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 July 9)
Affimed NV AFMD
Altimmune Inc ALT
argenx SE – ADR ARGX
Axonics Modulation Technologies Inc AXNX
Biondvax Pharmaceuticals Ltd – ADR BVXV
Bio-Rad Laboratories, Inc. BIOV
Cytokinetics, Inc. CYTK
DexCom, Inc. (NASDAQ: DXCMV
Dynavax Technologies Corporation DVAX
Eli Lilly And Co LLY
GENMAB A/S/S ADR GMAB
Horizon Therapeutics PLC HZNP
Immunomedics, Inc. IMMU
Intellia Therapeutics Inc NTLA
ITAMAR MED LTD/S ADR ITMR
Meridian Bioscience, Inc. VIVO
Nantkwest Inc NK
NeoGenomics, Inc. NEO
Neurocrine Biosciences, Inc. NBIX
Opko Health Inc. OPK
Pacira Biosciences Inc PCRX
Penumbra Inc PEN
Qiagen NV QGEN
Down In The Dumps
Stocks In Focus
Ziopharm Announces Initiation of Phase 1 Trial For Blood Cancer Cell Therapy
AbbVie's Allergan Unit's Botox Gets Label Expansion To Treat Pediatric Spasticity
Integra Lifesciences Pre-announces Above-consensus Q2 Revenues
Anixa Gets Intent-to-grant Patent Notice For Cancer Cell Therapy In Europe
Tonix Completes Enrollment In Late-stage Fibromyalgia Study Ahead of Schedule
Bionano Launches New Kit to Analyze Tumors and Tissues
Offerings
On The Radar
Clinical Readouts/Presentations
IPOs
Quidel Corporation QDEL
Regeneron Pharmaceuticals Inc REGN
Seattle Genetics, Inc. SGEN
TG Therapeutics Inc TGTX
Twist Bioscience Corp TWST
West Pharmaceutical Services Inc. WST
Zai Lab Ltd ZLAB
(Biotech Stocks Hitting 52-week Lows July 9)
ANI Pharmaceuticals Inc ANIP
Evolus Inc EOLS
immatics biotechnologies GmbH IMTX
Intercept Pharmaceuticals Inc ICPT
ORIC Pharmaceuticals Inc ORIC
Orchard Therapeutics PLC – ADR ORTX
Polypid Ltd PYPD
Recro Pharma Inc REPH
Repare Therapeutics Inc RPTX
ZIOPHARM Oncology Inc. ZIOP said it has initiated a phase 1 clinical trial to evaluate CD19-specific CAR-T, using its Rapid Personalized Manufacturing technology, or RPM, as an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas.
The company said it has used its non-viral Sleeping Beauty genetic engineering technology to infuse CAR-T the day after electroporation.
The stock rallied 9.23% to $3.55 in after-hours trading.
AbbVie Inc ABBV announced FDA Approval for its Allergan unit's sBLA seeking expanded use of Botox for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
Integra Lifesciences Holdings Corp IART pre-announced second-quarter revenue in the range of $254 million to $256 million, down 34% year-over-year. Analysts, on average, estimate revenues of $240.49 million.
Throughout the quarter, monthly sales performance improved sequentially due to the resumption of non-emergent surgical procedures and the easing of shelter-in-place restrictions, it added.
The stock added 2.53% to $47.50 in after-hours trading.
Anixa Biosciences Inc ANIX said the European Patent Office has issued an Intention to Grant notice for the first European patent covering its novel CAR-T cancer treatment technology, which has been licensed from The Wistar Institute and is being developed at the Moffitt Cancer Center.
The stock was seen jumping 13.01% to $3.30 in pre-market trading.
Tonix Pharmaceuticals Holding Corp. TNXP said it has met its target enrollment of approximately 470 participants in its Phase 3 RELIEF trial of its non-opioid, centrally acting analgesic - TNX-102 SL, 5.6 mg, - ahead of schedule.
The company said it expects to release interim analysis of data from the first 50% of the patients in September, and top-line results in the fourth quarter of 2020.
The stock was adding 2.26% to 67 cents in pre-market trading.
BioNano Genomics Inc BNGO said it has launched the new Bionano Prep SP Tissue and Tumor Kit, a DNA isolation kit developed expressly for analysis of tumors and tissue with its Saphyr system.
The kit, according to the company, has been designed to simplify isolation of Ultra High Molecular Weight DNA from a variety of solid tumors and tissue types.
The stock gained 8.38% to 53 cents in after-hours trading.
Centogene NV CNTG said it has priced its primary and secondary public offering of 3.5 million shares, comprising 2 million common shares offered by the company and 1.5 million offered by selling shareholders, at $14 per common share for total gross proceeds to the company of $28 million and total gross proceeds to the selling shareholders of $21 million.
Abeona Therapeutics Inc ABEO is due to present two abstracts related to its clinical program for recessive dystrophic epidermolysis bullosa, or RDEB, at the Society for Pediatric Dermatology annual meeting. The company will present detailed data on long-term pain relief following durable healing of wounds in RDEB patients treated with EB-101 in a Phase 1/2 study.
Kodiak Sciences Inc KOD will present at the American Society of Retina Specialists annual meeting, Phase 1b new data for KSI-301 in diabetic macular edema/wet age-related macular degeneration.
INVENTIVA S.A., a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis, mucopolysaccharidoses, and other diseases, priced Its initial public offering, or IPO, of 7.478 million ADSs, each representing one ordinary share. The aggregate gross proceeds is expected to be approximately $107.7 million. The offering is expected to close July 15.
The ADSs have been approved for listing on the NASDAQ under the ticker symbol IVA.
Nkarta, Inc. priced its upsized IPO of 14 million shares at $18 per share, above the estimated price range of $16-$17, for raising gross proceeds of $252 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol NKTX.
Poseida Therapeutics, Inc., a cell and gene therapy company, priced its IPO of 14 million shares at $16 per share, for generating gross proceeds of $224 million. The shares will be listed on the Nasdaq under the ticker symbol PSTX.
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