Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Cumberland Gets FDA Approval For IV-Delivered Ibuprofen For Use In Pre-Operative Administration
Cumberland Pharmaceuticals Inc. CPIX announced the U.S. Food and Drug Administration has approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration. The non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain.
The stock was jumping 94.55% to $4.28 in premarket trading.
Adagene Gets FDA Clearance For Commencing Phase 1b/2 Study Of Investigational Antibody In Solid Tumors
Adagene Inc. ADAG said the FDA has cleared the investigational new drug application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody, ADG116, in combination with Merck & Co., Inc.'s MRK Keytruda. The global trial will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific, the company said.
The stock was adding 7.76% to $9.16 in after-hours trading.
Outset Medical's New Sterilization Method Of Cartridge Used In Dialysis System Approved By FDA
Outset Medical, Inc. OM said the FDA has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its Tablo Hemodialysis System, enabling full production in North America. The Tablo cartridge is a single-use disposable that works in concert with the console to deliver dialysis treatment. Its "one-touch" design speeds and simplifies treatment set-up and take-down.
The stock was rising 5.06% to $48 in premarket trading.
Merck's Keytruda-Chemo Combo Approved In Japan For Treating Esophageal Cancer
Merck announced that its Keytruda has been approved by the Japan Pharmaceuticals and Medical Devices Agency for the first-line treatment of patients with radically unresectable, advanced or recurrent esophageal carcinoma in combination with chemotherapy based on data from the Phase 3 KEYNOTE-590 trial.
Regeneron Says REGN-COV Antibodies May Have Reduced Neutralization Activity Against Omicron Variant
Regeneron Pharmaceuticals, Inc. REGN said prior in vitro analyses and structural modeling regarding the individual mutations present in the omicron variant indicate that there may be reduced neutralization activity of both vaccine-induced and monoclonal antibody conveyed immunity, including the current REGEN-COV antibodies.
Further analyses are ongoing to confirm and quantify this potential impact using the actual omicron variant sequence.
The stock was down 2.79% at $636.12 in premarket trading.
Merck-AstraZeneca's Regulatory Filing For Expanding Label Of Breast Cancer Drug Accepted For Priority Review By FDA
Merck and AstraZeneca plc AZN announced a supplemental new drug application for Lynparza has been accepted and granted priority review by the FDA for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
ImmunoGen's Antibody-Drug Conjugate Aces Pivotal Ovarian Cancer Study
ImmunoGen, Inc. IMGN announced positive top-line data from the pivotal SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine monotherapy in patients with folate receptor alpha-high platinum-resistant ovarian cancer who have been previously treated with Avastin. The company said it is on track for submission of biologic license application in the first quarter of 2022.
The stock was jumping 29.05% to $6.13 in premarket trading.
Molecular Partners Says Its COVID-19 Treatment Candidate Found Effective Against Omicron Variant
Molecular Partners AG MOLN said its ensovibep retains activity with regard to all relevant individual positions mutated in omicron, the newly discovered viral variant of concern.
The company noted that testing on the full omicron variant has initiated, with results expected in the coming weeks The global Phase 2-3 EMPATHY clinical study evaluating ensovibep for COVID-19 is ongoing with topline phase 2 data available in early 2022, it added.
The stock was up 13.3% at $13.29 in premarket trading.
Exact Sciences, Pfizer Terminate Colorectal Cancer Screening Test Co-Promotion Agreement
Exact Sciences, Inc. EXAS said on Monday, it amended its October 2020 Cologuard promotion agreement with Pfizer, Inc. PFE. The amendment, effective Tuesday, indicates Pfizer will no longer promote the Cologuard colorectal cancer screening test to health care providers.
The amendment provides that the company pay Pfizer a total of $35.9 million in three installments during the second, third and fourth quarters of 2022 and eliminates its obligation to pay Pfizer royalties or other fees except for certain media fees, advertising fees and any detail fees owed to Pfizer for promoting the product prior to the termination of the agreement.
Offerings
Krystal Biotech, Inc. KRYS said it has commenced a $200-million underwritten public offering of its common stock. The shares jumped on Monday on the back of a positive Phase 3 readout.
The stock was moving up 8.23% at $95.50 in premarket trading.
Click here to access Benzinga's FDA Calendar.
On The Radar
PDUFA Dates
The FDA is scheduled to rule on VBI Vaccines Inc.'s VBIV biologic license application for its Sci-B-Vac meant to treat hepatitis B virus infection.
BeyondSpring Inc.'s BYSI NDA for plinabulin + G-CSF Combination has a PDUFA date of Tuesday. Plinabulin, in combination with granulocyte colony-stimulating factor, is being studied for the prevention of chemotherapy-induced neutropenia.
CTI BioPharma Corp.'s CTIC NDA for pacritinib also has a PDUFA date of Tuesday. Pacritinib, if approved, is expected to addresses unmet medical need of myelofibrosis patients with severe thrombocytopenia.
Clinical Readouts
MEI Pharma, Inc. MEIP is scheduled to host a live investor and analyst webcast at 8 a.m., reporting on data from the Phase 2 TIDAL study evaluating zandelisib in patients with relapsed or refractory follicular lymphoma.
The webcast will also review the zandelisib program and provide a corporate update.
Ahead of the webcast, the company released a statement saying the study produced positive results.
The stock was up 14.7% at $2.18 in premarket trading.
Earnings
RedHill Biopharma Ltd. RDHL (before the market open)
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
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