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iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), (ABBV) – The Each day Biotech Pulse: AzurRx Jumps On Knowledge, Agios’ Regulatory Software For Mitapivat Accepted For Precedence Evaluation, FDA Nod For GlaxoSmithKline

iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), (ABBV) - The Daily Biotech Pulse: AzurRx Jumps On Data, Agios' Regulatory Application For Mitapivat Accepted For Priority Review, FDA Nod For GlaxoSmithKline

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

Scaling The Peaks

(Biotech Shares Hitting 52-week Highs Aug. 17)

  • AbbVie Inc. (NYSE: ABBV)
  • Alkermes plc (NASDAQ: ALKS)
  • Century Therapeutics Inc (NASDAQ: IPSC)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • GlaxoSmithKline plc (NYSE: GSK)
  • Edward Lifesciences Corp (NYSE: EW)
  • Eli Lilly and Firm (NYSE: LLY) (introduced reorganization of enterprise items)
  • Innoviva Inc (NASDAQ: INVA)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Johnson & Johnson (NYSE: JNJ)
  • Maravai Lifesciences Holdings Inc (NASDAQ: MRVI)
  • NanoVibronix, Inc. (NASDAQ: NAOV)
  • Novo Nordisk A/S (NYSE: NVO)
  • Nuvalent Inc (NASDAQ: NUVL)
  • Omega Therapeutics Inc (NASDAQ: OMGA)
  • Pfizer, Inc. (NYSE: PFE)
  • Regeneron Prescription drugs Inc (NASDAQ: REGN) (moved on information COVID-19-affected Texas Governor Greg Abbott is being handled with the corporate’s antibody therapy)
  • Quest Diagnostics Included (NYSE: DGX)
  • ResMed Inc. (NYSE: RMD)
  • Virpax Prescription drugs Inc (NASDAQ: VRPX) (moved on announcement relating to FDA response for pursuing MMS019 as a prophylactic therapy in opposition to SARS and influenza viruses for each day use as an OTC product)
  • West Pharmaceutical Companies, Inc. (NYSE: WST)

Down In The Dumps

(Biotech Shares Hitting 52-week Lows Aug. 17)

