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Biotechnology News

Biogen: LEQEMBI IQLIK Autoinjector Available In U.S. For Early Alzheimer's

August 24, 2026 08:21 ET rttnewslogo20mar2024 lt

Eisai Co. (4523.T, EII.SG) and Biogen (BIIB) announced that once weekly lecanemab-irmb subcutaneous injection - LEQEMBI IQLIK - is now available in the U.S. for initiation therapy for early Alzheimer's disease in adults with mild cognitive impairment or mild dementia due to AD, collectively referred...

  • Arbutus Biopharma Stock Rises 11% On Launch Of $230 Mln Share Buyback August 21, 2026 10:28 ET

    Shares of Arbutus Biopharma Corporation (ABUS) are gaining about 11 percent on Friday morning after the company announced its plan to repurchase up to $230 million of its common shares through a modified Dutch Auction tender offer, returning proceeds from its recent settlement with Moderna to shareholders. The...

  • 3S Bio H1 Revenue Climbs 3.9 Percent August 21, 2026 05:06 ET

    3S Bio (SSRX, 01530.HK) Friday announced 26.5 percent increase in first half net earnings attributable to equity holders, while revenues were up 3.9 percent from the prior year. In its interim results for the first half the company reported Net profit attributable to equity holders of RMB 1.15 billion....

  • Brii Biosciences H1 Loss Narrows, Stock Up August 21, 2026 03:59 ET

    Shares of Brii Biosciences Limited (2137.HK) gained around 5% on the Hong Kong stock exchange, after the company reported Friday a narrower loss in its first half. Loss for the period attributable to owners of the company was RMB100.56 million, compared to loss of RMB148.067 million last year. Loss...

InnoCare Pharma Returns To Profit In H1 From Higher Revenue

August 24, 2026 07:51 ET Topstories2 30052024 lt

On Monday, InnoCare Pharma Limited (9969.HK) reported a return to profit in the first half of 2026, compared to a loss in the same half in the previous year, due to higher revenue generated. Profit attributable to the owners of the parent was RMB 246.36 million or RMB 0.14 per share, compared with...

Gilead: European Commission Approves Trodelvy Plus Keytruda In PD-L1-positive Metastatic TNBC

August 24, 2026 06:51 ET Topstories2 30052024 lt

Gilead Sciences (GILD) announced the European Commission has granted marketing authorization for Trodelvy in combination with Keytruda for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for...

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EyePoint LUGANO Phase 3 Trial Misses Primary Endpoint For Duravyu In Wet AMD

August 17, 2026 07:46 ET rttnewslogo20mar2024 lt

EyePoint, Inc. (EYPT), a clinical-stage biopharmaceutical company, on Monday reported topline results from the Phase 3 LUGANO trial, evaluating Duravyu, an investigational sustained-delivery treatment for wet age-related macular degeneration (wet AMD). The trial did not achieve its primary endpoint...

United Therapeutics Says FDA Accepts NDA For Ralinepag To Treat Pulmonary Arterial Hypertension

August 24, 2026 07:20 ET rttnewslogo20mar2024 lt

United Therapeutics Corp. (UTHR), a public benefit corporation, announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ralinepag to treat pulmonary arterial hypertension or PAH. The FDA has set a Prescription Drug User Fee Act target action...

Company Name
Drug
Event
Regeneron Pharmaceuticals Inc
(REGN)
Garetosmab (BLA)
Aug 2026
FDA decision on garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva (FOP)
Replimune Group Inc.
(REPL)
RP1 (vusolimogene oderparepvec) (Resubmitted BLA)
08/02/2026
FDA decision on RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma
Moderna, Inc
(MRNA)
mRNA-1010 (BLA)
08/05/2026
FDA decision on mRNA-1010, a seasonal influenza vaccine candidate
Lantheus Holdings Inc.
(LNTH)
MK-6240, a PET Imaging Agent (NDA)
08/13/2026
FDA decision on MK-6240, a PET Imaging Agent, for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease
Bristol Myers Squibb Co.
(BMY)
Iberdomide (NDA)
08/17/2026
FDA decision on Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
Merck & Co Inc.
(MRK)
KEYTRUDA (sBLA)
08/17/2026
FDA decision on KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev for the treatment of patients with muscle-invasive bladder cancer
Pfizer Inc.
(PFE)
PADCEV (sBLA)
08/17/2026
FDA decision on PADCEV plus KEYTRUDA for patients with Muscle-Invasive Bladder Cancer regardless of Cisplatin eligibility
Astellas Pharma Inc.
( ALPMY, 4503.T)
PADCEV (sBLA)
08/17/2026
FDA decision on PADCEV plus KEYTRUDA for patients with Muscle-Invasive Bladder Cancer regardless of Cisplatin eligibility
Capricor Therapeutics, Inc.
(CAPR)
Deramiocel (resubmitted BLA)
08/22/2026
FDA decision on Deramiocel to treat Duchenne muscular dystrophy cardiomyopathy
Ultragenyx Pharmaceutical Inc
(RARE)
DTX401 (BLA)
08/23/2026
FDA decision on DTX401 AAV gene therapy for the treatment of Glycogen Storage Disease Type Ia (GSDIa)

Biotech Stocks Facing FDA Decision In August 2026

July 31, 2026 09:13 ET fdade 31072026 lt

The August FDA calendar spans a wide range of indications - from the ultra-rare Fibrodysplasia Ossificans Progressiva (FOP) to melanoma, Alzheimer's disease, multiple myeloma, Duchenne muscular dystrophy (DMD), Glycogen Storage Disease, HIV, and essential thrombocythemia.

