Stock Track | Beta Bionics (BBNX) Soars 14.87% Pre-Market on Strong Q3 Earnings, Raised Guidance, and FDA Clearance

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Shares of Beta Bionics Inc. (NASDAQ: BBNX) surged 14.87% in pre-market trading on Wednesday, following the company's impressive third-quarter 2025 financial results, raised full-year guidance, and a recent FDA clearance for its iLet Bionic Pancreas System.

The medical device company, specializing in diabetes management technology, reported a narrower-than-expected loss of $0.33 per share for Q3, significantly beating the analyst consensus estimate of a $0.44 loss. This marks a substantial improvement from the $1.46 loss per share reported in the same quarter last year. Revenue for the quarter came in at $27.3 million, surpassing analyst projections of $23.97 million and representing a robust 63.14% increase from $16.7 million in the prior-year period.

Beta Bionics' strong performance was driven by impressive growth across its sales channels. The company's Durable Medical Equipment (DME) channel net sales reached $21.0 million, up from $14.5 million in Q3 2024, while the Pharmacy Benefit Plan (PBP) channel saw substantial growth, with net sales climbing to $6.2 million from $2.2 million in the same period last year.

In light of these results, Beta Bionics raised its full-year 2025 revenue guidance to over $96.5 million, up from the previous range of $88 million to $93 million. The company also increased its estimated gross margin forecast for the year to 54-55%, up from the prior range of 52-55%. This upward revision in guidance has further fueled investor optimism.

Adding to the positive momentum, Beta Bionics announced that it received Special 510(k) clearance from the FDA on September 29, 2025, for updates to its iLet device. This regulatory milestone is expected to strengthen the company's market position in the competitive diabetes management space.

Analysts have responded positively to Beta Bionics' strong performance and future outlook. Leerink Partners raised its target price for BBNX from $28 to $33, reflecting increased confidence in the company's growth prospects.

The combination of strong financial performance, raised guidance, product advancements, and positive analyst sentiment appears to be driving the significant pre-market stock price surge for Beta Bionics.

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