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Roche Gets FDA Approval for Enspryng in Thyroid Eye Disease
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Key Takeaways
Roche's Enspryng wins FDA nod for thyroid eye disease, marking its second approved indication.
Enspryng's FDA approval is based on data from the pivotal phase III SatraGO-1 and SatraGO-2 studies.
Roche's Enspryng is under priority FDA review for MOGAD, with a decision expected on Jan. 10, 2027.
Roche (RHHBY - Free Report) announced that the FDA has approved Enspryng (satralizumab) for the treatment of thyroid eye disease (TED). The latest approval makes Enspryng the first and only at-home subcutaneous treatment option for the condition, allowing patients or caregivers to administer the drug following healthcare provider training.
Enspryng is a humanized monoclonal antibody that targets IL-6, a key chemical messenger involved in the body's inflammatory response.
The latest FDA nod was based on data from the pivotal phase III SatraGO-1 and SatraGO-2 studies. While SatraGO-1 did not meet its prespecified primary efficacy endpoint at week 24, SatraGO-2 demonstrated significant improvements in proptosis (eye bulging) and diplopia (double vision) among patients with active TED.
Data from the SatraGO-2 study showed 52.9% of patients treated with Enspryng achieved a proptosis response compared with 23.4% in the placebo group. The proportion of patients experiencing a reduction in diplopia was 60.7% with Enspryng versus 25.8% with placebo. Consistent results were observed in the overall study population, which included patients with active and chronic TED.
In June 2026, the FDA accepted and granted priority review to Roche’s supplemental biologics license application (sBLA) seeking label expansion of Enspryng for the treatment of TED.
TED is an autoimmune disorder affecting approximately 155 per 100,000 people and can cause facial disfigurement and sight-threatening complications if left untreated.
RHHBY’s Price Performance
Year to date, shares of Roche have gained 12.3% compared with the industry’s rally of 17.4%.
Image Source: Zacks Investment Research
RHHBY’s Recent Developments With Enspryng
Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States.
The latest approval for the TED indication marks the second indication for Enspryng.
Last month, the FDA accepted and granted priority review to Roche’s sBLA seeking approval of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). A decision from the regulatory body is expected on Jan. 10, 2027.
The European Medicines Agency has also validated Roche’s application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027.
If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disorder for which there are currently no approved treatments.
Roche is also evaluating Enspryng across additional neurological autoimmune and inflammatory disorders that may respond to IL-6 signaling inhibition, including autoimmune encephalitis.
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 57.4% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 39.6% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Halozyme’s 2026 earnings per share have risen from $8.37 to $8.80, while estimates for 2027 have increased from $9.75 to $10.29 during the same time. HALO shares have skyrocketed 80.6% year to date.
Halozyme’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average negative surprise being 19.12%.
View the Zacks #1 Rank List
Image: Bigstock
Roche Gets FDA Approval for Enspryng in Thyroid Eye Disease
Key Takeaways
Roche (RHHBY - Free Report) announced that the FDA has approved Enspryng (satralizumab) for the treatment of thyroid eye disease (TED). The latest approval makes Enspryng the first and only at-home subcutaneous treatment option for the condition, allowing patients or caregivers to administer the drug following healthcare provider training.
Enspryng is a humanized monoclonal antibody that targets IL-6, a key chemical messenger involved in the body's inflammatory response.
The latest FDA nod was based on data from the pivotal phase III SatraGO-1 and SatraGO-2 studies. While SatraGO-1 did not meet its prespecified primary efficacy endpoint at week 24, SatraGO-2 demonstrated significant improvements in proptosis (eye bulging) and diplopia (double vision) among patients with active TED.
Data from the SatraGO-2 study showed 52.9% of patients treated with Enspryng achieved a proptosis response compared with 23.4% in the placebo group. The proportion of patients experiencing a reduction in diplopia was 60.7% with Enspryng versus 25.8% with placebo. Consistent results were observed in the overall study population, which included patients with active and chronic TED.
In June 2026, the FDA accepted and granted priority review to Roche’s supplemental biologics license application (sBLA) seeking label expansion of Enspryng for the treatment of TED.
TED is an autoimmune disorder affecting approximately 155 per 100,000 people and can cause facial disfigurement and sight-threatening complications if left untreated.
RHHBY’s Price Performance
Year to date, shares of Roche have gained 12.3% compared with the industry’s rally of 17.4%.
Image Source: Zacks Investment Research
RHHBY’s Recent Developments With Enspryng
Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States.
The latest approval for the TED indication marks the second indication for Enspryng.
Last month, the FDA accepted and granted priority review to Roche’s sBLA seeking approval of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). A decision from the regulatory body is expected on Jan. 10, 2027.
The European Medicines Agency has also validated Roche’s application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027.
If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disorder for which there are currently no approved treatments.
Roche is also evaluating Enspryng across additional neurological autoimmune and inflammatory disorders that may respond to IL-6 signaling inhibition, including autoimmune encephalitis.
RHHBY’s Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Werewolf Therapeutics (HOWL - Free Report) , Arvinas (ARVN - Free Report) and Halozyme Therapeutics (HALO - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 57.4% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 39.6% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Halozyme’s 2026 earnings per share have risen from $8.37 to $8.80, while estimates for 2027 have increased from $9.75 to $10.29 during the same time. HALO shares have skyrocketed 80.6% year to date.
Halozyme’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average negative surprise being 19.12%.