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Biotechnology News

Caris Life Sciences Authorized Buy Back Up To $100 Mln

June 08, 2026 08:42 ET rttnewslogo20mar2024 lt

Caris Life Sciences (CAI), an AI TechBio company, Monday announced that it has been authorized to repurchase up to $100 million of the company's outstanding common stock. The timing, manner, price, and amount of any repurchases will be determined at the Company's discretion based on a variety of factors,...

Standard BioTools Signs Deal To Merge With Treeline Biosciences

June 08, 2026 08:28 ET Topstories2 30052024 lt

Monday, Standard BioTools Inc. (LAB) announced an agreement with Treeline Biosciences, Inc., a clinical-stage biopharma company, to combine in an all-stock transaction. The transaction values Standard BioTools at net cash delivered at closing, plus $10 million, which is estimated to be $460 million....

Johnson & Johnson To Acquire Firefly Bio To Expand Oncology Pipeline

June 08, 2026 08:22 ET Topstories2 30052024 lt

Johnson & Johnson (JNJ) on Monday announced a definitive agreement to acquire Firefly Bio, Inc., a biotechnology company for $1 billion in cash. The transaction is expected to close later this year. The acquisition is expected to expand Johnson & Johnson's oncology pipeline with Firefly Bio's...

Tango Therapeutics Announces Positive Data From Pancreatic Cancer Study, Stock Surges In Pre-Market

June 08, 2026 09:27 ET rttnewslogo20mar2024 lt

Monday, Tango Therapeutics, Inc. (TNGX) announced positive initial data from its ongoing Phase 1/2 study of vopimetostat in combination with Revolution Medicines' RAS(ON) inhibitors daraxonrasib or zoldonrasib. During the study, patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal...

Pfizer Says FDA Approves Expanded HYMPAVZI Indication For Hemophilia A And B

June 08, 2026 07:08 ET rttnewslogo20mar2024 lt

Pfizer, Inc. (PFE) announced Monday that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without...

Company Name
Drug
Event
Eisai Co Ltd
(ESALY.PK, ESALF.PK, 4523.T, EII.SG)
LEQEMBI IQLIK (sBLA)
05/24/2026
FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
Biogen Inc.
(BIIB)
LEQEMBI IQLIK (sBLA)
05/24/2026
FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
BioArctic AB
( BRCTF, BIOA-B.ST, BIOA_B.ST)
Leqembi Iqlik subcutaneous autoinjector (sBLA)
05/24/2026
FDA decision on Leqembi Iqlik Subcutaneous Autoinjector for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease
MannKind Corp.
(MNKD)
Afrezza (sBLA)
05/29/2026
FDA decision on Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes
Cingulate Inc.
(CING)
CTx-1301 (NDA)
05/31/2026
FDA decision on CTx-1301 for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adults
Daiichi Sankyo Company Limited
( DSKYF, 4568.T)
DATROWAY (sBLA)
06/02/2026
FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
DATROWAY (sBLA)
06/02/2026
FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy
Arvinas, Inc.
(ARVN)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
Pfizer Inc.
(PFE)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
Rigel Pharmaceuticals Inc.
(RIGL)
Vepdegestrant (NDA)
06/05/2026
FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer

Biotech Stocks Facing FDA Decision In June 2026

June 03, 2026 10:01 ET fda 27052026 lt

June's FDA calendar offers plenty for investors to keep a close eye on. Among the key names are Spero Therapeutics, awaiting an FDA decision on its antibiotic for complicated urinary tract infections; Kiniksa Pharma, seeking approval for a technology transfer of the manufacturing process for Arcalyst drug substance; and Merck, pursuing the first FDA approval for its WELIREG - KEYTRUDA combination.

Biotechnology Weekly Update - March 31, 2026

March 31, 2026 15:49 ET
In this week’s video, we’ll cover major biotech moves and breakthroughs - from Novartis and Merck’s blockbuster acquisitions to the first new Hunter syndrome therapy in two decades. We’ll also look at a promising alternative to daily insulin injections and the near-term catalyst for Q3 Bio, which has been hitting new 52-week highs.

Target Recalls Up & Up Baby Wipes For Potential Microbial Contamination

June 05, 2026 02:03 ET rttnewslogo20mar2024 lt

Retailer Target Corp. is recalling select Up & Up Baby Wipes, due to potential microbial contamination, according to the U.S. Food and Drug Administration. The recall involves Up & Up FragranceFree Baby Wipes and Up & Up Fresh Cucumber Scented Baby Wipes with various counts and UPC numbers. The impacted wipes were manufactured by a supplier, Sapro Temizlik Urunleri, and sold at Target stores...

FDA Accepts Alvotech's AVT16, A Biosimilar To Vedolizumab, For Review; Stock Up

June 08, 2026 11:44 ET rttnewslogo20mar2024 lt

Alvotech (ALVO), a biotechnology company, announced that its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for intravenous administration, has been accepted for review by the FDA. According to the company, the Biologics License Application...

Results Date
Company Name
Ticker
Event
Indication
Early 2026
Immatics N.V
Pre-specified interim analysis data from Phase 3 trial of ACTengine IMA203
Second-line or later (2L+) unresectable or metastatic melanoma
Early 2026
Contineum Therapeutics Inc.,
Topline data readout from Phase 1b trial of PIPE-791
Chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP)
Early 2026
MoonLake Immunotherapeutics
Topline data from Phase 2 trial of sonelokimab (S-OLARIS)
Axial spondyloarthritis (axSpA)
Early 2026
Beam Therapeutics Inc.
Further data from dose-escalation portion of Part A of Phase 1/2 trial of BEAM-302
Alpha-1 antitrypsin deficiency (AATD)
Early 2026
Iovance Biotherapeutics, Inc.
Initial results from Phase 2 trial of Lifileucel (IOV-END-201)
Advanced endometrial cancer
Early 2026
AC Immune SA
Interim results from Phase 2 trial of ACI-24.060 (ABATE)
Alzheimer's disease
Early 2026
BridgeBio Pharma, Inc.
Topline results from Phase 3 trial of infigratinib (PROPEL 3)
Achondroplasia
Early 2026
Aclaris Therapeutics
Top line results from Phase 1a single ascending dose and multiple ascending dose portion of Phase 1a/1b trial of ATI-052
Immune-inflammatory diseases
Q2 2026
Recordati Industria Chimica e Farmaceutica S.p.A.
REC.MI, RICFY
Top-line results from Phase 2 trial of pasireotide
Post-bariatric hypoglycemia
Q2 2026
AN2 Therapeutics, Inc.
Data from Phase 1 first-in-human clinical trial and a non-human primate efficacy study of oral AN2-502998
Chronic Chagas disease

Chinese Researchers Successfully Transplant Two Pig Kidneys And A Liver Into A Human Body

June 08, 2026 14:19 ET pigs 08062026 lt

Chinese researchers have carried out the world's first transplant of two pig kidneys and a pig liver into a 53-year-old brain-dead man at the same time, marking an important step forward in xenotransplantation. The surgery was conducted at the Second Affiliated Hospital of Guangxi Medical University...

Enanta Pharma's RSV Bet And Immunology Ambitions

May 19, 2026 06:32 ET conference 19052026 lt

Enanta Pharmaceuticals Inc. (ENTA), a clinical-stage biotechnology company focusing on viral infections and immunological diseases, will be highlighting its investigational programs - Zelicapavir and EPS-3903 - at the American Thoracic Society (ATS) International Conference today.