Privacy Policy

HALIA THERAPEUTICS POLICY FOR EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

Halia Therapeutics, Inc. (Halia) is a clinical-stage biopharmaceutical company committed to developing novel, meaningful medicines for patients with serious diseases who may benefit from new treatment options.

CURRENTLY, NONE OF HALIA’S INVESTIGATIONALPRODUCTS ARE AVAILABLE FOR EXPANDED ACCESS.

In general, all new drug product candidates must be reviewed and approved by the U.S. Food and Drug Administration (FDA) before they can become commercially available in the United States for treating appropriate patients. Drugs that have not been approved by the FDA may or may not be effective as a treatment and may cause unexpected serious side effects.

Our product development pipeline consists of investigational therapeutics currently being tested in clinical trials and have not yet been approved by the FDA. Clinical trials are controlled research studies designed to evaluate whether a new therapy is safe and effective for patients, and they provide the most direct opportunity for patients to access a new product before regulatory approval. Halia’s investigational products are currently at an early stage of development, and we are currently focused on enrolling patients who meet the eligibility criteria for our sponsored clinical trials and continuing to learn more about our investigational products’ safety and efficacy. As a general policy, Halia's investigational products are currently accessible only to subjects participating in a Halia-sponsored clinical trial.  

In contrast, expanded access, also known as “compassionate use,” is a process by which a limited number of qualifying patients may be granted access to an investigational product on a case-by-case basis. Requests for expanded access must be initiated by a treating physician and generally apply to patients who do not qualify for clinical trials, have exhausted all available treatment options, and have an immediately life-threatening condition or serious disease or condition, among other criteria. You can learn more about expanded access by visiting the FDA website at Expanded Access | Information for Patients 

While we are mindful of the serious impact that these devastating diseases have on those affected, and we committed to completing the regulatory review and approval process through our ongoing clinical trials, we are not in a position to offer sponsor-initiated expanded access to our investigational products outside of our active clinical trials. We encourage patients to speak with their physicians about their eligibility for participation in any of Halia's clinical trials whenever possible. Additional information about Halia's clinical trials is available on ClinicalTrials.gov.

Although we do not currently offer sponsor-initiated expanded access to our investigational products, we may offer such access in the future. Halia may revise this expanded access policy at any time in the future. The posting of this policy does not guarantee access to any specific investigational product for any individual.

For more information regarding our investigational products or questions about our clinical trials, please submit a request to info@haliatx.com. Halia personnel will acknowledge receipt of any expanded access questions within ten business days of receipt.

CURRENTLY, HALIA CANNOT MAKE EXPANDED ACCESS AVAILABLE TO ITS INVESTIGATIONAL DRUGS.

Halia may revise this expanded access policy at any time in the future, and this posting will be updated should there be any policy change. For more information regarding our investigational drugs or questions about participation in one of our clinical trials, please submit a request to info@haliatherapeutics.com. Halia personnel will acknowledge receipt of any expanded access questions within ten business days of receipt. For additional information on expanded access to investigational drugs, visit the FDA’s website.