Valneva SE VALN recently applied for a label extension to the FDA to potentially extend the use of its chikungunya vaccine, IXCHIQ. Currently approved for adults, the vaccine may soon be accessible to adolescents aged 12 to 17 years, following the label extension.
This submission is backed by positive adolescent Phase 3 data that demonstrated a 99.1% immune response rate and a favorable safety profile in adolescents. Expanding access to this age group addresses a critical gap, particularly as chikungunya continues to pose a growing threat globally.
Impact of the News on VALN Stock
Subsequent to the news, the share price of VALN dropped 0.9% to $3.96 yesterday.
Although the shares were southbound, the latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.
Valneva boasts a market capitalization of $321.8 million. The company is estimated to report 8.3% earnings growth in 2024.
Long-Term Durability of VALV's IXCHIQ
Valneva’s inclusion of two-year antibody persistence data in the FDA submission strengthens IXCHIQ’s value proposition. The data revealed that 97% of participants retained their immune response after 24 months, offering a compelling advantage in endemic regions where consistent healthcare access may be limited. This durability positions IXCHIQ as a practical, single-dose solution for long-term protection against chikungunya.
Recent Global Expansion of VALN
The FDA application complements recent label extension submissions to the EMA and Health Canada, highlighting Valneva’s strategic push to enhance IXCHIQ’s global reach. Additionally, the company is actively pursuing marketing authorization in Brazil and expanding collaborations with CEPI to improve vaccine access in low- and middle-income countries. These efforts align with Valneva’s mission to address unmet medical needs in infectious diseases.
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Addressing a Growing Public Health Threat
Chikungunya’s geographical spread, exacerbated by climate change, underscores the urgency of accessible vaccines. With over 3.7 million cases reported in the Americas alone over the past decade, the disease imposes significant medical and economic burdens. Valneva’s advancements with IXCHIQ reinforce its leadership in specialty vaccines, offering hope for mitigating this escalating global health challenge.
By expanding IXCHIQ’s reach and demonstrating its long-term efficacy, Valneva solidifies its position as a key player in combating emerging infectious diseases.
Share Price Performance of VALN
Over the past three years, shares of VALN have plummeted 46% against the industry’s 3% growth.
Zacks Rank of Valneva and Key Picks
Valneva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Penumbra PEN, Haemonetics HAE and Globus Medical GMED, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Penumbra’s shares have risen 7.8% in the past year. Estimates for the company’s 2024 earnings per share have jumped 8.1% to $2.79 in the past 30 days. PEN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, the average surprise being 10.54%. In the last reported quarter, it posted an earnings surprise of 23.19%.
Estimates for Haemonetics’ fiscal 2025 earnings per share have jumped 0.4% to $4.59 in the past 30 days. Shares of the company have rallied 8.9% in the past year compared with the industry’s growth of 21.2%. HAE’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.82%. In the last reported quarter, it delivered an earnings surprise of 2.75%.
Estimates for Globus Medical’s 2024 earnings per share have increased 3.9% to $2.95 in the past 30 days. Shares of the company have surged 90.3% in the past year compared with the industry’s 15.1% rise. GMED’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 17.65%. In the last reported quarter, it delivered an earnings surprise of 27.69%.
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