Theravance Biopharma (TBPH) completes enrollment in pivotal Phase 3 CYPRESS trial

Rhea-AI Filing Summary

Theravance Biopharma, Inc. reported that it has completed enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study. This trial is evaluating a treatment in patients with symptomatic neurogenic orthostatic hypotension caused by multiple system atrophy.

The company described the study as pivotal and noted that all information related to this milestone is provided in a press release furnished as an exhibit. That press release is supplied for informational purposes and is not deemed filed under securities laws.

Insights

Biopharmaceutical clinical development analyst

Theravance reaches a key enrollment milestone in a pivotal Phase 3 study.

Theravance Biopharma, Inc. has completed enrollment in the open-label portion of its pivotal Phase 3 CYPRESS trial in symptomatic neurogenic orthostatic hypotension due to multiple system atrophy. A pivotal Phase 3 study is typically designed to support potential regulatory review if results are sufficiently strong, so reaching full enrollment is an important operational step.

The update focuses on trial progress rather than results, so there is no information here about safety, efficacy, or timelines beyond this enrollment milestone. The attached press release, furnished as an exhibit, is intended to provide additional detail but is expressly not treated as filed under securities law. Future disclosures about data from the CYPRESS study would be needed to understand any potential impact on the company’s outlook.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

FORM 8-K

Current Report Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): August 25, 2025

THERAVANCE BIOPHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

Cayman Islands		001-36033		98-1226628
(State or Other Jurisdiction of		(Commission File Number)		(I.R.S. Employer Identification
Incorporation)				Number)

c/o Theravance Biopharma US, LLC

901 Gateway Boulevard

South San Francisco, CA 94080

(650) 808-6000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary Share $0.00001 Par Value		TBPH		NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company    ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events

On August 25, 2025, Theravance Biopharma, Inc. (NASDAQ: TBPH) announced that it completed enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA).

A copy of the press release is furnished as Exhibit 99.1 to this Current Report.

The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

	99.1	Press Release dated August 25, 2025
	104	Cover Page Interactive Data File (cover page XBRL tags embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	THERAVANCE BIOPHARMA, INC.
Date:  August 25, 2025	By:	/s/ Aziz Sawaf
		Aziz Sawaf
		Senior Vice President and Chief Financial Officer

FAQ

What did Theravance Biopharma (TBPH) announce in this 8-K?

Theravance Biopharma announced that it has completed enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension due to multiple system atrophy.

What is the CYPRESS study mentioned by Theravance Biopharma (TBPH)?

The CYPRESS study is described as a pivotal Phase 3 clinical trial in patients with symptomatic neurogenic orthostatic hypotension that is due to multiple system atrophy.

Does this Theravance Biopharma 8-K include clinical results from the CYPRESS study?

The 8-K states that Theravance Biopharma has completed enrollment in the open-label portion of the CYPRESS study, but it does not provide clinical results in the text provided.

How did Theravance Biopharma (TBPH) share more details about the Phase 3 CYPRESS milestone?

Theravance Biopharma furnished a press release as Exhibit 99.1, which contains additional information about the completion of enrollment in the open-label portion of the CYPRESS study.

Is the Theravance Biopharma press release about CYPRESS considered filed with the SEC?

The company specifies that the information in this report, including Exhibit 99.1, is being furnished and is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934.

Can the CYPRESS study press release be automatically incorporated into other Theravance Biopharma filings?

The company states that the information in this report, including the press release, will not be incorporated by reference into any registration statement or other document unless specifically referenced.