| | Good morning, everyone. Damian here with details on biotech's biggest readout of 2022, a look at the need for better prophylactic Covid-19 treatments, and a lucrative bit of fake news. | | Can monkeypox be contained? Are snortable Covid-19 vaccines on the way? And when is a GIF worth $200,000? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT’s Helen Branswell joins us to explain the latest in the monkeypox outbreak and how health authorities are struggling to contain it. We also discuss the latest news in the life sciences, including some faked Alzheimer’s data, a brewing FDA controversy, and what it means when a scientific discovery gets turned into an NFT. Listen here. | Alnylam’s big day is at hand The biggest single binary on the biotech calendar will come within weeks, when Alnylam Pharmaceuticals will reveal whether its treatment for an increasingly prevalent heart disease can meet Wall Street’s blockbuster expectations. The drug is called patisiran, and Alnylam is studying its potential benefits for patients with ATTR-CM, a progressive heart disease once thought to be rare that is now understood to affect more than 400,000 people around the world. Yesterday, on its quarterly earnings call, Alnylam said it will soon have top-line data from a pivotal study testing whether patisiran can beat placebo on a measure of how far patients can walk in six minutes after 12 months of treatment. Success would lead to a filing for FDA approval and potential blockbuster sales. The only approved treatment for ATTR-CM is a pill from Pfizer, which made more than $2 billion last year and is on pace to bring in nearly $3 billion in 2022. The stakes for patisiran escalated late last year when an ATTR-CM treatment from BridgeBio Pharma failed in a similar trial. In that study, the placebo group did shockingly well on the so-called six-minute-walk test, confounding experts and casting doubt on Alnylam’s trial. There have since been months of debate over whether the BridgeBio trial was an aberration driven trial design and execution, or an omen that patisiran is destined to fail. The answer to that question will swing billions of dollars in Alnylam’s valuation, with the stock expected to move 50% in either direction depending on the data. | 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. | Vulnerable people are still waiting for better Covid drugs For the millions of immunocompromised people in the U.S. at high risk for Covid-19, the best bet is Evusheld, a prophylactic treatment whose demonstrated efficacy was significantly reduced by Omicron. And with few successor treatments in the drug industry’s pipeline, patients and their physicians feel they’ve been left behind. As STAT’s Jason Mast reports, only a handful of companies are working on treatments that might augment vaccination to better prevent infection. Meanwhile, the declining protective power of Evusheld, marketed by AstraZeneca, has led the estimated 10 million immunocompromised Americans to abandon hopes of ditching masks and returning to their pre-pandemic lives. “People are resigned to the fact that there's going to be another variant and trying to make their peace with that,” said Janet Handal, a kidney transplant recipient who takes immunosuppressive medicines. Read more. | Beware the fake press release Petros Pharmaceuticals, a company developing drugs for men’s health, has rarely traded above $3 a share in its roughly two years of existence, with a peak market cap of less than $75 million. That made yesterday’s news that the private investor Henry Crown and Company was buying Petros for $3.25 a share all the more shocking, sending the company’s share price up fourfold before Nasdaq halted trading. Turns out it wasn’t real. Someone wrote a fake press release announcing the made-up acquisition and got it distributed by GlobeNewswire, one of the world’s largest networks for corporate communications. Shares of Petros, which closed the previous day at about 80 cents, opened at more than $2.75. By late morning, GlobeNewswire deleted the release, and both Petros and Crown put out statements of their own instructing the world to please ignore the fake news. In the end, roughly 37 million shares of Petros changed hands yesterday, compared to an average volume of about 200,000, and it seems quite possible we will hear more about this matter in the future. | More reads - Researchers revive abandoned technique in effort to make artificial human eggs in a test tube, STAT
- Merck profit tops Wall Street view on strong Keytruda sales, Reuters
- Teladoc’s earnings point to potential threats to the telehealth industry, STAT
| Thanks for reading! Until next week, | | |
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