| | | |   | Hello, all. Damian here with news on the next big FDA debate, a look at the messy biotech IPO market, and a glimpse at the endless argument over Ginkgo Bioworks. | | | Amylyx’s path to FDA approval is looking complicated The share price of Amylyx Pharmaceuticals fell by as much as 50% yesterday after FDA reviewers took a critical view of the company’s investigational treatment for ALS.
As STAT’s Adam Feuerstein reports, agency scientists criticized the data supporting Amylyx’s drug, writing that they “may not be sufficiently persuasive” to warrant approval. The remarks came in FDA briefing documents released ahead of a Wednesday meeting in which independent advisers will review the data and make recommendations on a potential approval.
The drug, AMX0035, met its goal of slowing ALS progression in a single placebo-controlled trial. But the benefit was only “borderline statistically significant,” FDA reviewers wrote, and the overall case for AMX005 is “not robust.”
Read more. | Biogen’s pipeline gets a little smaller Biogen and partner Ionis Pharmaceuticals halted development of a novel treatment for ALS, the companies said yesterday, further diminishing a pipeline that already gets little respect among investors.
The news is that BIIB078 proved no better than placebo on a range of measures in a Phase 1 study enrolling about 100 adults with a form of ALS. Biogen and Ionis are discontinuing the drug, a decision that comes six months after tofersen, the companies’ most advanced ALS treatment, failed in a Phase 3 study.
While the rocky development and polarizing approval of Aduhelm has come to define Biogen in recent years, the company has also strived to convince Wall Street that its stable of investigational medicines is undervalued. The failure of BIIB078 is an incremental blow to that idea, but Biogen still has high hopes for a follow-on treatment for Alzheimer’s disease, a depression drug, and a lupus medicine. | Let’s advance and accelerate therapeutics — together Cytiva is a global provider of technologies and services that advance and accelerate the development, manufacture, and delivery of therapeutics. Our rich heritage dates back hundreds of years, and we got a fresh start in 2020. Our customers undertake life-saving activities ranging from biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services they need to work better, faster, and safer, leading to better patient outcomes. Learn more at Cytiva.com. | People are going to be fighting about Ginkgo for years Out on the extremes of the debate over Ginkgo Bioworks, you’ll find people who argue it will become the Amazon of biology and people who contend it’s biotech's answer to WeWork. Yesterday, Ginkgo hosted its first earnings call as a public company, and it’s pretty clear neither of those parties will be forced to concede defeat any time soon.
On the actual numbers, Ginkgo’s 2021 revenue and number of new projects came in right around what the company projected when it went public last year, and its expectations for 2022 are roughly in line with its long-term plan. That helped Ginkgo’s stock price rise about 8% after hours.
But the company is still down 60% since going public, and it’s unclear when that will change. Ginkgo’s bull case for itself, laid out last year, requires the company to achieve a 17-fold increase in revenue by 2025 and launch 10 times as many programs in a year as it has done in its entire history. The bear case is that it will not do that all. Each prediction will take years to play out, making yesterday’s presentation a little anticlimactic. | How many biotech IPOs is too many biotech IPOs? There’s an attractive explanation for biotech’s double-digit decline in recent months that goes like this: Market exuberance meant virtually any company could go public, and so a bunch of bad companies went public, and now the entire sector is suffering for it.
Bruce Booth, a partner at Atlas Venture, does not agree. In a lengthy look at the issue, he cites data showing that early-stage IPOs performed about as badly as late-stage ones and that newly listed companies aren’t doing any worse than the broader biotech industry. Booth concludes that “overall, I think it’s a mistake to blame ‘too many early stage IPOs’ for the plight of the markets today.”
But what’s difficult to determine is whether there have been too many biotech IPOs, period. As Booth notes, companies go public because it’s an easier and cheaper way to raise the cash they will undoubtedly need to develop new drugs, taking advantage of IPO windows while they can because the next downturn could be right over the horizon. The risk is that last year’s wide-open IPO window created a positive feedback loop of cash-strapped companies. There are now hundreds of publicly traded biotech firms, each with a need to raise large sums of money every year or so. What happens if investor demand never catches up to all that supply? | More reads - 'Stay alive': Wave of layoffs crashes into biotech startup inferno. FierceBiotech
- ‘A slow-moving glacier’: NIH’s sluggish and confusing efforts to study long Covid draws patient, researcher ire. STAT
- FDA approves UCB's drug for rare childhood epilepsy. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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