The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso.
Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
At the center of Biohaven’s agreement with SK Biopharmaceutical is the ion channel platform and the lead epilepsy candidate opakalim, for which Phase 2/3 data are expected later this year.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Gastroesophageal adenocarcinoma presents the biggest market opportunity for Jazz Pharmaceuticals’ Ziihera, according to Truist Securities, which forecasts peak sales of the drug to reach $2.5 billion.
Though the potential change is unconfirmed, media outlets reported Wednesday that one deputy commissioner would focus on the intersection between health and AI, while another will be dedicated to drugs.
FEATURED STORIES
Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the height of the COVID-19 pandemic.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14 to 16 September, where 59 agreements have been signed across three editions.
Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.
Real progress happens where unmet medical need is greatest and patient impact can be clearly measured. Pediatric rare cancers exemplify these criteria and have therefore generated continued investment, even in a capital-constrained environment.
If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines.
UPCOMING EVENTS
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Tuesday, September 1, 2026 8am–5:30pm PDT·San Francisco, California
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Wednesday, September 2, 2026 8am–6:10pm PDT·San Francisco, California
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Thursday, September 3, 2026 8am–6:10pm PDT·San Francisco, California
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Tuesday, September 8, 2026 8am–6:15pm PDT·San Francisco, California
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Tuesday, September 8, 2026 2–3pm EDT·Virtual
LATEST PODCASTS
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
In this episode of Denatured, you’ll hear from Ian McGowan, Chief Medical Officer at Synklino and James Hunter, associate professor of transplantation at Oxford University. We explore transplantation and antiviral innovation and why CMV remains one of the most persistent and consequential challenges facing transplant patients today.
Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide.
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SPECIAL EDITIONS
Job postings increase and competition dips, according to BioSpace data.
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
DEALS
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Haisco Pharmaceutical Group has been on a deal hot streak this year, inking major deals with Eli Lilly, AbbVie and more. The new company will take on one of Haisco’s core immunology assets. -
Roche, through its subsidiary Genentech, will gain access to the investigational asset HM17321, which is designed to not only elicit weight loss but also improve lean mass. -
The merger, which would create a new company bearing Ambros’ name, will help support development of Ambros’ non-opioid painkiller for patients with debilitating limb injuries. -
The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues. -
This is the third recent acquisition conducted by Denmark’s LEO Pharma in medical dermatology, a portfolio that marked 12% growth in the first half of the year.
WEIGHT LOSS
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Eli Lilly’s best play for Foundayo is to bring it overseas, a more price-sensitive market where the pharma can more readily outcompete Novo Nordisk “given the high margins of a small-molecule therapy,” Truist analyst Srikripa Devarakonda told BioSpace. -
The Phase 3 study is evaluating two doses of Novo’s Wegovy pill in people with obesity or overweight in combination with a reduced-calorie diet and increased physical activity. -
Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment. -
Despite coming away with an early victory over Eli Lilly in the oral obesity face-off, analysts don’t expect Novo Nordisk’s lead to last for very long. -
Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for weight loss.
POLICY
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The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr. -
Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients. -
While there are several FDA-approved psychiatric medicines on the market, many patients still struggle to achieve lasting symptom relief. Psychedelics could help fill this gap. -
A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allowance of novel trial designs for small patient populations. -
Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
Business stage is just one factor in whether biopharmas want job candidates to have oncology experience for oncology roles. Two recruiters explain when oncology expertise matters most, the mistakes job seekers make and how to make a good impression.
Working at a Big Pharma has its benefits, but there are limitations too. SERB Pharmaceuticals’ Thomas Kolaras discusses how moving to a midsize company creates new opportunities for sharpened thinking and leadership.
The choices that change a career often look like extra work at the time. Executive coach Angela Justice examines why the projects, questions, relationships and conversations people almost dismiss can become the ones they later recognize as turning points.
AI tools can help job seekers write resumes and mass apply to open positions, but those aren’t the only, or best, ways to use them. A career coach shares how she advises clients to make the most of AI during the application and interview process.
HOTBEDS
IN CASE YOU MISSED IT
Kaos Capital in a letter to other Capricor Therapeutics shareholders called for “an immediate meeting, board change, and capital-preservation plan.” The biotech recently put all other pipeline work on pause as it awaits an Aug. 22 PDUFA date for embattled cell therapy deramiocel.
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head. -
Investors had been pessimistic about the probability of success for the personalized cancer vaccine intismeran autogene, so the Phase 3 win was a welcome surprise. -
Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA. -
Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide.
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Ivonescimab notched its third approval in China last week, but the label update has tempered expectations for the Summit Therapeutics/Akeso drug, showing that progression-free survival declines over time.
NEUROSCIENCE
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The FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market. -
It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression. -
Epicrispr Biotechnologies is working on an epigenetic medicine for facioscapulohumeral muscular dystrophy, while Infinimmune will advance a pair of antibodies for atopic dermatitis. -
Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments. -
Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.
CELL AND GENE THERAPY
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The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new target action date for the therapy is November 22. -
The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September. -
Johnson & Johnson secured rights to prizlon-cel in 2023 for $245 million upfront. The asset in June last year showed a 100% response rate as a second-line option in a Phase 1b study for 10 patients with relapsed or refractory large B cell lymphoma. -
Capricor Therapeutics’ CEO Linda Marbán believes the FDA is willing to work with the biotech as the Aug. 22 deadline approaches for its Duchenne muscular dystrophy cell therapy deramiocel, with the biotech’s stock climbing 68% on the update. -
In November 2025, one patient died after receiving Intellia Therapeutics’ investigational gene silencer for transthyretin amyloidosis.
