H.C. Wainwright Reiterates Neutral Rating on Lipocine Inc (LPCN)

H.C. Wainwright analyst Yi Chen reiterated a Neutral rating and $4.00 price target on Lipocine Inc (NASDAQ: LPCN).

The analyst commented: "Last week, Lipocine announced the initiation of the Phase 3 BLOOM trial of LPCN1154 for the treatment of severe postpartum depression (PPD). Management expects to dose the first participant in early 4Q26. As a reminder, LPCN 1154 is an oral brexanolone being developed as a 48-hour at-home treatment for rapid symptom relief. Though the prior Phase 3 trial did not meet its primary endpoint in the full analysis set, exploratory post hoc analyses identified anomalies concentrated at one clinical site. Excluding the site, analyses suggested rapid and sustained improvement in depressive symptoms. Of note, the prior trial did show favorable safety and tolerability results. No treatment-related severe or serious adverse events were reported, and there were no instances of excessive sedation, loss of consciousness or treatment discontinuation. The company designed BLOOM to complement existing clinical data package and support a potential New Drug Application (NDA) under the 505(b)(2) pathway. Notably, BLOOM incorporates the following design and operational measures: (1) Consistent treatment regimen and endpoint, with primary efficacy endpoint being the change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score assessed at 60 hours post dosing initiation; (2) Site quality controls, with no selection of sites with significant operational or data quality concerns and participation by academic sites; (3) Measures intended to reduce placebo response; and (4) Prespecified sensitivity analyses. We believe that BLOOM could complete enrollment of 120 participants in mid-2027 and report topline data in 2H27. In the wake of this update, we reiterate our Neutral rating while setting a 12-month price target of $4 per share."

For an analyst ratings summary and ratings history on Lipocine Inc click here. For more ratings news on Lipocine Inc click here.

Shares of Lipocine Inc closed at $2.24 yesterday.

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