  • 4D pharma plc (NASDAQ: LBPS)
  • Absci Company (NASDAQ: ABSI)
  • ABVC BioPharma, Inc. (NASDAQ: ABVC)
  • ACADIA Prescription drugs Inc. (NASDAQ: ACAD)
  • AcelRx Prescription drugs Inc (NASDAQ: ACRX) (reacted to its second-quarter outcomes)
  • Obtain Life Sciences, Inc. (NASDAQ: ACHV)
  • Acurx Prescription drugs, Inc. (NASDAQ: ACXP) (introduced its second-quarter outcomes)
  • Adaptive Biotechnologies Company (NASDAQ: ADPT)
  • Adicet Bio Inc (NASDAQ: ACET)
  • Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
  • ADMA Biologics Inc (NASDAQ: ADMA)
  • Agile Therapeutics, Inc. (NASDAQ: AGRX)
  • Akouos Inc (NASDAQ: AKUS)
  • Akoya Biosciences, Inc. (NASDAQ: AKYA)
  • Alzamend Neuro Inc (NASDAQ: ALZN)
  • Angion Biomedica Corp. (NASDAQ: ANGN)
  • Utilized Genetic Applied sciences Company (NASDAQ: AGTC)
  • Aptinyx Inc. (NASDAQ: APTX)
  • Aptose Biosciences Inc. (NASDAQ: APTO)
  • Aravive, Inc. (NASDAQ: ARAV)
  • Enviornment Prescription drugs, Inc. (NASDAQ: ARNA)
  • Assertio Holdings, Inc. (NASDAQ: ASRT)
  • Athenex, Inc. (NASDAQ: ATNX)
  • Athira Pharma, Inc. (NASDAQ: ATHA) (introduced its second-quarter outcomes)
  • Avenue Therapeutics, Inc. (NASDAQ: ATXI)
  • AVITA Medical, Inc. (NASDAQ: RCEL)
  • Axsome Therapeutics, Inc. (NASDAQ: AXSM)
  • Aytu Biopharma, Inc. (NASDAQ: AYTU)
  • AzurRx BioPharma Inc (NASDAQ: AZRX)
  • Biocept Inc (NASDAQ: BIOC) (reacted to its quarterly outcomes)
  • Biodesix, Inc. (NASDAQ: BDSX)
  • Biomea Fusion, Inc. (NASDAQ: BMEA)
  • BiondVax Prescription drugs Ltd. (NASDAQ: BVXV)
  • BioXcel Therapeutics Inc. (NASDAQ: BTAI)
  • Caladrius Biosciences, Inc. (NASDAQ: CLBS)
  • Candel Therapeutics Inc (NASDAQ: CADL) (IPOed July 30)
  • Catalyst Biosciences Inc (NASDAQ: CBIO)
  • Cellectis S.A. (NASDAQ: CLLS)
  • Chemomab Therapeutics Ltd. (NASDAQ: CMMB)
  • CNS Prescription drugs, Inc. (NASDAQ: CNSP)
  • Live performance Prescription drugs Inc (NASDAQ: CNCE)
  • ContraFect Company (NASDAQ: CFRX)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • Deciphera Prescription drugs, Inc. (NASDAQ: DCPH)
  • Diffusion Prescription drugs Inc. (NASDAQ: DFFN)
  • DURECT Company (NASDAQ: DRRX)
  • Edgewise Therapeutics, Inc. (NASDAQ: EWTX)
  • Eloxx Prescription drugs, Inc. (NASDAQ: ELOX)
  • Ensysce Biosciences, Inc. (NASDAQ: ENSC) (introduced its second-quarter outcomes)
  • Enveric Biosciences, Inc. (NASDAQ: ENVB)
  • Epizyme, Inc. (NASDAQ: EPZM)
  • Esperion Therapeutics Inc (NASDAQ: ESPR)
  • Eton Prescription drugs, Inc. (NASDAQ: ETON) (introduced its second-quarter outcomes)
  • Evofem Biosciences, Inc. (NASDAQ: EVFM)
  • Exicure Inc (NASDAQ: XCUR)
  • FibroGen, Inc. (NASDAQ: FGEN)
  • Flexion Therapeutics, Inc. (NASDAQ: FLXN)
  • Forma Therapeutics Holdings Inc (NASDAQ: FMTX)
  • Frequency Therapeutics Inc (NASDAQ: FREQ)
  • Galecto, Inc. (NASDAQ: GLTO)
  • Gemini Therapeutics, Inc. (NASDAQ: GMTX)
  • Genocea Biosciences, Inc. (NASDAQ: GNCA)
  • GlycoMimetics, Inc. (NASDAQ: GLYC)
  • Heron Therapeutics, Inc. (NASDAQ: HRTX)
  • HOOKIPA Pharma Inc. (NASDAQ: HOOK)
  • Hoth Therapeutics, Inc. (NASDAQ: HOTH)
  • IMARA Inc. (NASDAQ: IMRA)
  • Indaptus Therapeutics, Inc. (NASDAQ: INDP)
