The Daily Biotech Pulse: AstraZeneca Goes Shopping, TYME Technologies & Syros Pharma Merger, FDA Clears Vertex Pharma's Stem Cell-Based Diabetes Therapy Study

Zinger Key Points
  • After Tyme Deal Syros expects to have cash into 2025.
  • Codiak's vaccine candidate stimulates comprehensive, durable immune response against multiple COVID-19 variants.

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

AstraZeneca Strengthens Its Hematological Cancer Pipeline With TeneoTwo Acquisition

AstraZeneca Plc 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.

TYME Technologies Shares Surge On Merger Agreement With Syros Pharma

Syros Pharmaceuticals Inc SYRS has agreed to acquire TYME Technologies Inc 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's Tucatinib Combo Shows Encouraging Antitumor Activity In Pretreated Colorectal Cancer

Seagen Inc 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. 

Sanofi's Flu Vaccines Included In CDC Preferred Higher-Dose Vaccines For 65 Years & Above 

The FDA approved Sanofi SA's 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.

Opana ER Antitrust Trial Concludes With Jury Verdict Favoring Endo

A federal jury in Chicago, Illinois, has returned a verdict in favor of Endo International plc's 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, DelSiTech Ink Licensing Pact For Zimura

Iveric bio Inc 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.

Also Read: This Analyst Cuts Price Target On Tesla, Here's The Biggest Price Target Changes For Tuesday

CEPI, Codiak BioSciences Join Forces To Develop Betacoronavirus Vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) and Codiak BioSciences 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.

Chinook Therapeutics' Kidney Disease Candidate Gets European Orphan Drug Tag

The European Commission has granted orphan drug designation for Chinook Therapeutics Inc's 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.

FDA Lifts Clinical Hold On Vertex Pharma's Stem Cell-Derived Diabetes Treatment Trial

The FDA has lifted the clinical hold placed on Vertex Pharmaceuticals Incorporated's 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. 

Insider Trading

Karuna Therapeutics Inc KRTX: A director purchases 120K shares at an average price of $122.80/share.

Athira Pharma Inc ATHA: Director Joseph Edelman discloses purchasing around 1.37 million shares at an average price of $2.99/share.

Tonix Pharmaceuticals Holding Corp TNXP: CEO Seth Lederman discloses purchasing 20,000 shares at an average price of $1.71/share.

On The Radar

Stock Split

Brickell Biotech Inc BBI: 1:45 reverse stock split.

Abeona Therapeutics Inc ABEO: 1:25 reverse stock split.

Posted In: COVID-19 VaccineJoseph EdelmanSeth LedermanBiotechLarge CapM&ANewsPenny StocksHealth CareFinancingSmall CapFDAInsider TradesStock SplitMoversTrading IdeasGeneral

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