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iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), ADMA Biologics (NASDAQ:ADMA) – The Daily Biotech Pulse: Merck Rallies On Antiviral Pill Data, Gilead Files For Yescarta Label Expansion, Exscientia IPO



Here is a roundup of prime developments within the biotech area during the last 24 hours.

Click on right here for accessing Benzinga’s FDA Calendar

Scaling The Peaks

(Biotech Shares Hitting 52-week Highs Sept. 30)

  • Biohaven Pharmaceutical Holding Firm Ltd. (NYSE: BHVN)
  • Cytokinetics, Included (NASDAQ: CYTK)
  • Eagle Prescription drugs, Inc. (NASDAQ: EGRX)
  • Leap Therapeutics, Inc. (NASDAQ: LPTX)
  • Legend Biotech Company (NASDAQ: LEGN)

Down In The Dumps

(Biotech Shares Hitting 52-week Lows Sept. 30)

  • 4D pharma plc (NASDAQ: LBPS)
  • ADMA Biologics, Inc. (NASDAQ: ADMA)
  • Agile Therapeutics, Inc. (NASDAQ: AGRX)
  • Alzamend Neuro, Inc. (NASDAQ: ALZN)
  • Utilized Genetic Applied sciences Company (NASDAQ: AGTC)
  • Utilized Molecular Transport Inc. (NASDAQ: AMTI)
  • Aptose Biosciences Inc. (NASDAQ: APTO)
  • Aridis Prescription drugs, Inc. (NASDAQ: ARDS)
  • Athersys, Inc. (NASDAQ: ATHX)
  • BioVie Inc. (NASDAQ: BIVI)
  • Black Diamond Therapeutics, Inc. (NASDAQ: BDTX)
  • Centessa Prescription drugs Restricted (NASDAQ: CNTA)
  • Chemomab Therapeutics Ltd. (NASDAQ: CMMB)
  • Clarus Therapeutics Holdings, Inc. (NASDAQ: CRXT)
  • CNS Prescription drugs, Inc. (NASDAQ: CNSP)
  • Cue Well being Inc. (NASDAQ: HLTH) (IPOed Sept. 24)
  • Cullinan Oncology, Inc. (NASDAQ: CGEM)
  • Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR)
  • Eledon Prescription drugs, Inc. (NASDAQ: ELDN)
  • Emergent BioSolutions Inc. (NYSE: EBS)
  • First Wave BioPharma, Inc. (NASDAQ: FWBI)
  • Forte Biosciences, Inc. (NASDAQ: FBRX)
  • Galapagos NV (NASDAQ: GLPG)
  • World Blood Therapeutics, Inc. (NASDAQ: GBT)
  • Graybug Imaginative and prescient, Inc. (NASDAQ: GRAY)
  • Harpoon Therapeutics, Inc. (NASDAQ: HARP)
  • HOOKIPA Pharma Inc. (NASDAQ: HOOK)
  • Humanigen, Inc. (NASDAQ: HGEN)
  • IMARA Inc. (NASDAQ: IMRA)
  • Inozyme Pharma, Inc. (NASDAQ: INZY)
  • Ionis Prescription drugs, Inc. (NASDAQ: IONS)
  • Jasper Therapeutics, Inc. (NASDAQ: JSPR)
  • Kala Prescription drugs, Inc. (NASDAQ: KALA)
  • LumiraDx Restricted (NASDAQ: LMDX)
  • MorphoSys AG (NASDAQ: MOR)
  • Nanobiotix S.A. (NASDAQ: NBTX)
  • Nautilus Biotechnology, Inc. (NASDAQ: NAUT)
  • NextCure, Inc. (NASDAQ: NXTC)
  • Orchard Therapeutics plc (NASDAQ: ORTX)
  • Pliant Therapeutics, Inc. (NASDAQ: PLRX)
  • RedHill Biopharma Ltd. (NASDAQ: RDHL)
  • RenovoRx, Inc. (NASDAQ: RNXT)
  • Silverback Therapeutics, Inc. (NASDAQ: SBTX)
  • Spruce Biosciences, Inc. (NASDAQ: SPRB)
  • TCR2 Therapeutics Inc. (NASDAQ: TCRR)
  • Titan Prescription drugs, Inc. (NASDAQ: TTNP)
  • Tiziana Life Sciences PLC (NASDAQ: TLSA)
  • Voyager Therapeutics, Inc. (NASDAQ: VYGR)
  • VYNE Therapeutics Inc. (NASDAQ: VYNE)
  • Zynex, Inc. (NASDAQ: ZYXI)

Shares In Focus

BioNTech Commences Mid-stage Examine of mRNA Vaccine In opposition to Colorectal Most cancers

BioNTech SE (NASDAQ: BNTX) introduced that the primary colorectal most cancers affected person has been handled with its individualized mRNA most cancers vaccine BNT122 in a Part 2 scientific trial.

The trial has been initiated within the U.S., Germany, Spain and Belgium. It is deliberate to enroll about 200 sufferers to judge the efficacy OF BNT122 in comparison with watchful ready after surgical procedure and chemotherapy, the present normal of look after these high-risk sufferers.

