| | | |   | Meghana (and Adam) here. Lots of vaccine debate coming up today; we also dissect some disappointments for Cassava Sciences, Imara Therapeutics, and 134 other companies. | | | A VRBPAC meeting worth watching The FDA will host a panel of outside vaccine experts today — and they may very well discuss why they weren’t asked to convene earlier. Last week, after all, regulators authorized another round of Covid-19 boosters for people 50 and older, and those with certain immunocompromising conditions. Typically, the FDA listens to VRBPAC experts before making such sweeping decisions. That said, there will be plenty else in store for today’s meeting. The experts will also discuss whether companies ought to update the vaccines to better match circulating coronavirus strains — and how that might best be achieved. STAT will live-blog the meeting all day. Read more. | A problem for Imara (and 134 other biotechs) Yesterday, Imara Therapeutics was developing a pill for a pair of inherited blood diseases. Today, it’s not, after an interim look at data from a study in beta-thalassemia and sickle cell disease showed no benefit for patients. Development of the drug has been discontinued, leaving Imara with a shattered stock price, a nearly empty pipeline, and some difficult decisions to make about its future. Imara ended last year with $90 million in cash. With the stock price at $1 per share, its market value is only $28 million, which means investors are sending the message that management’s best course of action would be to close shop and return the cash to beleaguered shareholders. To spend the money any other way would be a waste. It may not be any consolation, but there are 134 biotechs today that share Imara’s predicament, meaning they trade at a negative enterprise value, according to BTIG analyst Ken Storch. He’s keeping a running list. In January, the number was 117. The nearly 20% decline in biotech stocks this year has sparked a debate (at least on Twitter) over the question of whether easy access to massive amounts of capital in recent years has caused the roster of public biotechs to swell unhealthily. Investor demand cannot keep up with the oversupply. One proposed fix has been to clamp down on the entry of new IPOs. Not everyone likes that idea, particularly the folks who make money on new IPOs. But there’s another way: pruning the companies — that by unfortunate circumstances — are no longer worth the cash on their books. Imara, here’s looking at you. | 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. | Cassava is slow to enroll its Alzheimer’s trial Only a smattering of Alzheimer’s patients have been enrolled in Cassava Sciences’ late-stage clinical trials — suggesting that the company’s experimental drug, simufilam, is being seen skeptically by patients and physicians alike. After six months’ worth of enrollment, just 60 patients are being treated in two Phase 3 trials — studies that planned to enroll 1,750 patients. Cassava shares dropped 11% on the news; the company’s stock is down nearly 75% since its high last July.
Simulfilam is a pill meant to correct the structure of misfolded brain protein. But the company’s scientists have been accused of falsifying laboratory and early clinical studies of the drug — and independent experts claim that Cassava has exaggerated simulfam’s cognitive benefit. Cassava denies any wrongdoing, but that doesn’t seem to be helping its case in terms of boosting enrollment numbers. Read more. | How to (maybe) save time and billions of R&D dollars Drug development is a staggeringly expensive and time-consuming pursuit — but it doesn’t have to be that way, a trio of Accenture consultants opine. The problem is that R&D costs continue to rise, without a commensurate bump in the number of treatments approved. So, they say, modernizing how research and development works could ultimately help reduce costs — from billions of dollars to millions. It could also speed treatments to the market by five years, and add opportunities for additional revenue. This includes chasing innovations in personalized medicine like cell and gene therapies — which target smaller pools of patients and have high upfront costs, but “have a higher probability of technology and regulatory success in clinical trials.” Using more digital tools and data-driven research could also help optimize R&D, they say, along with speeding up the timelines of trials by recruiting smaller cohorts and involving fewer sites. Read more. | More reads - Biden administration ramps up long Covid research efforts following criticism. (STAT)
- Through 'serial de-risking,' Sage is getting closer to building an Alzheimer's contender. (FierceBiotech)
| Thanks for reading! Until tomorrow,  | | | |
No comments