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AZN's Klygefa Gets CHMP Nod for Generalised Myasthenia Gravis in EU
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Key Takeaways
AstraZeneca's Klygefa gains a positive CHMP opinion for AChR-positive gMG in the EU.
Klygefa improved MG-ADL scores versus placebo, with meaningful benefits seen from week one.
Klygefa offers once-weekly self-administration, with a safety profile consistent with C5 inhibitors.
AstraZeneca (AZN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of its rare-disease drug, Klygefa (gefurulimab), as an add-on therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are positive for anti-acetylcholine receptor (AChR) antibodies.
If approved, Klygefa would become the first and only dual-binding nanobody C5 inhibitor for the said patient population in the European Union (EU).
Klygefa is already approved in Japan and certain other countries for specific adults with gMG. The drug is under regulatory review in the United States, China and some other countries for the same indication.
gMG is a rare autoimmune disease that causes muscle weakness and can significantly affect patients’ daily activities. About 85% of people living with gMG are AChR antibody-positive. Across five major European countries, an estimated 82,500 people have gMG, including approximately 66,000 AChR antibody-positive patients.
Klygefa is designed as a once-weekly subcutaneous treatment that can be self-administered using an autoinjector. This could provide a convenient option for adults with gMG who need ongoing treatment.
Year to date, AZN’s shares have lost 8.8% against the industry’s 7.8% growth.
Image Source: Zacks Investment Research
CHMP Nod to AZN’s Klygefa Based on Phase III PREVAIL Data
The CHMP recommendation for Klygefa in AChR-positive gMG was supported by positive data from the pivotal phase III PREVAIL study. The study met its primary endpoint by demonstrating that treatment with Klygefa significantly improved the myasthenia gravis activities of daily living (MG-ADL) score, which measures patients’ ability to perform daily activities. At week 26, the improvement in the score was greater with Klygefa than with placebo, with a treatment difference of -1.6. A clinically meaningful improvement was observed as early as week one and was sustained through week 26. The treatment was generally well-tolerated, with a safety profile consistent with AZN’s marketed C5 inhibitors, including Soliris and Ultomiris.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #5 (Strong Sell).
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 16.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
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AZN's Klygefa Gets CHMP Nod for Generalised Myasthenia Gravis in EU
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of its rare-disease drug, Klygefa (gefurulimab), as an add-on therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are positive for anti-acetylcholine receptor (AChR) antibodies.
If approved, Klygefa would become the first and only dual-binding nanobody C5 inhibitor for the said patient population in the European Union (EU).
Klygefa is already approved in Japan and certain other countries for specific adults with gMG. The drug is under regulatory review in the United States, China and some other countries for the same indication.
gMG is a rare autoimmune disease that causes muscle weakness and can significantly affect patients’ daily activities. About 85% of people living with gMG are AChR antibody-positive. Across five major European countries, an estimated 82,500 people have gMG, including approximately 66,000 AChR antibody-positive patients.
Klygefa is designed as a once-weekly subcutaneous treatment that can be self-administered using an autoinjector. This could provide a convenient option for adults with gMG who need ongoing treatment.
Year to date, AZN’s shares have lost 8.8% against the industry’s 7.8% growth.
Image Source: Zacks Investment Research
CHMP Nod to AZN’s Klygefa Based on Phase III PREVAIL Data
The CHMP recommendation for Klygefa in AChR-positive gMG was supported by positive data from the pivotal phase III PREVAIL study. The study met its primary endpoint by demonstrating that treatment with Klygefa significantly improved the myasthenia gravis activities of daily living (MG-ADL) score, which measures patients’ ability to perform daily activities. At week 26, the improvement in the score was greater with Klygefa than with placebo, with a treatment difference of -1.6. A clinically meaningful improvement was observed as early as week one and was sustained through week 26. The treatment was generally well-tolerated, with a safety profile consistent with AZN’s marketed C5 inhibitors, including Soliris and Ultomiris.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 16.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.