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Thursday, September 8, 2022

With Upcoming Pivotal Data, Cantor Analyst Sees 145% Upside In Actinium

 

  • Cantor Fitzgerald initiated coverage on Actinium Pharmaceuticals Inc 
    ATNM
     with an Overweight rating and a price target of $20, almost an upside of 145%.
  • Actinium is a clinical-stage biopharmaceutical company that is currently developing oncology therapies.
  • This includes the lead program, IomabB, a targeted conditioning therapy administered in preparation for a bone marrow transplant (BMT), adoptive cell therapy (ACT), and Actimab-B, combined with other therapeutic therapy agents. 
  • The analyst believes that the SIERRA trial is the only randomized Phase 3 study that offers BMT as a treatment option for patients with active r/r Acute Myeloid Leukemia (AML). 
  • "We think it is essential to focus on a "Goldilocks" approach in finding a dose/regimen that balances safety and efficacy," the analyst writes.
  • The potential expansion of Iomab-B may also go beyond CD45 space, considering conditioning remains an integral part of adoptive cell therapies. 
  • "Actinium has already achieved proof of concept in some of these settings. We think this could dramatically expand the market opportunity and open the door for further partnerships." Cantor writes. 

Independent Biostatisticians Recommend Vistagen Continue Late-Stage Anxiety Trial

 

  • Vistagen Therapeutics Inc  completed an interim analysis of PALISADE-2, its second Phase 3 trial assessing drug candidate PH94B as an acute treatment of anxiety in adults with Social Anxiety Disorder.
  • The analysis concluded that PALISADE-2 should continue as planned.
  • Independent biostatisticians reviewed unblinded data from the 140 subjects who completed PALISADE-2 before the Company paused enrollment in the study in July 2022, following the announcement of topline results from its first Phase 3 trial, PALISADE-1.
  • The independent biostatisticians recommended that Vistagen continue PALISADE-2 as planned to the full enrollment of 208 subjects without adjusting the study size. 
  • Vistagen expects topline results from PALISADE-2 in the first half of 2023.

Purple Biotech Has Almost 400% Upside According To Chardan Analyst

 

  • Chardan Research initiated coverage of Purple Biotech  with a Buy rating and a price target of $11/share. 
  • The analyst is optimistic about the company's two clinical programs: 
    • Anti-CEACAM1 monoclonal antibody CM24 for pancreatic ductal adenocarcinoma (PDAC).
    • NT219, the company's insulin receptor substrate 1/2 and STAT3 dual inhibitor small molecule, being developed initially to treat head and neck squamous cell carcinoma (HNSCC). 
  • Both programs have shown supportive safety in the clinic and early signs of clinical activity to support further investigation. 
  • The company expects multiple data readouts from its programs over the next 12 months that could de-risk its development candidates. 
  • Chardan forecasts CM24 and NT219 reaching the U.S. market in 2027 and achieving probability-adjusted global sales in 2030E of $147 million and $61.7 million, respectively.

U.S. FDA approves Revance's Botox rival

 Revance Therapeutics said on Thursday it had received the U.S. Food and Drug Administration's approval for its injection that could rival AbbVie's Botox.

The company said Daxxify, its treatment for wrinkles that appear as people become older, has the ability to address the duration of treatment effect, which it believes is the greatest unmet need among the class of injections.

The U.S. approval of Daxxify was based on a late-stage trial of over 2,700 patients that showed the injection had a six-month median duration, with some patients even showing the effect at nine months.

The company received a "complete response letter" in November last year after the regulator pointed to "deficiencies" at its manufacturing site during an inspection.

https://finance.yahoo.com/news/1-u-fda-approves-revances-112723895.html