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SVRA: Reiterate Buy Rating Ahead of Critical Nov. 22 Molbreevi FDA Action Date; 1Q 2026 Earnings Recap
研报英文原文证据摘录
SVRA: Reiterate Buy Rating Ahead of Critical Nov. 22 Molbreevi FDA Action Date; 1Q 2026 Earnings Recap
May 12, 2026
Vamil Divan, M.D. vamil.divan@guggenheimpartners.com SVRA: Reiterate Buy Rating Ahead of Critical Nov. 22
212 823 6543 Molbreevi FDA Action Date; 1Q 2026 Earnings Recap
Daniel Krizay, Ph.D.
daniel.krizay@guggenheimpartners.com
212 823 6561 Key Message: Savara released its 1Q 2026 results and provided a corporate update
today after the close. There were no major surprises in the update, as all focus is centered Arseniy Shabashvili
arseniy.shabashvili@guggenheimpartners.com on the upcoming Nov. 22 FDA Action Date for Molbreevi in aPAP. Regulatory decisions
212 699 1971 from the European Medicines Agency (EMA) and U.K. Medicines and Healthcare
Products Regulatory Agency (MHRA) are also still expected in 1Q 2027 and 4Q 2026, Edouard Mullarky, Ph.D. respectively. We are updating our model to account for the quarterly results and recent edouard.mullarky@guggenheimpartners.com
212 518 9579 business updates, primarily by increasing our near- and long-term operating expense
estimates and moving our estimated Molbreevi drug launch to 4Q 2026 (from 3Q 2026)
to reflect the recent three-month extension to the FDA review timeline (see our note
HERE). We remain bullish on Molbreevi's potential following these corporate updates
SVRA BUY andthe highcontinueunmettoneedbelievein aPAP,Molbreevithe positiverepresentsPhasea >$1B3 dataU.S.thatcommercialthe companyopportunitydelivered givenin the
Savara Inc. IMPALA-2 trial, and a likely favorable pricing environment for the product. We reiterate
Sector: Biotechnology our Buy rating and $11 PT on SVRA shares.
Earnings Release • 1Q 2026 Earnings Recap: The 1Q 2026 loss per share of ($0.15) was slightly below
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