CymaBay Therapeutics, Inc. - CBAY STOCK NEWS

CymaBay Therapeutics (NASDAQ: CBAY) has announced the start of a global phase 3 study, RESPONSE, evaluating seladelpar for primary biliary cholangitis (PBC). The study aims to enroll 180 patients and assess the efficacy of seladelpar over 52 weeks. Results from the ENHANCE phase 3 study will be presented at The Liver Meeting® 2020. Financial results for Q3 2020 indicate a net loss of $11.4 million, significantly lower than last year, primarily due to reduced R&D expenses. CymaBay holds $161.3 million in cash, sufficient to fund operations into 2022.

CymaBay Therapeutics (NASDAQ: CBAY) announced a collaboration with the AdventHealth Translational Research Institute to evaluate MBX-2982, a GPR119 agonist, aimed at preventing hypoglycemia in type 1 diabetes (T1D). Funded by a $1.2 million grant from the Helmsley Charitable Trust, the Phase 2a study will assess the drug’s ability to enhance glucagon secretion during insulin-induced hypoglycemia. Previous studies indicate that GPR119 agonists may stimulate glucagon secretion effectively, addressing a significant unmet need in T1D management.

CymaBay Therapeutics (CBAY) announced a late-breaking presentation of the ENHANCE Phase 3 study results for seladelpar, focused on primary biliary cholangitis (PBC), to be held at The Liver Meeting Digital Experience™ 2020 from November 13-16. The oral presentation, led by Professor Gideon Hirschfield, aims to share efficacy and safety data regarding seladelpar, an innovative therapy receiving orphan designation from the FDA and EMA for PBC. CymaBay is also preparing to initiate a new global Phase 3 study to support seladelpar's registration.

CymaBay Therapeutics (NASDAQ: CBAY) will host a conference call on November 5, 2020, at 4:30 PM ET to discuss Q3 financial results and provide a business update. The company is focused on developing therapies for liver diseases and has a key product, seladelpar, which is under investigation for primary biliary cholangitis (PBC). Seladelpar has received orphan drug designation from the FDA and EMA, along with Breakthrough Therapy Designation from the FDA. For more information, visit their website.

CymaBay Therapeutics (NASDAQ: CBAY) announced participation in three upcoming virtual investor conferences. The Citi’s 15th Annual BioPharma Conference will be held on September 9, 2020. The H.C. Wainwright 22nd Annual Global Investment Conference is scheduled for September 14-16, 2020, while the Cantor Global Healthcare Conference will take place from September 15-17, 2020. CymaBay focuses on developing therapies for liver diseases, including its lead candidate, seladelpar, for primary biliary cholangitis, which has received FDA and EMA designations.

CymaBay Therapeutics (NASDAQ: CBAY) announced promising final results from a Phase 2 study of seladelpar for primary biliary cholangitis (PBC), presented at the Digital International Liver Congress™ 2020. The study showed sustained anti-cholestatic effects, with 55% and 69% of patients in the 5/10 mg and 10 mg groups meeting the composite responder criteria after one year. Significant improvement in pruritus was noted, with 93% of patients in the 10 mg group reporting substantial relief. Seladelpar was well tolerated with no serious drug-related adverse events. The findings reaffirm seladelpar's potential as a breakthrough therapy.

CymaBay Therapeutics (NASDAQ: CBAY) announces significant developments, including the FDA lifting all clinical holds on seladelpar for nonalcoholic steatohepatitis, primary biliary cholangitis (PBC), and primary sclerosing cholangitis. Positive topline results from the ENHANCE study in PBC demonstrate high efficacy, with 78.2% of patients achieving primary outcomes. The company reported a net loss of $10.7 million for Q2 2020, a decrease from $24 million in Q2 2019. With $168.9 million in cash, CymaBay's finances are stable to fund operations into 2022.

CymaBay Therapeutics has announced that the FDA has lifted clinical holds on its seladelpar Investigational New Drug Applications in NASH, PBC, and PSC. This allows the company to resume clinical development, focusing initially on Phase 3 trials for PBC. The development was halted in November 2019 due to atypical histological findings in a Phase 2 NASH study, but an independent review found no significant safety concerns. The move is viewed as a pivotal step forward for seladelpar, which has shown potential benefits in treating chronic liver diseases.

CymaBay Therapeutics (NASDAQ: CBAY) announced new data from a Phase 2 study of seladelpar for treating primary biliary cholangitis (PBC). The study showed significant improvement in pruritus, with 58% and 93% of patients experiencing at least a 20-point decrease in itching after one year with the 5/10 mg and 10 mg doses, respectively. Additionally, 81% and 78% of patients reported improved sleep disturbances associated with itch. Seladelpar, a selective PPARδ agonist, is on clinical hold pending FDA review. The findings were presented at Digestive Disease Week 2020.