Raymond James has reiterated a Strong Buy rating on Palvella Therapeutics (NASDAQ: PVLA) and kept a $193.00 price objective, underscoring continued optimism among sell-side analysts about the company ahead of pivotal clinical readouts.
The firm noted that Palvella has raised the internal bar for what it considers a decisive win in its Phase 3 microcystic lymphatic malformation - MLM - program. The threshold was set at a mean mLM-IGA score of at least +1.0, up from a previous benchmark of at least +0.5. Palvella’s stated upside case is at least +1.5.
Raymond James described the new internal threshold as surprising to many investors because it is materially lower than the +2.4 mean CGI-C result observed in the company’s Phase 2 program. Despite that gap, the firm said the revised bar should be adequate to support regulatory approval and clinician uptake provided that secondary endpoints, imaging data and patient interviews demonstrate similarly favorable trends.
The longer duration of the Phase 3 study and the expectation of a data-rich topline readout create opportunities, Raymond James added, for the company to persuade investors that QTORIN rapamycin delivers meaningful treatment benefit at the topline.
The firm outlined its rationale in detail, walking through Palvella’s reasoning for setting the higher bar in the MLM program, institutional investor expectations for the SELVA topline readout, and what stakeholders should expect from the dataset that is anticipated in March.
Market metrics underscore why the upcoming readouts matter to investors. The shares have risen 346% over the past 12 months, trading most recently at $85.66 and carrying a market capitalization of $1.01 billion.
Other brokerages and analysis have also signaled bullish views. Clear Street reiterated a Buy rating and maintained a $200.00 price target following an update on Palvella’s Phase 3 SELVA trial, which is focused on microcystic lymphatic malformation. TD Cowen raised its price target to $190.00 after citing a successful Breakthrough Therapy Designation meeting with the FDA for QTORIN rapamycin; TD Cowen continues to carry a Buy rating and had previously held a $133.00 target. TD Cowen also expressed optimism about the Phase 3 trial results expected in early 2026.
Separately, a systematic review published in Clinical and Experimental Dermatology was cited as supportive of the potential for QTORIN pitavastatin in porokeratosis, a genetic skin disorder with no current FDA-approved therapies. The pitavastatin program is expected to enter Phase 2 development for disseminated superficial actinic porokeratosis in the second half of 2026.
One market analysis noted that, on a relative basis, the stock appears overvalued versus its Fair Value. That analysis pointed investors toward additional proprietary analytics and financial-health metrics that can be consulted to more fully assess the risk-reward profile ahead of the critical readouts.
Context for investors
Analyst commentary centers on two main threads: whether Palvella’s raised efficacy threshold still supports approval and subsequent physician utilization, and whether the Phase 3 SELVA topline will deliver the data investors need to validate the company’s clinical case. The timing and richness of the forthcoming readouts are key inputs for both valuation and clinical confidence.
Given the recent broker updates and the stock’s substantial run-up over the last year, market participants will be watching the March topline and the early-2026 expectations closely.