What did the BEACON study show for brepocitinib in cutaneous sarcoidosis?

In the 31-patient BEACON study, the 45 mg arm achieved a 22.3-point mean improvement in CSAMI-A at Week 16 versus 0.7 points for placebo (Δ21.6, P<0.0001). Statistically significant separation was seen as early as Week 4. On the IGA, 69% of 45 mg patients reached Clear or Almost Clear versus 0% of placebo patients.

What are the next steps for brepocitinib?

Priovant plans to progress cutaneous sarcoidosis to a pivotal Phase 3 study starting in calendar 2026 after engaging with the FDA. An NDA for dermatomyositis has been submitted, and Phase 3 topline data in non-infectious uveitis are expected in the second half of calendar 2026.

How did Roivant's expenses and losses change in the quarter?

Loss from continuing operations, net of tax, was $313.7 million for the quarter ended December 31, 2025, compared with $208.9 million a year earlier. R&D expenses rose by $23.8 million to $165.4 million, mainly from program costs and share-based compensation. G&A expenses rose by $33.5 million to $175.1 million, including a $17.1 million headquarters relocation impairment and higher share-based compensation tied to the Priovant Exchange Offer.

What is Roivant's liquidity position?

Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025. The company says this supports cash runway into profitability. Immunovant's financing generated gross proceeds of approximately $550 million, extending its cash runway to the launch of IMVT-1402 in Graves' disease.

What other catalysts are expected in the second half of 2026?

Immunovant expects topline data from the potentially registrational D2T RA trial and the CLE proof-of-concept trial in the second half of 2026. Pulmovant expects topline data from the Phase 2 mosliciguat trial in PH-ILD in the same period. Immunovant expects Phase 3 batoclimab thyroid eye disease data in the first half of 2026.

ROIV 8-K: Earnings & Results

Q: What are the next steps for brepocitinib?

Priovant plans to progress cutaneous sarcoidosis to a pivotal Phase 3 study starting in calendar 2026 after engaging with the FDA. An NDA for dermatomyositis has been submitted, and Phase 3 topline data in non-infectious uveitis are expected in the second half of calendar 2026.

Q: How did Roivant's expenses and losses change in the quarter?

Loss from continuing operations, net of tax, was $313.7 million for the quarter ended December 31, 2025, compared with $208.9 million a year earlier. R&D expenses rose by $23.8 million to $165.4 million, mainly from program costs and share-based compensation. G&A expenses rose by $33.5 million to $175.1 million, including a $17.1 million headquarters relocation impairment and higher share-based compensation tied to the Priovant Exchange Offer.

Q: What is Roivant's liquidity position?

Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025. The company says this supports cash runway into profitability. Immunovant's financing generated gross proceeds of approximately $550 million, extending its cash runway to the launch of IMVT-1402 in Graves' disease.

Q: What other catalysts are expected in the second half of 2026?

Immunovant expects topline data from the potentially registrational D2T RA trial and the CLE proof-of-concept trial in the second half of 2026. Pulmovant expects topline data from the Phase 2 mosliciguat trial in PH-ILD in the same period. Immunovant expects Phase 3 batoclimab thyroid eye disease data in the first half of 2026.

01—Abstract

Summary

Summary of the 8-K filed February 6, 2026. Cited figures are marked; the original filing is the authoritative source.

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on February 6, 2026 to furnish Exhibit 99.1, a press release announcing positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS) and financial results for the fiscal quarter ended December 31, 2025.

In the BEACON study (31 patients), the 45 mg arm achieved a 22.3-point mean improvement in CSAMI-A at Week 16 versus a 0.7-point improvement for placebo (Δ21.6, P<0.0001). Priovant plans a Phase 3 CS study starting in calendar 2026, and an NDA for brepocitinib in dermatomyositis has been submitted to the FDA. Financially, the quarter showed a loss from continuing operations, net of tax, of $313.7 million^a, compared with $208.9 million a year earlier.

R&D expenses rose to $165.4 million^b from $141.6 million, and G&A expenses rose to $175.1 million from $141.5 million, including a $17.1 million impairment tied to the relocation of Roivant Sciences, Inc.'s U.S. headquarters. Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025, which the company says supports cash runway into profitability. Across the pipeline, Immunovant's D2T RA and CLE trials are expected to read out in the second half of 2026, and Immunovant financing generated gross proceeds of approximately $550 million.

Pulmovant's mosliciguat PH-ILD Phase 2 trial is fully enrolled with topline data expected in the second half of 2026. In litigation, a favorable summary judgment decision in the U.S. Moderna case was reported, with a jury trial scheduled for March 2026.

02—Key points

Key Highlights

Brepocitinib 45 mg met its primary endpoint in the Phase 2 BEACON study in cutaneous sarcoidosis: mean CSAMI-A improvement of 22.3 points at Week 16 versus 0.7 points for placebo (Δ21.6, P<0.0001).
Of 13 patients in the 45 mg arm, 62% achieved CSAMI-A <5 (functional remission) versus 0% of placebo patients; no serious adverse events were reported during the treatment period.
Priovant plans a pivotal Phase 3 CS study starting in calendar 2026 following FDA engagement, the third indication with a pivotal program for brepocitinib.
An NDA for brepocitinib in dermatomyositis was submitted to the FDA; Phase 3 non-infectious uveitis topline data are expected in the second half of calendar 2026.
Q3 FY2025 (quarter ended December 31, 2025) loss from continuing operations, net of tax, was $313.7 million ($0.38 per share), versus $208.9 million ($0.22 per share) a year earlier.
R&D expenses rose to $165.4 million and G&A expenses rose to $175.1 million, including a $17.1 million impairment from the relocation of Roivant Sciences, Inc.'s U.S. headquarters.
Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025; Immunovant financing generated gross proceeds of approximately $550 million.

03—Questions

Frequently Asked Questions

What did the BEACON study show for brepocitinib in cutaneous sarcoidosis?
In the 31-patient BEACON study, the 45 mg arm achieved a 22.3-point mean improvement in CSAMI-A at Week 16 versus 0.7 points for placebo (Δ21.6, P<0.0001). Statistically significant separation was seen as early as Week 4. On the IGA, 69% of 45 mg patients reached Clear or Almost Clear versus 0% of placebo patients.
What are the next steps for brepocitinib?
Priovant plans to progress cutaneous sarcoidosis to a pivotal Phase 3 study starting in calendar 2026 after engaging with the FDA. An NDA for dermatomyositis has been submitted, and Phase 3 topline data in non-infectious uveitis are expected in the second half of calendar 2026.
How did Roivant's expenses and losses change in the quarter?
Loss from continuing operations, net of tax, was $313.7 million for the quarter ended December 31, 2025, compared with $208.9 million a year earlier. R&D expenses rose by $23.8 million to $165.4 million, mainly from program costs and share-based compensation. G&A expenses rose by $33.5 million to $175.1 million, including a $17.1 million headquarters relocation impairment and higher share-based compensation tied to the Priovant Exchange Offer.
What is Roivant's liquidity position?
Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025. The company says this supports cash runway into profitability. Immunovant's financing generated gross proceeds of approximately $550 million, extending its cash runway to the launch of IMVT-1402 in Graves' disease.
What other catalysts are expected in the second half of 2026?
Immunovant expects topline data from the potentially registrational D2T RA trial and the CLE proof-of-concept trial in the second half of 2026. Pulmovant expects topline data from the Phase 2 mosliciguat trial in PH-ILD in the same period. Immunovant expects Phase 3 batoclimab thyroid eye disease data in the first half of 2026.

04—Continue

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