Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
J&J to Separate Its Consumer Health Business Into a New Publicly Traded Company
Johnson & Johnson JNJ announced its intent to separate its Consumer Health business, creating a new publicly traded company. Following the planned separation, the new Johnson & Johnson would remain a diverse health care company and continue its commitment to lead in global healthcare R&D and innovation, with a portfolio that blends its strong Pharmaceutical and Medical Device capabilities.
The new Consumer Health Company would be a leading global consumer health company, with its iconic brands such as Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and Band-aid.
The stock was advancing 3.95% to $169.50 in premarket trading.
Novo Nordisk's Diabetes Drug Gets Positive Recommendation From EMA Committee For New Dosage
Novo Nordisk A/S NVO announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending a label extension for the existing marketing authorization for Ozempic, to introduce a new dose of 2.0 mg. Ozempic is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults.
Click here to access Benzinga's FDA Calendar
Athersys Announces Japanese Partner's Timeline For MultiStem Treatment Programs
Athersys, Inc. ATHX announced timeline for regulatory filing for its MultiStem cell therapy in acute respiratory distress syndrome and ischemic stroke by Healios, its development and commercial partner in Japan.
Healios is targeting filing of the application for this orphan regenerative medicine product in ARDS in either the fourth quarter of 2021 or the first quarter of 2022.
Citing advice from the Pharmaceuticals and Medical Devices Agency, Healios now plans to disclose topline results from the TREASURE study to evaluate MultiStem treatment in ischemic stroke patients after data has been collected from the one-year follow-up visit of the last patient enrolled.
Healios expects this last follow-up visit to take place in March 2022. Unblinding for data analyses will occur after the collection of information from the last patient follow-up visit.
Athersys stock was slipping 7.81% to $1.18 in premarket trading.
Biogen, Eisai Announce Positive Phase 3 Data For FDA-Approved Alzheimer's Treatment
Eisai Co., Ltd. ESALY and Biogen, Inc. BIIB announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the Aduhelm Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer's disease. Reductions in plasma p-tau181 were also correlated with a lowering of amyloid beta plaque.
The pre-specified analysis of plasma samples was conducted by an independent lab, drawing from the two pivotal Aduhelm Phase 3 EMERGE and ENGAGE trials. The findings were presented today at the Clinical Trials on Alzheimer's Disease conference.
Biogen shares were up 3.26% at $275.27 in premarket trading.
Emergent Announces $250M Stock Buyback Program
Emergent BioSolutions Inc. EBS, which has faced a backlash due to its vaccine production issues, announced that its board has authorized management to repurchase up to $250 million of its common stock from time to time on the open market or in privately negotiated transactions. This repurchase authorization expires on Nov. 11, 2022.
The stock was adding 3.24% to $36.59 in premarket trading.
Adaptive Biotech's Minimal Residual Disease Assay clonoSEQ for Blood Cancer Patients to Get Medicare Coverage
Adaptive Biotechnologies Corporation ADPT announced that Palmetto GBA's Molecular Diagnostics Program has finalized a local coverage determination, which supports the Medicare coverage for clonoSEQ to detect and monitor minimal residual disease in patients with B-cell acute lymphoblastic leukemia, multiple myeloma and chronic lymphocytic leukemia.
The stock was gaining 2.96% to $34.75 in premarket trading.
Guardant Announces Publication Of Positive Results For Study Of Liquid Biopsy Test to Guide Colorectal Cancer Treatment
Guardant Health, Inc. GH said a study published in "Nature Medicine" reinforces the benefits of using the Guardant360 liquid biopsy test to help guide treatment decisions for patients with HER2-driven metastatic colorectal cancer. Led by the National Cancer Center Hospital East in Japan, the study demonstrates that the Guardant360 test can select patients for HER2-directed therapy, identify which patients are responding to treatment, as well as identify genetic alterations that predict resistance.
Earnings
AstraZeneca PLC AZN reported above-consensus revenues and core earnings per share for its third quarter. The company said COVID-19 vaccine ringed in revenues of $1.05 billion in the quarter and contributed slightly to profit. The company reaffirmed its fiscal-year 2021 guidance.
In premarket trading, the stock was slipping 3.18% to $60.92.
Acutus Medical, Inc. AFIB reported third-quarter revenues of $4.6 million, up from $3.2 million a year ago. The non-GAAP loss per share narrowed from 90 cents to 87 cents. The results trailed expectations.
Citing COVID-19 related uncertainty, the company lowered its full-year revenues guidance to $17 million to $17.5 million, below the $22.46 million consensus estimates.
The stock was plunging 23.12% to $5.12 in premarket trading.
Eledon Pharmaceuticals, Inc. ELDN reported a narrowing in its third-quarter loss from $5.51 per share in 2020 to 66 cents in 2021.
The stock was adding 14.34% to $5.66 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
On The Radar
Clinical Readouts
Society for Immunotherapy of Cancer Meeting Presentations
Checkmate Pharmaceuticals, Inc. CMPI: final clinical data from the Phase 1b study vidutolimod, in combination with Keytruda or as a monotherapy in melanoma
NextCure, Inc. NXTC: preclinical data for its lead drug candidate, NC318
OncoSec Medical Incorporated ONCS: Phase 2b data for TAVO and Keytruda in melanoma patients
Kadmon Holdings, Inc. KDMN: Phase 1 clinical data for KD033 in patients with metastatic or locally advanced solid tumors
American Academy of Ophthalmology 2021 Meeting Presentations
REGENXBIO Inc. RGNX/ Clearside Biomedical, Inc. CLSD: two-year results from the Phase 1/2a study of subretinal RGX-314 gene therapy for treating neovascular AMD and an update on suprachoroidal trials
Ocuphire Pharma, Inc. OCUP: Phase 2 data for oral APX3330 in diabetic retinopathy/diabetic macular edema, Phase 2 data for phentolamine ophthalmic solution and low-dose pilocarpine for treating presbyopia
14th CTAD Meeting Presentations
Annovis Bio, Inc. ANVS: Positive clinical outcomes of posiphen in two phase 2a studies - Alzheimer's disease and Parkinson's disease
American Association for the Study of Liver Diseases The Liver Meeting Presentations
Vir Biotechnology, Inc. VIR: Preliminary results from a Phase 1 study evaluating a single dose of VIR-3434, a novel neutralizing, vaccinal monoclonal antibody, for hepatitis B infection
Dicerna Pharmaceuticals, Inc. DRNA: results of a subpopulation pharmacokinetic and safety analysis from the Phase 1 trial of RG6346, which Dicerna is developing in collaboration with Roche Holding AG RHHBY for the treatment of chronic hepatitis B virus infection; interim Phase 1 data from Belcesiran in Alpha 1-antitrypsin deficiency-associated liver disease
Earnings
CASI Pharmaceuticals, Inc. CASI (before the market open)
ThermoGenesis Holdings, Inc. THMO (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)
Compugen Ltd. CGEN (before the market open)
Xtant Medical Holdings, Inc. XTNT (before the market open)
Iterum Therapeutics plc ITRM (before the market open)
PLx Pharma Inc. PLXP (before the market open)
NexImmune, Inc. NEXI (before the market open)
Medicenna Therapeutics Corp. MDNA (before the market open)
Forma Therapeutics Holdings, Inc. FMTX (before the market open)
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