A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

Inclusion Criteria:

1. Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) atScreening who have provided signed informed consent indicating that they understandthe purpose of, and procedures required for, the study, and are willing toparticipate in the study. If the patient is unable to consent for himself/herself, alegally authorized representative must provide informed consent on his/her behalf.

2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-bloodspecimen obtained within ≤ 96 hours (4 days) before randomization, and on clinicalcriteria judged attributable to candidemia/invasive candidiasis occurring at anytime from ≤ 12 hours prior to the qualifying positive index culture being takenthrough to randomization.

3. Patient's condition allows for appropriate infection source control measures,including removal of pre-existing intravascular catheters and devices, if necessary.

Exclusion Criteria:

1. Existing infection

2. Infection known to be due to Candida krusei, in blood or any other normallysterile site.

3. Inappropriate fungal infection source control.

4. Diagnosis of certain deep-seated Candida infections.

5. Life expectancy of < 72 hours in the opinion of the investigator.

6. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, orhemofiltration.

7. Ongoing neurological disorders, including specified conditions presenting with aCTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence ofthe current episode of candidemia / invasive candidiasis are not exclusionary).

8. Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunisticinfection within 6 months prior to Screening.

9. Other medical or psychiatric condition or laboratory abnormality that may increasethe risk of study participation or make the patient inappropriate for the study.

10. Current use of any prohibited concomitant medications or those unwilling/unable touse a permitted concomitant medication.

11. Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment atapproved doses and frequency to treat the current episode of candidemia and/orinvasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 dosesof a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia orinvasive candidiasis while on prophylaxis with an azole or amphotericin B).

12. Previous administration with an investigational drug or investigational vaccinewithin 30 days or 5 half-lives preceding the first dose of study drug used in thisstudy (whichever is longer).

13. Prior participation in this or any previous study of fosmanogepix.

14. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT orAST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolatedhyperbilirubinemia or documented Gilbert's syndrome.

15. Female patient is pregnant or lactating.

16. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin,fluconazole or to any of their excipients.

17. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and Sponsor andSponsor delegate employees directly involved in the conduct of the study and theirfamily members.