LOGO
LOGO

Biotechnology News

Simcere Pharma Reveals Research Deal With Stanford Medicine To Develop Treatment For IPF

June 12, 2026 04:54 ET rttnewslogo20mar2024 lt

Simcere Pharmaceutical Group Ltd. (2096.HK) announced on Friday that it has entered into a research collaboration agreement with Stanford Medicine to develop a treatment for irreversible Idiopathic Pulmonary Fibrosis or IPF, a chronic lung disease of unknown origin and with no known cure. Under the...

  • Ebola In Children - UNICEF And Other Organizations Step Up Efforts To Combat Growing Epidemic June 11, 2026 08:50 ET

    The Democratic Republic of Congo (DRC) saw an outbreak of Ebola last month, with a significant case count and rising death toll reported from the region. The United Nations declared a Public Health Emergency of International Concern in the DRC and Uganda, and has amplified efforts to protect vulnerable...

  • Viking Therapeutics Appoints Hubert Chen As Chief Medical Officer June 11, 2026 07:23 ET

    Viking Therapeutics, Inc. (VKTX), a clinical-stage biopharmaceutical company, Thursday announced that it has appointed Hubert Chen, as its Chief Medical Officer. Chen brings more than two decades of leadership experience in senior executive roles spanning drug discovery, clinical development, regulatory...

  • CervoMed Raises $10.5 Mln In Private Placement Funding, Shares Down June 10, 2026 10:02 ET

    On Wednesday, CervoMed Inc. (CRVO), a biotechnology company specialized in brain disorder treatment, announced that it has entered into a definitive securities purchase agreement for a private placement, expecting gross proceeds of approximately $10.5 million. Each unit includes either one share of...

Genmab Reports Epcoritamab Benefits Across Relapsed Follicular Lymphoma Subgroups

June 11, 2026 12:02 ET Topstories2 30052024 lt

Genmab A/S (GMAB) on Thursday presented new subgroup data from the Phase 3 EPCORE FL-1 trial showing that epcoritamab in combination with rituximab and lenalidomide (R2) delivered consistent efficacy and a manageable safety profile across multiple patient subgroups with relapsed or refractory follicular...

Humacyte Shares Fall 23%

June 11, 2026 11:09 ET Topstories2 30052024 lt

Humacyte, Inc. (HUMA) shares plunged 23.05 percent, losing $0.31 to $1.03 on Thursday, likely extending losses following the company's announcement yesterday, of a public offering of 47.62 million shares of common stock priced at $1.05 per share.

BioCryst Reports New Positive Data For ORLADEYO And Navenibart In Treating Hereditary Angioedema

June 12, 2026 12:06 ET rttnewslogo20mar2024 lt

BioCryst Pharmmaceuticals Inc. (BCRX), a biotechnology company, on Friday released new data from the real-world APeX-P study for ORLADEYO and the Phase 1b/2 ALPHA-STAR for Navenibart in treating hereditary angioedema. ORLADEYO (berotralstat) is an oral prophylactic therapy that increases plasma kallikrein...

GSK: Momelotinib Granted Orphan Drug Designations In The US, EU

June 12, 2026 02:22 ET rttnewslogo20mar2024 lt

GSK plc (GSK, GSK.L) announced that momelotinib has received Orphan Drug Designation from the FDA and European Medicines Agency for the treatment of VEXAS syndrome. The company said the planned phase II/III ATLAS trial will evaluate momelotinib's efficacy and safety in VEXAS syndrome and will support...

Company Name
Drug
Event
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
Camurus AB
(CAMX.ST)
Oclaiz (resubmitted NDA)
06/10/2026
FDA decision on Oclaiz for the treatment of patients with acromegaly
GSK plc
( GSK, GSK.L, GS71.DE)
Tebipenem HBr (NDA)
06/18/2026
FDA decision on tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis
Spero Therapeutics, Inc.
(SPRO)
Tebipenem HBr (NDA)
06/18/2026
FDA decision on tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis
Regeneron Pharmaceuticals Inc
(REGN)
ARCALYST (sBLA)
06/19/2026
FDA decision regarding the technology transfer to Samsung Biologics Co., Ltd. as replacement CDMO for ARCALYST

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...

BioCryst Reports New Positive Data For ORLADEYO And Navenibart In Treating Hereditary Angioedema

June 12, 2026 12:06 ET rttnewslogo20mar2024 lt

BioCryst Pharmmaceuticals Inc. (BCRX), a biotechnology company, on Friday released new data from the real-world APeX-P study for ORLADEYO and the Phase 1b/2 ALPHA-STAR for Navenibart in treating hereditary angioedema. ORLADEYO (berotralstat) is an oral prophylactic therapy that increases plasma kallikrein...

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

New Study Reveals How Socioeconomic Conditions Affect Brain Function Of Children

June 12, 2026 14:01 ET children 12062026 lt

A child's family income and the neighborhood they grow up in may play a much bigger role in brain development than previously believed, according to a new study published in Science. Researchers at Washington University in the United States analyzed brain scans from nearly 12,000 children aged 9 to...

  • Social Anxiety Cases Surge 71% In Canada Since 2002, New Research Shows June 12, 2026 13:39 ET

    A new Canadian study has found that social anxiety disorder (SAD) affects nearly one in seven adults, making it one of the country's most common mental health conditions. The findings, published in Psychiatry Research, showed that the number of people experiencing social anxiety has increased by 71%...

  • Music Therapy Shows Growing Promise But Faces Practical Barriers, Review Finds June 12, 2026 11:59 ET

    A new review suggests that music therapy may offer meaningful benefits for people living with neurological, psychiatric, and chronic health conditions, but its wider adoption in clinical practice continues to be limited by workforce shortages, inconsistent standards, and gaps in research.

  • AI-Designed Universal Coronavirus Vaccine Passes First Human Safety Trial June 11, 2026 14:30 ET

    Researchers at the University of Cambridge have achieved a major milestone in vaccine development by successfully testing an artificial intelligence (AI)-designed universal coronavirus vaccine in humans for the first time. Early results show that the vaccine is safe, well tolerated, and capable of generating...

  • View More

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.