The Daily Biotech Pulse: Opko Wins CDC Contract, Novartis Lowers Guidance, Pieris Study Placed On Partial Clinical Hold

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 20)

Abbott Laboratories ABT
ABIOMED, Inc. ABMD
Aclaris Therapeutics Inc ACRS
Alnylam Pharmaceuticals, Inc. ALNY
Altimmune Inc ALT
argenx SE – ADR ARGX
AstraZeneca plc AZN (announced positive Phase 1/2 readout for the coronavirus vaccine it is co-developing with the Oxford University)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
Bio-Rad Laboratories, Inc. Class B Common Stock BIO
Beigene Ltd BGNE
BIO-TECHNE Corp TECH
BioMarin Pharmaceutical Inc. BMRN
BioXcel Therapeutics Inc BTAI (reacted to positive late-stage readout for BXCK501 in treating schizophrenia and bipolar disorder)
Brainstorm Cell Therapeutics Inc BCLI
CALLIDITAS THER/S ADR CALT
Catalent Inc CTLT
Cytosorbents Corp Inc CTSO
Dynavax Technologies Corporation DVAX
Emergent Biosolutions Inc EBS
Fortress Biotech FBIO
GENMAB A/S/S ADR GMAB
Heat Biologics Inc HTBX
Illumina, Inc. ILMN
Immunomedics, Inc. IMMU
Inspire Medical Systems Inc INSP
Intuitive Surgical, Inc. ISRG
Ligand Pharmaceuticals Inc. LGND
Meridian Bioscience, Inc. VIVO
Nantkwest Inc NK
NeoGenomics, Inc. NEO
Novavax, Inc. NVAX
OncoSec Medical Inc ONCS
Opko Health Inc. OPK
Quest Diagnostics Inc DGX (said it has received emergency use authorization from the FDA to use specimen pooling with its proprietary molecular diagnostic test for COVID-19)
Penumbra Inc PEN
Quidel Corporation QDEL (announced data showing its COVID-19 antigen test has 96.7% sensitivity within five days of the onset of patient symptoms)
Regeneron Pharmaceuticals Inc REGN
Relay Therapeutics Inc RLAY (went public Thursday)
Sarepta Therapeutics Inc SRPT
Seattle Genetics, Inc. SGEN
Syros Pharmaceuticals Inc SYRS
TIZIANA LF SCIE/S ADR TLSA
Trevena Inc TRVN
Trinity Biotech plc TRIB
VBI Vaccines Inc VBIV
Veracyte Inc VCYT
West Pharmaceutical Services Inc. WST
Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 20)

Avidity Biosciences Inc RNA
Forma Therapeutics Holdings Inc FMTX

Stocks In Focus

Opko Health Unit Secures CDC Contract For COVID-19 Antibody Testing

Opko said its unit BioReference Lab was awarded a contract to provide commercial surge capacity testing for COVID-19 emergency response to the Centers for Disease Control and Prevention.

The contract calls for BioReference performing antibody testing to determine COVID-19 seroprevalence, providing results with key demographic information and analysis in collaboration with the CDC. The contract is effective July 20 and ongoing through Nov. 19, Opko said.

The stock was up 15.59% at $5.71 premarket Tuesday.

Novartis Misses Q1 Sales Estimates, Lowers 2020 Sales Outlook

Novartis AG NVS reported a 1% year-over-year decline in second-quarter net sales, with the company blaming the drop on forward purchasing in the first quarter.

Core EPS increased from $1.34 to $1.36, ahead of the $1.35 consensus estimate. The company lowered its guidance range and now expects mid-single digit net sales growth for fiscal year 2020. It guided to low-double digit core operating income growth.

The stock was losing 1.44% to $86.74 premarket.

Cytosorbents Pre-Announces Q2 Revenues, $40M Offering Of Common Stock

Cytosorbents announced preliminary second-quarter revenues of $9.8 million, a 61% year-over-year increase, helped by record quarterly sales of CytoSorb. Analysts estimated sales of $9.25 million for the quarter.

Separately, the company said it has commenced a $40-million underwritten public offering of its common stock.

The stock was slipping 9.05% to $10.50 premarket.

Emergent Biosolutions to Join S&P MidCap 400 Index

Emergent Biosolutions is set to replace Caesars Entertainment Corp. CZR in the S&P MidCap 400 effective July 24.

The stock was sliding 3% to $99 premarket.

Immuron's Technology Platform Found Effective Against Coronavirus In Gastrointestinal Tract

IMMURON LTD/S ADR IMRN said its IMM-124E — used to manufacture its flagship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan and Protectyn — has demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2, the virus that causes COVID-19.

The stock was jumping 123.15% to $23.23 premarket.

Acadia Pharma's Lead Asset Flunks Late-Stage Study In Major Depressive Disorder

ACADIA Pharmaceuticals Inc. ACAD announced negative top-line results from its 298 patient Phase 3 CLARITY study, which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder.

The company said the study did not meet the primary endpoint with statistical significance.

Separately, the company said the FDA has accepted its sNDA for Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis, with a PDUFA action date of April 3, 2021.

The stock was down 11.13% premarket at $49.25.

Pieris' Early Stage Cancer Drug Study Placed On Partial Clinical Hold

Pieris Pharmaceuticals Inc PIRS said its phase 1 studies of PRS-343 have been placed on partial clinical hold by the FDA. The company said it is conducting an additional in-use and compatibility study requested by the agency.

PRS-343 is in development for the treatment of HER2-positive solid tumors.

In premarket trading Tuesday, the stock was retreating 5.79% to $3.09.

Histogenics Announces Fund Purchase Of Up To $10M In Shares

Histogen Inc HSTO said it has entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, a Chicago-based institutional investor.

In premarket trading Tuesday, the stock was advancing 2.86% to $3.24.

Offerings

Kiniksa Pharmaceuticals Ltd KNSA said it is commencing a public offering of $100 million in Class A common shares. All are being offered by the company.

Kiniksa said it intends to use the net proceeds from the offering to advance the development of its product candidates, aid commercialization activities and fund other R&D activities as well as for working capital and general corporate purposes.

In after-hours trading, the stock declined 7.04% to $22.20.

On The Radar

Clinical Readouts

Novavax said Gregory Glenn, president of R&D, will present the progress of NVX-CoV2373, its COVID-19 vaccine candidate at the 2nd International Society for Vaccines Virtual Congress. The presentation is scheduled for 9:55 a.m. ET.