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CymaBay Therapeutics, Inc. (CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced FDA clearance of the company’s Investigational New Drug Application (IND) for seladelpar to treat primary sclerosing cholangitis (PSC). The company intends to initiate a Phase 2 study to evaluate the safety, tolerability, and efficacy of seladelpar in patients with PSC in the third quarter. PSC is a rare, chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts.
For a week now, the market has been seeing trading range action with a generally positive bias. That is continuing Monday as market players look ahead to the Federal Reserve interest rate decision on Wednesday afternoon.
Looking deeper into a target of a CRISPR deal, a fundraising for more-targeted approach to mental health therapies and more in our Health Care Digest.
CymaBay Therapeutics, Inc. (CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that Sujal Shah, President and Chief Executive Officer, will participate in a fireside chat at Raymond James Life Sciences and MedTech Conference on Wednesday, June 19, 2019 at 8:00 a.m. ET (5:00 a.m. PT) at the Lotte New York Palace in New York City. A live audio webcast of the presentation can be accessed through the Investors section of the CymaBay Therapeutics corporate website at http://ir.cymabay.com/events. Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases PBC and NASH.
CymaBay Therapeutics (CBAY) is currently enrolling patients in its Phase 3 registrational trial, ENHANCE, to evaluate the use of its investigational PPARδ (peroxisome proliferator-activated receptor delta) agonist, seladelpar, in PBC (primary biliary cholangitis).
CymaBay Therapeutics (CBAY) closed at $6.17 on June 12, 1.98% higher than its previous close, 28.01% above its 52-week low of $4.82, and 58.87% below its 52-week high of $15.
Intercept Pharmaceuticals (ICPT) closed at $80.99 on June 12, 0.90% higher than its previous close, 10.93% above its 52-week low of $73.01, and 39.44% below its 52-week high of $133.74.
This year, CymaBay Therapeutics (CBAY) has fallen 21.60% and Viking Therapeutics (VKTX) has risen 4.31%. While both clinical-stage companies focus on advancing their nonalcoholic steatohepatitis research and development programs, Viking seems to be ahead, considering its successful Phase 2 trials.
While the market driven by short-term sentiment influenced by the accomodative interest rate environment in the US, increasing oil prices and optimism towards the resolution of the trade war with China, many smart money investors kept their cautious approach regarding the current bull run in the first quarter and hedging or reducing many of their […]
CymaBay (CBAY) plummets as a phase IIb study on lead candidate, seladelpar, fails to show meaningful reductions in liver fat.
The small-cap biotech company released disappointing trial data on Tuesday, triggering a selloff. Raymond James analyst Steven Seedhouse says the stock is now a Strong Buy.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on June 11) BIOFRONTERA AG/ADR (NASDAQ: BFRA ) BIO-TECHNE Corp ...
It is not uncommon to see companies perform well in the years after insiders buy shares. The flip side of that is that...
Shares of CymaBay Therapeutics Inc. plummeted 43% in premarket trade Tuesday after the biotech said data from an ongoing Phase 2 trial showed patients with nonalcoholic steatohepatitis (NASH) who were treated with investigational drug seladelpar did not show significant reductions in liver fat when compared with those on a placebo. However, treatment with seladelpar did result in a reduction in biomarkers associated with liver injury, the company said. "While the reductions in liver fat were minimal, we remain encouraged by the significant improvements in biochemical markers of liver injury that we observed at week 12," said Pol Boudes, CymaBay's chief medical officer. "The 52-week liver biopsy data will allow us to understand whether the improvement in liver injury markers will translate into histological improvement. The observed improvement in markers of liver injury are consistent with the observed effects of seladelpar in PBC and further support the potential for seladelpar to improve liver health." In NASH, fat builds up in the liver, triggering inflammation and cell injury that can lead to serious complications like cirrhosis, or liver scarring. There have been several trial updates in the NASH space so far this year from companies like Gilead Sciences Inc. and Intercept Pharmaceuticals Inc. , but they have not been promising, according to Jefferies health desk trader Jared Holz. "Investors have not been impressed with current data," he wrote in a note to clients Tuesday morning. Shares of CymaBay Therapeutics Inc. have gained 41% in the year to date through Monday, while the S&P 500 has gained 15%.
CymaBay Therapeutics (NASDAQCBAY) announced results from an ongoing 52-week Phase 2b dose-ranging, paired liver biopsy study of "seladelpar" for the treatment of nonalcoholic steatohepatitis. ...
- Reductions in liver fat were minimal and not significant compared to placebo- Reductions in markers of liver injury were robust and clinically meaningful- Seladelpar.
CymaBay Therapeutics (CBAY) needs investors to pay close attention to the stock based on moves in the options market lately.
Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in development for PBC and nonalcoholic steatohepatitis (NASH). A poster presentation titled “Capturing the experience and impact of itch in patients with primary biliary cholangitis (PBC),” highlighted results from a qualitative study designed to understand the experience and impact of itch on PBC patients and to examine the validity of three existing pruritus patient-reported outcome (PRO) measures (Itch Numeric Rating Scale (NRS), 5-D Itch Scale, and the Itch Visual Analogue Scale (VAS)).
Biotech stocks came under pressure this week along with the broader market, which succumbed to the negative sentiment generated by U.S.-China trade tensions. However, they recouped some of these losses, ...