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Roche Gets FDA Priority Tag for Enspryng in Rare Autoimmune Disorder
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Key Takeaways
Roche's Enspryng sBLA for MOGAD received FDA priority review, with a decision due on Jan. 10, 2027.
The sBLA is supported by phase III METEOROID data showing a 68% lower relapse risk versus placebo.
If approved, Enspryng could become the first and only disease-modifying therapy for MOGAD.
Roche (RHHBY - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Jan. 10, 2027.
MOGAD is a rare autoimmune disease of the central nervous system that can cause unpredictable attacks affecting the optic nerves, spinal cord or brain.
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.
Separately, the European Medicines Agency has validated Roche’s application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027.
Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States.
RHHBY’s Price Performance
Year to date, shares of Roche have gained 5.6% compared with the industry’s rally of 12.3%.
Image Source: Zacks Investment Research
More on RHHBY’s Enspryng Progress
The FDA’s acceptance of the Enspryng application in MOGAD was based on positive data from the phase III METEOROID study, which met its primary endpoint. Data from the study showed that treatment with Enspryng reduced the risk of a new MOGAD relapse by 68% compared with placebo. Also, at 48 weeks, 87% of patients treated with Enspryng remained relapse-free compared with 67% in the placebo arm.
Treatment with Enspryng also demonstrated significant improvements across the METEOROID study’s key secondary measures, including the annualized relapse rate, MRI lesion activity and rescue therapy use.
Enspryng is a humanized monoclonal antibody that targets IL-6, a key chemical messenger involved in the body's inflammatory response.
Besides MOGAD, Roche is evaluating Enspryng across additional neurological autoimmune and inflammatory disorders that may respond to IL-6 signaling inhibition, including autoimmune encephalitis and thyroid eye disease (TED).
In June 2026, the FDA accepted and granted priority review to Roche’s sBLA seeking label expansion of Enspryng for the treatment of TED. A final decision from the regulatory body is expected on Oct. 15, 2026.
A potential approval will make Enspryng the first at-home subcutaneous disease-modifying standard of care for TED.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 0.7% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 117.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 62.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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Roche Gets FDA Priority Tag for Enspryng in Rare Autoimmune Disorder
Key Takeaways
Roche (RHHBY - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Jan. 10, 2027.
MOGAD is a rare autoimmune disease of the central nervous system that can cause unpredictable attacks affecting the optic nerves, spinal cord or brain.
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.
Separately, the European Medicines Agency has validated Roche’s application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027.
Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States.
RHHBY’s Price Performance
Year to date, shares of Roche have gained 5.6% compared with the industry’s rally of 12.3%.
Image Source: Zacks Investment Research
More on RHHBY’s Enspryng Progress
The FDA’s acceptance of the Enspryng application in MOGAD was based on positive data from the phase III METEOROID study, which met its primary endpoint. Data from the study showed that treatment with Enspryng reduced the risk of a new MOGAD relapse by 68% compared with placebo. Also, at 48 weeks, 87% of patients treated with Enspryng remained relapse-free compared with 67% in the placebo arm.
Treatment with Enspryng also demonstrated significant improvements across the METEOROID study’s key secondary measures, including the annualized relapse rate, MRI lesion activity and rescue therapy use.
Enspryng is a humanized monoclonal antibody that targets IL-6, a key chemical messenger involved in the body's inflammatory response.
Besides MOGAD, Roche is evaluating Enspryng across additional neurological autoimmune and inflammatory disorders that may respond to IL-6 signaling inhibition, including autoimmune encephalitis and thyroid eye disease (TED).
In June 2026, the FDA accepted and granted priority review to Roche’s sBLA seeking label expansion of Enspryng for the treatment of TED. A final decision from the regulatory body is expected on Oct. 15, 2026.
A potential approval will make Enspryng the first at-home subcutaneous disease-modifying standard of care for TED.
RHHBY’s Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 0.7% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 117.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 62.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.