Rani announces preclinical development of RT-111, a RaniPill GO capsule containing ustekinumab biosimilar for the potential treatment of psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis -
- RT-102 Phase 1 repeat-dose topline data anticipated in 4Q 2022 -
- Initiation of in vivo studies with fully-autonomous RaniPill HC anticipated in 4Q 2022 -
Findings Derived from Company’s Extensive Thyroid Nodule Database and Whole-Transcriptome Capabilities
Veracyte, Inc. (Nasdaq: VCYT) today announced data that provide new insights into thyroid tumor behavior. The findings were derived from whole-transcriptome analyses of Veracyte’s extensive thyroid nodule database and were presented at the American Thyroid Association Annual Meeting, held October 19-23 in Montreal.
In one study, Veracyte researchers reviewed over 300 pathology reports from the training sets used to develop the company’s market-leading Afirma Genomic Sequencing Classifier (GSC). Levels of tumor invasion and metastasis were scored and tested against over 400 literature-derived gene expression signatures to identify potential predictors of these tumor behaviors. They found that the top-performing signatures were able to stratify nodules as low-risk with a negative predictive value for no invasion or metastasis of 95% and 100%, respectively. Conversely, the highest-performing signatures had a positive predictive value of 57% for invasion and 41% for metastasis.
“We evaluated gene expression-based signatures with the potential to predict thyroid tumor invasion and metastasis. This information could potentially be used to help personalize surgery and therapy decisions for patients with thyroid cancer,” said Joshua Klopper, M.D., Veracyte’s medical director, Endocrinology, who presented the poster. “Moreover, these findings underscore the potential to utilize our significant thyroid nodule database and whole-transcriptome capabilities to help unlock the next phase of innovation in thyroid cancer care.”
Additional data presented at the ATA conference demonstrate the Afirma GSC’s ability to inform diagnosis and treatment decisions for patients with thyroid nodules. While thyroid stimulating hormone receptor (TSHR) mutations are mostly associated with benign thyroid nodules, researchers found that when the Afirma GSC identified a thyroid nodule with a TSHR mutation and a result that was “suspicious” for cancer, the risk of malignancy was significantly higher at 15.3%, compared to those classified by the Afirma GSC as benign where the extrapolated risk is <1.5%.
The company expects to obtain approval of the drug, a protease inhibitor known as ensitrelvir, and to start generating sales in the second half of the fiscal year, Shionogi said in a statement.
The drugmaker now expects revenue of 410 billion yen ($2.75 billion) in the year through March 2023, up by 10 billion yen from its previous guidance. The annual operating profit forecast of 120 billion yen was unchanged, while the company reduced estimates for half-year results.
Shionogi said last month that ensitrelvir demonstrated a significant reduction in some COVID symptoms, when compared with a placebo in a late-stage trial in Asia. Regulators in Japan previously denied emergency approval for the pill, saying they wanted to see more data on its effectiveness.
Shares of Acumen Pharmaceuticals Inc. were up 10% to $8.41 in premarket trading Monday after the company said regulators granted fast-track designation to its Alzheimer's disease treatment.
The U.S. Food and Drug Administration gave the designation to ACU193, a clinical-stage monoclonal antibody. Acumen is currently studying the drug in a Phase 1 trial examining safety and proof of mechanism.
