Makary out at the FDA
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.

Makary out at the FDA
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.
Advancing the 'best of both' – BMS, Hengrui enter $15.2B deal
In a deal potentially worth up to $15.2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. is joining efforts with Bristol Myers Squibb Co. to advance 13 early development programs in the fields of oncology, hematology and immunology. Shanghai-based Hengrui will hold exclusive rights in mainland China, Hong Kong and Macau, while Princeton, N.J.-based BMS will hold exclusive rights in the rest of the world. The deal includes four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five assets that the two companies will jointly discover and develop.
Roche secures CE mark for Alzheimer’s blood test
Roche Holding AG secured CE marking for the Elecsys plasma phosphorylated-tau 217 blood test designed to rule in and rule out amyloid pathology, a hallmark of Alzheimer's disease. Developed with Eli Lilly and Co., the test brings to the market another much-needed solution to help clinicians diagnose Alzheimer’s patients following the FDA approval of Fujirebio Diagnostics Inc.’s blood test last year.
Coming through on Veppanu with back-loaded Rigel deal
Rigel Pharmaceuticals Inc. CEO Raul Rodriguez said breast cancer therapy Veppanu (vepdegestrant) could become his firm’s “largest product with the current label,” and other opportunities with the drug are lined up behind, albeit “still a bit early.”
Metis Techbio, Impact Tx cleared for Hong Kong IPOs
Metis Techbio Co. Ltd. is seeking a potential HK$2.11 billion (US$270 million) raise through a stock sale May 13, marking the largest biotech raise on the Hong Kong Stock Exchange this year to date. Hangzhou, China-based Metis is an AI-based nanoparticle drug formulation and delivery-focused company. Synthetic lethality-based cancer drugmaker Impact Therapeutics Inc., of Shanghai, plans to debut on the same day with a US$117 million IPO.
Today's news in brief
BioWorld briefs for May 12, 2026.
MHRA sets out proposal to redefine gene therapies
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to correct the mismatch between regulatory terminology and modern science, which MHRA says “can lead to uncertainty” over how a product is classified and to “inconsistent oversight and potential barriers for developers."
Commerce gives Rx companies 30 days to submit US onshoring plans
Companies seeking a break in the soon-to-be-implemented U.S. Section 232 biopharma tariffs have 30 days to apply for a company-specific onshoring agreement with the Department of Commerce, according to the procedures the department laid out in a notice to be published in the May 13 Federal Register.
Two-step HIV vaccine induces broadly neutralizing antibodies
A designed chimeric virus induced broadly neutralizing antibodies against the macaque equivalent of HIV. The strategy works in two steps: first it uses an envelope protein with a mutation that reduces the glycan shield that makes it invisible to the immune system, and then it exposes the part of the protein most likely to generate these antibodies capable of blocking many variants of the virus. The macaques developed potent and diverse antibodies with this approach, which pave the way for the development of an HIV-1 vaccine.

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Analysis and data insight

Follow-ons hit 7-year high, lead med-tech's $10B start to 2026
Financings
Med-tech financing activity in the first four months of 2026 reached $10.05 billion, similar to 2025’s $10.31 billion and 2022’s $10.62 billion. While below the peak years of 2019-2021, when financings were above $15 billion in the time period, total value is still above the levels seen in...
Budo judo moves aplenty for Climb in autoimmune
Clinical
Climb Bio Inc. outlined May 5 an enticing data spill ahead this year with Fc-enhanced monoclonal antibody budoprutug (budo) in autoimmune diseases. Mizuho analyst Joseph Catanzaro appreciated in his report Wellesley Hills, Mass.-based Climb’s “conviction that CD19 represents a best-in-class...
Moderna, Vir among early 2026 top infectious disease gainers
Infection
Infectious disease-focused biopharma stocks, tracked on the BioWorld Infectious Disease Index (BIDI), saw their collective shares roughly follow the path of broader markets like the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) in early 2026. The BIDI ended April up...
Hantavirus is ‘sentinel’ more than acute pandemic threat
Science
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading...

