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Biotechnology News

Twist Bioscience Corp Q2 Loss Rises

May 04, 2026 17:23 ET rttnewslogo20mar2024 lt

Twist Bioscience Corp (TWST) released Loss for its second quarter of -$44.021 million The company's bottom line totaled -$44.021 million, or -$0.71 per share. This compares with -$39.328 million, or -$0.66 per share, last year. The company's revenue for the period rose 19.3% to $110.715 million...

  • Mirum Pharma's Phase 2b Study Of Volixibat For Sclerosing Cholangitis Meets End Point, Shares Gain May 04, 2026 08:52 ET

    Mirum Pharmaceuticals, Inc. (MIRM), Monday said that its VISTAS Phase 2b study evaluating Volixibat met primary endpoint in patients with primary sclerosing cholangitis or PSC. The company said the result support the potential for Volixibat as the first treatment for cholestatic pruritus in patients...

  • MacroGenics Expands Zynyz Royalty Deal With Sagard May 04, 2026 08:13 ET

    MacroGenics, Inc. (MGNX) on Monday said it has entered into an expanded royalty purchase agreement with Sagard Healthcare Partners, under which it will receive funding in exchange for a capped share of future sales of Zynyz. The amended agreement, that builds on an initial deal signed in June 2025,...

  • Pasithea Therapeutics Appoints Kartik Krishnan As CMO May 04, 2026 07:37 ET

    Pasithea Therapeutics Corporation (KTTA) said on Monday that it has appointed Kartik Krishnan as chief medical officer with effect from May 1. Krishnan has over 20 years of experience in clinical development, pharmacovigilance, clinical operations, and others. Prior to joining Pasithea, Krishnan...

Vertex Pharmaceuticals Inc. Announces Rise In Q1 Profit

May 04, 2026 16:10 ET Topstories2 30052024 lt

Vertex Pharmaceuticals Inc. (VRTX) reported a profit for its first quarter that Increases, from last year The company's bottom line came in at $1.031 billion, or $4.02 per share. This compares with $646.3 million, or $2.49 per share, last year. Excluding items, Vertex Pharmaceuticals Inc. reported...

Amgen To Invest Additional $300 Mln In US Manufacturing Network

May 04, 2026 09:37 ET Topstories2 30052024 lt

Amgen Inc. (AMGN) Monday revealed its plan to invest an additional $300 million in its U.S. manufacturing network to further advance U.S.-based production capacity. The investment in Juncos, Puerto Rico is expected to enhance next-generation technologies and support a reliable supply of medicines for...

J & J's Caplyta Shows Better Efficacy Among Adjunctive MDD Treatments In Network Meta-Analysis

May 04, 2026 08:40 ET rttnewslogo20mar2024 lt

Johnson & Johnson (JNJ) on Monday reported positive results from a network meta-analysis comparing Caplyta with other FDA-approved atypical antipsychotics used as add-on treatments for major depressive disorder in adults. The analysis, based on data from 10 registrational studies, found that Caplyta...

  • Takeda Pharmaceutical Announces Positive Data From TAK-881 Trial May 04, 2026 08:33 ET

    Monday, Takeda Pharmaceutical Company Limited (TAK) announced positive topline data from TAK-881-3001, a pivotal Phase 2/3 clinical trial evaluating TAK-881 in patients with Primary Immunodeficiency Disease or PID. The trial evaluated the pharmacokinetic, efficacy, safety, tolerability and immunogenicity...

  • Pfizer Reports Positive Results From Phase 3 MagnetisMM-5 Study Of ELREXFIO In Multiple Myeloma April 29, 2026 07:11 ET

    Pfizer Inc. (PFE) on Wednesday reported positive topline results from the Phase 3 MagnetisMM-5 study evaluating ELREXFIO in adults with relapsed or refractory multiple myeloma who had received at least one prior line of treatment. The study met its primary endpoint, showing a statistically significant...

  • AbbVie Says Rinvoq Tops Humira In Rheumatoid Arthritis Study April 28, 2026 07:35 ET

    AbbVie Inc. (ABBV) on Tuesday reported positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study, showing that Rinvoq outperformed Humira in treating adults with moderate to severe rheumatoid arthritis. The study met its primary endpoint, with Rinvoq demonstrating superiority over...

