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Valneva (VALN) Up on Antibody Persistence Data on Chikungunya Jab
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Valneva SE (VALN - Free Report) announced positive 12-month antibody persistence data following vaccination with a single dose of its chikungunya vaccine candidate, VLA1553.
The antibody persistence study enrolled 363 healthy adult participants and followed them from month six to month 12 after vaccination. Data from the same showed that 99% of participants retained neutralizing antibody titers above the seroresponse threshold following a single dose of the chikungunya vaccine after 12 months – the primary endpoint.
Shares of Valneva were up 5.4% on Monday following the announcement of the news. The stock, however, has plunged 73.2% so far this year compared with the industry’s decline of 43.5%.
Image Source: Zacks Investment Research
VALN announced positive immunogenicity and safety data from the phase III study, VLA1553-301 in March 2022.
Per the company, after this positive data, management decided to set up an antibody persistence study – VLA1553-303 – to monitor a subset of participants and check the long-term durability of the antibody response following a single dose of the chikungunya vaccine.
In August 2022, Valneva started a rolling biologics license application (BLA) submission with the FDA, seeking approval for its single-shot chikungunya vaccine, VLA1553, in adults. The company remains on track to complete rolling submission for the BLA by 2022-end.
If approved, VLA1553 will also be the first vaccine for chikungunya and Valneva will be eligible for a priority review voucher. VLA1553 was granted Breakthrough Designation therapy and Fast Track designations by the FDA.
Apart from VLA1553, Valneva is also developing a vaccine for Lyme disease VLA15.
Last week, the company reported six-month antibody persistence data after completing a three-dose or a two-dose vaccination schedule of VLA15, in adults and children aged five through 65 years. Shares of VALN jumped on this news.
Data from the phase II VLA15-221 study showed that the antibody levels generated by VLA15 in both vaccination schedules remained above baseline.
Please note that Valneva is developing VLA15 in collaboration with drug giant, Pfizer (PFE - Free Report) .
The company entered into a collaboration with Pfizer in 2020 to co-develop VLA15 for Lyme disease.
Following the initiation of the phase III study for VLA15 in Lyme disease this year, PFE made a $25 million payment to Valneva as a milestone payment.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Aeglea BioTherapeutics have narrowed 7.3% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. AGLE witnessed an earnings surprise of 3.60% on average.
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Valneva (VALN) Up on Antibody Persistence Data on Chikungunya Jab
Valneva SE (VALN - Free Report) announced positive 12-month antibody persistence data following vaccination with a single dose of its chikungunya vaccine candidate, VLA1553.
The antibody persistence study enrolled 363 healthy adult participants and followed them from month six to month 12 after vaccination. Data from the same showed that 99% of participants retained neutralizing antibody titers above the seroresponse threshold following a single dose of the chikungunya vaccine after 12 months – the primary endpoint.
Shares of Valneva were up 5.4% on Monday following the announcement of the news. The stock, however, has plunged 73.2% so far this year compared with the industry’s decline of 43.5%.
Image Source: Zacks Investment Research
VALN announced positive immunogenicity and safety data from the phase III study, VLA1553-301 in March 2022.
Per the company, after this positive data, management decided to set up an antibody persistence study – VLA1553-303 – to monitor a subset of participants and check the long-term durability of the antibody response following a single dose of the chikungunya vaccine.
In August 2022, Valneva started a rolling biologics license application (BLA) submission with the FDA, seeking approval for its single-shot chikungunya vaccine, VLA1553, in adults. The company remains on track to complete rolling submission for the BLA by 2022-end.
If approved, VLA1553 will also be the first vaccine for chikungunya and Valneva will be eligible for a priority review voucher. VLA1553 was granted Breakthrough Designation therapy and Fast Track designations by the FDA.
Apart from VLA1553, Valneva is also developing a vaccine for Lyme disease VLA15.
Last week, the company reported six-month antibody persistence data after completing a three-dose or a two-dose vaccination schedule of VLA15, in adults and children aged five through 65 years. Shares of VALN jumped on this news.
Data from the phase II VLA15-221 study showed that the antibody levels generated by VLA15 in both vaccination schedules remained above baseline.
Please note that Valneva is developing VLA15 in collaboration with drug giant, Pfizer (PFE - Free Report) .
The company entered into a collaboration with Pfizer in 2020 to co-develop VLA15 for Lyme disease.
Following the initiation of the phase III study for VLA15 in Lyme disease this year, PFE made a $25 million payment to Valneva as a milestone payment.
Zacks Rank & Stocks to Consider
Valneva currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited (ASLN - Free Report) and Aeglea BioTherapeutics, Inc. , both carrying a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Aeglea BioTherapeutics have narrowed 7.3% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. AGLE witnessed an earnings surprise of 3.60% on average.