SAB Biotherapeutics Gets FDA Breakthrough Therapy Status On Influenza Treatment

 

• Earlier today, SAB Biotherapeutics Inc's 
  SABS+41.6%+ Free Alerts
   SAB-176, an investigational therapy for post-exposure prophylaxis for influenza, received FDA Breakthrough Therapy Designation soon after securing FDA Fast Track Status for the candidate.
• Last Friday, SAB Biotherapeutics' 2022 10-K was released. The analyst says it has no impact on the company; unfortunately, this does not warrant any further investor focus.
• 4Q22 EPS was ($0.19), compared to HC Wainwright's estimate of ($0.04). 
• The analyst says that the FDA is aligned with the company's manufacturing approach, which could address multiple strains of influenza annually. 
• In December 2021, the company announced that SAB-176 met the primary endpoint of statistically significant reductions in viral load compared to the placebo.
• SAB expects SAB-176 to be treated like a vaccine with annual changes to its targets and readily available for each flu season. 
• It forecasts a 2027 launch for SAB-176 with sales of $12.5 million that year and $290 million in 2030.
• HC Wainwright reiterates its Buy rating with a price target of $4.
• Chardan writes that SAB-176 is most likely to proceed with a partner. The analyst reiterates a Buy rating with a price target of $3.
• The analyst notes that SAB-195 is the company's top priority preclinical pipeline candidate for two infection indications.
• Preclinical data indicate that SAB-195 can neutralize both C. diff. bacteria and multiple strains of toxins. The company is conducting IND-enabling activities, with IND filing expected in 1Q24

https://www.benzinga.com/analyst-ratings/analyst-color/23/04/31865108/sab-biotherapeutics-gets-fda-breakthrough-therapy-status-on-influenza-treatment-can