ESSA Pharma

ESSA Pharma terminated masofaniten clinical trials, withdrew IND/CTAs due to futility analysis. The company is exploring strategic options to maximize shareholder value, including potential mergers, asset sales, or new product development. Financial results show a net loss of $28.5M for FY 2024, with $126.8M in cash reserves.

Adenosine antagonists market growth driven by R&D in neurodegenerative diseases, oncology, and cardiovascular disorders. Innovations in formulation and delivery systems enhance efficacy and safety, increasing adoption. Key companies include Arcus Biosciences, Corvus Pharmaceuticals, Portage Biotech, Palobiofarm, iTeos Therapeutics. Promising drugs like Etrumadenant, Ciforadenant, PORT-6, and Inupadenant are in various clinical trial phases.

The FDA accepted Bayer's sNDA for Nubeqa (darolutamide), an oral ARi for metastatic hormone-sensitive prostate cancer, based on positive Phase III ARANOTE trial results. Nubeqa, in combination with ADT, met the trial's primary endpoint of radiological progression-free survival. If approved, Nubeqa's indication would expand to include mHSPC with or without chemotherapy.

ESSA Pharma halted development of its lead drug candidate, masofaniten, after a Phase II trial showed no added efficacy when combined with enzalutamide. Oppenheimer and Piper Sandler downgraded ESSA's stock, reflecting uncertainties and the need for strategic alternatives to maintain investor interest.

Maury Raycroft from Jefferies downgraded ESSA Pharma (EPIX) to a Hold, with a $1.70 price target, due to the discontinuation of masofaniten programs and uncertainty about future developments. The company has $100 million in cash but lacks clarity on its path forward.

ESSA Pharma terminated the Phase II trial of masofaniten, an AR inhibitor for mCRPC, after an interim review showed higher-than-expected PSA90 response with enzalutamide alone and no clear benefit when combined with masofaniten. The trial, involving 52 patients, aimed to assess the combination versus enzalutamide alone, but futility analysis indicated low probability of meeting primary endpoint.

The phase 2 study (NCT05075577) examining masofaniten (EPI-7386) + enzalutamide vs enzalutamide monotherapy in metastatic castration-resistant prostate cancer (mCRPC) was discontinued due to low likelihood of meeting primary endpoint of PSA90 response. Combination therapy showed 64% PSA90 vs 73% monotherapy, and 88% PSA50 vs 87% monotherapy. Safety was well-tolerated with no new signals.

Eli Lilly's Q3 sales of GLP-1 drugs Mounjaro and Zepbound missed analyst projections, leading to a stock decline and lowered revenue guidance for 2024. Despite strong underlying growth, factors like inventory cuts and 'lumpiness' in stocking contributed to the shortfall. Lilly plans to boost marketing efforts for the drugs.