Jefferies analyst Michael Yee believes the positive Phase III topline results from Acorda Therapeutics (ACOR) competitor Sunovion for APL-130277 in Parkinson's patients came in as expected. While APL-130277 data compares favorably over Inbrija's 3.92 point difference at week 12, Yee cautions to compare directly head-to-head since patient baseline characteristics could be different. Acorda remains a "reasonably likely" acquisition candidate in 2018 given its $300M-$500M-plus Parkinson's asset Inbrija, Yee tells investors in a research note. The analyst does not think Biogen (BIIB) should buy the company, but sees other potential suitors in AbbVie (ABBV), Allergan (AGN), Mitsubishi, Roche (RHHBY) and Shire (SHPG). He believes a takeover price could be north of $2B. Yee keeps a Hold rating on Acorda with a $25 price target.

FY24 consensus $11.10.

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."

Notable companies reporting before tomorrow's open, with earnings consensus, include Exxon Mobil (XOM), consensus $2.20... Chevron (CVX), consensus $2.87... AbbVie (ABBV), consensus $2.23... HCA Healthcare (HCA), consensus $5.01... Colgate-Palmolive (CL), consensus 81c... Charter (CHTR), consensus $7.92... AutoNation (AN), consensus $4.27.

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.

AbbVie announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study that evaluated the efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. In the LEVEL UP study, upadacitinib showed superior efficacy versus dupilumab in the primary endpoint, demonstrating that a significantly higher proportion of patients simultaneously achieved both a 90% or greater reduction in Eczema Area and Severity Index and a Worst Pruritus Numerical Rating Scale of 0 or 1 at Week 16.

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Check out this morning's top movers from around Wall Street, compiled by The Fly. UP AFTER EARNINGS... To see the rest of the story go to thefly.com. See Story Here