HilleVax (HLVX) Tanks as Norovirus Vaccine Study in Infants Fails

HilleVax, Inc. HLVX announced that its phase IIb NEST-IN1 study, evaluating its investigational virus-like particle-based vaccine candidate, HIL-214, in infants for the prevention of acute gastroenteritis (AGE) caused by norovirus infection, failed to meet its primary or secondary efficacy endpoints.

The double-blind, placebo-controlled study evaluated the efficacy, safety and immunogenicity of HIL-214 in infants around five months old.

Per the company, the NEST-IN1 study had 51 primary endpoint events, with 25 in the vaccine arm and 26 in the placebo arm. Data from the study showed that HIL-214 had a vaccine efficacy of only 5% against moderate or severe norovirus-related AGE.

The NEST-IN1 study failed to meet its primary efficacy endpoint against moderate or severe AGE events related to GI.1 or GII.4 norovirus genotypes. Also, vaccination with HIL-214 failed to demonstrate a clinical benefit across the study’s secondary endpoints.

Following the disappointing results, HilleVax decided that it would stop further development of HIL-214 in infants.

Shares of the company were down 88.3% on Jul 8 following the announcement of the news. The stock has plunged 89.8% so far this year compared with the industry’s decrease of 7.9%.

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Previously, HIL-214 demonstrated a clinical benefit for the prevention of AGE caused by norovirus infection in adults.

Notably, the phase IIb NOR-211 study, which evaluated HIL-214 in adults, showed statistically significant vaccine efficacy against moderate or severe AGE due to norovirus. The study in infants was conducted following the success of the study in adults.

HLVX will continue to study HIL-214 and another phase I-ready vaccine candidate, HIL-216, in adults.

In the absence of a marketed product, the successful development of HIL-214 and other vaccine candidates remains the key focus for HilleVax. Any further setbacks related to its pipeline development will significantly hinder the company’s growth prospects.

Zacks Rank & Stocks to Consider

HilleVax currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. ACRV, Anavex Life Sciences Corp. AVXL and RAPT Therapeutics, Inc. RAPT, 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.

In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 43.9%.

ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.

In the past 60 days, estimates for Anavex Life Sciences’ 2024 loss per share have narrowed from 57 cents to 55 cents, while loss per share estimates for 2025 have narrowed from 87 cents to 80 cents. Year to date, AVXL shares have declined 51.6%.

Anavex Life Sciences’ earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 17.33%.

In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, RAPT shares have declined 88.2%.

RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.

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