The inventory was down 2.84% at $265.23 in premarket buying and selling.

Merck Pronounces Constructive Part 3 Outcomes For Oral Antiviral Remedy In Non-hospitalized Gentle-to-moderate COVID-19 Sufferers

Merck & Co., Inc. (NYSE: MRK) and Ridgeback Biotherapeutics introduced that molnupiravir, an investigational oral antiviral medication, considerably decreased the chance of hospitalization or loss of life at a deliberate interim evaluation of the Part 3 MOVe-OUT trial in in danger, non-hospitalized grownup sufferers with mild-to-moderate COVID-19.

On the interim evaluation, molnupiravir decreased the chance of hospitalization or loss of life by roughly 50%. About 7.3% of sufferers who obtained molnupiravir have been both hospitalized or died via Day 29 following randomization in contrast with 14.1% of placebo-treated sufferers.

Via Day 29, no deaths have been reported in sufferers who obtained molnupiravir, as in comparison with 8 deaths in sufferers who obtained placebo.

On the advice of an impartial Knowledge Monitoring Committee and in session with the FDA, recruitment into the examine is being stopped early on account of these constructive outcomes. Merck mentioned it plans to submit an software for emergency use authorization to the FDA as quickly as potential based mostly on these findings and plans to submit advertising and marketing functions to different regulatory our bodies worldwide.

Merck shares have been 4.91% greater at $78.79 in premarket buying and selling.

Associated Hyperlink: Aduhelm’s ‘Blockbuster Potential’ Is Underappreciated, Says Biogen Analyst

Gilead Information Regulatory Utility For Approval of Yescarta Cell Remedy In Superior B-cell Lymphoma Second-line Setting
Gilead Sciences, Inc.
(NASDAQ: GILD) introduced that it has submitted a supplemental biologics license software to the Meals and Drug Administration for Yescarta (axicabtagene ciloleucel) to broaden its present indication to incorporate the remedy of adults with relapsed or refractory giant B-cell lymphoma within the second-line setting.

Bristol-Myers Squibb Says European Regulator Accepts For Evaluation 2 Of its Regulatory Purposes

Bristol-Myers Squibb Firm (NYSE: BMY) introduced that the European Medicines Company has validated its advertising and marketing authorization software for mavacamten, an investigational remedy of sufferers with obstructive hypertrophic cardiomyopathy.

Individually, the corporate mentioned the EMA has additionally validated its MAA for the LAG-3-blocking antibody relatlimab and Opdivo fixed-dose mixture for first-line remedy of grownup and pediatric sufferers with superior melanoma.

Haemonetics’ Vascade Machine Receives FDA Indication For Identical-day Discharge Following Atrial Fibrillation Ablation

Haemonetics Company (NYSE: HAE) introduced that the Vascade MVP venous vascular closure system obtained FDA indication for same-day discharge following atrial fibrillation ablation.

The identical-day discharge labeling was granted following the conclusion of the primary two registries within the AMBULATE same-day discharge scientific examine collection, which evaluated the security and efficacy of utilizing Vascade MVP to facilitate same-day discharge of AF ablation sufferers.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Gilead’s sBLA for Tecartus, a CAR T-cell remedy that’s being evaluated in grownup sufferers with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Medical Readouts/Displays

European Affiliation for the Examine of Diabetes 57th Annual Assembly Displays

Precigen, Inc. (NASDAQ: PGEN): Further knowledge from the AG019 Part 1b/2a scientific trial in Kind 1 diabetes (6 am)

American Society for Bone and Mineral Analysis Annual Assembly Displays

Entera Bio Ltd. (NASDAQ: ENTX): interim 3-month evaluation from Part 2 examine of oral PTH in postmenopausal ladies with low bone mass (8pm)

Worldwide Symposium on Retinal Degeneration Displays

Adverum Biotechnologies, Inc. (NASDAQ: ADVM): new scientific knowledge on ADVM-022 intravitreal injection gene remedy from the Part 1 OPTIC trial in moist age-related macular degeneration (4 pm)

REGENXBIO Inc. (NASDAQ: RGNX) & Clearside Biomedical, Inc. (NASDAQ: CLSD): interim outcomes at six months of follow-up for sufferers in Cohort 1 of the Part 2 AAVIATE trial of RGX-314 in sufferers with moist age-related macular degeneration

ID Week Displays

AstraZeneca PLC (NASDAQ: AZN) & Vaccitech plc (NASDAQ: VACC): asymptomatic An infection and length of viral shedding in symptomatic breakthrough infections in a Part 3 examine of AZD1222

IPOs

Exscientia plc (NASDAQ: EXAI), an AI-driven pharmatech firm, priced its upsized preliminary public providing of 13.85 million ADSs, representing 13.85 million atypical shares at an preliminary public providing worth of $22 per ADS, for whole gross proceeds of roughly $304.7 million. All ADSs bought within the providing have been provided by Exscientia. The ADSs are anticipated to start buying and selling on the Nasdaq underneath the ticker image “EXAI.”

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