| | | |   | | | It’s Death Star-level bad The XBI plunged 18% in April 2022 — the second-worst month ever for the closely tracked biotech stock index. Only January 2016, when the XBI fell 28%, was worse. It hardly matters. Friday’s 3% drop was one more awful trading session in a ceaseless string that has now extended the biotech bear market to 14 months. “This is by far the worst sentiment in biotech, even worse than 2002, which was horrible,” Dan Rosenblum tweeted. He’s been trading biotech stocks for 23 years, so he knows a few things. In a nod to the scrolling text that opens every Star Wars movie, Oleg Nodelman, founder and managing partner of the biotech hedge fund EcoR1 Capital, titled his April letter to limited partners “The Last Biotech Investor” and painted this dire scene: The bear market reigns. The peaceful biotech sector has been decimated, and fears of inflation, a war in Ukraine and a dearth of positive clinical data threaten to put many underfunded biotech companies unwilling to take on dilution out of business. Only big pharma balance sheets and their insatiable need for revenue growth stand against the rising tyranny, and some market participants are certain that Pfizer will return and restore a spark of hope to the fight. But M&A has been slow to come. As dwindling cash balances race against a bounce in the market, the brave biotech CEOs mount a desperate escape… |
Paxlovid fails at preventing infection
Late on Friday afternoon, Pfizer dropped some bad news: a clinical trial failed to show that giving Paxlovid to household contacts of people who had Covid prevented spread of the infection.
That’s disappointing because studies of monoclonal antibodies had shown that those treatments were effective at keeping people from catching from Covid from people in their households who were infected. Studies of the Regeneron, Eli Lilly, and AstraZeneca monoclonals all showed an 80% reduction in infection. But for Paxlovid, the infections were reduced 32% for a five-day course (the course authorized for treatment) and 37% for those who received a 10-day course.
What went wrong? Myron Cohen, of the University of North Carolina, wondered if trial design might play a role, or if the drug isn’t getting to mucosal tissues vulnerable to infection. Dan Barouch, of Beth Israel Deaconess Medical Center, pointed out that the antibody studies had been against other strains of the virus, but also that Paxlovid works once the virus starts replicating, which may be less effective for preventing infections. Paul Sax, of Brigham and Women's Hospital, also favored this explanation.
All three emphasized that more data are needed, and that the new data does not affect whether to treat high-risk people with Paxlovid, which they say still is likely to have big benefits.
Read more. | Biotech investors: How to find value in a bear market How are top investors navigating the longest biotech bear market in almost 20 years? RBC Capital Markets Healthcare Desk Sector Strategist Chris McCarthy discusses with Ben Snedeker, Senior Therapeutics Analyst at HealthCor Management and Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. Learn how focusing on market fundamentals and clinical trial pipelines can unlock opportunities to invest in therapeutics companies with potential for long-term growth. Get the insights. | Microbiome might impact Covid-19 immune response Covid-19 can often affect the gastrointestinal system, with symptoms that include diarrhea, nausea, and vomiting. So researchers, noting that both respiratory and GI tracts are home to flourishing microbiota, delved into the flora of people affected with the virus. In a review published in Nature, they found that microbiota-derived metabolites potentially impact immune responses to Covid-19. “There is growing evidence that the substantial perturbation of the microbiota during Covid-19 is associated with disease severity and mortality and post-acute Covid-19 syndrome (PACS),” the authors say. The paper suggests that therapies like fecal microbiota transplantation, probiotics, prebiotics, microbiota-derived metabolites, and engineered symbiotic bacteria might mitigate inflammation — and thus symptoms — brought on by Covid-19. | Sanofi evacuates MS trial participants in Ukraine During an earnings call last week week, Sanofi said it moved clinical trial patients out of Ukraine — with hopes to keep its multiple sclerosis study on track. About 11% of Sanofi’s study sites for its experimental MS drug, tolebrutinib, are in Ukraine, FierceBiotech writes. The company’s Ukraine-based teams have made “really heroic efforts” to evacuate Ukrainian patients in war zones, Sanofi’s global R&D chief said during an earnings call. The drug giant’s CEO called it a “Herculean effort.” They’re being moved either to the western part of the country, which is somewhat safer, or to clinical sites in neighboring countries. “We’ve taken mitigation efforts as well to expand recruitment outside those territories to add extra patients in case we lose some data,” the R&D chief said. “But so far so good, I would say, and we are still on track with the submissions that we’ve shared previously.” | More reads - Ionis Pharmaceuticals shares slip after eplontersen study changes. (MarketWatch)
- China’s Covid-19 defenses have a missing piece: Vaccinating the elderly. (Wall Street Journal)
- Substituting genetic ancestry for race in research? Not so fast. (STAT)
| Thanks for reading! Until tomorrow,  | | | |
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