BioCentury | Aug 4, 2020
Product Development

Aug. 3 Quick Takes: CymaBay gains on PBC readout; plus expanded labels for Epidiolex, Spravato, Voyager-AbbVie deal ends, Immunic and more

...CymaBay plans to re-start pivotal trial Shares of CymaBay Therapeutics Inc. (NASDAQ:CBAY) rose $1.33 (37%) to $4.88 Monday...
...and pruritus compared with placebo, and similar safety and tolerability profiles between the two groups. CymaBay...
...the therapy, including a clinical hold, that sent its stock tumbling (see “More Woes for CymaBay”...
BioCentury | Jul 24, 2020
Product Development

July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit

...idiopathic hypersomnia in adults. CymaBay hold lifted FDA lifted its clinical holds on seladelpar from CymaBay Therapeutics Inc....
BioCentury | Jun 29, 2020
Regulation

Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

...Inc. (NASDAQ:NGM) slipped 12%, 89bio Inc. (NASDAQ:ETNB) lost 6%, and Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) and CymaBay Therapeutics Inc....
BioCentury | Jun 16, 2020
Product Development

Inventiva resuscitates hopes for PPAR in NASH

...elafibranor missed the primary endpoint in the Phase III RESOLVE-IT trial. And a year ago, CymaBay Therapeutics Inc....
...endpoint in Phase IIb testing (see “ Genfit’s PPAR Agonist Fails to Resolve NASH” and “CymaBay...
BioCentury | May 13, 2020
Product Development

May 12 Quick Takes: Skyhawk, Merck expand deal; plus Sanofi’s Sarclisa and clinical updates drive gains for Gamida, CymaBay

...analysis early based on an IDMC recommendation. Panel backs restarting trials of CymaBay’s NASH therapy CymaBay Therapeutics Inc....
...with a standard umbilical cord blood transplant. BioCentury Staff Sarclisa, isatuximab-irfc (SAR650984) Omidubicel (NiCord) Merck & Co. Inc. Skyhawk Therapeutics Inc. CymaBay Therapeutics Inc. Sanofi Gamida...
BioCentury | May 12, 2020
Product Development

May 11 Quick Takes: Genfit’s elafibranor misses in NASH Phase III; plus AstraZeneca, Merck, Protalix and TolerogenixX

...NASH). Buysiders had been watching the trial with caution, as fellow PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Feb 22, 2020
Management Tracks

Everest names new CEO; plus Merck, Gilead, Turning Point, Adaptimmune, AskBio and more

...treat non-alcoholic steatohepatitis and other fibrotic diseases, as well as cancer. Boudes was CMO of CymaBay Therapeutics Inc....
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

...agonist. Buysiders have been watching the trial with caution, as fellow PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

...year-end, but buysiders are watching it with caution. In June, the PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Nov 25, 2019
Clinical News

Months after NASH failure, more woes for CymaBay's lead product on safety

...more trials, all developing seladelpar for liver indications. The $4.22 (76%) decline to $1.33 for CymaBay Therapeutics Inc....
...value has declined 88%, and its market cap has fallen to about $91 million (see "CymaBay...
...NASH study, seladelpar had met a secondary endpoint of reducing liver injury biomarkers. On Monday, CymaBay...
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BioCentury | Aug 4, 2020
Product Development

Aug. 3 Quick Takes: CymaBay gains on PBC readout; plus expanded labels for Epidiolex, Spravato, Voyager-AbbVie deal ends, Immunic and more

...CymaBay plans to re-start pivotal trial Shares of CymaBay Therapeutics Inc. (NASDAQ:CBAY) rose $1.33 (37%) to $4.88 Monday...
...and pruritus compared with placebo, and similar safety and tolerability profiles between the two groups. CymaBay...
...the therapy, including a clinical hold, that sent its stock tumbling (see “More Woes for CymaBay”...
BioCentury | Jul 24, 2020
Product Development

July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit

...idiopathic hypersomnia in adults. CymaBay hold lifted FDA lifted its clinical holds on seladelpar from CymaBay Therapeutics Inc....
BioCentury | Jun 29, 2020
Regulation

Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

...Inc. (NASDAQ:NGM) slipped 12%, 89bio Inc. (NASDAQ:ETNB) lost 6%, and Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) and CymaBay Therapeutics Inc....
BioCentury | Jun 16, 2020
Product Development

Inventiva resuscitates hopes for PPAR in NASH

...elafibranor missed the primary endpoint in the Phase III RESOLVE-IT trial. And a year ago, CymaBay Therapeutics Inc....
...endpoint in Phase IIb testing (see “ Genfit’s PPAR Agonist Fails to Resolve NASH” and “CymaBay...
BioCentury | May 13, 2020
Product Development

May 12 Quick Takes: Skyhawk, Merck expand deal; plus Sanofi’s Sarclisa and clinical updates drive gains for Gamida, CymaBay

...analysis early based on an IDMC recommendation. Panel backs restarting trials of CymaBay’s NASH therapy CymaBay Therapeutics Inc....
...with a standard umbilical cord blood transplant. BioCentury Staff Sarclisa, isatuximab-irfc (SAR650984) Omidubicel (NiCord) Merck & Co. Inc. Skyhawk Therapeutics Inc. CymaBay Therapeutics Inc. Sanofi Gamida...
BioCentury | May 12, 2020
Product Development

May 11 Quick Takes: Genfit’s elafibranor misses in NASH Phase III; plus AstraZeneca, Merck, Protalix and TolerogenixX

...NASH). Buysiders had been watching the trial with caution, as fellow PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Feb 22, 2020
Management Tracks

Everest names new CEO; plus Merck, Gilead, Turning Point, Adaptimmune, AskBio and more

...treat non-alcoholic steatohepatitis and other fibrotic diseases, as well as cancer. Boudes was CMO of CymaBay Therapeutics Inc....
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

...agonist. Buysiders have been watching the trial with caution, as fellow PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

...year-end, but buysiders are watching it with caution. In June, the PPARδ inhibitor seladelpar from CymaBay Therapeutics Inc....
BioCentury | Nov 25, 2019
Clinical News

Months after NASH failure, more woes for CymaBay's lead product on safety

...more trials, all developing seladelpar for liver indications. The $4.22 (76%) decline to $1.33 for CymaBay Therapeutics Inc....
...value has declined 88%, and its market cap has fallen to about $91 million (see "CymaBay...
...NASH study, seladelpar had met a secondary endpoint of reducing liver injury biomarkers. On Monday, CymaBay...
Items per page:
1 - 10 of 212