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BiomX Hits FDA Roadblock Over Nebulizer Device as Cystic Fibrosis Trial Remains on Hold

MarketDash Editorial Team
11 days ago
BiomX is working through FDA questions about a third-party nebulizer device while an independent safety panel gives the green light to continue its BX004 cystic fibrosis trial with adjusted dosing.

BiomX Inc. (PHGE) announced Tuesday that it's still waiting for the FDA to clear its Phase 2b trial of BX004 for cystic fibrosis patients to resume enrolling participants in the United States. The holdup? The agency is continuing its evaluation of the nebulizer device used to actually deliver the drug.

Here's what makes this situation somewhat unusual: the FDA isn't concerned about the drug itself. No safety or efficacy questions have been raised about BX004, the actual therapeutic candidate. Instead, the clinical hold centers entirely on the third-party nebulizer device that administers the treatment. BiomX is working with the device manufacturer to respond to recent FDA follow-up information requests, hoping to get the hold lifted so U.S. enrollment can restart.

The Device Question That's Stalling Progress

The FDA recently sent BiomX additional follow-up questions about the nebulizer device. The company says it's working closely with the device manufacturer to pull together the information the agency wants, and management considers the outstanding items "readily addressable." That's corporate speak for "we think we can handle this," though the timeline remains unclear.

Meanwhile, enrollment and dosing continue outside the United States according to the trial protocol, which means the study isn't completely frozen. But the U.S. portion remains on hold until BiomX satisfies the FDA's device-related questions.

Good News from the Safety Panel

In what counts as encouraging news amid the regulatory delay, an independent Data Monitoring Committee recently completed a safety review of the BX004 Phase 2b trial. The DMC looked at participants who experienced adverse events, and their verdict was essentially thumbs up: they recommended the study continue, albeit with an adjusted dosing regimen.

Following the DMC's recommendations, BiomX is updating the trial protocol. Chief Executive Officer Jonathan Solomon said the company is "encouraged by the DMC's conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented."

Timeline Pushed and Cash Running Low

With the protocol adjustments and regulatory delays, BiomX now expects topline results in the second quarter of 2026. That timeline comes with a significant caveat: "pending availability of financial resources and other factors." Translation: the company needs to figure out how to fund this.

Here's why that matters. As of September 30, 2025, BiomX reported cash and restricted cash of $8.1 million. The company estimates that stash will fund operations into the first quarter of 2026. If topline results aren't expected until Q2 2026, you don't need an MBA to spot the gap. BiomX will need additional financing to complete the trial.

The company recently announced a 1-for-19 reverse stock split, often a signal that a company is trying to maintain exchange listing requirements as its share price slides.

Stock Trading Near 52-Week Lows

BiomX (PHGE) shares were down 7.18% at $5.36 on Wednesday, trading near the stock's 52-week low of $4.65. Investors appear to be pricing in the regulatory uncertainty, cash concerns, and extended timeline for trial results.

The path forward requires BiomX to satisfy the FDA's device questions, implement the adjusted dosing protocol, and secure enough funding to reach the finish line. That's a lot of moving pieces for a company with limited cash and a stock price hovering near yearly lows.

Back to News

BiomX Hits FDA Roadblock Over Nebulizer Device as Cystic Fibrosis Trial Remains on Hold

MarketDash Editorial Team
11 days ago
BiomX is working through FDA questions about a third-party nebulizer device while an independent safety panel gives the green light to continue its BX004 cystic fibrosis trial with adjusted dosing.

BiomX Inc. (PHGE) announced Tuesday that it's still waiting for the FDA to clear its Phase 2b trial of BX004 for cystic fibrosis patients to resume enrolling participants in the United States. The holdup? The agency is continuing its evaluation of the nebulizer device used to actually deliver the drug.

Here's what makes this situation somewhat unusual: the FDA isn't concerned about the drug itself. No safety or efficacy questions have been raised about BX004, the actual therapeutic candidate. Instead, the clinical hold centers entirely on the third-party nebulizer device that administers the treatment. BiomX is working with the device manufacturer to respond to recent FDA follow-up information requests, hoping to get the hold lifted so U.S. enrollment can restart.

The Device Question That's Stalling Progress

The FDA recently sent BiomX additional follow-up questions about the nebulizer device. The company says it's working closely with the device manufacturer to pull together the information the agency wants, and management considers the outstanding items "readily addressable." That's corporate speak for "we think we can handle this," though the timeline remains unclear.

Meanwhile, enrollment and dosing continue outside the United States according to the trial protocol, which means the study isn't completely frozen. But the U.S. portion remains on hold until BiomX satisfies the FDA's device-related questions.

Good News from the Safety Panel

In what counts as encouraging news amid the regulatory delay, an independent Data Monitoring Committee recently completed a safety review of the BX004 Phase 2b trial. The DMC looked at participants who experienced adverse events, and their verdict was essentially thumbs up: they recommended the study continue, albeit with an adjusted dosing regimen.

Following the DMC's recommendations, BiomX is updating the trial protocol. Chief Executive Officer Jonathan Solomon said the company is "encouraged by the DMC's conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented."

Timeline Pushed and Cash Running Low

With the protocol adjustments and regulatory delays, BiomX now expects topline results in the second quarter of 2026. That timeline comes with a significant caveat: "pending availability of financial resources and other factors." Translation: the company needs to figure out how to fund this.

Here's why that matters. As of September 30, 2025, BiomX reported cash and restricted cash of $8.1 million. The company estimates that stash will fund operations into the first quarter of 2026. If topline results aren't expected until Q2 2026, you don't need an MBA to spot the gap. BiomX will need additional financing to complete the trial.

The company recently announced a 1-for-19 reverse stock split, often a signal that a company is trying to maintain exchange listing requirements as its share price slides.

Stock Trading Near 52-Week Lows

BiomX (PHGE) shares were down 7.18% at $5.36 on Wednesday, trading near the stock's 52-week low of $4.65. Investors appear to be pricing in the regulatory uncertainty, cash concerns, and extended timeline for trial results.

The path forward requires BiomX to satisfy the FDA's device questions, implement the adjusted dosing protocol, and secure enough funding to reach the finish line. That's a lot of moving pieces for a company with limited cash and a stock price hovering near yearly lows.