NEW YORK CITY (dpa-AFX) - This week's biotech highlights Lilly's strong Phase 3b maintenance results for Zepbound and Foundaya, Rigel's global license for the first FDA-approved PROTAC therapy Veppanu, and Bristol Myers Squibb's $15.2 billion collaboration with Hengrui Pharma. The regulatory front saw ATyr refining its Phase 3 path for Efzofitimod, Apyx gaining expanded AYON clearance, and argenx broadening VYVGART's label. On the clinical side, Alpha Tau, SELLAS, and Lilly reported positive updates across oncology, hematology, and obesity.
Let's unpack the specifics.
FDA Approvals and Rejections
ATyr Pharma Refines Phase 3 Path for Efzofitimod in Sarcoidosis
aTyr Pharma, Inc. (ATYR) outlined updated regulatory guidance and clinical plans for Efzofitimod in pulmonary sarcoidosis following a Type C FDA meeting, with the agency recommending endpoints tied to patient function and quality of life, including FVC as the primary and KSQ-Lung as the key secondary measure.
The company plans to file an IND in June 2026 for a global Phase 3 trial enrolling about 372 patients, using a 5 mg/kg IV dose every three weeks, according to FDA feedback to enhance exposure while maintaining safety.
Prior EFZO-FIT data showed clinically meaningful FVC improvements in patients with restrictive lung disease and positive trends in patient-reported outcomes.
ATRY closed Thursday's trading (May 14, 2026) at $0.55, up 41.42%
Apyx Medical Gains Expanded FDA Clearance for AYON System
Apyx Medical Corporation (APYX) received expanded FDA 510(k) clearance for its AYON body- contouring platform to add power to liposuction capability, introducing a second fat-removal modality designed to improve efficiency and reduce surgeon effort.
The system integrates fat removal, contouring, and Renuvion tissue contraction in one platform, and the company plans a limited commercial launch while working with early adopters.
APYX closed Thursday's trading at $4.36, up 13.54%
ARGX Wins FDA Approval Expanding VYVGART Label to All Adult GMG Patients
argenx SE (ARGX) received FDA approval expanding the labels for VYVGART and VYVGART Hytrulo to treat all adult generalized myasthenia gravis (gMG) patients regardless of antibody status, supported by Phase 3 ADAPT SERON data showed rapid and significant MG-ADL improvements including a 3.35-point mean gain at week 4 and sustained benefit across cycles.
Safety remained consistent with prior studies, and the franchise generated $1.3 billion in Q1 2026 sales, up 63% year-over-year, with full-year 2025 revenue reaching $4.2 billion.
ARGX closed Thursday's trading at $822.13, up 2.42%
Deals
WORK Medical Partners with Novabioplus to Build AI-Driven BioToken Model
WORK Medical Technology Group Ltd. (WOK) signed a strategic cooperation agreement with Shanghai Novabioplus Biotechnology Co., Ltd. to develop next-generation intelligent medical models, combining WORK's AI capabilities with Novabioplus' protein data resources to advance for 'AI+' programs spanning membrane protein design, antibody sequence optimization, enzyme molecule design, and peptide design.
The collaboration centers on creating 'BioTokens,' digital assets derived from protein sequences and functional datasets to enable verifiable biomolecular design and new value pathways in biopharma R&D.
Management called the deal a milestone in WORK's shift from device manufacturing to a broader life-sciences digital ecosystem.
WOK closed Thursday's trading at $1.30, down 52.90%.
Rigel Pharma Licenses FDA-Approved PROTAC Therapy Veppanu from Arvinas, Pfizer
Rigel Pharmaceuticals, Inc. (RIGL) signed a global license agreement with Arvinas, Inc. (ARVN) and Pfizer Inc. (PFE) to develop, manufacture and commercialize Veppanu, the fist approved PROTAC therapy for ER-positive/HER2-negative, ESR1-mutated metastatic breast cancer.
The agreement includes $70 million upfront, $15 million for transaction activities, and up to $320 million in milestones, with tiered mid-teens to mid-twenties royalties.
Rigel will lead U.S. commercialization and fund up to $40 million in development over four years, with closing expected mid-June 2026.
RIGL closed Thursday's trading at $31.92, down 0.65%.
Bristol Myers, Hengrui Sign $15.2 B Multi-Program Drug Development Pact
Bristol Myers Squibb (BMY) and Hengrui Pharma (01276.HK) entered a strategic collaboration covering 13 early-stage oncology, hematology and immunology programs, with BMS gaining global rights to Hengrui assets outside China and Hengrui receiving rights to BMS assets within its territories.
The deal includes $600 million upfront and up to $950 million in near-term payments with a total potential value of $15.2 billion.
The transaction is expected to close in Q3 2026.
BMY closed Thursday's trading at $56.77, up 0.67%.
Clinical Trials- Breakthroughs & Setbacks
Alpha Tau Posts Strong Interim Glioblastoma Data in REGAIN Trial
Alpha Tau Medical Ltd. (DRTS) reported encouraging interim results from its U.S. REGAIN study of Alpha DaRT in recurrent glioblastoma, with two of the first three patients showing complete responses and disappearance of tumor lesions on MRI scans. The therapy delivers radium-224 directly into tumor to release localized alpha radiation targeting resistant brain cancer cells.
DRTS closed Thursday's trading at $10.41, up 7.99%.
SELLAS Advances Galinpepimut-S In AML Phase 2a Trial
SELLAS Life Sciences Group, Inc. (SLS) reported progress in its Phase 2a study of Galinpepimut-S in acute myeloid leukemia, noting continued enrolment and early signals of clinical activity supporting its potential as a novel immunotherapy in this high-need setting. The company said the trial remains on track, with updates expected later in 2026.
SLS closed Thursday's trading at $7.42, up 13.63%.
Lilly Reports Positive Phase 3b Zepbound and Foundaya Data
Eli Lilly & Company (LLY) announced positive results from the Phase 3b SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN trials, confirming durable weight-loss maintenance across its obesity portfolio. In SURMOUNT-MAINTAIN, patients switching from maximum tolerated dose to 5 mg Zepbound regained only 5.6 kg at 60 weeks, sustaining nearly all prior weight loss versus placebo. In ATTAIN-MAINTAIN, Foundaya preserved all but 0.9 kg when patients transitioned from Wegovy, while Zepbound maintained all but 5 kg, underscoring long-term efficacy of both therapies.
LLY closed Thursday's trading at $1006.70, down 0.89%.
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