Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Kura Announces Lifting Of Clinical Hold On Phase 1 Blood Cancer Study
Kura Oncology, Inc. KURA announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia. The partial clinical hold was lifted following agreement with the FDA on the company's mitigation strategy for differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.
The stock was gaining 4.33% to $12.30 in premarket trading.
Opiant Commences Mid-Stage Study Of OPNT002 For Treating Alcohol Use Disorder
Opiant Pharmaceuticals, Inc. OPNT announced that the first patient has been dosed in a Phase 2 clinical trial of OPNT002, nasal naltrexone, for the treatment of alcohol use disorder. The trial will determine whether OPNT002 reduces heavy drinking as measured by a change in the World Health Organization drinking risk levels.
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ASLAN Commences Phase 2b Study Of Atopic Dermatitis Drug
ASLN announced that it has screened the first patient in its Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis.
Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to provide a differentiated treatment option for patients. ASLAN expects to report topline findings from the 16-week treatment period in the first half of 2023.
The stock was adding 3.15% to 95 cents in premarket trading.
Regulus Announces Positive Feedback From FDA Following Pre-IND Meeting Regarding Kidney Disease Drug
Regulus Therapeutics, Inc. RGLS has completed a pre-investigational new drug meeting with the FDA. The purpose of the meeting was to obtain input from the FDA on pre-clinical, clinical and regulatory matters pertaining to the company's next generation compound RGLS8429 as a potential treatment for autosomal dominant polycystic kidney disease.
Based on the minutes received from the FDA earlier this week, the company said it is on track to submit an IND application in the second quarter of 2022 to obtain clearance for initiation of the Phase 1 clinical trial.
Intuitive Surgical Q4 Beat Expectations
Intuitive Surgical, Inc. ISRG reported fourth-quarter revenues of $1.55 billion, up from $1.33 billion a year ago. The non-GAAP earnings per share increased from $1.19 to $1.30, ahead of the $1.28-per-share consensus estimate.
The stock was slipping 5.20% to $277.51 in premarket trading.
Sorrento Says Antibody Treatment Potent Against Omicron Variant
Sorrento Therapeutics, Inc. SRNE announced the release of new data on the omicron variant neutralizing antibody STI-9167, COVISHIELD, an advanced stage antibody discovered and developed for clinical trials in an ongoing collaboration between immunologists and virologists at Sorrento and the Icahn School of Medicine at Mount Sinai in New York.
Spike protein binding assays and neutralization assays using viruses representing all known SARS-CoV-2 variants of concern have been completed with STI-9167, and this nAb was observed to bind with high affinity and provide highly potent neutralizing activity.
The stock was adding 2.40% to $4.27 in premarket trading.
Sonoma Announces New Distribution Partnerships In U.S. And China For Dental Care Products
Sonoma Pharmaceuticals, Inc. SNOA announced that it has added Salus Medical as an additional distribution partner in the U.S. for dental care and expanded its oral and dental care lines to China via a partnership deal with Anlicare International.
The stock was plunging 29.18% to $3.01 in premarket trading.
Arbutus Gains On Insider Buying
Arbutus Biopharma Corporation ABUS disclosed in multiple filing that its executives, including CEO William Collier, exercised options to buy shares in the company.
The stock was adding 3.56% to $2.91 in premarket trading.
On The Radar
Société Francophone du Nerf Périphérique Annual Meeting Presentations
Alnylam Pharmaceuticals, Inc. ALNY: full 18-month results from the HELIOS-A Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis; The management will discuss the data via a conference call on Friday at 8:30 am
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