Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
LogicBio Phase 1/2 Study Of Genome Editing Therapy In Methylmalonic Acidemia Placed On Clinical Hold
LogicBio Therapeutics, Inc. LOGC announced the U.S. Food and Drug Administration has notified the company that its Phase 1/2 SUNRISE clinical trial of LB-001 in pediatric patients with methylmalonic acidemia has been placed on clinical hold.
LB-001 is LogicBio's investigational, single-administration, adeno-associated virus genome editing therapy.
The company noted as reported earlier, the third patient dosed in the SUNRISE trial, who is in the younger age group of 6 months to 2 years old, experienced a drug-related serious adverse event, which was categorized as a case of thrombotic microangiopathy.
The stock was sliding 16% to $1.26 in premarket trading.
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Atea Announces Publication Of Positive Data On Investigational COVID-19 Treatment
Atea Pharmaceuticals, Inc.AVIR announced the publication in the peer-reviewed journal "Nature Communications" new data demonstrating bemnifosbuvir's unique mechanism of action that provides the potential to create a high barrier to resistance with broad antiviral activity across SARS-CoV-2 variants of concern.
Bemnifosbuvir is an orally administered, direct-acting antiviral agent derived from Atea's purine nucleotide prodrug platform. In Phase 2 clinical trials, bemnifosbuvir has demonstrated rapid and sustained antiviral activity in high-risk patients with COVID-19 and has been shown to be generally safe and well tolerated.
Oncolytics Announces Safety Clearance For Phase 1/2 Study Of Oncolytic Viral Therapy Combo In Pancreatic Cancer
Oncolytics Biotech, Inc ONCY announced the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study of its pelareorep in combination with Roche Holding AG's RHHBY Tecentriq following evaluation by the study's Data Safety Monitoring Board.
The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial's third-line metastatic colorectal cancer cohort remains ongoing.
Earnings
Gilead Sciences, Inc.'s GILD fourth-quarter revenues fell 2% to $7.2 billion, dragged by lower Veklury revenues, and non-GAAP earnings fell from $2.19 per share to 69 cents per share, reflecting primarily a $1.25 billion charge related to a legal settlement.
For 2022, the company expects product sales of $23.8 billion and $24.3 billion and non-GAAP EPS of $6.20-$6.70.
The results as well as the guidance were lackluster.
The stock was shedding 2.92% to $66.47 in premarket trading.
Novartis AG NVS reported fourth-quarter net sales growth of 4% to $13.23 billion and operating income growth of 9% to $2.56 billion. On constant-currency basis, both metrics climbed 6% and 12%, respectively. The top-line result was shy of estimates. Core EPS came in at $1.40, in line with the consensus estimate.
For 2022, the company expects mid-single-digit revenue growth in both sales and core operating income.
Boston Scientific Corporation's BSX fourth-quarter net sales climbed 15.4% to $3.127 billion and adjusted EPS rose from 23 cents to 45 cents. The results exceeded the consensus estimates. The company forecasts full-year 2022 sales growth of 6-8% and adjusted EPS of $1.73-$1.79. The guidance trailed expectations.
In premarket trading, the stock was shedding 3.45% to $42.
Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates
On The Radar
Clinical Readouts/Presentations
Athersys, Inc. ATHX is scheduled to host a webcast on Wednesday, at 10 am, wherein it will make a presentation on its MultiStem clinical programs. The company is due to present an outlook of its ischemic stroke program, including perspectives on the upcoming Phase 2/3 TREASURE data readout. The study is evaluating over 200 stroke patients.
The company will also present clinical data from the MultiStem acute respiratory distress syndrome program, including data from both the MUST-ARDS and the ONE-BRIDGE clinical trials. Reflecting on the combined clinical data and supporting information, the company's management will provide its outlook for MultiStem for the treatment of ARDS and its plans for moving the program forward.
Earnings
AbbVie Inc. ABBV (before the market open)
Arrowhead Pharmaceuticals, Inc. ARWR (after the close)
Hologic, Inc. HOLX (after the market close)
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