Q3 2022: Layoffs Continue, Alzheimer’s Soars and Accelerated Approvals Fall

The third quarter of 2022 came to a close Friday, and a review of the quarter’s top news suggests many companies were facing the same issues. Among these overarching themes are job cuts, a shift in focus away from COVID-19, an unexpected boost in the Alzheimer’s research space and increased scrutiny of accelerated approvals by the FDA.

Hard Financial Times and Job Cuts

Q3 2022 saw a number of biopharma companies laying off staff. Many of these came in September alone.

• Bristol Myers Squibb announced plans to cut jobs at two different locations in San Diego. BMS said the cuts were associated with the $4.1 billion acquisition of Turning Point Therapeutics in August.
• AbbVie also filed a Worker Adjustment and Retraining Notification (WARN) in California announcing plans to lay off 99 people at its Irvine, California site. The job cuts will go into effect in November.
• Vesalius Therapeutics reported it would lay off 43% of its staff, accounting for the loss of 29 jobs. The news came just 6 months after the Massachusetts-based company’s launch.
• Palisade Bio announced plans to slash 20% of its workforce
• IMV announced it would lay off one-third of its staff as part of a strategic reorganization
• ObsEva SA, as part of a previously announced restructuring, reported it was cutting 70% of its headcount, including Katja Buhrer, the company’s chief strategy officer.
• In mid-September, once high-flying Rubius Therapeutics announced it was pink-slipping 75% of its staff as part of a restructuring strategy to focus on its Red Cell Therapeutics technology.
• Zymergen reported in August it would cut 80 jobs. Zymergen also announced its co-founder and CSO, Zach Serber, was leaving the company. This restructuring came shortly after Ginkgo Bioworks announced plans to acquire the company for $300 million.

COVID-19 Controversies and Slowdown

The third quarter also marked a slowing of the COVID-19 pandemic. Pres. Joe Biden declared the pandemic over in the United States in late September, although he noted there were still infections.

Some companies appeared to be backing away from the space, while others are still working to get their drugs or vaccines to the market.

Miami-based Veru has an FDA Pulmonary-Allergy Drugs Advisory Committee meeting scheduled for Nov. 9 to evaluate its Emergency Use Authorization request for sabizabulin in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.

“New therapeutics, like sabizabulin, that greatly reduce deaths in hospitalized patients with moderate to severe COVID-19 infection are still greatly needed,” said Sam Fisch, executive director of investor relations and corporate communications at Veru on Sept. 20.

Clover Biopharmaceuticals received a European Union Good Manufacturing Practice certificate to support potential commercial manufacturing of its vaccine candidate, SCB-2019. And Revive Therapeutics amended its protocol for a Phase III trial in the U.S. of bucillamine for mild to moderate COVID-19.

The Lancet Commission published an evaluation of the World Health Organization’s COVID-19 pandemic response in mid-September. The WHO responded, saying the organization welcomed the feedback and recommendations, but also noted areas where the Commission’s criticisms missed the mark.

The same day, the WHO advised against the use of GlaxoSmithKline and Vir Biotechnology’s sotrovimab, Regeneron Pharmaceuticals’ REGEN-COV and recommended limited use of Gilead Sciences’ remdesivir.

Anti-Amyloid's Last-Minute Rally

In an unexpected turn, Eisai and Biogen reported positive data from a Phase III trial of lecanemab in Alzheimer’s disease. This appeared to, at least momentarily, rejuvenate the Alzheimer’s disease market. The drug appeared to slow progression of the disease in a way the companies said was “highly statistically significant.”

The announcement caused Biogen’s stock to rocket almost 50%, while Eisai’s rose 17%. It also boosted competitors Eli Lilly and Roche, which also increased 6 to 7% at the announcement.

Evan Seigerman, an analyst with BMO, called the data an “unequivocal win” for Biogen and Alzheimer’s patients.

Cynthia Carlsson, M.D., senior professor in Alzheimer’s disease and director of the Wisconsin Alzheimer’s Institute at the University of Wisconsin School of Medicine and Public Health told BioSpace the data was “encouraging,” but cautioned that “we really need to dig deeper into the data.” 

The ODAC Meetings

The quarter also marked several notable FDA advisory committee meetings. Along with the Sept. 29 publication of the U.S. Department of Health and Human Services Office of Inspector General report, this suggests a crackdown on accelerated approvals.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met September 22-23 to discuss Oncopeptides’ Pepaxto. In what Oncopeptides’ CEO Jakob Lindberg told BioSpace was an “unexpectedly contentious” meeting, ODAC voted 14-2 against the drug. Pepaxto has been on the market since 2021 for multiple myeloma under an accelerated approval pathway.

The EMA, however, asked to evaluate the data itself and in June, the drug received full approval in Europe for an earlier line of therapy.

ODAC also discussed Secura Bio’s Copiktra (duvelisib), which was already approved as a third-line treatment for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The committee voted 8-4 against the drug’s benefit-risk profile.

The HHS IG report found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials. It also reported that since the inception of the accelerated approval pathway, 13% of all accelerated approval drug applications have been withdrawn, half since January 2021.