| | | |   | Good morning, everyone. Damian here with the latest twist in the KRAS saga, the sudden popularity of debt, and an update from Biogen. | | | Amgen’s pathbreaking cancer treatment disappoints Amgen’s Lumakras made history in 2021 as the first medicine granted conditional approval for difficult-to-treat cancers with mutations to a gene called KRAS. But more recent data suggest the drug isn’t as powerful as it once seemed, with the latest disappointment coming from a study designed to confirm that pioneering approval.
As STAT’s Adam Feuerstein reports, Lumakras met its primary endpoint in the lung cancer trial by delaying tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel, a lower-than-expected improvement that will likely lead to full FDA approval. However, a secondary analysis of overall survival trended in the wrong direction: Patients given docetaxel lived longer by three weeks compared to patients treated with Lumakras.
To oncologists, the results were a surprising setback, even though Amgen’s drug met its primary goal. “If you had asked any lung cancer specialist what was going to happen when you compare Lumakras to docetaxel, none would have told you that there’d be no survival benefit,” said Benjamin Levy, a lung cancer physician and clinical director of medical oncology at Johns Hopkins Sidney Kimmel Cancer Center. “The Lumakras story is not over by any means, but these results are going to disappoint the field, there’s no doubt about that.”
Read more. | Biogen, still searching for a CEO, might make steeper cuts Biogen has already promised to cut $1 billion from its expenses, and if the firm’s next pivotal trial in Alzheimer’s disease comes up negative, it could dig deeper into its budget, the company’s chief financial officer said yesterday.
Speaking at the Morgan Stanley investor conference, Biogen CFO Michael McDonnell said that after spending about $5.2 billion in 2021, the company has reduced its 2022 guidance for expenditures to about $4.5 billion, a figure that doesn’t take into account cost cuts initiated earlier this year. “And if we don’t have a good outcome on lecanemab,” the Alzheimer’s therapy with Phase 3 data expected this month, “we’d have to step back and say, ‘Is there more action that we have to take?’” McDonnell said.
Absent from Biogen’s Morgan Stanley presentation was CEO Michel Vounatsos, who plans to resign as soon as the board picks his replacement. As for that process, McDonnell said “it’s progressing as planned” and declined to provide a timeline for the company’s decision. | Over a decade later, what’s next for the future of immunotherapy? Since 2011, the FDA has approved over three dozen novel immunotherapy treatments for patients with various forms of cancer. While these therapies have improved outcomes for some patients, there are others whose tumors don’t respond well enough to these medicines. Learn how the next generation and personalization of immunotherapies will help deliver more options for people with cancer. | Biotech isn’t afraid of a little debt For Sarepta Therapeutics and Alnylam Pharmaceuticals, the path to profitability is paved with sizable debt.
Yesterday, Sarepta said it would sell $1 billion in interest-bearing notes that will mature in 2025. The same day, Alnylam said it would sell $900 million worth of similar notes that mature in 2027. In each case, the companies can pay down the debt in cash, shares, or a combination thereof.
Sarepta said outright that the proceeds of the offering, “along with current cash and projected revenue,” will be sufficient to fund the company’s operations through profitability. Alnylam, which plans to “achieve sustainable non-GAAP profitability” by the end of 2025, made no such claim. | Bluebird, at a financial crossroads, keeps losing CFOs Bluebird Bio, a gene therapy pioneer that has recently flirted with insolvency, will soon part with its second chief financial officer amid a make-or-break period for the company.
Bluebird said yesterday that Jason Cole, a long-time employee who took over as CFO in March, will leave the company next month “to pursue new career opportunities.” Cole’s predecessor, Gina Consylman, resigned after about six months on the job. Katherine Breedis of Danforth Advisors will serve as Bluebird’s interim CFO as it looks for Cole’s replacement.
Meanwhile, Bluebird is in the midst of a risky turnaround. Last month, the company won FDA approval for its first gene therapy, targeting the blood disorder beta thalassemia, and it could win a second approval, for an extremely rare neurological disorder, by Friday. Neither treatment is expected to become a blockbuster, but each approval comes with a sellable voucher for a speedy FDA review. Such vouchers have been going for about $100 million each in recent years, and Bluebird, which recently laid off employees and cut spending to conserve cash, could use the money. | More reads - Biden appoints former government scientist as first leader of ARPA-H, STAT
- AstraZeneca beats US shareholder lawsuit over COVID-19 vaccine disclosures, Reuters
- China competition spurs Biden push for domestic biotech subsidies, Washington Post
| Thanks for reading! Until tomorrow,  | | | |
No comments