3 Widely Used Medicines Classified as Carcinogenic by WHO’s Cancer Research Agency

August 13, 2026 05:33 ET
The World Health Organization’s cancer research agency, the International Agency for Research on Cancer (IARC), has classified three widely used medicines as carcinogenic to humans.

Longeveron To Enter 1-for-10 Reverse Stock Split For Minimum Bid Price Compliance; Shares Plunge

August 25, 2026 02:59 ET rttnewslogo20mar2024 lt

Longeveron Inc. (LGVN), a clinical-stage biotechnology company developing cellular therapy, announced a 1-for-10 reverse split of the company's Class A common stock, par value $0.001 per share and Class B common stock, par value $0.001 per share. The reverse stock split is intended to help the company...

Results Date
Company Name
Ticker
Event
Indication
Mid 2026
Avalo Therapeutics, Inc.
Topline data from Phase 2 trial of AVTX-009 (LOTUS)
Hidradenitis suppurativa
Mid 2026
Karyopharm Therapeutics Inc.
Top-line data from Phase 3 trial of selinexor (XPORT-EC-042)
TP53 wild-type endometrial cancer
Mid 2026
Kezar Life Sciences, Inc.
Topline Phase 2b data of zetomipzomib (PALIZADE)
Active lupus nephritis
Mid 2026
Moleculin Biotech Inc
Interim data from Phase 2/3 trial of Annamycin in combination with cytarabine (MIRACLE)
Relapsed or refractory acute myeloid leukemia
Mid 2026
ArriVent Biopharma, Inc.
Topline data from Phase 3 trial of Firmonertinib (FURVENT )
Non-small cell lung cancer (NSCLC) patients whose tumors contain EGFR exon 20 insertion mutations
Mid 2026
EyePoint, Inc.
Topline data from phase III trial of DURAVYU (LUGANO)
Wet age-related macular degeneration
Mid 2026
Pliant Therapeutics, Inc.
Data from Phase 2b trial of bexotegrast (BEACON-IPF)
Idiopathic pulmonary fibrosis (IPF).
Mid 2026
MetaVia Inc.
Interim data readout from Part 3 of Phase 1 trial of DA-1726
Obesity
Mid 2026
Spyre Therapeutics, Inc.
Part ATopline results from Phase 2 trial of SPY002 (SKYLINE)
moderately to severely active UC
Mid 2026
ACADIA Pharmaceuticals Inc
Topline results from Phase 2 study of ACP-204 (RADIANT)
Alzheimer’s disease psychosis

Does The Timing Of Your First And Last Meal Affect Your Health?

August 24, 2026 14:03 ET breakfastfood 24082026 lt

A large study of adults in the U.S. suggests that when you eat your first and last calories of the day may be linked to how long you live. For the study, researchers looked at health and diet information from 31,044 adults aged 40 and older, collected between 1999 and 2018. Participants reported everything...

  • Taking Screenshots May Actually Make It Harder To Remember Things, Study Finds August 24, 2026 13:38 ET

    A new study published in Memory & Cognition suggests that taking screenshots may actually make it harder to remember what we see. The study involved 892 undergraduate students aged 17 to 27 at Binghamton University. In most experiments, students used their own smartphones to look at artwork. They...

  • Regular Lunch Habits Link To Better Energy And Health August 21, 2026 17:46 ET

    Eating lunch between 12 p.m. and 2 p.m. may help support energy levels, blood sugar control and overall metabolic health, according to research summarised by Health. However, consistency in meal timing may matter more than adhering to an exact lunchtime.

  • DRC To Receive 70,000 Ervebo Vaccine Doses As Ebola Outbreak Intensifies August 21, 2026 14:02 ET

    The Democratic Republic of the Congo (DRC) is set to receive 70,000 doses of the Ervebo Ebola vaccine as the country continues to deal with its largest Ebola outbreak, the World Health Organization (WHO) said on Thursday. This comes after Congolese government requested the release of Ervebo vaccines...

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Legend Biotech Appoints Bash As Interim CEO Following Ying Huang's Departure; Stock Down

July 27, 2026 08:31 ET rttnewslogo20mar2024 lt

Legend Biotech Corporation (LEGN), a clinical-stage biopharmaceutical company, announced Monday that its Board of Directors had appointed Alan Bash as the interim Chief Executive Officer (CEO) after Ying Huang stepped down from the role on July 24, 2026. Huang joined Legend Biotech in July 2019 and...