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H.C. Wainwright's Ed Arce maintains Buy rating on Arcturus Therapeutics (ARCT) with $63 target, citing promising COVID-19 vaccine advancements, EMA recommendation for Kostaive, and robust pipeline. Canaccord Genuity also maintains Buy with $74 target.

Arcturus Therapeutics maintains Buy rating and $63.00 price target after EMA's CHMP recommends Kostaive vaccine approval. The vaccine, aimed at preventing COVID-19 in adults, is already approved in Japan and could gain European Commission authorization by early 2025. Arcturus also received FDA approval for a flu vaccine clinical trial and reported improved Q3 2024 earnings. The company plans to file a Biologics License Application for Kostaive in the U.S. in H1 2025.

CSL announced EMA's CHMP recommended garadacimab for HAE, a once-monthly treatment inhibiting factor XIIa. The decision is based on Phase 3 VANGUARD trial data showing 62% attack-free status and 86.5% reduction in attacks. The EC decision is expected in Q1 2025.

Non-cystic fibrosis bronchiectasis market driven by rising prevalence, early diagnosis, and drug development. Over 15 companies, including Zambon SpA, Insmed, and AstraZeneca, are developing 15+ pipeline therapies. Key drugs in trials include Colistimethate sodium, Benralizumab, and Brensocatib.

uniQure won a dispute against Pfizer over patent EP 3 581 650, which protects a Factor IX polypeptide mutant for treating haemophilia, forming the basis of uniQure’s drug Hemgenix. Pfizer’s Beqvez, approved by the EMA, challenges EP 650 for lack of inventive step but admits infringement if valid. The UK High Court upheld uniQure’s patent, and Pfizer plans to appeal. The EPO’s Opposition Division indicated EP 650’s validity, with an oral hearing scheduled for October 2025. A Dutch ruling is expected on November 27.

Canaccord Genuity maintains Buy rating on Arcturus Therapeutics, raising price target to $74. Arcturus reported $25M milestone payments from Kostaive sales in Japan, with updates on ARCT-032 and ARCT-810 for 2025. The company anticipates EU approval for Kostaive and first commercial revenue. Arcturus's robust cash balance supports its path to profitability. Recent news includes a net loss of $6.9M in Q3 2024, but a positive cash runway into Q1 2027. InvestingPro data supports Canaccord's optimism, noting Arcturus's strong financial health and recent stock price increase.

Arcturus Therapeutics reported a net loss of $6.9 million in Q3 2024 but remains optimistic with a cash runway into Q1 2027. The company launched its first commercial product, KOSTAIVE, in Japan, receiving a $25 million milestone payment. Arcturus plans to file a BLA for KOSTAIVE in the U.S. in H1 2025 and anticipates interim Phase 2 data for ARCT-032 and ARCT-810 in early 2025. The company's cash reserves are $294.1 million, and it secured $462.1 million in upfront payments and milestones from CSL.

Clazakizumab failed to meet primary efficacy outcomes in the IMAGINE Phase 3 trial for chronic active antibody-mediated rejection (caAMR) in kidney transplant recipients, showing no difference in eGFR change from baseline at week 52 compared to placebo, with no safety concerns observed.