With a midstage peek at the data on Veradermics’ oral formulation of the molecule behind the ubiquitous hair regrowth treatment Rogaine, analysts are feeling increasingly confident that the New Haven, Connecticut-based company is a cut above the rest when it comes to the opportunity in the under-tapped market for female pattern hair loss.
The late clinical-stage biotech on Wednesday unveiled topline results from an open-label, phase 2 study of its lead asset VDPHL01—an extended-release oral formulation of minoxidil, first approved as the topical treatment Rogaine in 1988—in women with mild-to-moderate pattern hair loss.
Encouraged by the positive results, Veradermics suggested in a July 15 release that its drug, should it pass muster with the FDA, holds the potential to become the first oral treatment for female pattern hair loss with a formal U.S. approval.
Digging into the readout, female participants in the study who received a 4.5-mg dose of Veradermics’ candidate either once or twice a day for half a year saw what the company defined as a “potentially differentiated clinical profile” marked by swift onset of activity, consist patient responses, hair count increases and overall tolerability.”
More specifically, VDPHL01 at the once- and twice-a-day dosing was able to help patients hit an average vellus hair count of 22.7 hairs/cm² and 23.3 hairs/ cm², respectively, and 88.9% and 90% of participants tied the drug to “improved” or “much improved” hair coverage on a patient reported outcomes rating scale at the trial’s six-month mark.
Study investigators also noted that a little more than 67% of patients demonstrated hair growth improvements at just two months into the trial.
In a Wednesday note to clients, analysts at Jefferies opined that the hair count numbers in both treatment arms exceeded their expectations, branding the efficacy “best in class” for female pattern hair loss.
Investors responded well to the midstage readout, too, helping carry Veradermics’ stock price up by more than 14% as of late Wednesday morning.
Meanwhile, analysts at Citi wrote to clients that the results “strengthen our view that VDPHL01 could address a sizable, underserved female pattern hair loss market where topical adherence is poor, oral minoxidil is widely favored in practice, and no FDA-approved oral option exists.”
The Citi team noted that because Veradermics’ study was small and open label, “randomized validation remains necessary.” Nevertheless, the efficacy, patient-reported benefit and efficacy seen helped raise the team’s confidence ahead of a phase 2/3 readout in the same female population slated for the first half of 2027.
The phase 2 Study ‘207’ recruited 28 participants. Veradermics noted in its release Wednesday that it’s now in the active recruitment phase for the phase 2/3 trial, coded Study ‘306’.
The Citi team dubbed that readout the ‘key validation event’ for Veradermics moving forward, noting that, should the drug succeed, it could meaningfully set itself apart from off-label use of immediate-release oral minoxidil.
Many patients are unsatisfied with topical Rogaine, Veradermics has argued previously, and off-label use of oral minoxidil must often be weighed alongside potential cardiac concerns, analysts pointed out this week.
In a validation of its efforts, Veradermics in February raised a total of $256.4 million for its public debut onto the New York Stock Exchange, adopting the symbol “MANE.” Prior to that milestone, Veradermics solidified a $150 million series C funding round in October.
The company is developing VDPHL01 in both female and male pattern hair loss.
Back in April, the company released positive phase 2/3 results on its asset in men.