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Biotechnology News

ANI Pharmaceuticals Boosts FY26 Outlook; Stock Up 7.2% - Update

May 08, 2026 07:31 ET rttnewslogo20mar2024 lt

While reporting financial results for the first quarter on Friday, biopharmaceutical company ANI Pharmaceuticals, Inc. (ANIP) raised its adjusted earnings and net revenue guidance for the full-year 2026. For fiscal 2026, the company now projects adjusted earnings in the range of $9.19 to $9.69 per...

  • National HealthCare Corp. Q1 Profit Advances May 08, 2026 07:12 ET

    National HealthCare Corp. (NHC) released earnings for its first quarter that Increases, from last year The company's earnings totaled $35.86 million, or $2.27 per share. This compares with $32.21 million, or $2.07 per share, last year. Excluding items, National HealthCare Corp. reported adjusted...

  • ANI Pharmaceuticals, Inc. Bottom Line Advances In Q1 May 08, 2026 07:03 ET

    ANI Pharmaceuticals, Inc. (ANIP) announced a profit for its first quarter that Increases, from last year The company's bottom line totaled $29.49 million, or $1.28 per share. This compares with $15.27 million, or $0.69 per share, last year. Excluding items, ANI Pharmaceuticals, Inc. reported adjusted...

  • Odyssey Therapeutics Prices Upsized IPO Of 15.50 Mln Shares At $18/shr May 08, 2026 02:27 ET

    Odyssey Therapeutics Inc. announced the pricing of its upsized initial public offering of 15.50 million shares of common stock at $18.00 per share. The company has also granted underwriters a 30-day option to purchase up to an additional 2.33 million shares at the same price, less underwriting discounts...

Artiva Biotherapeutics Prices $300 Mln Stock, Pre-Funded Warrants Offering; Shares Rise

May 08, 2026 07:27 ET Topstories2 30052024 lt

Artiva Biotherapeutics, Inc. (ARTV), a clinical-stage biotechnology company, on Friday announced the pricing of an underwritten offering of stock and pre-funded warrants. The offering consists of 23.87 million shares of stock priced at $11.52 per share and pre-funded warrants to purchase 2.17 million...

6.42 Mln Doses Of Illicit Medicines Seized In Global Crackdown

May 08, 2026 07:17 ET interpol 08052026 lt

A total of 6.42 million doses of unapproved and counterfeit pharmaceuticals worth $15.5 million have been seized in a global crackdown. Operation Pangea XVIII, coordinated by Interpol across 90 countries during March 10 - 23, led to 269 arrests and the dismantling of 66 criminal groups involved in the illicit pharmaceutical trade. Law enforcement agencies worldwide launched 392 investigations an

Artiva Announces Encouraging Early Data For AlloNK In Multiple Autoimmune Diseases; Stock Up

May 08, 2026 07:16 ET rttnewslogo20mar2024 lt

Artiva Biotherapeutics, Inc. (ARTV) on Friday announced positive initial data from ongoing studies evaluating its cell therapy candidate AlloNK in combination with rituximab for patients with autoimmune diseases. The company's shares were up more than 10% in pre-market trading.

Eisai, Biogen Say FDA Extends Review Of LEQEMBI IQLIK As A Starting Dose For Early AD

May 08, 2026 03:11 ET rttnewslogo20mar2024 lt

Eisai Co. Ltd (ESALY.PK) and Biogen Inc. (BIIB) on Friday said the U.S. Food and Drug Administration has extended by three months the review of LEQEMBI IQLIK as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24,...

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
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

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...

BioCardia Aligns With FDA On Helix Transendocardial Delivery Catheter Marketing Pathways

May 08, 2026 11:52 ET rttnewslogo20mar2024 lt

BioCardia Inc. (BCDA), a clinical-stage regenerative medicine company, on Friday announced alignment with the U.S. food and drug administration after a pre-submission meeting on the Helix transendocardial delivery catheter system. Helix was designed for the minimally invasive, targeted delivery of...

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

Eating Eggs May Lower Alzheimer's Risk, Study Finds

May 08, 2026 14:24 ET eggs 08052026 lt

Researchers at Loma Linda University Health found that eating eggs may help lower the risk of Alzheimer's disease in adults aged 65 and older. The researchers used data from the Adventist Health Study-2, which includes health and diet information from more than 96,000 people. For this study, they...

  • New Study Reveals Growing Challenges Of Middle Age In US May 08, 2026 13:25 ET

    New research led by psychologist Frank Infurna revealed that middle age has become harder in the United States compared to other rich countries. The study, which looked at survey data from 17 countries, found that Americans born in the 1960s and early 1970s feel lonelier and more depressed than older...

  • Healing From The Inside Out: How Childhood Experiences Shape Mental Health Across A Lifetime May 08, 2026 10:34 ET

    A new study published in Psychiatric Quarterly suggests that the emotional echoes of childhood- both good and bad- may play a far more powerful role in shaping mental health than previously understood.

  • 6.42 Mln Doses Of Illicit Medicines Seized In Global Crackdown May 08, 2026 07:17 ET

    A total of 6.42 million doses of unapproved and counterfeit pharmaceuticals worth $15.5 million have been seized in a global crackdown. Operation Pangea XVIII, coordinated by Interpol across 90 countries during March 10 - 23, led to 269 arrests and the dismantling of 66 criminal groups involved in the illicit pharmaceutical trade. Law enforcement agencies worldwide launched 392 investigations an

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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.