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Here's a roundup of top developments in the biotech space over the last 24 hours:
AstraZeneca Plc (NASDAQ:AZN) has agreed to acquire TeneoTwo, Inc, including its Phase 1 clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma.
Deal consideration includes an upfront payment of $100 million. AstraZeneca will make additional contingent R&D-related milestone payments of up to $805 million and additional contingent commercial-related milestone payments of up to $360 million to TeneoTwo's equity holders.
Syros Pharmaceuticals Inc (NASDAQ:SYRS) has agreed to acquire TYME Technologies Inc (NASDAQ:TYME), including its pipeline assets and net cash, after accounting for wind-down and transaction expenses currently estimated to be approximately $60 million.
Syros expects to issue approximately 74.3 million shares. TYME stockholders are expected to receive approximately 0.4312 shares of Syros shares for each share of TYME share.
TYME shares are up 42.3% at 38 cents during the premarket session.
Seagen Inc (NASDAQ:SGEN) announced full results from the phase 2 MOUNTAINEER trial, which showed Tukysa (tucatinib) combined with trastuzumab was well-tolerated with durable responses in patients with previously treated HER2-positive metastatic colorectal cancer.
At a median duration of follow-up of 20.7 months, the data showed a 38.1% confirmed objective response rate in Tukysa plus trastuzumab combo regime.
The median duration of response in these patients was 12.4 months. Median progression-free survival was 8.2 months, and median overall survival was 24.1 months.
The FDA approved Sanofi SA's (NASDAQ:SNY) licensure request for influenza vaccine approval for the upcoming 2022-2023 flu season, including Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent.
This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.
Following this licensure, Sanofi will begin to ship their vaccines, helping to ensure more people, including some in the most vulnerable population of 65 years and older.
A federal jury in Chicago, Illinois, has returned a verdict in favor of Endo International plc's (NASDAQ:ENDP) subsidiaries in an antitrust trial under the caption In re Opana ER Antitrust Litigation.
Plaintiffs in the cases alleged that the terms of a 2010 patent settlement agreement between Endo and Impax Laboratories Inc (now Amneal Pharmaceuticals Inc) violated the antitrust laws.
A trial of all plaintiffs' claims began in June and concluded with a verdict in favor of Endo on all counts.
Shares are up 16.6% at 66 cents during the premarket session.
Iveric bio Inc (NASDAQ:ISEE) and DelSiTech Ltd announced an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura (avacincaptad pegol) using DelSiTech's silica-based sustained release technology.
Iveric Bio will pay DelSiTech an upfront payment of €1.25 million, development & commercial milestones, and sales-based royalties.
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The Coalition for Epidemic Preparedness Innovations (CEPI) and Codiak BioSciences (NASDAQ:CDAK) announced the latest funding award under CEPI's $200 million program to advance the development of COVID-19 vaccines and other Betacoronaviruses.
CEPI will provide seed funding of up to $2.5 million to Codiak BioSciences to continue the advancement of vaccine candidates from its pan Betacoronavirus program through preclinical studies.
The European Commission has granted orphan drug designation for Chinook Therapeutics Inc's (NASDAQ:KDNY) BION-1301 for primary IgA nephropathy.
The decision follows a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency.
The FDA has lifted the clinical hold placed on Vertex Pharmaceuticals Incorporated's (NASDAQ:VRTX) Phase 1/2 trial of VX-880 for people with type 1 diabetes with severe hypoglycemia.
The FDA instituted a clinical hold on the study due to a determination of insufficient information to support dose escalation with the product.
Three patients have been dosed in the Phase 1/2 study with VX-880.
Karuna Therapeutics Inc (NASDAQ:KRTX): A director purchases 120K shares at an average price of $122.80/share.
Athira Pharma Inc (NASDAQ:ATHA): Director Joseph Edelman discloses purchasing around 1.37 million shares at an average price of $2.99/share.
Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP): CEO Seth Lederman discloses purchasing 20,000 shares at an average price of $1.71/share.
Brickell Biotech Inc (NASDAQ:BBI): 1:45 reverse stock split.
Abeona Therapeutics Inc (NASDAQ:ABEO): 1:25 reverse stock split.
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