Target $19
Tuesday, June 11, 2019
CymaBay downdraft snares Genfit
The seladelpar-stoked selloff in CymaBay Therapeutics has engulfed fellow NASH player Genfit SA (GNFT -13.3%).
Seladelpar activates the peroxisome proliferator-activated receptor δ (PPARδ), expressed in a range of liver cells, which plays a key role in regulating genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism.
Genfit’s lead drug is elafibranor, a PPAR alpha/delta agonist.
CymaBay down on disappointing data on NASH candidate
CymaBay Therapeutics (NASDAQ:CBAY) craters 40% premarket on light volume (so far) in reaction to 12-week data from a Phase 2b clinical trialevaluating seladelpar in patients with nonalcoholic steatohepatitis (NASH).
All three doses (10 mg, 20 mg and 50 mg) of seladelpar failed to outperform placebo in terms of the relative or absolute change in liver fat content (LFC) from baseline, the proportion of subjects achieving at least a 30% relative reduction in LFC or the proportion of subjects achieving at least a 5% absolute reduction in LFC (the 20 mg cohort slightly beat control in this group).
Treatment with seladelpar did produce positive changes in four liver enzymes associated with improved liver function and reduced stress.
Seladelpar, an orally available PPARδ agonist, has performed better in patients with primary biliary cholangitis but this is a much smaller potential market compared to NASH.
Management will host a conference call this morning to discuss the results.
Motus GI up on FDA nod for next-gen Pure-Vu
Thinly traded nano cap Motus GI Holdings (NASDAQ:MOTS) is up 21% premarket on increased volume in reaction to its announcement that the FDA has granted 510(k) clearance for its next-generation Pure-Vu System used to facilitate the cleaning of a poorly prepared colon during a colonoscopy.
Veracyte Details Real-World Performance of Sequencer in Thyroid Cancer Diagnosis
Veracyte, Inc. (Nasdaq: VCYT) announced today that findings from a new real-world study show that the company’s Afirma® Genomic Sequencing Classifier (GSC) helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test. Findings from the clinical utility study, conducted by researchers at The Ohio State University, appear online in the journal Thyroid and add to the growing body of independent evidence demonstrating the performance of the next-generation genomic test.
In the study, researchers evaluated records for all patients whose thyroid nodules were indeterminate for cancer based on cytopathology and who subsequently underwent molecular testing with the Afirma GSC or the original Afirma Gene Expression Classifier (GEC) between February 2011 and December 2018. Based on a cohort of 164 Afirma GSC-tested nodules and 343 Afirma GEC-tested nodules, they found that the next-generation test identified 58 percent more nodules as benign (76.2 percent vs. 48.1 percent) and that the rate of surgery among indeterminate thyroid nodules decreased by 66.4 percent (from 52.5 percent with the Afirma GEC to 17.6 percent with the Afirma GSC). The “benign call” rate among Hürthle cells – a common but difficult-to-diagnose thyroid nodule subtype – was also significantly higher using the Afirma GSC (88.8 percent vs. 25.7 percent).
“Our findings show that use of the Afirma GSC has enabled us to identify many more patients as benign when their thyroid nodules were indeterminate compared to the original test and, as a result, to help significantly reduce unnecessary thyroid surgeries among these patients,” said Jennifer A. Sipos, M.D., endocrinologist and professor at The Ohio State University and an author of the new study. “The next-generation test’s results were particularly striking for patients with Hürthle cells who previously had little other choice than to undergo diagnostic surgery, which carries risks and is costly.”
The new study marks the third recent independent publication by a major medical center demonstrating that its use of the Afirma GSC helped to significantly reduce surgeries in thyroid cancer diagnosis.
Zynerba Advances Cannabidiol Treatment With New Patent Win
Zynerba Pharmaceuticals Inc ZYNE 17.2%, a company that focuses on treating rare and near-rare neuropsychiatric disorders through cannabinoid therapies, said Tuesday it received a new U.S. patent for one of its cannabis-focused treatments.
Zynerba said the U.S. Patent and Trademark Office issued US Patent No. 10,314,792, titled “Treatment of Autism Spectrum Disorder with Cannabidiol.” The patent includes claims related to methods of treating autism through the administration of a synthetic cannabidiol.
Zynerba’s patent will expire in 2038 and is part of the company’s growing intellectual property portfolio that covers its cannabidiol product candidate, Zygel.
The announcement also follows a patent win titled “Treatment of Fragile X Syndrome with Cannabidiol,” which includes claims related to treating Fragile X Syndrome through a purified cannabidiol.
Zynerba continues to enroll patients for an open-label Phase 2 BRIGHT study which studies the safety, tolerability and efficacy of Zygel. The study will consist of children and adolescents with Autism Spectrum Disorder.
The company said it expects to report top-line data in the first half of 2020.
Subscribe to:
Comments (Atom)