Financings

Mobia debuts on Nasdaq to bring stroke therapy to more patients
Medical technology
Mobia Medical Inc. began trading on Nasdaq under the ticker MOBI on May 8. The company priced its IPO at the midpoint of its proposed $14 to $16 range, selling 10 million shares at $15 each and raising approximately $150 million. The stock closed at $11.75 its first day of trading, down 21.7%.

Medical technology

Bright Uro secures FDA approval for abdominal sensor
Regulatory
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multichannel urodynamic studies. The new sensor will allow clinicians to perform multichannel urodynamics, capturing both abdominal and detrusor...

US FDA tries out 1-day inspections
Regulatory
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.
Multiple appearances on Priority Watch List leading to action?
Regulatory
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.

Newco news

Eyes are first prize for newco Link Biologics
Science
The classic origin story for a biotech startup is that of a scientist who nurtures his work out of a university and to commercial success. For Link Biologics Ltd. and its TSG6-based pipeline, the story is the other way around; it began with now-CEO Reuben Dawkins meeting University of Manchester...
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...
Tortugas launches with $106M for neurology, neuropsychiatric drugs
Financings
Tortugas Neuroscience Inc. came out of its shell to announce the raising of $106 million between its seed and series A financing rounds. “We like the symbolism of the sea turtle – long-lived, persistent, very determined,” Tortugas CEO Jeff Jonas said of the company’s name.
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...

U.S.

MBX highlights early data for monthly obesity drug MBX-4291
Clinical
Shares of MBX Biosciences Inc. hit a 52-week high on preliminary phase I data for its MBX-4291, a GLP-1/GIP co-agonist prodrug for obesity. Though early and still blinded, findings from the trial showed promising efficacy, along with good tolerability and the potential for once-monthly dosing,...

Europe

Swiss Biotech reports record private investment, employment in 2025
Analysis and data insight
Privately-funded biotechs in Switzerland raised a record CHF1.15 billion (US$1.47 billion) in 2025, an increase of 38% over 2024, and 45% of the total capital raised by the sector. This was a significant advance on previous years, when private companies typically attracted about 30% of overall...

Cytospire raises £61M series A to target EGFR in solid tumors
Financings
Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance the lead program CYT-X300 to the clinic in the treatment of EGFR-positive solid tumors. The company’s pan gamma delta (γδ) TCEs are...
UCB onboards more autoimmune TCEs with $2.2B Candid buy
Cancer
UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026.

Clinical

Abdakibart phase II graded, puts Avalo in HS upper class
Dermatologic
Avalo Therapeutics Inc. may have designed in lead asset abdakibart, a drug for hidradenitis suppurativa (HS) that offers a novel mechanism of action, wide dosing interval, and more-than-satisfying outcomes on the Hidradenitis Suppurativa Clinical...
Viridian’s Reveal-2 beats expectations with elegrobart in TED
Ocular
Top-line data from the Reveal-2 phase III trial of elegrobart to treat chronic thyroid eye disease (TED) drove Viridian Therapeutics Inc.’s stock up by 33.6%, positioning the company for a BLA filing in the first quarter of 2027. The trial met...
Celcuity rises on gedatolisib on top-line data in breast cancer
Cancer
As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of...
Up to BAT in PSC, Mirum base case proven with phase IIb
Endocrine/metabolic
Entering what Mirum Pharmaceuticals Inc. CEO Chris Peetz called “a new phase of growth and value creation,” the company plans to submit an NDA to the U.S. FDA in the second half of this year, based on phase IIb data from the Vistas trial with oral...
How to Summit up? Dis-Harmoni on ivonescimab NSCLC phase III
Cancer
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell...
Bio Korea 2026 kicks off with spotlight on oligonucleotides
Analysis and data insight
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...

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