Associated tags: Food and Drug Administration, PBC, Therapy, Fibrosis, Hepatitis, European Medicines Agency, Liver, Conditional sentence, Pharmaceutical industry, Patient, Conference, Primary biliary cholangitis
Locations: EUROPE
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Itch Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.
Key Points:
- Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.
- The study’s primary endpoint measure reflects registrational studies of the current second line PBC treatment authorized by the EMA.
- In this study seladelpar demonstrated statistically significant improvements in biochemical markers of disease progression and PBC-related pruritus (itch) pre-specified endpoints.
- “Validation of the European Marketing Authorization Application for seladelpar and the start of the agency’s formal review is an important step forward in seladelpar’s journey to potential approval in Europe.
Retrieved on:
Wednesday, February 28, 2024
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Pharmaceutical industry NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
Key Points:
- NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
- “2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar.
- Net loss for the year ended December 31, 2023 and 2022 was $105.4 million and $106.0 million, or ($0.99) and ($1.21) per share, respectively.
- Net loss for the three months ended December 31, 2023 was higher than the three months ended December 31, 2022 primarily due to higher operating expenses.
Retrieved on:
Tuesday, February 20, 2024
NEWARK, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to three employees on February 16, 2024 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
Key Points:
- NEWARK, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to three employees on February 16, 2024 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
- The Compensation Committee of the Board of Directors of CymBay approved the grant of non-qualified stock options to purchase an aggregate of 99,000 shares of CymaBay common stock as inducements material to the employees entering into employment with CymaBay in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grants.
- These stock option grants have an exercise prices of $32.18 per share, which was equal to the closing price of CymaBay’s common stock on the Grant Date.
- The stock options will vest and become exercisable as to 25% of the underlying shares on the first anniversary of the Grant Date, and will vest and become exercisable as to the remaining 75% of the underlying shares in 36 equal monthly installments from the first anniversary of the Grant Date, subject to the applicable employee’s continued employment with CymaBay on such vesting dates.
Retrieved on:
Monday, February 12, 2024
Upon completion of the proposed transaction, Diamondback's existing shareholders are expected to own approximately 60.5% of the combined company.
Key Points:
- Upon completion of the proposed transaction, Diamondback's existing shareholders are expected to own approximately 60.5% of the combined company.
- Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.
- Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email [email protected] or [email protected] .
- Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct.
Retrieved on:
Monday, February 12, 2024
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Pharmaceutical industry NEWARK, Calif., Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid. The FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.
Key Points:
- PBC is a rare, chronic condition that can lead to inflammation and eventually liver cirrhosis.
- People living with PBC can also experience symptoms that significantly impact their quality of life such as pruritus (itch) and fatigue.
- Seladelpar is an investigational, potent, selective, orally active PPARδ agonist, or delpar, in development for PBC treatment.
- "We are encouraged by the agency's decision to grant priority review for seladelpar, and its recognition of the significant need for new treatment options for people living with PBC.
Retrieved on:
Wednesday, January 31, 2024
NEWARK, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that members of its management team will participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference, February 7-8, in New York, NY, Raymond James & Associates’ 45th Annual Institutional Investors Conference, March 4-6, in Orlando, Florida, and Leerink Partners Global Biopharma Conference, March 11-13, in Miami, Florida.
Key Points:
- NEWARK, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that members of its management team will participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference, February 7-8, in New York, NY, Raymond James & Associates’ 45th Annual Institutional Investors Conference, March 4-6, in Orlando, Florida, and Leerink Partners Global Biopharma Conference, March 11-13, in Miami, Florida.
Retrieved on:
Tuesday, January 16, 2024
NEWARK, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to two employees on January 12, 2024 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
Key Points:
- NEWARK, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to two employees on January 12, 2024 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
- The Compensation Committee of the Board of Directors of CymBay approved the grant of non-qualified stock options to purchase an aggregate of 52,000 shares of CymaBay common stock as inducements material to the employees entering into employment with CymaBay in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grants.
- These stock option grants have an exercise price of $23.76 per share, which was equal to the closing price of CymaBay’s common stock on the Grant Date.
- The stock options will vest and become exercisable as to 25% of the underlying shares on the first anniversary of the Grant Date, and will vest and become exercisable as to the remaining 75% of the underlying shares in 36 equal monthly installments from the first anniversary of the Grant Date, subject to the applicable employee’s continued employment with CymaBay on such vesting dates.
Retrieved on:
Wednesday, January 3, 2024
NEWARK, Calif., Jan. 3, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced the first published findings demonstrating the impact of seladelpar on serum interleukin-31 (IL-31) levels and its correlation with pruritus improvement in people with primary biliary cholangitis (PBC). Seladelpar is a first-in-class oral, selective PPARδ agonist being investigated for the treatment of patients with PBC. The latest findings from a post-hoc analysis of the Phase 3 ENHANCE study, were published today in the open access journal Hepatology and are the first peer-reviewed published report of a correlation in decreases in IL-31, bile acids and pruritus symptoms in PBC following treatment with an investigational agent.
Key Points:
- Seladelpar is a first-in-class oral, selective PPARδ agonist being investigated for the treatment of patients with PBC.
- IL-31 is a cytokine known to mediate pruritus and blocking IL-31 signaling can provide relief in pruritic skin diseases.
- Baseline IL-31 levels also closely correlated with total (r=0.54, p
- While current treatments for cholestatic pruritus remain limited, these data can help inform potential novel therapeutic approaches."
NEWARK, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that its President and Chief Executive Officer, Sujal Shah, will present at the upcoming 42nd Annual JP Morgan Healthcare Conference taking place January 8 -11 in San Francisco, California.
Key Points:
- NEWARK, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that its President and Chief Executive Officer, Sujal Shah, will present at the upcoming 42nd Annual JP Morgan Healthcare Conference taking place January 8 -11 in San Francisco, California.
Retrieved on:
Monday, December 18, 2023
NEWARK, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to four employees on December 15, 2023 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
Key Points:
- NEWARK, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to four employees on December 15, 2023 (the “Grant Date”) in connection with the employees’ commencement of employment at CymaBay.
- The Compensation Committee of the Board of Directors of CymBay approved the grant of non-qualified stock options to purchase an aggregate of 176,000 shares of CymaBay common stock as inducements material to the employees entering into employment with CymaBay in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grants.
- These stock option grants have an exercise prices of $22.03 per share, which was equal to the closing price of CymaBay’s common stock on the Grant Date.
- The stock options will vest and become exercisable as to 25% of the underlying shares on the first anniversary of the Grant Date, and will vest and become exercisable as to the remaining 75% of the underlying shares in 36 equal monthly installments from the first anniversary of the Grant Date, subject to the applicable employee’s continued employment with CymaBay on such vesting dates.
