Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
Texas Attorney General Ken Paxton claims that through an alleged kickback scheme Eli Lilly “fraudulently sought to maximize profits at taxpayer expense.”
Insmed’s Brinsupri is the first DPP1 inhibitor approved by the FDA and the first treatment for bronchiectasis to reach the market.
Jefferies analysts said these detailed safety outcomes confirm the gene therapy’s positive risk/benefit profile in ambulatory patients with Duchenne muscular dystrophy.
Alastair Thomson, chief data officer at the HHS sub-agency, announced his resignation in opposition to Health Secretary Robert F. Kennedy Jr.'s “stupid” decision to cancel $500 million worth of contracts focused on mRNA technology.
For $1.3 billion in aggregate—including upfront and milestone payments—Bayer will get exclusive global access to Kumquat Biosciences’ small-molecule KRAS G12D blocker.
FEATURED STORIES
Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these six biotechs are playing in the largely underappreciated longevity space, developing therapies that may improve the quality of aging.
The industry sector focused on aging is only about 10 years old, but acting on what scientists already know, a new crop of biotechs, backed by investors, are taking a disease-centric approach to extending the human lifespan.
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target.
Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical industry’s reputation amid mounting criticism.
Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know.
FROM BIOSPACE INSIGHTS
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Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
Job Trends
Nearly half of BioSpace poll respondents recently took a biopharma job they were overqualified for, a finding that didn’t surprise a talent acquisition expert, who said it’s become much more likely to happen.
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SPECIAL EDITIONS
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
DEALS
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Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.” -
Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space. -
AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow. -
The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules. -
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.
WEIGHT LOSS
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The deal is Lilly’s second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins. -
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks. -
In what Guggenheim Partners called one of Metsera’s “critical program milestones” this year, its ultra-long-acting amylin injection MET-233i showed promising weight-loss after a little more than a month of treatment. -
Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy. -
Eli Lilly joins up with Camurus to make long-acting versions of the pharma’s obesity and diabetes drugs, joining the industry’s growing pipeline of programs that are differentiated by the frequency of dosing.
POLICY
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Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details. -
While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.” -
In a post on X, Health Secretary Robert F. Kennedy Jr. alleged that the Vaccine Injury Compensation Program has “devolved into a morass of inefficiency, favoritism, and outright corruption.” -
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday. -
Health Secretary Robert F. Kennedy Jr. wants to remove all members of the USPSTF for being too “woke,” according to reporting by the Wall Street Journal. An HHS spokesperson, however, says no final decision has been made about the panel.
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HOTBEDS
REPORTS
If people are your greatest asset, it is imperative that your organization maintains a positive employer brand presence and talent pipeline. This report covers how you can build a strong employer brand with prospective employees, current employees - and former employees.
In challenging conditions, how can employers optimize the employee experience to retain their top talent and make the most of their current teams?
In the 2020 US Life Sciences Diversity & Inclusion report, BioSpace dives into how different segments of employees experience and perceive policies, attitudes and actions. Our data suggests that there are significant disparities between segments.
CANCER
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While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy. -
Pfizer insists that the discontinuation of the Phase II study was due to recruitment difficulties and was not linked to maplirpacept’s safety or efficacy. -
In a detail-thin announcement, Amgen said that adding bemarituzumab to chemotherapy improved overall survival, though analysts pledged to wait for more data on safety and tolerability before assessing the drug. -
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month. -
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
NEUROSCIENCE
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Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation. -
The FDA found that data from a single Phase II study were “insufficient” to justify an accelerated approval review for sevasemten in Becker muscular dystrophy.
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While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development. -
Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes. -
The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.
CELL AND GENE THERAPY
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While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential. -
The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
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The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets. -
Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta.
