Early FDA wins: Corcept’s Lifyorli, Denali’s Avlayah
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.

Early FDA wins: Corcept’s Lifyorli, Denali’s Avlayah
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
Merck adds Terns’ promising CML drug in $6.7B buyout
Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Terns, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster drug Keytruda (pembrolizumab).
PKU ballyhoo averting Street’s gaze from Maze phase II AMKD win?
Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD).
Drama encases ACIP, CDC amid lawsuit, deadline
Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.
Today's news in brief
BioWorld briefs for March 25, 2026.
Innovent’s IBI-302 meets phase III endpoints in neovascular AMD
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
Unapproved Anktiva claims earn Immunitybio FDA warning
Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA.
UK’s MHRA sets out new scheme to promote replacement of animal models
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications.
FDA reclassifies skin lesion diagnostic devices
The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

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Analysis and data insight

With improved technologies, biomarkers, failed drugs may come into their own
Conferences
At BioEurope Spring 2026, pharma representatives and investors shared their thoughts about current and future landscapes of different disease areas, and on how to move toward success – both at the level of individual companies and for indications as a whole.
Looking for ‘tip of the spear science’ via M&As, investments
Conferences
The first day of Bio-Europe Spring, being held for the first time in Lisbon this year, featured panels on the partnering landscape in specific indications, as well as a more general panel on “Piecing Together the Therapeutic Landscape with Analyst Insights.” One theme of the panel was that by and...
US FDA clears four NMEs, including those for dermatitis, achondroplasia
Regulatory
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when approvals reached 12 in January and 16 in February (28 total), early 2026 activity is consistent with historical ranges.
Study: GLP-1RAs associated with less risk of mental illness getting worse
Diabetes
In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated...

Financings

Immutrin raises £65M series A to take another run at reversing amyloidosis
Newco news
Newco Immutrin Ltd. has raised £65 million (US$86.9 million) in a series A to take its lead antibody program through to clinical proof of concept in transthyretin amyloid cardiomyopathy.

Medical technology

Wait almost over, as SBIR nears reauthorization
Regulatory
A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.

CMR works with Nvidia to transform surgical robotics platforms
Robotic surgery
CMR Surgical Ltd.’s participation in Nvidia’s Physical AI health care robotics initiative is expected to accelerate the development of the next generation of intelligent surgical robotic systems powered by data, simulation and AI. As demand for minimally invasive procedures grows, more companies...
US Supreme Court says no to Takeda class action challenge
Regulatory
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.

Newco news

Excalipoint closes $68.7M seed round for cancer T-cell engagers
Financings
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
R1’s $77.5M series A to fund CKD trial of oral phosphate inhibitor
Financings
Newco R1 Therapeutics Inc. has launched with an oversubscribed $77.5 million series A, providing the means to take AP-306, a potentially first-in-class hyperphosphatemia therapy through phase IIb development in patients with chronic kidney disease.
Enodia jumps ahead in Sec61 targeting, adds Kezar’s program
Financings
Enodia Therapeutics Inc. was spun out of The Institut Pasteur by Argobio Studio based on the work of Caroline Demangel, co-founder of Enodia and head of the immunobiology and therapy unit at The Institut Pasteur. Demangel’s lab discovered the mechanism of action of mycolactone, a natural Sec61...
Kyron-Servier deal focused on programmable glycoprotein platform
Deals and M&A
Newco Kyron Bio is showing its colors after sealing a research agreement with Servier SA, underpinning a claim that it has overcome one of the longest-running challenges of the biotech industry, and developing technology to precisely control the glycosylation of therapeutic proteins.
Harbour Biomed spins out newco in $1.2B CTLA-4 deal
Deals and M&A
Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion.

U.S.

Karyopharm phase III Sentry entry bucks rux in MF; to FDA next
Clinical
What one analyst called an “intriguing” overall survival signal in phase III results has Karyopharm Therapeutics Inc. planning to meet with the U.S. FDA about a would-be sNDA filing for Xpovio (selinexor) in myelofibrosis (MF).

Europe

Lab-grown pig implant paves way to treat esophageal atresia
Science
Scientists at Great Ormond Street Children’s Hospital in London have reported a new advance for tissue engineered grafts in a lab-grown esophagus that has sufficient muscle regeneration to coordinate peristalsis, enabling the recipient to swallow. The aim is to generate grafts that can be used to...

Promise of exercise in a pill as Atrogi pivots from type 2 diabetes to obesity
Clinical
Atrogi AB is making a bid for a slice of the obesity market and has dosed the first overweight subjects with ATR-258, an oral therapy it says mimics the effects of exercise, driving loss of fat whilst sparing muscle.
Mestag raises $40M to take fibroblast program into phase I cancer trial
Clinical
Mestag Therapeutics Ltd. has raised a $40 million round from existing investors as it completes final preparations for its lead program MST-0312 to enter clinical development in mid-2026. MST-0312 is a bispecific antibody aimed at the lymphotoxin-β receptor (LTBR), which is essential for the...

Clinical

Triple crown: T2D purse for Lilly’s phase III retatrutide?
Diabetes
Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and...
Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer
Cancer
Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
Structure’s oral GLP-1 data mark bullish year for obesity pills
Cardiovascular
The GLP-1 fight has moved from injectables to pills, and Structure Therapeutics Inc. is in the ring with phase III-ready aleniglipron. According to the Bay Area biotech, its oral once-daily glucagon-like peptide-1 (GLP-1) drug candidate,...
Australia publishes first clinical practice guideline for psychedelics
Neurology/psychiatric
Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain...
Post-Emanate, Rhythm’s next Imcivree news aHO lot better?
Endocrine/metabolic
Low expectations for Rhythm Pharmaceuticals Inc.’s phase III study dubbed Emanate with Imcivree (setmelanotide) in a handful of rare genetic obesities meant hardly any share price consequence, and the stock (NASDAQ:RYTM) closed March 17 at $87.68,...
Cytomx soars as early colorectal cancer data beat expectations
Cancer
Shares of Cytomx Therapeutics Inc. hit a new 52-week high as the company unveiled preliminary data from an ongoing phase I study of varsetatug masetecan (Varseta-M) in late-line metastatic colorectal cancer.

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