H.C. Wainwright has raised its price objective for BrainsWay (NASDAQ: BWAY) to $30.00 from $24.00, retaining a Buy rating on the shares. The new target equates to roughly a 30% upside from the stock’s then-current trading price of $23.04, with the shares already trading close to a 52-week high of $24.84.
The analyst move follows confirmation that Neurolief’s ProlivRx system received Premarket Approval (PMA) from the U.S. Food and Drug Administration for use as an adjunctive therapy in adult patients with major depressive disorder (MDD) who did not achieve satisfactory improvement after at least one prior antidepressant medication. The FDA approved the device as a Class III product for both at-home and in-clinic use, a detail H.C. Wainwright highlights in its rationale.
H.C. Wainwright noted that the ProlivRx approval makes the system the first and only at-home neuromodulation treatment with FDA labeling for patients with treatment-refractory MDD, a distinction the firm cites in support of its valuation change. The approval represents the second Neurolief product authorized in the U.S.; the Relivion MG device is already FDA-cleared and CE-marked for migraine treatment.
On the valuation side, the firm’s increase in its target price is driven in part by a modest expansion of its forward earnings multiple to 7.3x from approximately 7x. In addition, the updated target incorporates $100 million in total intrinsic value tied to BrainsWay’s strategic investment in Neurolief.
H.C. Wainwright’s note also highlights recent financial and operational data for BrainsWay. Over the last 12 months the stock produced a price return of 115.53% and the company reported revenue growth of 27.08%. InvestingPro data cited by the analyst shows BrainsWay holding more cash than debt on its balance sheet and carrying a current ratio of 3.19. At the same time, the shares trade at a high price-to-earnings multiple of 93.44. InvestingPro Tips indicate analysts expect net income growth this year and the service lists more than 15 additional insights on the company’s financial profile and outlook.
Separately, the company announced a series of regulatory and payer developments that expand its treatment offerings and coverage. The FDA granted a label expansion for BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) system to include adolescents aged 15 to 21, broadening the device’s approved age range. Insurer activity has followed: Optum Behavioral Health extended coverage for BrainsWay’s Deep TMS therapy to adolescents, and Highmark Blue Cross Blue Shield plans to expand coverage to include BrainsWay’s accelerated Deep TMS protocol for both adolescents and adults, with that policy expected to take effect in February 2026.
H.C. Wainwright previously raised its price target for BrainsWay to $24 while maintaining a Buy rating after the company’s Analyst and Investor Day, a milestone the firm references alongside the more recent adjustments tied to Neurolief’s regulatory progress and BrainsWay’s balance-sheet metrics.
Context and implications
The combination of a distinct regulatory milestone for an at-home neuromodulation device and insurer coverage moves for Deep TMS expands BrainsWay’s addressable market in the treatment of depression. H.C. Wainwright’s valuation change is conservative in scale - a small multiple uptick plus explicit recognition of the Neurolief stake - signaling the firm is incorporating discrete asset-level value rather than applying a broader re-rating.
Investors will likely weigh the demonstrated top-line growth and strong stock performance over the past year alongside the company’s elevated P/E, the latter reflecting market expectations for continued earnings improvement. The balance-sheet strength noted by InvestingPro - more cash than debt and a current ratio of 3.19 - is supportive of ongoing commercial and regulatory initiatives but does not eliminate execution risk.
Summary of recent developments
- H.C. Wainwright raised its price target on BrainsWay to $30.00 from $24.00 and maintained a Buy rating.
- Neurolief’s ProlivRx system received FDA PMA for adjunctive treatment of adult MDD patients who failed at least one antidepressant; approval covers at-home and in-clinic use.
- FDA expanded the label for BrainsWay’s Deep TMS to include adolescents aged 15 to 21; major payers have expanded coverage for adolescent and accelerated protocols, with Highmark’s policy set to take effect in February 2026.