This week in the biotech space, there were regulatory approvals across the U.S. and Europe, collaborations, acquisitions, and positive data readouts spanning multiple therapeutic areas, including primary biliary cholangitis, fatigue, resectable lung cancer, and moderate-to-severe atopic dermatitis.
Let's unpack the specifics.
FDA Approvals and Rejections
FDA Approves AstraZenca's IMFINZI + BCG Combo for High-Risk NMIBC
AstraZeneca (AZN) secured FDA approval for IMFINZI (durvalumab) combined with BCG for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), supported by positive Phase 3 POTOMAC data showing a significant disease-free survival benefit and a 32% reduction in recurrence or death versus BCG alone.
Safety remained consistent with known profiles, and no new signals emerged. Regulatory reviews are also underway in the EU and Japan.
AZN closed Thursday's trading (May 28, 2026) at $185.33, down 0.17%.
FDA Expands JNJ's TREMFYA Label in Psoriatic Arthritis
Johnson & Johnson (JNJ) gained FDA approval to add structural joint-damage inhibition data to the TREMFYA label for adults with active psoriatic arthritis, confirming it as the only IL-23 inhibitor with proven protection against further joint damage. The update highlights durable symptom control with no new safety signals, reinforcing TREMFYA's differentiated positioning in first-line PsA care.
JNJ closed Thursday's trading at $230.80, down 0.21%
FDA Approves Ironwood's LINZESS for Functional Constipation in Ages 2-5
Ironwood Pharmaceuticals Inc. (IRWD) received FDA approval for LINZESS to treat functional constipation in children aged 2-5, expanding its long-standing GC-C agonist franchise. The decision was supported by a 12-week Phase 3 trial showing improved spontaneous bowel movements and a favourable safety profile. LINZESS, co-developed with AbbVie, is now available in a 72-mcg pediatric dose.
IRWD closed Thursday's trading at $3.60, down 2.96%.
AbbVie's DECNUPAZ Approved for Ultra-Rare BPDCN
AbbVie (ABBV) secured FDA approval for DECNUPAZ, its first CD123-targeting ADC, to treat adults with Blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive and ultra-rare blood cancer. The decision was supported by Phase 1/2 CADENZA data showing a 69.7% composite complete response rate and durable responses with a median duration of 9.7 months. The drug carries a boxed warning for hepatotoxicity and other safety risks.
ABBV closed Thursday's trading at $218.63, up 1.50%.
EC Approves Agios's PYRUKYND for Thalassaemia-Related Anaemia in Adults
Agios Pharmaceuticals, Inc. (AGIO) and partner Avanzanite Bioscience secured approval from the European Commission for PYRUKYND (Mitapivat) to treat anaemia in adults with transfusion-dependent alpha- or beta-thalassaemia, marking its second EU indication after PK deficiency. The decision was based on Phase 3 ENERGIZE and ENERGIZE-T data showing meaningful improvements in haemoglobin. Under a 2025 agreement, Avanzanite will commercialise PYRUKYND across the EEA, the UK and Switzerland.
AGIO closed Thursday's trading at $30.42, up 6.29%
EU Approves Pharming's Joenja for Rare Immunodeficiencies APDS
Pharming Group (PHAR) received European Commission approval for Joenja (leniolisib) to treat activated PI3K delta syndrome (APDS) in patients 12 and older, marking the first authorised therapy for this rare primary immunodeficiency in the EU. The company plans its first European launch in Germany in the third quarter of 2026, with broader rollouts pending reimbursement agreements. Joenja is already marketed in the U.S. and U.K., with additional global reviews ongoing.
PHAR closed Thursday's trading at $13.66, up 1.86%.
Deals
Pfizer Enters Deal With Innovent Biologics To Co-Develop Oncology Medicines
Pfizer Inc. (PFE), a biopharmaceutical company, announced that it has entered into a strategic global licensing and collaboration agreement with Innovent Biologics to research and develop 12 early-stage cancer medicines.
As part of the agreement, Innovent will receive an upfront payment of $650 million and is eligible for up to $9.85 billion in payments for development, regulatory, and commercial milestones. The transaction is expected to close in the third quarter of 2026, subject to the regulatory approvals.
PFE closed Thursday's trade at $26.14, down 0.27%.
20/20 Biolabs Secures Vermont Statewide Firefighter Cancer Screening Deal
20/20 Biolabs, Inc. (AIDX) announced that its OneTest multi-cancer early detection blood test has been selected by the state of Vermont for a statewide firefighter cancer screening initiative in partnership with National Diagnostic Services (NDS).
