Biotech Stock Roundup: NVAX Q3 Results, SNDX Down on AML Data, RNA Surges on Study Data

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As the third-quarter earnings season ends this week, the focus in the biotech sector is mostly on pipeline and key regulatory updates. Novavax NVAX was in focus this week as investors were disappointed with the lowered guidance.

Recap of the Week’s Most Important Stories:

Novavax’s Q3 Results

Novavax incurred a third-quarter 2024 loss of 76 cents per share, narrower than the Zacks Consensus Estimate of a loss of 87 cents. In the year-ago quarter, the company reported a loss of $1.26 per share.

Revenues in the quarter amounted to $85 million, which beat the Zacks Consensus Estimate of $57 million. However, the top line declined 55% on a year-over-year basis.

Novavax expects 2024 total revenues to be in the range of $650-$700 million, down from its previously issued guidance of $700-$800 million due to lower COVID-19 vaccine uptake in ex-U.S. markets.

Novavax also announced that the FDA has lifted the clinical hold on its two pipeline programs, COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The agency had initially placed this hold after a study participant who took the CIC shot as part of a phase II study reported nerve damage. With this hold removed, management is working with study investigators and other partners to start the phase III immunogenicity study on both vaccines as quickly as possible.

Novavax currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Syndax Announces Data From AML Study

Syndax Pharmaceuticals SNDX announced positive top-line results for revumenib, an oral small-molecule menin inhibitor, from the AUGMENT-101 study. The results were announced from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the phase II portion of the AUGMENT-101 study of revumenib.

The primary endpoint was met with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23%. The overall response rate was 47% in a heavily pre-treated population, including 75% with prior venetoclax exposure in the efficacy population. 17% of patients who achieved an overall response underwent hematopoietic stem cell transplant following treatment with revumenib, with three resuming revumenib therapy post-transplant. The candidate showed a favorable safety and tolerability profile, as only 5% of patients discontinued due to treatment-related adverse events.

The new drug application (NDA) for revumenib, an oral menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia was granted Priority Review and is being reviewed under the FDA’s Real-Time Oncology Review Program with a target action date of Dec. 26, 2024.

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