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Biotechnology News

Nuvalent Stock Climbs 39% On $10.6 Bln Takeover Deal With GSK

June 09, 2026 08:05 ET gsk 09062026 lt

Shares of Nuvalent, Inc. were surging around 39 percent in the pre-market activity on the Nasdaq, after the clinical-stage biopharma company focused on cancer therapies agreed to be acquired by British drug major GSK plc, in a deal valued at $10.6 billion or 8.0 billion pounds. Further, GSK maintained its 2026 guidance range of 7 percent to 9 percent growth in core operating profit and core EPS.

  • Caris Life Sciences Authorized Buy Back Up To $100 Mln June 08, 2026 08:42 ET

    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

    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

    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...

Bavarian Nordic Wins DKK 700 Million Smallpox/Mpox Vaccine Supply Contract

June 09, 2026 07:16 ET Topstories2 30052024 lt

Bavarian Nordic A/S (BAVA.CO), a vaccine developer, on Tuesday announced the award of a government contract valued at more than DKK 700 million to supply its MVA-BN smallpox/mpox vaccine to an undisclosed country. Deliveries under the contract are scheduled to take place in 2026 and 2027. The company...

GSK To Acquire Nuvalent For $124/shr; To Be Accretive To Core EPS In 2029

June 09, 2026 02:29 ET Topstories2 30052024 lt

GSK plc (GSK, GSK.L) has entered an agreement to acquire Nuvalent, Inc. (NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion. The company noted that the acquisition includes three products in lung cancer in a single transaction....

TG Therapeutics Announces Positive Data From BRIUMVI Study, Initiates Phase 2 Trial; Stock Gains

June 09, 2026 10:03 ET rttnewslogo20mar2024 lt

Tuesday, TG Therapeutics, Inc. (TGTX) announced positive topline Phase 1 data for BRIUMVI in patients with myasthenia gravis, a chronic autoimmune neuromuscular disease. At Week 24, 82 per cent of patients who received BRIUMVI achieved the Minimal Clinically Important Difference in MG-ADL, with a...

RedHill: FDA Grants Rare Pediatric Disease Designation To Opaganib

June 09, 2026 08:08 ET rttnewslogo20mar2024 lt

RedHill Biopharma Ltd. (RDHL) announced the FDA has granted rare pediatric disease designation to opaganib for treatment of neuroblastoma. The rare pediatric disease designation to opaganib provides for a Priority Review Voucher, subject to certain conditions. Opaganib has received Orphan Drug designation...

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...

Disc Medicine Aligns With FDA On Path Forward For Bitopertin In EPP

June 09, 2026 11:40 ET rttnewslogo20mar2024 lt

the CRL for its NDA of bitopertin in erythropoietic protoporphyria (EPP). The company confirmed alignment with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a CRL response and potentially support a traditional approval.

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

Introducing Eggs Early May Reduce Allergy Risk In Babies, Study Finds

June 09, 2026 13:00 ET eatingegg 09062026 lt

Giving babies eggs early in life may help reduce their risk of developing egg allergies, especially for infants with eczema, according to a new study. The study, conducted by researchers from The University of Queensland and Murdoch Children's Research Institute, analyzed data from more than 7,200...

Cullinan Therapeutics - Expanding The Reach Of T Cell Engagers Beyond Cancer

June 09, 2026 07:07 ET scientist 08062026 lt

Cullinan Therapeutics Inc. (CGEM), a clinical-stage biopharmaceutical company, is scheduled to host an Immunology Day tomorrow, i.e., June 10, 2026. When we alerted readers to CGEM on June 29, 2025, it was at $7.93. The stock, which touched a high of $16.74 on February 27, 2026, has given back some of its gains and currently trades around $13.