New hypertension option as Astrazeneca’s Baxfendy wins FDA nod
Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.

New hypertension option as Astrazeneca’s Baxfendy wins FDA nod
Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.
Regeneron’s fianlimab lags in melanoma, does $2.3B deal with Parabilis
Regeneron Pharmaceuticals Inc. stuck with the tradition of releasing bad news on Friday afternoon and good news on Monday morning with a pair of announcements bracketing the weekend. On May 15, 2026, the Tarrytown, N.Y.-based company announced disappointing data for its LAG-3 inhibitor fianlimab. And then on May 18, 2026, Regeneron announced better news in the form of a deal with Parabilis Medicines Inc.
WHO declares Ebola outbreak a public health emergency of international concern
The threat posed by the Ebola outbreak in the Democratic Republic of Congo has intensified, with the confirmation that it is caused by the Bundibugyo species of the virus, for which there are no approved vaccines or antiviral therapies. At the same time, the high positivity rate, with eight laboratory confirmed cases out of 13 samples collected in various areas, and more reports of suspected cases and clusters of deaths, all point to a potentially much larger outbreak than currently is being detected and reported.
Bundibugyo is harsh reminder of need for broad vaccine strategies
On Sunday, May 17th, 2026, the World Health Organization classified the ongoing Bundibugyo ebolavirus outbreak in the Democratic Republic of Congo (DRC) as a public health emergency of international concern (PHEIC). The rapid escalation to PHEIC is due to several factors. Given the high number of cases, the outbreak has likely been going undetected for some time, and may be a “much larger outbreak than what is currently being detected and reported, with significant local and regional risk of spread,” according to the WHO statement. The outbreak appears to already have crossed the border from the DRC into Uganda at least twice. And all this is happening with a virus for which there are no approved treatments or vaccines.
US Supreme Court swats down several biopharma IRA challenges
It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.
Today's news in brief
BioWorld briefs for May 18, 2026.
Sen. Cassidy’s primary loss increases uncertainty
On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.
Boston Sci invests $1.5B in Mirus, gains option for TAVR system
Boston Scientific Corp. has invested $1.5 billion for a 34% equity stake in Mirus LLC in a deal under which it is also gaining an exclusive option to acquire the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.
Med-tech M&A’s blockbuster streak continues with $19B April value
Med-tech M&A value through the first four months of 2026 reached $62.01 billion, the highest total for the period since 2022’s $73.58 billion and a dramatic step up from 2025’s $20.03 billion and 2024’s $5.74 billion over the same period.
Degron closes $40M series A to advance molecular glue degraders
Degron Therapeutics Inc. closed a $40 million series A extension round that will see the company advance its molecular glue degraders targeting previously undruggable or insufficiently drugged proteins.

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Analysis and data insight

Biopharma deal and M&A values soar in early 2026
Deals and M&A
Biopharma deal value through the first four months of 2026 reached $92.98 billion, outpacing every recent year and running well ahead of 2025’s strong $79.82 billion over the same period. January and February each cleared $30 billion, while March and April totaled $18.05 billion and $13.3 billion,...
USPTO doubles down on inconsistencies in dual IPR-court action
Medical technology
The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.
In the mix post-Ventyx, more NLRP3s to seize?
Endocrine/metabolic
Eli Lilly and Co.’s buyout of Ventyx Biosciences Inc. for $1.2 billion at the start of the year brought to the forefront NLR family pyrin domain containing 3 (NLRP3) inhibitors on which a handful of developers have been working, and research in the space continues to roll out, as with the paper...
Life sciences ‘sweet’ opportunity in US-China talks
Medical technology
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings...

Financings

Sonomind raises €20M for ultrasound neuromodulation technology
Clinical
Sonomind SAS raised €20 million (US$23 million) in a series A funding round for its ultrasound-based neuromodulation technology for depression. The funds will be used for clinical trials of the non-invasive device, which uses a custom-made acoustic lens to precisely target deep regions within the...

Medical technology

Medical devices evolving into intelligent, adaptive systems
Cardiovascular
The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into...

Makary out at the FDA
Regulatory
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....
Roche secures CE mark for Alzheimer’s blood test
Diagnostics
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...

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...
Sonire starts US study of cancer HIFU after $18M series A
Clinical
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
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.

U.S.

Andes virus cases rise to 11; Hondius passengers in quarantine to June 21
Infection
The number of cases of hantavirus infection has risen from eight to 11, following the repatriation of passengers from the cruise ship MV Hondius, with World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus warning the danger is not over. “In fact, it has entered a new phase as...

Europe

MHRA sets out proposal to redefine gene therapies
Gene therapy
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...

Scarlet raises $4M to take manufactured red blood cells into clinic
Financings
Scarlet Therapeutics Ltd. has demonstrated its manufactured red blood cells (RBCs) act in the same way as their natural counterparts in vivo, opening the way for the cells to be used as drug delivery vehicles and raising the possibility they could replace conventional blood transfusions. To build...
Hantavirus is ‘sentinel’ more than acute pandemic threat
Analysis and data insight
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...

Clinical

Budo judo moves aplenty for Climb in autoimmune
Analysis and data insight
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...
Phase II Engene trouble: NMIBC detalimogene data throttle stock
Cancer
Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.
Entrada sinks on mixed DMD data with ENTR-601-44
Musculoskeletal
A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite...
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...
MMI’s Symani system treats Alzheimer’s patient in IDE study
Medical technology
Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic...
Cytokinetics metrics satisfy in nHCM phase III
Cardiovascular
Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic...

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