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IPO
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
Rina-S is the last candidate standing from Genmab’s $1.8 billion ProfoundBio acquisition two years ago, with the Danish drugmaker ending development of another clinical program stemming from the buyout.
A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market.
If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.
CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.
Renewed pharma interest in GPCR biology and radioligand therapies is drawing attention to functional peptide screening platforms.
Shares of REGENXBIO declined 37% on a mixed data readout and other updates from the company’s first quarter earnings call Thursday.
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data.
FDA
In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
Degron Therapeutics will have stiff competition in immunology, as Novartis inked a $5.7 billion agreement with Monte Rosa Therapeutics last year to develop molecular glues for undisclosed immune-mediated conditions.