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AlloVir (ALVR) Up on Third RMAT Status From FDA for Posoleucel
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AlloVir, Inc. (ALVR - Free Report) announced that the FDA has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation to its allogeneic, off-the-shelf, multi-virus-specific T-cell therapy, posoleucel, for the prevention of multiple life-threatening infections from six viruses in allogeneic hematopoietic cell transplant (allo-HCT) patients.
The RMAT designation is granted to speed up the development and review of regenerative therapies that target serious or life-threatening conditions
The latest RMAT tag has been granted to posoleucel for the prevention of clinically significant infections and disease from six devastating viruses — adenovirus (AdV), BK virus (“BKV”), cytomegalovirus (“CMV”), Epstein-Barr virus (“EBV”), human herpesvirus-6 (HHV-6) and JC virus (“JCV”) – in the given patient population.
This marks the third RMAT designation to have been been granted to posoleucel by the FDA.
Shares of AlloVir were up 15.5% following the announcement of the news on Wednesday. The ALVR stock has dipped 51.7% so far this year compared with the industry’s decline of 17.4%.
Image Source: Zacks Investment Research
The third RMAT designation for posoleucel was based on initial data from a phase II study that evaluated the potential of posoleucel in preventing life-threatening infections from the aforementioned six common viruses in patients following allo-HCT.
The FDA has already granted Regenerative Medicine Advanced Therapy designation to posoleucel for the treatment of hemorrhagic cystitis (“HC”) caused by BKV, and for the treatment of AdV infection in allo-HCT pateints.
Last month, AlloVir initiated a phase III study evaluating posoleucel for addressing life-threatening viral infections from six common viruses mentioned above in high-risk allo-HCT patients.
Posoleucel is AlloVir’s lead product candidate. The company is currently conducting three phase III studies on posoleucel for treating virus-associated HC, AdV infection and the prevention of infections and diseases caused by posoleucel’s six target viruses.
AlloVir currently has no approved product in its portfolio. Therefore, the successful development of posoleucel, along with other pipeline candidates, remains in key focus for the company.
Image: Shutterstock
AlloVir (ALVR) Up on Third RMAT Status From FDA for Posoleucel
AlloVir, Inc. (ALVR - Free Report) announced that the FDA has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation to its allogeneic, off-the-shelf, multi-virus-specific T-cell therapy, posoleucel, for the prevention of multiple life-threatening infections from six viruses in allogeneic hematopoietic cell transplant (allo-HCT) patients.
The RMAT designation is granted to speed up the development and review of regenerative therapies that target serious or life-threatening conditions
The latest RMAT tag has been granted to posoleucel for the prevention of clinically significant infections and disease from six devastating viruses — adenovirus (AdV), BK virus (“BKV”), cytomegalovirus (“CMV”), Epstein-Barr virus (“EBV”), human herpesvirus-6 (HHV-6) and JC virus (“JCV”) – in the given patient population.
This marks the third RMAT designation to have been been granted to posoleucel by the FDA.
Shares of AlloVir were up 15.5% following the announcement of the news on Wednesday. The ALVR stock has dipped 51.7% so far this year compared with the industry’s decline of 17.4%.
Image Source: Zacks Investment Research
The third RMAT designation for posoleucel was based on initial data from a phase II study that evaluated the potential of posoleucel in preventing life-threatening infections from the aforementioned six common viruses in patients following allo-HCT.
The FDA has already granted Regenerative Medicine Advanced Therapy designation to posoleucel for the treatment of hemorrhagic cystitis (“HC”) caused by BKV, and for the treatment of AdV infection in allo-HCT pateints.
Last month, AlloVir initiated a phase III study evaluating posoleucel for addressing life-threatening viral infections from six common viruses mentioned above in high-risk allo-HCT patients.
Posoleucel is AlloVir’s lead product candidate. The company is currently conducting three phase III studies on posoleucel for treating virus-associated HC, AdV infection and the prevention of infections and diseases caused by posoleucel’s six target viruses.
AlloVir currently has no approved product in its portfolio. Therefore, the successful development of posoleucel, along with other pipeline candidates, remains in key focus for the company.
Zacks Rank & Stocks to Consider
AlloVir currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Corbus Pharmaceuticals Holdings, Inc. (CRBP - Free Report) , Gemini Therapeutics, Inc. and Minerva Neurosciences, Inc. (NERV - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Corbus Pharmaceuticals’ loss per share estimates have narrowed 19.4% for 2022 and 16.2% for 2023 over the past 60 days.
Earnings of CRBP have surpassed the Zacks Consensus Estimate in three of the trailing four quarters and missed the same on the other occasion.
Gemini Therapeutics’ loss per share estimates have narrowed 69.1% for 2022 and 72.1% for 2023 over the past 60 days.
Earnings of GMTX have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Minerva Neurosciences’ loss per share estimates have narrowed 20.4% for 2022 and 19.7% for 2023 over the past 60 days.
Earnings of NERV have surpassed estimates in one of the trailing four quarters, met the same once and missed the same on the other two occasions.