  • InflaRx N.V. (NASDAQ: IFRX)
  • Insmed Included (NASDAQ: INSM)
  • Intercept Prescription drugs Inc (NASDAQ: ICPT)
  • iRhythm Applied sciences Inc (NASDAQ: IRTC)
  • Itamar Medical Ltd. (NASDAQ: ITMR)
  • Kamada Ltd (NASDAQ: KMDA)
  • Karyopharm Therapeutics Inc. (NASDAQ: KPTI)
  • Keros Therapeutics, Inc. (NASDAQ: KROS)
  • Kiniksa Prescription drugs, Ltd. (NASDAQ: KNSA)
  • Kinnate Biopharma Inc. (NASDAQ: KNTE) (introduced its second-quarter outcomes)
  • Kura Oncology, Inc. (NASDAQ: KURA)
  • Liminal BioSciences Inc. (NASDAQ: LMNL) (introduced its second-quarter outcomes)
  • Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT)
  • Longeveron Inc. (NASDAQ: LGVN)
  • Madrigal Prescription drugs, Inc. (NASDAQ: MDGL)
  • Medicenna Therapeutics Corp. (NASDAQ: MDNA)
  • Moleculin Biotech, Inc. (NASDAQ: MBRX)
  • MorphoSys AG (NASDAQ: MOR)
  • Nabriva Therapeutics plc (NASDAQ: NBRV)
  • Nanobiotix S.A. (NASDAQ: NBTX)
  • Nektar Therapeutics (NASDAQ: NKTR)
  • Oncorus, Inc. (NASDAQ: ONCR)
  • OncoSec Medical Included (NASDAQ: ONCS) (introduced administration adjustments)
  • Orchard Therapeutics plc (NASDAQ: ORTX)
  • Palisade Bio, Inc. (NASDAQ: PALI)
  • Panbela Therapeutics, Inc. (NASDAQ: PBLA)
  • Passage Bio, Inc. (NASDAQ: PASG)
  • Phio Prescription drugs Corp. (NASDAQ: PHIO)
  • Pluristem Therapeutics Inc. (NASDAQ: PSTI)
  • Praxis Precision Medicines, Inc. (NASDAQ: PRAX)
  • Progenity, Inc. (NASDAQ: PROG)
  • Protara Therapeutics, Inc. (NASDAQ: TARA)
  • Pulmatrix, Inc. (NASDAQ: PULM)
  • Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (introduced its second-quarter outcomes)
  • Recursion Prescription drugs, Inc. (NASDAQ: RXRX)
  • Regencell Bioscience Holdings Restricted (NASDAQ: RGC)
  • Rhythm Prescription drugs, Inc. (NASDAQ: RYTM)
  • Rockwell Medical, Inc. (NASDAQ: RMTI) (introduced its second-quarter outcomes)
  • RxSight, Inc. (NASDAQ: RXST) (IPOed July 30)
  • Scopus BioPharma Inc. (NASDAQ: SCPS)
  • scPharmaceuticals Inc. (NASDAQ: SCPH)
  • SI-BONE, Inc. (NASDAQ: SIBN)
  • Sigilon Therapeutics, Inc. (NASDAQ: SGTX)
  • Seres Therapeutics, Inc. (NASDAQ: MCRB)
  • Singular Genomics Methods, Inc. (NASDAQ: OMIC)
  • Soleno Therapeutics, Inc. (NASDAQ: SLNO)
  • Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN)
  • Sonoma Prescription drugs, Inc. (NASDAQ: SNOA) (introduced its second-quarter outcomes)
  • Stoke Therapeutics, Inc. (NASDAQ: STOK)
  • Syros Prescription drugs, Inc. (NASDAQ: SYRS)
  • T2 Biosystems, Inc. (NASDAQ: TTOO)
  • Taysha Gene Therapies, Inc. (NASDAQ: TSHA)
  • Teligent, Inc. (NASDAQ: TLGT)
  • TG Therapeutics, Inc. (NASAQ: TGTX)
  • TherapeuticsMD, Inc. (NASDAQ: TXMD)
  • TransCode Therapeutics, Inc. (NASDAQ: RNAZ)
  • Unicycive Therapeutics, Inc. (NASDAQ: UNCY)
  • Universe Prescription drugs INC (NASDAQ: UPC)
  • VectivBio Holding AG (NASDAQ: VECT)
  • Viveve Medical, Inc. (NASDAQ: VIVE)
  • Vor Biopharma Inc. (VOR)
  • VYNE Therapeutics Inc. (NASDAQ: VYNE)
  • X4 Prescription drugs, Inc. (NASDAQ: XFOR)
  • Xeris Prescription drugs, Inc. (NASDAQ: XERS)
  • ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP)
  • ZIVO Bioscience, Inc. (NASDAQ: ZIVO)

