Amylyx's ALS drug is selling

Amylyx Pharmaceuticals' recently approved treatment for ALS is outpacing analysts' expectations, the company said yesterday, defying some downbeat rumors about its early commercial performance.

Demand for the drug, Relyvrio, turned out to be higher than expected, Amylyx said at an investor conference yesterday, and now the company expects its revenue to "meaningfully exceed" Wall Street's estimates for 2022.

Amylyx's near-term prospects depend on whether insurers choose to cover Relyvrio, which won accelerated approval in September and carries a list price of $158,000 per year. More important is whether the treatment succeeds in an ongoing Phase 3 study, expected to read out in mid-2024. If that trial is negative, Amylyx has promised to withdraw its drug from the market.

earnings

How are biotech's payday lenders doing?

D3 vis exported to PNG (39)

Royalty Pharma's business — buying long-term rights to other companies' drugs in exchange for short-term cash — should be countercyclical. As biotech companies struggle to raise money, Royalty, one of precious few ports in a storm, should be able to negotiate for increasingly favorable terms.

And yet Royalty's valuation has fallen more than 25% since the start of 2021, decreasing in line with the biotech industry despite the company's steadily growing cash receipts.

Royalty's next chance to change the narrative comes later this morning, when the company will present its full 2022 results and make the case for why its business outlook should only benefit from a prolonged biotech downturn.

M&A

The plodding end of a biotech saga

Sesen Bio, a biotech company whose lead drug came undone due to investigator misconduct and toxic side effects, has finally convinced key shareholders to get behind its plans for a reverse merger, promising a cash payment to make the deal happen.

Under the agreement, Sesen will merge with Carisma Therapeutics, a private, early-stage company working on genetically engineered immune cells, in an all-stock transaction, allowing Carisma to go public without an IPO. To appease shareholders who threatened to block the deal, Sesen is offering a $75 million cash payout, which is three times larger than its first proposal.

The offer is likely to get the deal over the finish line when shareholders vote on March 2, but it also weakens Carisma's position going forward. The company once expected to have about $180 million in cash to fund its operations after the merger. Paying off Sesen's shareholders will cut into the balance sheet.

Regulatory

Medicare is tinkering with the program that doomed Aduhelm

The once-obscure regulatory tool Medicare used to decimate the potential of Aduhelm could soon change.

As STAT's Rachel Cohrs reports, a group of advisers to Medicare urged the program to make its restricted coverage policy more transparent and better reflective of diversity data. The pathway is called Coverage with Evidence Development, and Medicare uses it for drugs, diagnostics, and medical devices with unclear supporting evidence, allowing some beneficiaries to access them while demanding manufacturers to continue studying their effects.

Medicare's advisers recommended requiring a written plan that describes a schedule for completing such studies, including milestones to ensure the research is conducted in a timely manner. They also urged Medicare to clarify what the goal of follow-on studies should be, and to add language stipulating that the results should "provide evidence of net benefit."

Read more.

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