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Biotechnology News

Definium Therapeutics Stock Soars 50% On Positive Phase 3 Depression Trial Results

June 22, 2026 11:45 ET rttnewslogo20mar2024 lt

Definium Therapeutics, Inc. (DFTX) shares surged 49.73 percent, gaining $12.17 to $36.65 on Monday, after the company reported positive topline results from its Phase 3 Emerge study evaluating DT120 (lysergide) ODT 100 µg in adults with major depressive disorder (MDD).

  • AbbVie To Buy Apogee Therapeutics For $135.11/Share In Cash June 22, 2026 07:24 ET

    Monday, AbbVie Inc. (ABBV) announced an agreement to acquire Apogee Therapeutics (APGE) for $135.11 per share in cash, valuing the latter at approximately $10.9 billion. Under the agreement, the company will acquire Apogee's diverse pipeline of multiple clinical-stage candidates in development across...

  • Insilico, SK Biopharmaceuticals Sign $2.5 Bln AI Drug Discovery Deal June 22, 2026 01:35 ET

    InSilico Medicine Cayman TopCo (3696.HK) on Monday announced partnership with SK Biopharmaceuticals Co., Ltd. (326030.KS) to discover artificial intelligence-enabled drug candidates targeting neuroimmune disorders of the central nervous system, in a deal worth more than $2.5 billion. Under the agreement,...

  • Incyte's Minjuvi Approved In Japan For Relapsed Or Refractory DLBCL June 19, 2026 12:12 ET

    Incyte Biosciences (INCY) in Japan announced on Friday that Japan's Ministry of Health, Labour and Welfare has approved Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma.

Apogee Therapeutics Stock Soars 47% After AbbVie Acquisition

June 22, 2026 11:06 ET Topstories2 30052024 lt

Apogee Therapeutics, Inc. (APGE) shares surged 46.72 percent, gaining $42.23 to $132.61 on Monday, after AbbVie announced a definitive agreement to acquire the biotechnology company in an all-cash transaction valued at approximately $10.9 billion.

AbbVie To Acquire Immunology Drug Maker Apogee For $10.9 Bln Cash; Shares Climb

June 22, 2026 09:47 ET abbvie 22062026 lt

Biopharmaceutical company AbbVie, Inc. announced Monday an agreement to acquire inflammatory and immunological drug maker Apogee Therapeutics for $135.11 per share in cash, for a total equity value of around $10.9 billion. Following the news, AbbVie shares are gaining 4 percent, while Apogee shares are surging around 47 percent.

Exelixis Announces STELLAR-303 Trial Results For Zanzalintinib Combination

June 22, 2026 08:57 ET rttnewslogo20mar2024 lt

Exelixis, Inc. (EXEL) on Monday reported final analysis results from the phase 3 STELLAR-303 trial evaluating zanzalintinib in combination with Roche's Tecentriq versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer. In the STELLAR-303 trial,...

EU Approves Sanofi's Cenrifki For Non-Relapsing Secondary Progressive Multiple Sclerosis

June 23, 2026 01:55 ET rttnewslogo20mar2024 lt

Sanofi SA (SNY) on Tuesday said the European Commission has approved Cenrifki for the treatment of secondary progressive multiple sclerosis (SPMS) in adults who have not experienced relapses in the past two years. The approval was supported by results from the Phase 3 HERCULES study, which showed...

Company Name
Drug
Event
argenx SE
( ARGX, ARGX.BR)
VYVGART (sBLA)
05/10/2026
FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative).
Daiichi Sankyo Company Limited
( DSKYF, 4568.T)
ENHERTU (sBLA)
05/18/2026
FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
ENHERTU (sBLA)
05/18/2026
FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer
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

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...

UniQure Announces $150 Million Proposed Public Offering

June 23, 2026 03:10 ET rttnewslogo20mar2024 lt

uniQure N.V. (QURE), a gene therapy company has launched a proposed $150 million underwritten public offering as it looks to strengthen its balance sheet and support ongoing development programs.

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
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
MoonLake Immunotherapeutics
Topline data from Phase 2 trial of sonelokimab (S-OLARIS)
Axial spondyloarthritis (axSpA)
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

Depression May Change How Children View Emotions, Study Finds

June 22, 2026 14:13 ET depressedchild 22062026 lt

A new study from Binghamton University suggests that depression may affect how children pay attention to emotional facial expressions, such as happy or sad faces. Researchers also found that these patterns vary depending on whether a child has a family history of depression. During the study, scientists...

Definium Therapeutics Emerges Strong After MDD Trial Success; Two Near-Term Readouts In Focus

June 22, 2026 12:32 ET brainparts 22062026 lt

Now that Definium Therapeutics Inc. (DFTX) has reported positive results from its Phase 3 Emerge trial, greater clarity has emerged around the clinical profile and potential of its lead investigational asset, DT120 Orally Disintegrating Tablet.