival data in treatment-naïve AML that positions...
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