Biotech Stocks Surge After Hours: Cassava, Helius, Werewolf, Aytu, Equillium Lead Late-Day Moves

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(RTTNews) - Several biotech names posted strong gains in Monday's after-hours session, driven by clinical updates, strategic shifts, and upcoming catalysts. Volume spikes and late-day news helped push prices higher, setting the stage for potential follow-through in regular trading.

Shares of Cassava Sciences (SAVA) surged in after-hours trading on Monday, climbing 37.1% to $3.18 following a regular session close of $2.32, which itself marked a 1.75% gain. The sharp move came on unusually high volume, with more than 11 million shares exchanging hands, well above the average daily volume of just over 1 million.

The rally appears to be driven by renewed interest in Cassava's pipeline, particularly its investigational drug simufilam. While the company previously ended its Alzheimer's program after disappointing Phase III results earlier this year, recent updates have shifted focus toward simufilam's potential in treating TSC-related epilepsy. Cassava recently reported positive preclinical data supporting this new direction, and leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, signal a strategic pivot in clinical priorities.

Looking ahead, any updates on the simufilam program or progress in its diagnostic candidate, SavaDx, could serve as a near-term catalyst. The company's participation in recent biotech conferences also suggests ongoing efforts to reframe its narrative around emerging therapeutic applications.

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Helius Medical Technologies (HSDT) rose 15.67% in after-hours trading on Monday, reaching $18.53 after closing the regular session at $16.02, where it had already dropped 33.61%. The rebound in extended hours came on the heels of heavy volume and renewed attention to the company's recent strategic developments.

The sharp intraday decline followed a volatile stretch for Helius, which has seen its stock swing dramatically in recent weeks. The company recently announced a $500 million private placement backed by Pantera Capital and Summer Capital to launch a Solana-focused treasury vehicle. This move marks a significant pivot from its core neurotech business, drawing attention from both digital asset and healthcare sectors.

Despite the crypto-linked headlines, Helius continues to advance its medical device pipeline. The Portable Neuromodulation Stimulator (PoNS) recently completed a stroke registrational program with positive results, and the company is preparing a submission to the FDA under the Breakthrough Device designation.

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Werewolf Therapeutics (HOWL) extended its gains in after-hours trading on Monday, rising 9.78% to $2.02 after closing the regular session at $1.84, up 23.49%. The move came on volume exceeding 2 million shares, significantly above the company's average daily volume, suggesting heightened interest around recent developments.

Werewolf is advancing multiple conditionally activated cytokine therapies through its proprietary INDUKINE platform. The company's lead candidate, WTX-124, is currently in a Phase 1/1b trial targeting advanced solid tumors, including cutaneous melanoma. Interim data from this study is expected in Q4 2025, which could serve as a key inflection point for the stock.

Recent headlines include Werewolf's participation in the H.C. Wainwright 27th Annual Global Investment Conference, where management reiterated timelines for clinical readouts and outlined progress across its pipeline. The company also reported Q2 results last month, noting a net loss of $17.98 million and confirming that its cash position remains sufficient to support operations into 2026.

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Aytu BioPharma Inc. (AYTU) rose 7.63% in after-hours trading on Monday, reaching $2.68 after closing the regular session at $2.49, up 2.05%. The move came on volume nearly double the daily average, suggesting renewed attention ahead of a key company update.

The price action follows Aytu's announcement that it will report full-year and Q4 fiscal 2025 results on September 23, 2025. This upcoming earnings release is expected to provide clarity on the company's commercial performance and progress with EXXUA, its extended-release antidepressant recently acquired through an exclusive agreement with Fabre-Kramer Pharmaceuticals.

In addition to EXXUA, Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics, including Adzenys XR-ODT and Cotempla XR-ODT. The company has also recently extended its loan agreement with Eclipse, thereby boosting liquidity to support its commercialization efforts.

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Equillium Inc. (EQ) rose 10.34% in after-hours trading on Monday, reaching $1.60 after closing the regular session at $1.45, down 0.68%. The rebound came on moderate volume, following a stretch of heightened volatility and sporadic price spikes over the past month.

The company has been active across multiple fronts. Equillium recently announced up to $50 million in financing to advance EQ504, its novel aryl hydrocarbon receptor modulator, into clinical development. EQ504 has been highlighted in several poster presentations at immunology conferences, and the company has received feedback from the FDA regarding its regulatory pathway. Meanwhile, its lead candidate, itolizumab (EQ001), remains in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis.