Sarepta Therapeutics, a leading biotech company, has announced a significant reorganization of its executive team and strategic direction following recent setbacks in its gene therapy program. The shake-up comes as the company grapples with the fallout from patient deaths associated with its Duchenne muscular dystrophy (DMD) treatment, Elevidys.

Executive Reshuffling and Strategic Shift

Sarepta's leadership overhaul includes several key appointments:

• Patrick Moss, formerly senior vice president of U.S. market access and sales, has been promoted to chief commercial officer, replacing outgoing chief customer officer Dallan Murray.
• Ian Estepan has been named chief operating officer.
• Louise Rodino-Klapac, Ph.D., will serve as president of R&D and technical operations.
• Ryan Wong takes on the role of chief financial officer.
• Rachael Potter, Ph.D., previously SVP and head of research sciences, has been elevated to chief scientific officer.

These changes are part of a broader strategic pivot for Sarepta, which is now shifting focus away from gene therapies and towards siRNA programs. This realignment is accompanied by a significant workforce reduction, with the company cutting approximately 500 jobs, representing 36% of its staff.

Regulatory Challenges and Product Concerns

The FDA has requested that Sarepta add a black box warning for acute liver injury to the label of Elevidys, the company's flagship product. This development follows the deaths of two patients who received the DMD gene therapy, prompting a reevaluation of the treatment's safety profile.

Industry-Wide Leadership Changes

Several other pharmaceutical and biotech companies are also experiencing leadership transitions:

BioNTech and Prime Medicine Executive Departures

BioNTech, known for its COVID-19 vaccine development, is losing its chief strategy officer, Ryan Richardson, who will leave at the end of September to pursue new opportunities. Richardson played a crucial role in the company's financial growth, including its $325 million series B round and 2019 IPO.

Prime Medicine is bidding farewell to its chief scientific officer, Jeremy Duffield, M.D., Ph.D., after a five-year tenure. Duffield will remain in an advisory capacity until March 2026, continuing to vest his equity awards during this period.

Other Notable Appointments and Transitions

• Novartis CFO Harry Kirsch is set to retire next year, with Mukul Mehta, currently head of business planning and analysis, digital finance, and tax, slated to succeed him.
• Harvard Bioscience will see Jim Green step down as CEO and president, to be replaced by John Duke.
• Uniquity Bio has appointed Will Kane as its new president and CEO, following the departure of co-founder and former CEO Brian Lortie.
• Recludix Pharma has promoted Brian Hodous, Ph.D., to chief scientific officer.
• Alumis has elevated Sanam Pangali to chief legal officer and corporate secretary after Sara Klein's retirement.
• Synendos Therapeutics has brought on George Garibaldi, M.D., as chief medical officer to advance its lead candidate.
• Tract Bio has appointed Chris Galloway, M.D., as chief medical and development officer as it prepares for an IND application.
• Zyus Life Sciences has named Julie Stakiw, M.D., as its new chief medical officer.
• PureTech Health's CEO Bharatt Chowrira, Ph.D., has stepped down, with Robert Lyne serving as interim CEO.
• Satellos Bioscience has recruited Wildon Farwell, M.D., formerly of Dyne Therapeutics, as its new CMO.
• Vor Bio has appointed Qing Zuraw, M.D., as chief development officer.

These leadership changes reflect the dynamic nature of the pharmaceutical and biotech industries, as companies adapt to challenges, pursue new strategies, and position themselves for future growth.