Celcuity’s Revtorpyk wins FDA nod in breast cancer
For the second time in two months, Celcuity Inc. failed to generate investor excitement despite disclosing positive news, this time following the U.S. FDA approval of Revtorpyk (gedatolisib) in a subset of breast cancer patients, marking the firm’s first foray into the commercial space and introducing a new treatment option for patients. Wall Street instead focused on an unanticipated launch delay, sending shares of Celcuity (NASDAQ:CELC) down 17.6% to close July 15 at $91.51.

Celcuity’s Revtorpyk wins FDA nod in breast cancer
For the second time in two months, Celcuity Inc. failed to generate investor excitement despite disclosing positive news, this time following the U.S. FDA approval of Revtorpyk (gedatolisib) in a subset of breast cancer patients, marking the firm’s first foray into the commercial space and introducing a new treatment option for patients. Wall Street instead focused on an unanticipated launch delay, sending shares of Celcuity (NASDAQ:CELC) down 17.6% to close July 15 at $91.51.
CDC nominee’s qualifications shadowed by Kennedy agenda
U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response.
Hansoh takes newco route to globalize IL-23 asset
Hansoh Pharmaceutical Group Co. Ltd. has taken a new step in the evolution of China’s “newco” strategy, combining its newly created U.S. company, Avere Therapeutics Inc., with Nasdaq-listed Nextcure Inc. in a deal designed less to merge pipelines than to create a public vehicle for global development of a China-originated asset.
Women’s health investment climbs but funding challenges remain
There is no doubt that investment into women’s health is increasing. According to a new report by W Group, in 2025, $1.55 billion in disclosed equity was raised by 85 women’s health companies, across more than 30 countries. However, challenges remain.
New research identifies EBV antigen targets for MS therapies
New research has teased out specific aspects of how Epstein-Barr virus (EBV) sparks the immune response that leads on to the development of multiple sclerosis (MS), opening the way to the rational design of vaccines and antivirals that address the root cause of the disease.
Today's news in brief
BioWorld briefs for July 15, 2026.
Senator calls for investigation of Kennedy’s ‘election interference’
There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he’s facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary.
GABA signaling linked to immune resistance in some tumors
Certain cancers that contain organized clusters of immune cells known as tertiary lymphoid structures (TLS) do not respond to treatment as well as expected. Even though they have TLS that support the elimination of cancer cells, they remain resistant to immunotherapy. γ-Aminobutyric acid (GABA), better known as the brain’s major inhibitory neurotransmitter, may play a role in this lack of response by acting as an immunoregulatory metabolite, according to a study led by scientists at Sorbonne Université.
FTC settling case against CVS’ PBM
In an effort to drive down out-of-pocket costs for Americans, the U.S. FTC is resolving an antitrust case through a proposed second settlement with a large pharmacy benefit manager (PBM) and its affiliates.

Analysis and data insight

Asia deal flurry draws AZ, Spero to $1B+ Dizal, Innovent assets
Deals and M&A
Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.
Danaher-Masimo close caps med tech’s strongest first-half since 2022
Deals and M&A
Med-tech M&As through the first half (H1) of 2026 reached $75.73 billion in collective value, the highest H1 total since 2022’s $120.4 billion and well above every other year in BioWorld’s records. June contributed $12.21 billion, a rebound from May’s relatively quiet $1.51 billion.
Combination locked out in ATTR-CM? ‘Dead,’ expert says
Clinical
The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis...
SEC reform good for life sciences startups, but getting pushback
Medical technology
Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of...

Financings

Drug Farm bags $55M series D to advance AI-developed ALPK1 drug
Cardiovascular
Drug Farm Biotechnology Co. Ltd. closed a $55 million series D round to advance its AI-developed alpha-protein kinase 1 (ALPK1) inhibitor, DF-003, in a phase III trial for ROSAH syndrome, a rare genetic disease that can lead to blindness.

Medical technology

Newronika gains CE mark for adaptive DBS system with Webbiobank
Regulatory
Newronika SpA received CE mark certification for its latest adaptive deep brain stimulation (aDBS) system, which includes the integration of Webbiobank, its proprietary cloud-based neural data platform.

Zeta secures FDA clearance for TMS robotic system
Regulatory
Zeta Surgical Inc. received U.S. FDA 510(k) clearance for its transcranial magnetic stimulation (TMS) robotic system which is designed to support precise and repeatable TMS therapy for patients with treatment-resistant depression.
Science fiction realized: BCI tech is here
After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care,...

Newco news

Oblenio’s $62M series B for trispecific antibody in autoimmune diseases
Financings
A year and a half from its formation, Oblenio Bio has generated positive nonhuman primate data for LBL-051 in chronic autoimmune diseases and closed a $62 million series B to move the trispecific T-cell engager into the clinic.
Bionyra closes $165M series A to develop antibodies for inflammation
Financings
Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases.
Ethyreal launches to treat the underlying cause of Graves’, TED
Conferences
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.
Skape Bio unlocks GPCR targets with de novo-designed miniproteins
Science
Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating...
Newco news: Oorja energizes with $30M for IPF
Respiratory
Oorja Bio Inc., named after the phonetic spelling of “energy” in Sanskrit, secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and...

U.S.

Samsung Bioepis’ Keytruda biosimilar hits phase I, III endpoints
Clinical
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and...

Europe

First purpose-designed Ebola Bundibugyo vaccine ready for phase I
Clinical
The Oxford Vaccine Group has delivered on its promise, and after starting work in mid-May has completed preclinical testing and is ready to begin a phase I trial of a vaccine against the Bundibugyo Ebola virus that is causing the current serious disease outbreak in the Democratic Republic of Congo.

UK to launch Alzheimer patient database to speed up trials
Clinical
The U.K. is setting up a nationwide registry of people with dementia, who will be pre-screened and consented, to speed up recruitment to clinical trials and collect real-world evidence of effectiveness once therapies are approved.
NEJM paper on Tavneos pivotal trial retracted by academic authors
Regulatory
The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.

Clinical

Takeda's mezagitamab adds quality-of-life gains to ITP responses
Hematologic
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP)...
Forte, First Tracks soar on CD122 success in vitiligo; celiac next
Immune
Encouraging phase I data this week of new treatments for vitiligo, a chronic autoimmune disorder that destroys melanocytes, drove investor excitement, with Forte Biosciences Inc. the latest company to disclose a statistically significant benefit.
Seres’ SER-155 takes on immune checkpoint inhibitor-related enterocolitis
Cancer
While the emergence of immune checkpoint inhibitor (ICI) therapy in recent years has significantly improved cancer outcomes, some patients have been unable to experience the full therapeutic benefits of ICIs due to significant gastrointestinal...
Island Pharma targets Ebola species lacking approved treatments
Infection
Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare...
Phase II DMD Trailhead data hike Satellos’ stock
Musculoskeletal
Pending talks with regulators, Satellos Bioscience Inc. may seek accelerated approval in Duchenne muscular dystrophy (DMD) for SAT-3247, which yielded positive results in the adult phase II Trailhead study. Shares of Toronto-based Satellos...
With tardy Tvardi phase I win, skin in STAT3 game plus GI
Dermatologic
Tvardi Therapeutics Inc. rebounded from a phase II blowup last fall in idiopathic pulmonary fibrosis (IPF) with oral STAT3 inhibitor TTI-101 by showing that a next-gen phosphate prodrug dubbed TTI-109 kept its potency in phase I without...

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