Shares In Focus

Agios’s Mitapivat Software Accepted For Regulatory Evaluation

Agios Prescription drugs, Inc. (NASDAQ: AGIO) mentioned the Meals and Drug Administration accepted its new drug software for mitapivat for the therapy of adults with pyruvate kinase deficiency. The NDA was granted a precedence assessment designation and has been given a PDUFA motion date of Feb. 17, 2022.

The inventory was up 3.02% to $46 in after-hours buying and selling.

Click on right here to entry Benzinga’s FDA Calendar

GlaxoSmithKline’s Strong Tumor Drug Permitted by FDA, Triggering Milestone Fee For AnaptysBio

GlaxoSmithKline introduced that the FDA permitted a second indication for Jemperli for the therapy of grownup sufferers with mismatch restore poor recurrent or superior strong tumors, as decided by an FDA-approved check, which have progressed on or following prior therapy and who haven’t any passable different therapy choices.

Jemperli was generated by AnaptysBio, Inc. (NASDAQ: ANAB) utilizing its proprietary somatic hypermutation antibody platform and subsequently developed by Tesaro, now part of GSK, below a collaboration settlement.

AnaptysBio has earned a $20 million milestone cost on account of this second FDA approval for Jemperli in dMMR recurrent or superior strong tumors.

AnaptysBio was rallying 7.19% to $27.

AzurRx Stories Optimistic Section 2 Knowledge For Combo Remedy For Treating Pancreatic Insufficiency In Cystic Fibrosis Sufferers

AzurRx introduced constructive topline outcomes from its Section 2 mixture trial evaluating MS1819 together with the present normal of care, porcine-derived pancreatic enzyme substitute remedy, for the therapy of extreme exocrine pancreatic insufficiency in sufferers with cystic fibrosis.

“Knowledge collected from 20 sufferers indicated that MS1819 together with PERT led to clinically significant enhancements within the major efficacy endpoint, the Coefficient of Fats Absorption,” the corporate mentioned.

The inventory was leaping 38.09% to 72.8 cents in premarket buying and selling.

Marinus Declares Optimistic Section 2 Knowledge For Oral Ganaxolone as Adjunctive Therapy For Seizures In Tuberous Sclerosis Advanced Sufferers

Marinus Prescription drugs, Inc. (NASDAQ: MRNS) introduced topline information from its Section 2 trial evaluating security and efficacy of adjunctive oral ganaxolone therapy in 23 sufferers with seizures related to tuberous sclerosis advanced, with major endpoint exhibiting a median 16.6% discount in 28-day seizure frequency relative to baseline in TSC sufferers.

The secondary endpoint of fifty% responder price at 30.4% is per the Marigold Section 3 CDKL5 deficiency dysfunction trial of 24.5 %, the corporate mentioned. Sufferers with focal seizures confirmed a median 25.2% discount in focal seizure frequency, the most typical seizure kind in TSC sufferers, it added.

Marinus mentioned it expects to start enrollment in a world Section 3 trial of adjunctive ganaxolone in roughly 160 TSC sufferers throughout the fourth quarter.

The inventory was slipping 2.16% to $11.78 in premarket buying and selling.

South Korea In Talks to Expedite Moderna COVID-19 Vaccine Provide

Moderna, Inc. (NASDAQ: MRNA) is including to Tuesday’s good points. A report within the Korean Occasions mentioned the nation’s well being officers together with Samsung Biologics are in superior dialogue with Moderna to expedite the latter’s COVID-19 vaccine provide.

South Korea intends to obtain 24 million doses from Moderna by the top of October. Moderna has a take care of South Korea to provide 40 million vaccine doses by the top of 2021, and out of this solely 2.45 million doses have been delivered so far.

Moderna shares have been seen rising 1.79% to $409.05 in premarket buying and selling.

Sutro’s Antibody-drug Conjugate STRO-002 Will get Quick Monitor Designation For Treating Epithelial Ovarian, Fallopian Tube Most cancers

Sutro Biopharma, Inc. (NASDAQ: STRO) mentioned the FDA has granted quick observe designation for STRO-002, an antibody-drug conjugate, for the therapy of sufferers with platinum-resistant epithelial ovarian, fallopian tube, or major peritoneal most cancers who’ve acquired one to 3 prior traces of systemic remedy.

Associated Hyperlink: Consideration Biotech Traders: Mark Your Calendar For August PDUFA Dates

Cabaletta Declares Optimistic Security Knowledge From Section 1 Examine of DSG3-CAART In Pemphigus Vulgaris Sufferers

Cabaletta Bio, Inc. (NASDAQ: CABA) introduced constructive 28-day information from the second dose cohort, on the 100 million cell dose stage, within the Section 1 medical trial of DSG3-CAART for the therapy of sufferers with mucosal-dominant pemphigus vulgaris.

Regardless of a five-fold increased dose than the preliminary cohort, there have been no clinically related adversarial occasions or dose-limiting toxicities noticed both acutely or within the 28-day DLT monitoring interval following infusion, the corporate mentioned.

The inventory was up 3.10% at $7.64 in premarket buying and selling.

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