Credit Suisse analyst Evan Seigerman noted that the FDA announced approval for Novartis' (NVS) Zolgensma for the treatment of Spinal Muscular Atrophy, or SMA, in patients with bi-allelic mutations in the SMN1 gene under 2 years of age. The current wholesale acquisition cost for Biogen's (BIIB) Spinraza equates to a per-year treatment cost of $500,000 for the first year loading phase and $250,000-$375,000 per year for maintenance thereafter, which compares to a WAC of $2.125M for Zolgensma, which is administered just once, noted Seigerman. While investors generally expected Zolgensma would be approved, the breadth of the label was on the higher end of expectations, Seigerman tells investors. The pricing and label support his below consensus view of Spinraza, as he continues to expect that Zolgensma will become the preferred first option for infant-onset type 1 SMA, said the analyst, who reiterates his $198 price target and Underperform rating on Biogen shares.

RBC Capital lowered the firm's price target on Sage Therapeutics (SAGE) to $15 from $26 and keeps a Sector Perform rating on the shares after its Q1 earnings miss. The analyst also cites the company's limited additional detail on Zurzuvae launch relative to what was already provided by partner Biogen (BIIB), other than some prescription metrics. Sage's pipeline remains high-risk, though dalzanemdor may still have some shot in Huntington's Disease despite the recent Parkinson's Disease failure, the firm tells investors in a research note.

Biogen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for TOFIDENCE, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI, IMRALDI and FLIXABI, offering an extension to the cost-effective treatment options with an additional mechanism of action. "The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies," said Ian Henshaw, Global Head of Biosimilars at Biogen. "Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe."

Wedbush analyst Laura Chico raised the firm's price target on Biogen to $215 from $213 and keeps a Neutral rating on the shares. It remains early days for newly launching products like Skyclarys, Leqembi and Zurzuvae, the firm notes. That being said, it is encouraging to start to see revenue growth for Leqembi and continued growth for Skyclarys. Wedbush continues to see a gap between the newly launching products and earlier-stage development programs that will need to be addressed. However, larger-scale BD deals are likely easier to complete in 2025.

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TD Cowen analyst Yaron Werber raised the firm's price target on BeiGene (BGNE) to $236 from $235 and keeps a Buy rating on the shares. The firm updated its model to reflect lower collaborative revenue given termination of Novartis (NVS) agreement for tisle in Sep 2023.