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Atossa Gets FDA Rare Pediatric Disease Tag For (Z)-Endoxifen In McCune-Albright Syndrome

May 04, 2026 09:04 ET rttnewslogo20mar2024 lt

Atossa Therapeutics, Inc. (ATOS) on Monday said the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation to (Z)-endoxifen for the treatment of McCune-Albright Syndrome in females. McCune-Albright Syndrome is a rare genetic disorder caused by mutations in the GNAS gene,...

Company Name
Drug
Event
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
Camizestrant (NDA)
04/30/2026
FDA panel to review Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy whose tumours express ESR1 gene mutations
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
Truqap (sNDA)
04/30/2026
FDA panel to review Truqap in combination with abiraterone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer
Axsome Therapeutics, Inc.
(AXSM)
AXS-05
04/30/2026
FDA decision on AXS-05 for the treatment of Alzheimers disease agitation
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

Biotech Stocks Facing FDA Decision In May 2026

April 28, 2026 08:01 ET fda 28042026 lt

The May FDA calendar appears relatively light. The upcoming regulatory milestones include a potential label expansion of argenx SE's VYVGART, and an additional indication for Daiichi Sankyo Company and AstraZeneca plc's cancer therapy Enhertu, among others.

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.

A2MC Recalls Platinum USA Infant Formula In US Over Cereulide Presence

May 04, 2026 09:29 ET rttnewslogo20mar2024 lt

a2 Milk Company Ltd. (ACOPF, A2M.AX), a dairy company, announced a recall of select infant milk formula, manufactured by Synlait Milk Limited and sold only in the United States, citing the presence of cereulide. The recall involves three batches of a2 Platinum USA label infant milk formula, comprising...

Cytokinetics To Report Topline ACACIA-HCM Phase 3 Results For Aficamten Today

May 05, 2026 00:01 ET rttnewslogo20mar2024 lt

Cytokinetics, Incorporated (CYTK) is preparing to unveil the first topline data from ACACIA-HCM, its pivotal Phase 3 clinical trial evaluating Aficamten in adults with non-obstructive hypertrophic cardiomyopathy (nHCM).

Results Date
Company Name
Ticker
Event
Indication
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
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
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
Avadel Pharmaceuticals plc
Data from Phase 3 trial of LUMRYZ (REVITALYZ)
Idiopathic hypersomnia (IH)
Q2 2026
Wave Life Sciences Ltd.
Six-month follow-up data from 400 mg Cohort 3 of Phase 1 trial of WVE-007 (INLIGHT)
Obesity

New Study Explores Coffee's Impact On Gut-Brain Connection

May 04, 2026 15:30 ET coffee 04052026 lt

Researchers at APC Microbiome Ireland, based at University College Cork, have made an important discovery about how coffee affects the body. For the first time, they closely studied how coffee, whether or not it contains caffeine, interacts with the 'gut-brain axis,' the system that connects the digestive...

  • Health Gap Widens In UK With Decline In Healthy Life Expectancy May 04, 2026 14:01 ET

    The number of years that people in Britain can expect to live in good health has fallen sharply over the past decade, with more individuals experiencing illness well before reaching retirement age, according to a new study. Between 2012 and 2014 and 2022 and 2024, healthy life expectancy (HLE) in...

  • A2MC Recalls Platinum USA Infant Formula In US Over Cereulide Presence May 04, 2026 09:29 ET

    a2 Milk Company Ltd. (ACOPF, A2M.AX), a dairy company, announced a recall of select infant milk formula, manufactured by Synlait Milk Limited and sold only in the United States, citing the presence of cereulide. The recall involves three batches of a2 Platinum USA label infant milk formula, comprising...

  • Takeda Pharmaceutical Announces Positive Data From TAK-881 Trial May 04, 2026 08:33 ET

    Monday, Takeda Pharmaceutical Company Limited (TAK) announced positive topline data from TAK-881-3001, a pivotal Phase 2/3 clinical trial evaluating TAK-881 in patients with Primary Immunodeficiency Disease or PID. The trial evaluated the pharmacokinetic, efficacy, safety, tolerability and immunogenicity...

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What's Powering Viemed's Next Chapter?

April 29, 2026 07:57 ET respiratorytherapist 29042026 lt

Shares of Viemed Healthcare Inc. (VMD), a provider of home medical equipment and post-acute healthcare services in the United States, touched a new 52-week high of $10.10 during intraday trading yesterday. The company's sustained financial performance, combined with multiple growth engines, makes it a compelling long-term stock to watch.