Notably, the contract is expected to generate approximately $0.5 million in revenue for the firm to test approximately one-third of eligible Vermont firefighters through the end of 2026.
AIDX closed Thursday's trade at $0.95, down 2.06%.
Kaos Capital Acquires 4.9% Stake in BioRestorative Therapies Kaos Capital announced it has acquired a 4.9% stake in BioRestorative Therapies, Inc. (BRTX) and is seeking immediate engagement with the board.
Kaos Capital noted the company's potential to explore broader strategic options, including opportunities in the AI sector, and emphasised that shareholders are not currently realising meaningful value from the existing business.
BRTX closed Thursday's trial at $0.47, up 10.65%.
Lilly To Acquire Curevo, LimmaTech and Vaccine Company
Eli Lilly and Company (LLY) announced agreements to acquire three companies: Curevo Inc, LimmaTech Biologics AG, and Vaccine Company, Inc., to expand its research and development efforts into infectious diseases.
The acquisitions bring in Curevo's lead product candidate, Amezosvatein; LimmaTech Biologics' vaccines targeting bacterial pathogens; and the Vaccine company's proprietary In Vivo Nanoparticle technologies.
Under the terms of the agreement, Lilly will acquire Curevo, and Curevo shareholders could receive up to $1.5 billion in cash, including upfront and milestone payments.
Lilly will acquire LimmaTech for up to $780 million in cash, including an upfront payment and additional payments tied to clinical and regulatory milestones.Lilly will also acquire Vaccine Company, whose shareholders could receive up to $1.55 billion in cash, including upfront and milestone-based payments.
LLY closed Thursday's trading at $1126.80, up 4.05%.
Clinical Trials - Breakthroughs & Setbacks
Ipsen Releases New Phase 3 and Phase 4 Data of IQIRVO in Treating Cholangitis and Fatigue
Ipsen S.A. (IPN.PA), a biopharmaceutical company, announced new positive data from the two Phase 3 ELATIVE studies for IQIRVO, an oral, once-daily peroxisome proliferator-activated receptor agonist for treating primary biliary cholangitis, fatigue, and pruritus.
Data from the Phase 3 ELATIVE studies indicated a clinically meaningful improvement in moderate-to-severe fatigue observed in 67% of patients. 72% of patients also showed a decrease of 15% or more in ALP levels, and 59% reported normalisation of ALP levels at 52 weeks.
IPN.PA closed Thursday's trading at 155.80 Euros.
GSK Reports Positive Pivotal Data For Bepirovirsen In Chronic Hepatitis B
GSK plc (GSK) announced positive pivotal data for Bepirovirsen, its investigational antisense oligonucleotide for the treatment of chronic hepatitis B, from two phase III trials, B-Well 1 and B-Well 2. Pooled data from both trials showed that 6-month treatment with Bepirovirsen, with an acceptable safety and tolerability profile, achieved a statistically significant and clinically meaningful 19% functional cure response rate in the overall study population, meeting the primary endpoint. In a key secondary endpoint, a functional cure rate of 26% was achieved among participants with HBsAg levels =1000 IU/ml, representing approximately 45% of diagnosed CHB cases globally.
GSK closed Thursday's trading at $51.24, down 0.66%.
Apogee Unveils Positive Phase 2 APEX Trial of Zumilokibart in moderate-to-severe Atopic Dermatitis
Apogee Therapeutics, Inc. (APGE) released positive 16-week Part B induction dose optimisation results from the Phase 2 APEX Trial of Zumilokibart in moderate-to-severe Atopic Dermatitis.
In the Phase 2 APEX clinical trial results, Zumilokibart met its primary and secondary endpoints with high statistical significance, including 65.9% of patients treated with mid-dose Zumilokibart achieving an Eczema Area and Severity Index (EASI) score of 75. APGE closed Thursday's trading at $77.82, up 0.09%.
Junshi's Toripalimab Combo Meets Phase 3 Endpoints in Resectable Lung Cancer
Junshi Biosciences Co., Ltd (1877.HK) announced that its Phase 3 NEOTORCH study of Toripalimab combined with platinum-based chemotherapy in patients with resectable stage II-III non-small cell lung cancer met its primary endpoints in the final analysis.
The trial achieved event-free survival and major pathological response (MPR) endpoints in stage II-III patients and MPR in stage III patients, thereby crossing the predefined efficacy boundary.
1877.HK closed Thursday's trade at HK$20.28.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.