Clinical

Delta-Fly eyes NDA path despite AML phase III miss

Fri, 17 Apr 2026 12:00:00 -0400

Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

Ebenbuild’s tech for predicting lung drug deposition validated

Fri, 17 Apr 2026 12:00:00 -0400

The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated strong agreement with in vivo imaging data across multiple inhalation scenarios.

Lilly’s GLP-1 Foundayo aces MACE in DILI of a phase III

Thu, 16 Apr 2026 12:00:00 -0400

Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk.

Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I

Wed, 15 Apr 2026 12:00:00 -0400

“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January. Secretomes refer to the collection of bioactive molecules secreted by cells in the extracellular space, including proteins, enzymes, growth factors and extracellular vesicles such as exosomes.

‘Immune reset’ is ambition of Tr1x’s allogenic Tr1 cell therapy

Tue, 14 Apr 2026 12:00:00 -0400

Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is to reset the immune system rather than continuously suppress it, and we believe we have a unique technology to do that.”

Cortec prepares to implant BCI tech into third stroke patient

Tue, 14 Apr 2026 12:00:00 -0400

Cortec GmbH is preparing to implant its brain-computer interface (BCI) technology into a third stroke patient, with early clinical data showing that the device leads to significant improvement in hand and arm function. The company believes its Brain Interchange system could transform the lives of millions of patients.

Synox en route to approval on positive phase III for TGCT

Mon, 13 Apr 2026 12:00:00 -0400

Synox Therapeutics Ltd. is preparing to file for FDA approval of emactuzumab in treating tenosynovial giant cell tumor (TGCT), after announcing positive top-line phase III results.

Spyre’s SPY-001 induces better outcomes in ulcerative colitis

Mon, 13 Apr 2026 12:00:00 -0400

Spyre Therapeutics Inc. is off to a good start in its goal to create the best combination therapy for inflammatory bowel disease, a group of chronic, relapsing autoimmune conditions of the digestive tract that encompasses Crohn’s disease and ulcerative colitis. The Waltham, Mass.-based company estimates the market for IBD is currently at approximately $25 billion but will jump to around $40 billion in 2030.

MRD word heard loud, clear in Allogene LBCL cema-cel phase II

Mon, 13 Apr 2026 12:00:00 -0400

“Home-run” efficacy and what Cowen analyst Tyler Van Buren called “pristine” safety in the phase II Alpha3 study with CAR T therapy cemacabtagene ansegedleucel (cema-cel) sent shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) skyward to a $4.46 high, up nearly 64%, on April 13. Shares eventually closed at $3.06, up 34 cents.

Revolution’s daraxonrasib nails endpoints in pancreatic cancer trial

Mon, 13 Apr 2026 12:00:00 -0400

“Unprecedented,” “remarkable” and “transformative” were just a few of the descriptives tossed out by Wall Street analysts in response to Revolution Medicines Inc.’s phase III readout, showing RAS inhibitor daraxonrasib hit its overall survival and progression-free survival endpoints in previously treated patients with metastatic pancreatic ductal adenocarcinoma, setting up the company for potential regulatory filings this year and triggering another round of M&A speculation.

Amplia halts enrollment in phase II pancreatic cancer trial

Tue, 07 Apr 2026 12:00:00 -0400

Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.

Five-drug VIPOR regimen shows promise in aggressive blood cancer

Tue, 07 Apr 2026 11:00:00 -0400

Deep molecular advances are enabling precision medicine for the field of hematology, Wyndham Wilson said during a plenary session at the 2026 Korean Society of Hematology International Conference March 26.

Oral ‘roid void in PPD? Lipocine MINI bike may have wheels

Thu, 02 Apr 2026 12:00:00 -0400

Hopes in postpartum depression (PPD) with an oral version of brexanolone – a synthetic formulation of the endogenous neurosteroid allopregnanolone, approved by the U.S. FDA in 2019 when given intravenously for PPD – were dashed, at least near term, when Lipocine Inc. reported that the candidate failed in a phase III placebo-controlled trial.

Five-drug VIPOR regimen shows promise in aggressive blood cancer

Wed, 01 Apr 2026 12:00:00 -0400

Assay what? Eyes on Pepgen’s DM1 phase II

Wed, 01 Apr 2026 12:00:00 -0400

Phase II data disclosed March 31 by Pepgen Inc. in myotonic dystrophy type 1 (DM1) hobbled the stock but might have been much different if not for one outlier in the 5-mg/kg multiple ascending dose cohort of the ongoing phase II Freedom2-DM1 trial – and Wall Street is pondering what the hitch means for the Boston-based firm as well as the competitive space.

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD