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Biogen Gets EU Nod for First Postpartum Depression Drug
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Key Takeaways
{\"0\":\"Biogen gained EU approval for Zurzuvae, the first postpartum depression drug in the region.\",\"1\":\"Approval followed strong phase III SKYLARK results showing rapid, sustained symptom relief.\",\"2\":\"Zurzuvae sales hit $46.4M in Q2 2025, up 68% sequentially, exceeding Biogen\'s internal expectations.\"}
Biogen (BIIB - Free Report) announced that the European Commission (“EC”) has approved Zurzuvae (zuranolone) to treat postpartum depression (PPD) in adults after childbirth.
Following this approval, Zurzuvae became the first and only treatment approved for PPD indication in the European Union (“EU”). This oral drug is required to be taken once daily as part of a 14-day treatment course. The FDA approved the drug for a similar indication in August 2023.
The EC decision is based on results from the phase III SKYLARK study, which met the primary and all key secondary endpoints. Data from the study showed that treatment with Zurzuvae provided rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared with placebo.
PPD is a leading cause of maternal mortality in Europe, which often goes undiagnosed and untreated. Biogen estimates that 20% of women with a recent pregnancy in the region experience PPD symptoms.
BIIB’s Stock Performance
This year so far, shares of Biogen have lost 5% against the industry’s 3% growth.
Image Source: Zacks Investment Research
More on Biogen’s Zurzuvae
Zurzuvae was developed by Biogen in partnership with Sage Therapeutics, which was recently acquired by Supernus Pharmaceuticals (SUPN - Free Report) . Per the partnership terms, BIIB and SUPN share equal profits and losses for the commercialization of Zurzuvae in the United States. In ex-U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea, where Shionogi holds the rights) and pays royalties to Supernus Pharmaceuticals.
Sales of Zurzuvae have been encouraging since its commercial launch in December 2023 in the United States. During the second quarter of 2025, Biogen recorded $46.4 million from the drug’s sales, up 68% on a sequential basis, driven by increased demand. The drug’s launch uptake also exceeded the company’s internal expectations.
Zurzuvae is one of the four new product launches by Biogen – alongside Alzheimer’s disease drug Leqembi, Friedreich's Ataxia drug Skyclarys and ALS drug Qalsody – which have the potential to revive growth in the long term.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $6.53 to $7.25. EPS estimates for 2026 have increased from $7.07 to $7.74 during the same period. Year to date, shares of ANIP have surged 72%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 22.66%.
Estimates for CorMedix’s 2025 EPS have increased from $1.10 to $1.52 over the past 60 days, while the same for 2026 has increased from $1.46 to $2.12. CRMD shares have soared 37% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
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Biogen Gets EU Nod for First Postpartum Depression Drug
Key Takeaways
Biogen (BIIB - Free Report) announced that the European Commission (“EC”) has approved Zurzuvae (zuranolone) to treat postpartum depression (PPD) in adults after childbirth.
Following this approval, Zurzuvae became the first and only treatment approved for PPD indication in the European Union (“EU”). This oral drug is required to be taken once daily as part of a 14-day treatment course. The FDA approved the drug for a similar indication in August 2023.
The EC decision is based on results from the phase III SKYLARK study, which met the primary and all key secondary endpoints. Data from the study showed that treatment with Zurzuvae provided rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared with placebo.
PPD is a leading cause of maternal mortality in Europe, which often goes undiagnosed and untreated. Biogen estimates that 20% of women with a recent pregnancy in the region experience PPD symptoms.
BIIB’s Stock Performance
This year so far, shares of Biogen have lost 5% against the industry’s 3% growth.
Image Source: Zacks Investment Research
More on Biogen’s Zurzuvae
Zurzuvae was developed by Biogen in partnership with Sage Therapeutics, which was recently acquired by Supernus Pharmaceuticals (SUPN - Free Report) . Per the partnership terms, BIIB and SUPN share equal profits and losses for the commercialization of Zurzuvae in the United States. In ex-U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea, where Shionogi holds the rights) and pays royalties to Supernus Pharmaceuticals.
Sales of Zurzuvae have been encouraging since its commercial launch in December 2023 in the United States. During the second quarter of 2025, Biogen recorded $46.4 million from the drug’s sales, up 68% on a sequential basis, driven by increased demand. The drug’s launch uptake also exceeded the company’s internal expectations.
Zurzuvae is one of the four new product launches by Biogen – alongside Alzheimer’s disease drug Leqembi, Friedreich's Ataxia drug Skyclarys and ALS drug Qalsody – which have the potential to revive growth in the long term.
BIIB’s Zacks Rank
Biogen currently carries a Zacks Rank #3 (Hold).
Biogen Inc. Price
Biogen Inc. price | Biogen Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) and CorMedix (CRMD - 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.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $6.53 to $7.25. EPS estimates for 2026 have increased from $7.07 to $7.74 during the same period. Year to date, shares of ANIP have surged 72%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 22.66%.
Estimates for CorMedix’s 2025 EPS have increased from $1.10 to $1.52 over the past 60 days, while the same for 2026 has increased from $1.46 to $2.12. CRMD shares have soared 37% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.