Chiesi snags on-demand HAE drug in $1.9B Kalvista buy
In its largest acquisition to date, Chiesi Group is buying Kalvista Pharmaceuticals Inc. for $27 per share, a roughly 40% premium to the previous day’s closing price, putting the total deal value at about $1.9 billion. In return, the Italian pharma firm adds to its rare disease franchise Kalvista’s recently approved hereditary angioedema (HAE) drug, plasma kallikrein inhibitor Ekterly (sebetralstat), which has gotten off to a strong commercial launch as the only orally available, on-demand treatment for HAE.

Chiesi snags on-demand HAE drug in $1.9B Kalvista buy
In its largest acquisition to date, Chiesi Group is buying Kalvista Pharmaceuticals Inc. for $27 per share, a roughly 40% premium to the previous day’s closing price, putting the total deal value at about $1.9 billion. In return, the Italian pharma firm adds to its rare disease franchise Kalvista’s recently approved hereditary angioedema (HAE) drug, plasma kallikrein inhibitor Ekterly (sebetralstat), which has gotten off to a strong commercial launch as the only orally available, on-demand treatment for HAE.
Supremes weigh in on skinny labels in long-awaited argument
The U.S. Supreme Court’s ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market.
AA meeting of minds as PTC, Novartis push votoplam in HD
What PTC Therapeutics Inc.’s latest data with votoplam might mean in the Huntington’s disease (HD) landscape became grist for Wall Street after the firm unveiled top-line results from the phase II Pivot-HD study, sharing data from the 24-month interim analysis of the long-term extension effort.
China’s new IIT rules could reshape early stage drug development
China’s investigator-initiated trial (IIT) system is increasingly being used to generate early human data in cell and gene therapies, and new changes that widen the pathway are expected to drive more multinational companies to conduct IITs in China, panelists said during the Chinabio Partnering Forum in Shanghai April 28-29.
Bio Korea 2026 kicks off with spotlight on oligonucleotides
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
Caredx to acquire Naveris for up to $260 million
Caredx Inc. has agreed to acquire Naveris Inc., a precision oncology diagnostics company, for up to $260 million, as part of its strategy to accelerate growth. The acquisition comes as Caredx, an organ transplant diagnostic firm, reshapes its portfolio, expanding its oncology profile while recently divesting its lab products business.
MFDS clears Curocell’s anbal-cel as first homegrown CAR T therapy
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
Today's news in brief
BioWorld briefs for April 29, 2026.
Enterobiotix raises $25.7M for phase IIb of microbiome pill in IBS
Microbiome specialist Enterobiotix Ltd. has raised £19 million (US$25.7 million) to fund phase IIb development of its lead program EBX-102-02 in the treatment of irritable bowel syndrome with constipation (IBS-C).
Innervation can slow, as well as speed, tumor growth, study finds
Innervation by the sympathetic nervous system is typically a boon to tumors. But researchers from Weill Cornell Medicine and colleagues have shown that in some cases, the relationship between tumors and the nervous system is more complex. Depending on context, innervation can either assist or obstruct tumor growth. “The nervous system typically has been considered as a driver of cancer growth, but here we’ve found that it can be a brake on cancer growth in some contexts,” said David Simon, an assistant professor of biochemistry and biophysics at Weill Cornell Medicine.
FDA looks toward a future of continuous real-time trials
Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.
Purdue sentenced in federal court, ordered to pay $5B
More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties.

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Analysis and data insight

US legislative reforms needed to make biosimilars competitive
Regulatory
Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.
Xenon spikes, Theravance sinks after phase III readouts in March
Clinical
BioWorld tracked 209 clinical trial readouts across phases I through III in March 2026, up from 152 in February and 144 in January. Among late-stage programs, 26 phase III trials reported positive results, two produced mixed results, and three failed to meet key endpoints. By phase, March updates...
Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest
Deals and M&A
A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
China partnerships lead biopharma deal surge in Q1 2026
Deals and M&A
Biopharma deal value reached $79.22 billion in the first quarter (Q1) 2026, marking a strong start to the year and an increase of about 17% from $67.6 billion in Q1 2025 and similar to $78.93 billion in Q4 2025. The total is the highest first-quarter tally in recent years, and the highest quarter...

Financings

Nervonik raises $52.5M to advance PNS system
Medical technology
Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system designed to treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including...

Medical technology

Med-tech companies highlight PFA data as competition intensifies
Clinical
New data on pulsed field ablation (PFA) presented at Heart Rhythm 2026 in Chicago over the weekend continue to show the benefits and superiority of the technologies in treating patients with atrial fibrillation. The PFA landscape is fast-evolving and med-tech players are jostling for market share...

Edwards raises 2026 guidance on strong TAVR performance
U.S.
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings...
Cochlear’s 39% stock plunge resets ‘defensive growth’ narrative
Analysis and data insight
Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed.

Newco news

Pilatus PLT-012 takes immunometabolic approach to reprogram TME
Cancer
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin...
Anaptysbio’s spinout First Tracks hits the slopes
Immune
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end...
Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I
Clinical
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for...
‘Immune reset’ is ambition of Tr1x’s allogenic Tr1 cell therapy
Clinical
Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is...
Realta secures another $40M for its hypoxic ischemic encephalopathy treatment
Financings
Realta Life Sciences Inc. raised an additional $40 million in the final tranche of its series A investment, bringing the total the company has raised to more than $150 million through mission-driven investors and a family-office model.

U.S.

Soligenix plummets on trial halt for Hybryte in lymphoma
Clinical
Soligenix Inc. intends to spend the next weeks further analyzing data and reviewing strategic options in the wake of a disappointing interim analysis from a pivotal phase III study testing Hybryte, its synthetic hypericin, in cutaneous T-cell lymphoma.

Europe

Netrin-1 inhibitor blocks chemo resistance in pancreatic cancer
Clinical
Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.

Xeltis secures CE mark for Axess, its hemodialysis conduit
Clinical
Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related...
Whole genome sequencing unveils blood cancer trajectory
Conferences
A new study tracking the genomic evolution of chronic myeloproliferative neoplasms has shown that progression to myelofibrosis or acute myeloid leukemia is encoded in mutations that occur years before the transformation is clinically evident.

Clinical

Death a sticking point in Erasca molecular glue phase I
Cancer
A patient death marred Erasca Inc.’s phase I dose-escalation efforts with pan-RAS molecular glue ERAS-0015 in cancer, and shares (NASDAQ:ERAS) ended April 28 at $9.90, down $9.25. ERAS-0015 is being tested in RAS-mutant solid tumors, specifically...
Akeso sets durability bar as immuno-oncology 2.0 race heats up
Conferences
Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to...
Early data position Junshi in next-gen immuno-oncology race
Conferences
Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American...
Nektar’s rezpeg more than worth its SALT in alopecia phase IIb
Dermatologic
With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals...
Delta-Fly eyes NDA path despite AML phase III miss
Regulatory
Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy...
Lilly’s GLP-1 Foundayo aces MACE in DILI of a phase III
Diabetes
Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with...

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