Chutes & Ladders—Aquestive CEO heads for the exits while seizure med remains in regulatory limbo

 Chutes and LaddersWelcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer, and we will feature it here at the end of each week.


Aquestive CEO dashes as the FDA mulls its latest approval request

Aquestive Therapeutics

Aquestive CEO Keith Kendall
(Aquestive)

Keith Kendall, CEO of Aquestive Therapeutics, is leaving, ending a tenure that's lasted almost the full existence of the company. His move comes as Aquestive's approval request for Libervant to treat breakthrough seizures remains in limbo with regulators. The company was slated to receive a decision by the end of last year but the FDA delayed it, citing "orphan-drug exclusivity issues". 

Kendall first joined the company 16 years ago as chief financial officer before being promoted to co-President and COO in 2011. He was then tapped as CEO three years later in 2014. Under his leadership, the company went public and has won six FDA approvals, including for Saboxone, the company's treatment for opioid dependence. The reins to Aquestive will now be immediately handed over to COO Daniel Barber, although Kendall is staying on through the rest of the year to help Barber's transition and oversee the company's business strategy. Fierce Biotech


Bear market takes toll on Applied Molecular Transport, co-founder out amid job cuts

Applied Molecular Transport

Applied CEO Randy Mrsny
(LinkedIn)

Almost two years after closing its IPO and launching onto Wall Street, Applied Molecular Transport is cutting 40% of staff to stay afloat, joining more than 40 other biotechs since the start of the year. As part of the corporate changes, co-founder and Chief Scientific Officer Randy Mrsny, Ph.D., is stepping down. 

Since going public, the company has been taken for a ride that only Wall Street could provide. After launching in June 2020 at roughly $18 a share, the company saw its value skyrocket amid a biotech boom spurred by the COVID pandemic. But the tables turned in early 2021 when investors began to sour on a market that had become too saturated with companies that had little to no data. Since peaking in March 2021 at more than $69.50 per share, its value has fallen more than 95%, now at $3.20 per share.

As part of the cost-saving measures just announced, the company is going all in on AMT-101, a potential treatment for chronic pouchitis that's preparing for phase 3 trial. Applied says it's "evaluating next steps" for AMT-126, its earlier-stage oral med for GI barrier repair. Fierce Biotech


Scholar Rock CMO Chyung moving on following pipeline trim, 25% workforce reduction

Scholar Rock

Scholar Rock CMO Yung Chyung
(Scholar Rock)

With R&D expenses mounting, Scholar Rock is reshuffling its pipeline, focusing almost entirely on its lead asset apitegromab. As a part of the cost-saving measures, 25% of the workforce is being shown the door. Additionally, the company's chief medical officer Yung Chyung, M.D. is stepping down to pursue other endeavors, including those in global health. 
 

The overall objective for the company is to trim down on its preclinical work, which as of now includes at least five assets. Instead, Scholar Rock will focus on its most promising asset, apitegromab, which continues enrollment of a phase 3 trial to treat spinal muscular atrophy. It's unclear whether the company will continue to pursue apitegromab as a treatment for myostatin-related disorders, which is currently near phase 1. The company also said it will prioritize SRK-181 to treat solid tumors in patients unresponsive to anti-PD-(L)1 therapies. 

As for Chyung, he'll stay on through June 30 to help the executive and development teams transition. His departure marks the end of a six-year tenure following stints at Dyax Corp and Genzyme. The company said a search for his replacement is ongoing. Fierce Biotech


> Flagship Pioneering is merging Inzen Therapeutics and Cygnal Therapeutics to form Sonata Therapeutics. Former Inzen CEO Volker Herrmann, M.D., will lead the new venture after Cygnal CEO Pearl Huang, Ph.D., recently announced her departure. Fierce Biotech

> Jérémie Mariau is the new CEO of IBD-focused Thabor Therapeutics. Marieau most recently spent seven years as the top executive at ILTOO Pharma, similarly leading its efforts to develop inflammatory treatments. Release

