Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Aug. 18)
- AbbVie Inc. ABBV
- Alkermes plc ALKS
- Bio-Rad Laboratories, Inc. BIO
- Crinetics Pharmaceuticals, Inc. CRNX
- Gilead Sciences, Inc. GILD
- GlaxoSmithKline plc GSK (announced FDA approval for label expansion for its Jemperli)
- Novo Nordisk A/S NVO
- Innoviva, Inc. INVA
- Intuitive Surgical, Inc. ISRG
- Maravai LifeSciences Holdings, Inc. MRVI
- Omega Therapeutics, Inc. OMGA (IPOed July 30)
- Pfizer, Inc. PFE
- Regeneron Pharmaceuticals, Inc. REGN
- ResMed Inc. RMD
- TScan Therapeutics, Inc. TCRX
- Virpax Pharmaceuticals, Inc. VRPX
- West Pharmaceutical Services, Inc. WST
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Aug. 18)
- Absci Corporation ABSI
- Achieve Life Sciences, Inc. ACHV
- Adaptive Biotechnologies Corporation ADPT
- ADMA Biologics, Inc. ADMA
- Akouos, Inc. AKUS
- Angion Biomedica Corp. ANGN
- Aptinyx Inc. APTX
- Arena Pharmaceuticals, Inc. ARNA
- AVROBIO, Inc. AVRO
- Axsome Therapeutics, Inc. AXSM
- Biomea Fusion, Inc. BMEA
- BiondVax Pharmaceuticals Ltd. BVXV
- Catalyst Biosciences, Inc. CBIO
- Checkmate Pharmaceuticals, Inc. CMPI
- Chemomab Therapeutics Ltd. CMMB
- CNS Pharmaceuticals, Inc. CNSP
- Compass Therapeutics, Inc. CMPX
- ContraFect Corporation CFRX
- CymaBay Therapeutics, Inc. CBAY
- CytomX Therapeutics, Inc. CTMX
- Epizyme, Inc. EPZM
- Esperion Therapeutics, Inc. ESPR
- EyeGate Pharmaceuticals, Inc. EYEG
- FibroGen, Inc. FGEN
- Flexion Therapeutics, Inc. FLXN
- Heron Therapeutics, Inc. HRTX
- IN8bio, Inc. INAB (IPOed July 30)
- iRhythm Technologies, Inc. IRTC
- Keros Therapeutics, Inc. KROS
- Liminal BioSciences Inc. LMNL
- Madrigal Pharmaceuticals, Inc. MDGL
- Moleculin Biotech, Inc. MBRX
- Neoleukin Therapeutics, Inc. NLTX
- Oncorus, Inc. ONCR
- Orchard Therapeutics plc ORTX
- Otonomy, Inc. OTIC
- Protara Therapeutics, Inc. TARA
- Qualigen Therapeutics, Inc. QLGN
- Recursion Pharmaceuticals, Inc. RXRX
- scPharmaceuticals Inc. SCPH
- Singular Genomics Systems, Inc. OMIC
- Soleno Therapeutics, Inc. SLNO
- Spectrum Pharmaceuticals, Inc. SPPI
- Teligent, Inc. TLGT
- TherapeuticsMD, Inc. TXMD
- Tiziana Life Sciences PLC TLSA
- Trevena, Inc. TRVN
- Trevi Therapeutics, Inc. TRVI
- Universe Pharmaceuticals INC UPC
- VYNE Therapeutics Inc. VYNE
- X4 Pharmaceuticals, Inc. XFOR
Stocks In Focus
Coherus Announces Positive Late-Stage Data From Lung Cancer Study
Coherus Biosciences, Inc. CHRS and Shanghai Junshi Biosciences announced positive interim results from the pivotal Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer.
The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival compared to chemotherapy alone.
Coherus shares were jumping 21.07% to $17.12 in premarket trading.
Paratek's Antibiotic Gets Orphan Drug Designation For Bacterial Infection
Paratek Pharmaceuticals, Inc. PRTK said the Food and Administration has granted orphan drug designation for Nuzyra in the treatment of infections caused by nontuberculous mycobacteria.
This orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex, which is the focus of an ongoing Phase 2b study initiated by Paratek.
The stock was slipping 1.73% to $5.12 in premarket trading.
Related Link: The Week Ahead In Biotech: Fate Therapeutics Data Readout, RenovoRx IPO In Focus Amid Tapering Earnings News Flow
Illumina Acquires Cancer Diagnostics Company Grail
Illumina, Inc. ILMN announced the acquisition of GRAIL, a health care company focused on life-saving early detection of multiple cancers. The company said it will hold GRAIL as a separate company during the European Commission's ongoing regulatory review.
Illumina first announced its intention to acquire GRAIL nearly a year ago, four years after it was spun off. GRAIL's Galleri blood test detects 50 different cancers before they are symptomatic.
The stock was down 0.46% at $508.26.
Click here to access Benzinga's FDA Calendar.
Adagene Announces Clinical Study Collaboration For Evaluating ADG106-Keytruda Combo In Solid Tumor/Hematological Malignancies
Adagene Inc. ADAG announced that it has entered into a third clinical trial collaboration and supply agreement with Merck & Co., Inc. MRK. The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck's Keytruda in advanced or metastatic solid and/or hematological malignancies.
See also: BEST CANCER INSURANCE
On The Radar
Clinical Readouts
Fate Therapeutics, Inc. FATE is scheduled to present at an investor event new Phase 1 data from FT516 and FT596 programs in relapsed/refractory lymphoma.
Plus Therapeutics, Inc. PSTV will present at the Conference on Brain Metastases, hosted by the Society for Neuro-Oncology, data from one planned clinical trial and one completed preclinical study evaluating its lead investigational drug, Rhenium-186 Nanoliposome for the treatment of leptomeningeal metastases.
Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
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