On Wednesday, AEON Biopharma, Inc. (NYSE: AEON) stock received continued support from H.C. Wainwright, with the investment firm maintaining a Buy rating and a $6.00 price target.
AEON Biopharma recently revealed its strategy to conduct a Phase 3 study in cervical dystonia, aiming to achieve label extrapolation for all of Botox's approved uses by following a 351k biosimilar pathway.
The company's decision to pursue the biosimilar pathway could open the door to the entire Botox market with just one Phase 3 study. This move is based on the FDA's growing tendency to approve fully extrapolated labels for biosimilars, even when questions arise regarding the mechanism of action.
AEON Biopharma has taken proactive steps by setting up an initial biosimilar advisory meeting with the FDA, slated for early third quarter of 2024. The purpose of this in-person meeting is informational, yet AEON has already submitted a substantial analytical data set with its meeting request.
The company anticipates a series of discussions with the FDA to ensure that its program development plan is in alignment with regulatory expectations. The analyst from H.C. Wainwright reiterated the firm's positive stance, citing the strategic pathway AEON is taking to potentially access a broader market with its biosimilar product.
In other recent news, AEON Biopharma, Inc. has made significant strategic shifts in its operations. The company has refocused on a biosimilar regulatory pathway for its lead drug candidate, ABP-450, following discussions with the U.S. Food and Drug Administration.
This move involves conducting a pivotal clinical study on ABP-450 for the treatment of cervical dystonia, using AbbVie Inc (NYSE:ABBV).’s BOTOX as the reference product. AEON aims to demonstrate that ABP-450 is highly similar to BOTOX in terms of safety, purity, and potency.
Further, AEON Biopharma has undergone a significant restructuring involving cost reductions and layoffs to extend its financial runway into Q4 2024. This includes changes in key leadership roles, with CEO Marc Forth taking over as principal financial officer. The strategic reorganization follows the discontinuation of the Phase 2 study of ABP-450.
Additionally, H.C. Wainwright has adjusted its outlook on AEON Biopharma, reducing the price target from $18.00 to $6.00 while maintaining a Buy rating. Despite setbacks, H.C. Wainwright remains confident in the potential of ABP-450 and awaits further updates on the company's business plans. These developments are part of the recent news surrounding AEON Biopharma.
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