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 Jan. 20)
- 10X Genomics Inc TXG
- ABIOMED, Inc. ABMD
- Aclaris Therapeutics Inc ACRS
- Adamis Pharmaceuticals CorpADMP (announced IND submission of Tempol for COVID-19 treatment)
- Akari Therapeutics PLC AKTX
- Aligos Therapeutics Inc ALGS
- Alimera Sciences Inc ALIM
- Atea Pharmaceuticals Inc AVIR
- Beigene Ltd BGNE
- Bicycle Therapeutics PLC BCYC
- BIO-TECHNE Corp TECH
- BioCryst Pharmaceuticals, Inc. BCRX
- Biodesix Inc BDSX
- BioVie Inc BIVI
- Caladrius Biosciences Inc CLBS
- Cara Therapeutics Inc CARA
- CareDx Inc CDNA
- Castle Biosciences Inc CSTL
- Celcuity Inc CELC
- Cellectis SA CLLS
- Celsius Holdings, Inc. CELH
- Dare Bioscience Inc DARE
- DermTech Inc DMTK
- Dyne Therapeutics Inc DYN
- Edap Tms SA EDAP (reacted to fourth-quarter results)
- Eli Lilly And Co LLY
- ENDRA Life Sciences Inc NDRA
- ESSA Pharma Inc EPIX
- Evelo Biosciences Inc EVLO (announced positive Phase 1b data for drug to treat atopic dermatitis)
- EXACT Sciences Corporation EXAS
- Fulgent Genetics Inc FLGT
- Genetron Holdings Ltd – ADR GTH
- Gritstone Oncology Inc GRTS (announced a nonexclusive license to Genevant's LNP technology to develop vaccines against SARS-CoV-2)
- Guardant Health Inc GH
- Halozyme Therapeutics, Inc. HALO
- Idera Pharmaceuticals Inc IDRA
- Ideaya Biosciences Inc IDYA
- ImmuCell Corporation ICCC
- Inari Medical Inc NARI
- Infinity Pharmaceuticals Inc. INFI
- Inspire Medical Systems Inc INSP
- Insulet Corporation PODD
- Integra Lifesciences Holdings Corp IART
- Inventiva ADR Representing Ord Shs IVA
- iTeos Therapeutics Inc ITOS
- Jazz Pharmaceuticals PLC JAZZ
- Johnson & Johnson JNJ
- Jounce Therapeutics Inc JNCE
- Krystal Biotech Inc KRYS
- LeMaitre Vascular Inc LMAT
- Ligand Pharmaceuticals Inc. LGND
- Maravai Lifesciences Holdings Inc MRVI
- Merus NV MRUS
- Mustang Bio Inc MBIO
- Natera Inc NTRA
- Neuronetics Inc STIM
- Obalon Therapeutics Inc OBLN (announced a deal to merge with ReShape Lifesciences)
- Organogenesis Holdings Inc ORGO
- Orphazyme A S ADR ORPH
- Pacific Biosciences of California Inc PACB
- PRA Health Sciences Inc PRAH
- Precision BioSciences Inc DTIL
- Relay Therapeutics Inc RLAY
- Repligen Corporation RGEN
- Rhythm Pharmaceuticals Inc RYTM
- Profound Medical Corp PROF
- Stoke Therapeutics Inc STOK
- Supernus Pharmaceuticals Inc SUPN
- Surface Oncology Inc SURF
- Syneos Health Inc SYNH
- Titan Medical Inc. TMDI
- Twist Bioscience Corp TWST
- Vericel Corp VCEL
- Xencor Inc XNCR
- Zai Lab Ltd – ADR ZLAB
Down In The Dumps
None of the biotech/medical device/diagnostic stocks hit 52-week highs in the session.
Stocks In Focus
Bristol-Myers Squibb's Regulatory Application For Esbriet Label Expansion Accepted For Priority Review
Bristol-Myers Squibb Co BMY said the FDA has accepted its supplemental New Drug Application and granted priority review for Esbriet for the treatment of unclassifiable interstitial lung disease. The FDA is expected to make a decision on approval by May 2021.
