| |   | Hello, everyone. Damian here with a preview of a weighty week of earnings calls, news on a promising gene therapy, and the start of the year's biggest Alzheimer's disease conference. | | | How is Moderna going to spend all that money? Friday’s announcement that Moderna is due another $1.7 billion in Covid-19 vaccine revenue resolved some of investors’ anxieties, sending its stock price up about 4%. But the good news will only amplify a familiar question when Moderna reports earnings this week: How are you going to turn that present cash into future profits?
Thanks to that order from the U.S. government Moderna will likely increase its full-year revenue projection when it discloses second-quarter results on Wednesday. And it will surely have increased its cash reserves, reported at $19.3 billion at the end of the last quarter, which will bring about the question of just how to spend it.
Since Moderna’s vaccine began making money, CEO Stéphane Bancel has consistently said the company’s top priority would be investing in the in-house research that got it here in the first place, with a secondary goal of buying or licensing technologies that might be complementary. But his rhetoric has escalated in recent months, saying in May that the company was “looking at a lot of opportunities literally across the world” and had “never been so busy.” With biotech valuations down and Moderna’s cash reserves growing, Wall Street will be eager for an update. | Sarepta takes an FDA gamble Sarepta Therapeutics plans to seek FDA approval for its Duchenne muscular dystrophy gene therapy earlier than expected, a risky move that could help the company reach the market faster.
As STAT’s Adam Feuerstein reports, Sarepta plans to ask the FDA to approve its one-time treatment based on its ability to increase patients’ levels of the protein dystrophin rather than waiting on data from a larger study that would confirm its functional benefits.
The news sent Sarepta’s share price up more than 10%, as an accelerated approval could give Sarepta an edge in what could be a competitive market. But there’s no guarantee the FDA will agree with the company’s read on the data, and Sarepta may yet have to wait on longer-term data expected in the second half of 2023.
Read more. | STAT Event: Creating AI That Improves Health On August 3, hear how researchers aim to create a “data economy” to ensure that artificial intelligence lives up to its promise. Register now to join. | The latest referendum on Gilead Gilead Sciences, superlatively successful at inventing antiviral medicines, has spent more than $40 billion in recent years trying to become a leader in oncology, with results ranging from middling to disastrous. Now, on the eve of the next big test of its strategy, the company gets a chance to explain.
Gilead’s next quarterly Q&A, slated for tomorrow, will likely feature management’s explanation of how the company plans to compete in the treatment of breast cancer. Gilead spent $21 billion to enter the field in 2020, and now recent data from a competing AstraZeneca therapy promise to change the standard of care and make its acquisition look short-sighted.
The majority of questions will likely focus on domvanalimab, another in-licensed cancer treatment with data expected in the next month or so. The drug is aimed at an emerging molecular target called TIGIT, which functions like a brake on the immune system. A series of clinical disappointments, most recently from Roche, have dampened enthusiasm for TIGIT’s potential. Gilead, which paid more than $1 billion for the rights to domvanalimab, needs to persuade investors that this time will be different. | Alzheimer’s researchers brace for a decisive year For roughly the past decade, the Alzheimer's Association International Conference has played host to the presentation of — and ensuing debate over — data on the latest attempt to finally treat the underlying causes of the disease. But this year’s iteration of the field’s biggest annual meeting will be different: With the Aduhelm saga largely in the rear-view, researchers are looking ahead to a trio of trials that will shape the next 10 years.
AAIC 2022, beginning today in San Diego, is a chance for the field to brace itself for the biggest cumulative test of the notion that removing toxic plaques from the brain can treat Alzheimer’s. In September, partners Biogen and Eisai will have Phase 3 data on lecanemab, an intravenous antibody treatment. Before the end of the year, Roche will have results from a two-year study on gantenerumab, a subcutaneous treatment aimed at the same target. And, in 2023, Eli Lilly expects final data on the similar donanemab.
A clean sweep of success would benefit each player, affirming the amyloid hypothesis, cementing a new class of therapies, and maybe even rescuing Aduhelm’s stalled commercial rollout. A series of outright failures would close the book on at least this generation of plaque-targeting treatments, if not the idea itself. But every outcome in between has complicated implications, all of which are sure to be discussed at AAIC this week. | More reads - A ViiV deal to license its HIV prevention shot to poor countries runs into criticism. STAT
- AstraZeneca to double number of countries where US biotech arm sells rare disease drugs. Financial Times
- This billionaire has quietly driven Boston’s biotech industry for decades. Boston Globe
| Thanks for reading! Until tomorrow,  | | | |
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