| | | |   | Good morning, all. Damian here reminding you to tune in tomorrow afternoon for a virtual STAT event on an under-discussed aspect of revolutionary new medicines: It's hard to actually make them. Experts from BioNTech and BioMarin Pharmaceutical will explain how they overcame daunting manufacturing challenges. Register to attend here. | | | What’s the next act for Amylyx? Amylyx Pharmaceuticals’ eight-year effort to develop a new treatment for ALS could come to fruition Thursday, when the FDA is expected to hand down a decision on AMX0035, its investigational drug. If that ruling goes in Amylyx’s favor, as is widely expected, the company will face pivotal choices that will shape its future.
First among them is figuring out what to charge. In Canada, where AMX0035 won approval earlier this year, it costs about $160,000 per year. As Evercore ISI analysts Umer Raffat and Michael DiFiore wrote yesterday, Amylyx has two options: Follow the biotech trend of maximizing drug prices for rare diseases like ALS, or charge something similar to the Canadian price.
Then comes the matter of launching AMX0035. Only about 5,000 people in the U.S. are diagnosed with ALS each year, suggesting Amylyx will not need a massive sales infrastructure to get its drug out there. But small biotech companies have often struggled to make the transition from research to commercialization, and there’s no guarantee the grassroots support for AMX0035 will translate into a successful rollout. | Illumina’s chance to change the narrative With its stock price cut in half since January and an $8 billion merger starting to look like a boondoggle, Illumina is hosting a sort of genomic Lollapalooza that might help shift the narrative in what has been a punishing year.
This week brings the Illumina Genomics Forum, a four-day event with guests including Barack Obama and Bill Gates, gathering with the mission of “redefining what's possible together,” as CEO Francis deSouza put it in a press release. To Wall Street, the question is whether Illumina might have something up its sleeve to mend its declining financial outlook. That could include new details on what Illumina calls “Chemistry X,” a technology for reading large swathes of DNA, or the launch of a novel product. News of a cheaper way to do sequencing would also go over well, SVB Securities analyst Puneet Souda wrote in a note to clients yesterday.
Meanwhile, Illumina has struggled to grow revenue at its previous pace, cutting its full-year guidance last month. And 2020’s acquisition of Grail, the cancer testing firm Illumina expected to brighten the future, has become an antitrust headache that might force the company to divest it at a loss. | 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. | A rich biotech can’t buy respect The Belgian biotech firm Galapagos is supposed to be in the middle of a turnaround, after appointing the superlatively experienced Paul Stoffels as CEO in April. Instead, the company has lost 40% of its value since then and now has the worst enterprise value in all of biotech.
When you subtract Galapagos’ debt and nearly $5 billion in cash from the company’s market cap, you get about negative $2 billion, the lowest number in the industry and a sign that investors don’t believe management can do its job of turning money into promising drug research.
In June, Stoffels said the broader biotech downturn would be good for Galapagos, as the increasing difficulty of raising funds would put his cash-rich company in an enviable bargaining position with potential partners and acquisition targets. But nothing has materialized since then, and Galapagos’ dwindling stock price means its enterprise value is falling further into the negatives. | Novavax’s big market might never arrive After a series of delays led Novavax and its undoubtedly effective Covid-19 vaccine to watch from the sideline as competitors made billions, the investment thesis pivoted. Novavax may have missed its first opportunity to profit, the thinking went, but the company would produce a booster shot more tolerable than those of its rivals and make up ground in the endemic market.
But that market might be smaller than Novavax hoped. As of last week, only about 4 million people in the U.S. have received one of the Omicron-specific boosters authorized at the beginning of the month, according to CDC data. That’s tracking well behind 2021, when about 10 million people got boosters within three weeks of their availability, according to Reuters.
Novavax, whose share price fell 10% yesterday and is down nearly 90% on the year, expects to submit its Omicron booster for authorization in the fourth quarter, which could make it available in early 2023. Whether it has any commercial impact remains to be seen. | More reads - Google and Fitbit launch new cloud tools to help hospitals use wearables, STAT
- GSK will be helmed by two women as drugmaker hires Brown as CFO, Bloomberg
- Recession fears save pharma from drug-pricing concerns, Wall Street Journal
| Thanks for reading! Until tomorrow,  | | | |
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