Addex Says Licensee J&J's Janssen Unit Approved To Start Phase 2a Epilepsy Drug Study
Addex Therapeutics ADR ADXN said its partner Johnson & Johnson's Janssen Pharmaceuticals has received FDA investigational new drug approval to begin a Phase 2a proof-of-concept study with the selective metabotropic glutamate type 2 receptor positive allosteric modulator JNJ-40411813 in patients with epilepsy. The first patient is expected to be treated during the second quarter of 2021.
Janssen licensed the pipeline asset from Addex.
Addex shares were soaring 67.87% to $17.10 premarket Thursday.
Boston Scientific To Buy Cardiac Health Solutions Provider Preventice
Boston Scientific Corporation BSX said it has entered into a definitive agreement to acquire Preventice Solutions, Inc., a privately held company offering a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors — including short and long-term Holter monitors — to cardiac event monitors and mobile cardiac telemetry.
The transaction consists of an upfront cash payment of $925 million and up to an additional $300 million in potential commercial milestone payments.
Boston now holds an equity stake of approximately 22%, which is expected to result in a net payment of approximately $720 million upon closing and a milestone payment of up to approximately $230 million.
INmune Bio Reports Positive Early Stage Data For Alzheimer's Drug
INmune Bio, Inc. INMB, a clinical-stage immunology company, said results from a Phase 1b study demonstrate that its Alzheimer's disease candidate XPro1595 led to decreasing neuroinflammation, with significant improvements in biomarkers of neurodegeneration and synaptic function.
The stock was rallying 41.88% to $35.64 premarket Thursday.
Lineage Cell CFO to Depart
Lineage Cell Therapeutics Inc LCTX said Brandi Roberts, its chief financial officer, provided notice of her resignation Jan. 15 in order to accept a leadership position at another company. Brian Culley, Lineage's CEO, will serve as interim chief financial officer until a CFO has been appointed, the company said.
The stock was up 9.67% at $3.29 premarket.
Dynavax Appoints Ironwood Pharma Executive As CFO
Dynavax Technologies CorporationDVAX announced the appointment of Kelly MacDonald as SVP and chief financial officer effective March 1. MacDonald will replace Michael Ostrach, who is retiring following a 14-year stint at the company.
MacDonald last served as chief accounting officer and VP of finance at Ironwood Pharmaceuticals, Inc.IRWD.
Ora Sure's Saliva Collection Device Included In FDA Authorized Exome Sequencig-Based Platform
OraSure Technologies, Inc. OSUR said its Oragene Dx (OGD-610) saliva collection device was included as a component in the De Novo authorization granted by the FDA to Helix for their Helix Laboratory Platform, a whole exome sequencing platform. This is the first exome sequencing-based platform authorized by the FDA. Oragene Dx is a product of OraSure's DNA Genotek subsidiary.
The stock was up 8.18% to $14.42 in premarket trading Thursday.
Inovio Pharmaceuticals Inc INO, which is developing a DNA vaccine for the coronavirus vaccine, priced its underwritten public offering of 17.7 million shares of its common stock at $8.5 per share, for raising gross proceeds of $150.5 million. All of the shares are being sold by Inovio.
The company said it intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and R&D expenses, and for general corporate purposes, including working capital and general and administrative expenses.
The stock shed 7.3% premarket to $9.01.
Dyne Therapeutics priced its underwritten public offering of 6 million shares of its common stock at a public offering price of $28 per share, for raising gross proceeds of $168 million. All of the shares are being offered by Dyne.
OncoSec Medical Inc ONCS said it intends to offer shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering will be offered by the company.
The stock was down 4.51% premarket at $5.50.
OncoCyte Corp OCX announced that it has entered into definitive agreements with its two largest institutional investors — Pura Vida and Broadwood Partners — to purchase approximately $25 million of its common shares in a registered offering priced at $3.424 per share.
The stock jumped 10.68% premarket to $4.56.
InVitae Corp NVTA said it has commenced an underwritten public offering of $400 million of shares of its common stock. All of the shares are being offered by the company.
The stock was down 2.86% premarket at $55.30.
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