Summary:
The CYTK PDUFA for Omecamtiv Mecarbil is coming up on February 28 for heart failure with reduced ejection fraction (HErEF)
The Dec 13 AdComm vote was negative: committee voted 8-3 that Omecamtiv benefits do not outweigh risks
Other exciting heart failure assets in 2023 include the ESPR presentation in March and two additional PDUFA decisions!
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CYTK's asset Omecamtiv Mecarbil has a PDUFA target action date of February 28, 2023 for the possible treatment of heart failure with reduced ejection fraction (HErEF). Omecamtiv Mecarbil is a selective cardiac myosin activator.
Two Phase 3 trials have been completed to evaluate Omecamtiv Mecarbil for heart failure: GALACTIC-HF (a cardiovascular outcomes study in collaboration with AMGN) and METEORIC-HF (an exercise capacity study). The GALACTIC-HF trial evaluated the lowering of adverse cardiac outcomes through improving contractility in heart failure. The second Phase 3 trial evaluating Omecamtiv mecarbil was the METEORIC-HF trial to evaluate exercise capacity by cardiopulmonary exercise testing after 20 weeks of omecamtiv mecarbil treatment. Topline data was reported on Feb 15, 2022. To see the results from both Phase 3 trials, see our full analysis after signing up for Free!
This Phase 3 trial was an outcomes trial, similar to the ESPR CLEAR outcomes trial that first reported data in December 2022. Full data from the CLEAR Outcomes trial will be presented at ACC in March 2023. It will be interesting to see how this compares to the GALACTIC-HF outcomes study. If you want to see the full ESPR analysis, become an Amp Pro a paid subscriber! Learn more HERE.
There are many other exciting heart failure & heart disease catalysts in our database with upcoming events including ESPR Outcomes data and multiple PDUFAs! See Table 1 for a sneak peek of these companies and sign up for free to get the full list! See all the major cardiac catalyst dates with a free account here
Table 1. Heart failure events through H1 2023
Hedge funds and CYTK
CYTK was held in 8 of the 35 biotech hedge funds we tracked in Q3 2022. We look forward to Q4 hedge fund data, coming in the middle of February, to see how many were holding CYTK at the end of 2022. See which hedge funds held CYTK in our free forum after signing up!
We are very excited for the CYTK PDUFA in February and beyond as heart failure assets are in the spotlight.
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