The Daily Biotech Pulse: Addex Jumps On Positive Data For Out-Licensed Drug, COVID-19 Vaccine Developer Inovio Announces $150M Follow-On Offering, Boston Scientific Goes Shopping

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 (NASDAQ:TXG)
• ABIOMED, Inc. (NASDAQ:ABMD)
• Aclaris Therapeutics Inc (NASDAQ:ACRS)
• Adamis Pharmaceuticals Corp(NASDAQ:ADMP) (announced IND submission of Tempol for COVID-19 treatment)
• Akari Therapeutics PLC (NASDAQ:AKTX)
• Aligos Therapeutics Inc (NASDAQ:ALGS)
• Alimera Sciences Inc (NASDAQ:ALIM)
• Atea Pharmaceuticals Inc (NASDAQ:AVIR)
• Beigene Ltd (NASDAQ:BGNE)
• Bicycle Therapeutics PLC (NASDAQ:BCYC)
• BIO-TECHNE Corp (NASDAQ:TECH)
• BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
• Biodesix Inc (NASDAQ:BDSX)
• BioVie Inc (NASDAQ:BIVI)
• Caladrius Biosciences Inc (NASDAQ:CLBS)
• Cara Therapeutics Inc (NASDAQ:CARA)
• CareDx Inc (NASDAQ:CDNA)
• Castle Biosciences Inc (NASDAQ:CSTL)
• Celcuity Inc (NASDAQ:CELC)
• Cellectis SA (NASDAQ:CLLS)
• Celsius Holdings, Inc. (NASDAQ:CELH)
• Dare Bioscience Inc (NASDAQ:DARE)
• DermTech Inc (NASDAQ:DMTK)
• Dyne Therapeutics Inc (NASDAQ:DYN)
• Edap Tms SA (NASDAQ:EDAP) (reacted to fourth-quarter results)
• Eli Lilly And Co (NYSE:LLY)
• ENDRA Life Sciences Inc (NASDAQ:NDRA)
• ESSA Pharma Inc (NASDAQ:EPIX)
• Evelo Biosciences Inc (NASDAQ:EVLO) (announced positive Phase 1b data for drug to treat atopic dermatitis)
• EXACT Sciences Corporation (NASDAQ:EXAS)
• Fulgent Genetics Inc (NASDAQ:FLGT)
• Genetron Holdings Ltd – ADR (NASDAQ:GTH)
• Gritstone Oncology Inc (NASDAQ:GRTS) (announced a nonexclusive license to Genevant's LNP technology to develop vaccines against SARS-CoV-2)
• Guardant Health Inc (NASDAQ:GH)
• Halozyme Therapeutics, Inc. (NASDAQ:HALO)
• Idera Pharmaceuticals Inc (NASDAQ:IDRA)
• Ideaya Biosciences Inc (NASDAQ:IDYA)
• ImmuCell Corporation (NASDAQ:ICCC)
• Inari Medical Inc (NASDAQ:NARI)
• Infinity Pharmaceuticals Inc. (NASDAQ:INFI)
• Inspire Medical Systems Inc (NYSE:INSP)
• Insulet Corporation (NASDAQ:PODD)
• Integra Lifesciences Holdings Corp (NASDAQ:IART)
• Inventiva ADR Representing Ord Shs (NASDAQ:IVA)
• iTeos Therapeutics Inc (NASDAQ:ITOS)
• Jazz Pharmaceuticals PLC (NASDAQ:JAZZ)
• Johnson & Johnson (NYSE:JNJ)
• Jounce Therapeutics Inc (NASDAQ:JNCE)
• Krystal Biotech Inc (NASDAQ:KRYS)
• LeMaitre Vascular Inc (NASDAQ:LMAT)
• Ligand Pharmaceuticals Inc. (NASDAQ:LGND)
• Maravai Lifesciences Holdings Inc (NASDAQ:MRVI)
• Merus NV (NASDAQ:MRUS)
• Mustang Bio Inc (NASDAQ:MBIO)
• Natera Inc (NASDAQ:NTRA)
• Neuronetics Inc (NASDAQ:STIM)
• Obalon Therapeutics Inc (NASDAQ:OBLN) (announced a deal to merge with ReShape Lifesciences)
• Organogenesis Holdings Inc (NASDAQ:ORGO)
• Orphazyme A S ADR (NASDAQ:ORPH)
• Pacific Biosciences of California Inc (NASDAQ:PACB)
• PRA Health Sciences Inc (NASDAQ:PRAH)
• Precision BioSciences Inc (NASDAQ:DTIL)
• Relay Therapeutics Inc (NASDAQ:RLAY)
• Repligen Corporation (NASDAQ:RGEN)
• Rhythm Pharmaceuticals Inc (NASDAQ:RYTM)
• Profound Medical Corp (NASDAQ:PROF)
• Stoke Therapeutics Inc (NASDAQ:STOK)
• Supernus Pharmaceuticals Inc (NASDAQ:SUPN)
• Surface Oncology Inc (NASDAQ:SURF)
• Syneos Health Inc (NASDAQ:SYNH)
• Titan Medical Inc. (NASDAQ:TMDI)
• Twist Bioscience Corp (NASDAQ:TWST)
• Vericel Corp (NASDAQ:VCEL)
• Xencor Inc (NASDAQ:XNCR)
• Zai Lab Ltd – ADR (NASDAQ: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 (NYSE: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 (NASDAQ: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 (NASDAQ: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. (NASDAQ: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.

Related Link: The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications

Lineage Cell CFO to Depart

Lineage Cell Therapeutics Inc (NYSE: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 Corporation(NASDAQ:DVAX) 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.(NASDAQ:IRWD).

Ora Sure's Saliva Collection Device Included In FDA Authorized Exome Sequencig-Based Platform

OraSure Technologies, Inc. (NASDAQ: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.

Offerings

Inovio Pharmaceuticals Inc (NASDAQ: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 (NASDAQ: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 (NYSE: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 (NYSE: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. 

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates