Inclusion Criteria:

• Completed a TNX-103 parent study.

• Investigator has confirmed that participant may derive clinical benefit from continued access to TNX-103.

• If the participant has developed any condition that would have rendered them ineligible for the parent study, then eligibility has been discussed and agreed with the Sponsor.

• Participants are willing and able to comply with all scheduled visits.

• Participants are able and willing to provide signed informed consent.

• Female patients of childbearing potential must have a negative pregnancy test result at the Enrollment visit and must not be pregnant, lactating, or planning a pregnancy through 7 months after the last dose of study drug.

• Female patients of childbearing potential will be included if they are either sexually inactive (abstinent) for 90 days prior to the first dose of study drug, or are using 1 of the following highly effective birth control methods (i.e., results in <1% failure rate when used consistently and correctly):

  • Intrauterine device in place for at least 3 months prior to the first dose of study drug and throughout the study.

  • Surgical sterilization of the partner (provided they are the sole sexual partner), defined as vasectomy for 6 months minimum and assessed as surgical success.

  • Combined (estrogen- or progestogen-containing) hormonal contraception associated with the inhibition of ovulation (either oral, intravaginal, or transdermal).

  • Progestogen-only hormonal contraception associated with the inhibition of ovulation (either oral, injectable, or implantable).

  • Intrauterine hormone releasing system.

  • Bilateral tubal occlusion.

• Female patients of nonchildbearing potential will be included if they meet one of the below:

  • surgically sterile (hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Enrollment visit)

  • postmenopausal, defined as spontaneous amenorrhea for at least 1 year and for female patients <55 years of age, with folliclestimulating hormone in the postmenopausal range at Enrollment, based on the laboratory’s reference ranges

• Male patients with female partners of childbearing potential will be included if they agree to use highly effective methods of birth control during their participation in the study and for a period of 4 months after the last dose of study drug.

• Patients must agree to abstain from egg or sperm donation through 7 months for female patients and 4 months for male patients after administration of the last dose of study drug.

Exclusion Criteria:

• Any patient who, in the opinion of the investigator or sponsor, is not an appropriate candidate for participation due to safety concerns, inability to comply with study procedures, or any other reason that may compromise the integrity of the trial or the well-being of the participant.

• Known estimated glomerular filtration rate <30 mL/min/1.73 m2.

• Known history of chronic liver disease with severe hepatic impairment and/or cirrhosis, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication, with severe hepatic impairment and/or cirrhosis); Child-Pugh class C.

• Pregnancy or breastfeeding in females.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/15/2025. Questions regarding updates should be directed to the study team contact.