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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.
Regulators overseeing rare disease treatments need better tools to weigh competing risks in real time. Sarepta Therapeutics’ Elevidys is a prime example of why.
IPO
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.
The company plans to divest a drug it has made for 40 years, citing increasing production costs and falling prices.
Following Monday’s clinical defeat by Eli Lilly, Novo Nordisk cut the 2027 list prices for its three GLP-1 medicines by as much as 50%, while boasting Phase 2 data for its invesigational triple-G agonist.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
In August last year, the Health Department cut around $500 million in mRNA research funding, with Health Secretary Robert F. Kennedy Jr. saying the agency would instead divert the money “toward safer, broader vaccine platforms.”
Ecnoglutide, which Pfizer licensed from Sciwind Biosciences, is already approved in China for type 2 diabetes mellitus, and a marketing application for weight loss has been accepted by regulatory authorities in the country.
Following a disappointing Phase 3 performance and given Gossamer Bio’s balance sheet, seralutinib’s path to the market for pulmonary arterial hypertension has become unclear, according to analysts at Guggenheim Partners.