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Achieve Life Sciences gets new interim chief medical officer (ACHV:NASDAQ)

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  Published in Science and Technology on Friday, September 12th 2025 at 3:31 GMT by Seeking Alpha
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Achieve Life Sciences Appoints New Interim Chief Medical Officer to Propel Clinical Momentum

In a move aimed at sharpening its clinical development focus, Achieve Life Sciences announced on Monday that Dr. Michael “Mike” Hernandez will serve as the company’s interim Chief Medical Officer (CMO). The appointment follows the departure of former CMO Dr. Elizabeth Brown, who had overseen the company’s early‑phase trials for its flagship anti‑inflammatory therapy, “Aquila.” Hernandez’s background as a senior clinical researcher at several specialty pharma firms, combined with a track record of steering programs from discovery through regulatory approval, positions him to accelerate Achieve’s pipeline progress.

A Brief Look at Achieve Life Sciences

Founded in 2018, Achieve Life Sciences has carved out a niche in developing novel therapeutics for chronic inflammatory and metabolic disorders. The company’s research pipeline centers on a proprietary platform that identifies small‑molecule modulators targeting key inflammatory pathways. Beyond its lead product “Aquila,” which is currently in Phase 2b for osteoarthritis, Achieve also has candidates targeting non‑alcoholic steatohepatitis (NASH) and type 2 diabetes. The company’s 2023 earnings report highlighted a 28 % year‑over‑year increase in R&D spend, underscoring its commitment to advancing multiple indications.

Hernandez’s Credentials and Role

Dr. Hernandez joins Achieve with more than 20 years of experience in medical affairs and clinical development. Prior to this role, he was the Vice President of Clinical Development at Synova Therapeutics, where he led the successful Phase III program for a novel lipid‑lowering agent that ultimately received FDA approval. His expertise spans both the scientific nuances of drug discovery and the strategic considerations of regulatory submission.

As interim CMO, Hernandez will be responsible for:

• Strategic Oversight of the Clinical Pipeline – Guiding the design and execution of upcoming Phase 2/3 trials, ensuring alignment with regulatory milestones.
• Regulatory Engagement – Acting as the primary liaison with the FDA and EMA, shaping briefing documents and addressing pre‑submission queries.
• Operational Excellence – Overseeing clinical operations, data integrity, and cross‑functional collaboration with the scientific and commercial teams.
• Talent Development – Attracting and mentoring clinical researchers, and building a high‑performance medical affairs function.

In a statement to the press, Achieve’s CEO, Sarah Kim, emphasized that “Hernandez’s deep expertise in both the science and the regulatory process is exactly what we need as we move Aquila closer to pivotal trials. His leadership will help us streamline our development strategy and strengthen our positioning with investors and regulators alike.”

Impact on Achieve’s Strategic Trajectory

The company’s pipeline is poised for a critical expansion this year. Aquila has shown promising results in a 24‑week Phase 2b study, with a 45 % reduction in joint pain scores among participants who received the highest dose. Hernandez will work closely with the clinical team to design the next Phase 3 study, projected to enroll 600 patients across 12 centers in North America and Europe. Achieve’s management believes that the new study could be the cornerstone for a 2026 FDA filing.

Beyond Aquila, Achieve’s NASH candidate—an oral small‑molecule that modulates the gut‑liver axis—has entered a pivotal Phase 2 trial. Hernandez’s role will also encompass strategic planning for this program, ensuring that it meets the stringent endpoints set by the International Clinical Trial Registry and the FDA’s guidance on NASH.

From a financial perspective, analysts see the interim appointment as a stabilizing factor that could reassure investors. In the days following the announcement, Achieve’s shares rose 3.5 % in after‑hours trading, reflecting renewed confidence in the company’s development path. Market commentary noted that the appointment of an experienced clinician at the helm of medical affairs often signals a company’s readiness to accelerate clinical milestones and potentially negotiate better partnership terms.

A Broader Context: The Life‑Sciences Landscape

The appointment also comes at a time when the broader life‑sciences sector is emphasizing the importance of strong clinical leadership. With numerous biotech companies scrambling to fill gaps left by departing executives, the hiring of seasoned medical professionals is becoming a common strategic move. Dr. Hernandez’s background in both academic research and industry leadership makes him an attractive candidate for firms aiming to bridge the gap between discovery science and regulatory approval.

The company’s board has also indicated that the interim appointment is part of a broader talent‑search strategy. A formal search for a permanent CMO is underway, with a preference for candidates who have led multiple successful Phase 3 programs and have a proven track record in global regulatory submissions. Until a permanent appointment is made, Hernandez will act as the chief medical steward, ensuring continuity in Achieve’s clinical operations.

Looking Ahead

Achieve Life Sciences’ decision to bring Dr. Hernandez on board underscores the company’s commitment to maintaining momentum in its clinical pipeline while navigating the complexities of modern drug development. As the company moves forward with its Phase 3 plans for Aquila and the NASH candidate, the new interim CMO will play a pivotal role in aligning scientific innovation with regulatory strategy.

For investors and stakeholders, the move signals that Achieve is not only expanding its therapeutic portfolio but also strengthening the leadership framework that will guide its future growth. With a robust pipeline and a seasoned clinical leader in place, the company is positioning itself for the critical milestones that will define the next few years in the fight against chronic inflammatory and metabolic diseases.