> Former Tempus Labs CMO Kimberly Blackwell, M.D., will take over as CEO of Zentalis Pharmaceuticals after Anthony Sun, M.D., stepped down. However, Sun is staying on to run Zentalis' joint venture, Zentera Therapeutics, which is based in Shanghai. Release

> Commercial journeyman Ryan Bleeks will take the helm of Visiox Pharma as it prepares to submit two approval requests to the FDA this year. Emblematic of Visiox's anticipation for market growth, Bleeks comes equipped with more than two decades of commercial experience, most recently as a VP at RVL Pharmaceuticals. Release

> Promontory Therapeutics has found its new clinical chief, nabbing Johan Baeck, M.D., to be chief medical officer following his stint as SVP of clinical development and medical affairs at Jounce Therapeutics. Promontory's former CMO, Joseph O'Donnell, M.D., will continue at the company as senior medical director. Release

> After acquiring Atrin Pharmaceuticals, Aprea Therapeutics is rearranging its executive team, moving chief business officer Greg Korbel to chief operating officer. Some members of Atrin leadership are also staying on, including CEO Oren Gilad, Ph.D., who will become Aprea's new president in addition to Ze’ev Weiss, who fills Korbel's shoes as CBO. Release

> Adamis Pharmaceuticals CEO Dennis Carlo, Ph.D., is retiring effective immediately, departing from his seat on the board as well. He'll be replaced by the company's co-founder and Chief Business Officer David Marguglio, who will look for someone to take his seat on the company's board. Release

> Genentech vet Anne Fung, M.D., has been tapped to be chief medical officer of Perceive Bio. The company hopes Fung will progress its ophthalmology-focused pipeline beyond just perceptions with concrete clinical data. Release

> To help bring its oral vaccine vision to reality, U.K.-based iosBio has brought aboard Craig Laferrière as chief development officer. Laferrière most recently worked for an international vaccine consulting firm following a stint as a medical adviser on the vaccine team at Pfizer Canada. Release

> ImmPACT Bio is prioritizing manufacturing know-how with its latest hire, tapping Sylvain Roy as chief technology officer. Evidently, Roy's latest role leading manufacturing operations for ImmunityBio was enticing to ImmPACT as it develops new CAR-T treatments. Release

> Former Vertex CEO Jeff Leiden, M.D., Ph.D., has been appointed chair of Odyssey Therapeutics' board. During his six-year tenure at Vertex, Leiden oversaw the company's evolution from developing hepatitis C therapies to becoming a cystic fibrosis powerhouse. Release

> ProJenX has found its leader, naming serial biotech exec Stan Abel as CEO. ProJenX was launched by Medical Excellence Capital in collaboration with Project ALS as a clinical output focused primarily on potential therapies for ALS. Release

> Timothy Sherwood is getting promoted at Aquavit Pharmaceuticals, jumping up to chief operating officer after leading the company's global commercial operations. Sherwood first joined the company in 2019 as VP of finance and HR. Release

> OncoPep is hiring Victor Moyo to be its new chief medical officer as the company progresses its lead asset, PVX-410, through the clinic. Developing that asset will be Moyo's primary focus, but OncoPep said he'll also "contribute heavily" to preclinical work. Release

> Former Arena CFO Laurie Stelzer has found the same gig at a new home, being named CFO at Mirati Therapeutics. Her departure from Arena came after the company was acquired by Pfizer. Release

> Clinical research behemoth WCG has a new leader, naming Sam Srivastava for the job. He comes after a number of stints in the healthcare sector, including at Cigna and United Health Group. Release

> Reaction Biology is shoring up its executive team, bringing on Alan Findlater as its new chief development officer and Emily Doyle as chief people officer. A spokesperson told Fierce Biotech that both of these roles have been newly created. Fierce Biotech