The Daily Biotech Pulse: Regeneron Acquires Checkmate Pharma, Moderna's Bivalent Booster COVID-19 Vaccine Update, Priority Review For AstraZeneca's Enhertu

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

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Regeneron Buys Cancer-Focused Checkmate Pharmaceuticals For $250M

Regeneron Pharmaceuticals Inc REGN has agreed to acquire Checkmate Pharmaceuticals Inc CMPI at $10.50 per share. 

The proposed acquisition values Checkmate's equity value at approximately $250 million.

Checkmate's lead investigational candidate is vidutolimod, an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 agonist delivered in a virus-like particle.

CMPI shares are surging 19.1% at $2.87 during the premarket session.

Moderna's Bivalent Booster COVID-19 Vaccine Candidate Shows Superior Neutralizing Activity Vs. SpikeVax Against Multiple Variants

Moderna Inc MRNA has announced new clinical data from its bivalent COVID-19 booster platform.

The data includes data on the Company's first bivalent booster candidate, mRNA-1273.211, which contains mutations in several recent variants, including Omicron. 

A 50 µg booster dose of mRNA-1273.211 demonstrated superiority against Beta, Delta and Omicron variants one month after administration that continued six months after administration for Beta and Omicron variants.

A 50 µg booster dose of mRNA-1273.211 was generally well tolerated.

Shares are down 2.42% at $151.00 during the premarket session.

Click here to access Benzinga's FDA Calendar

AstraZeneca's Enhertu Receives Priority Review in US In Previously Treated HER2 Mutant Lung Cancer Setting

The FDA has accepted for review AstraZeneca plc AZN-Daiichi Sankyo's DSNKY supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting.

The application covers unresectable or metastatic NSCLC whose tumors have a HER2 mutation and have received prior systemic therapy. 

The application has also been granted Priority Review.

Acadia's Non-Opioid Post-Operative Pain Med Flunks In Mid-Stage Study

Acadia Pharmaceuticals Inc ACAD announced topline results from a Phase 2 trial evaluating the efficacy and safety of ACP-044 for acute pain following bunionectomy surgery. 

The primary endpoint, a comparison of cumulative pain intensity scores over 24 hours between the ACP-044 1600 mg once daily, ACP-044 400 mg four times daily, and placebo treatment arms, was not met.

A trend favoring the ACP-044 400 mg once every six hours treatment group was observed on the primary endpoint, a difference of -10.5 points compared to placebo. 

Navidea's Cancer Imaging Agent Scores Indian Approval

India's Central Drugs Standard Control Organisation has approved Navidea Biopharmaceuticals Inc's NAVB Lymphoaim (Lymphoseek / Tc99m tilmanocept).

Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.

BioXcel Therapeutics Receives Strategic Financing Of $260M From Oaktree, Qatar Investment Authority

BioXcel Therapeutics Inc BTAI announced strategic financing from Oaktree Capital Management and Qatar Investment Authority for gross funding of $260 million.

The Company will use the funding to support its commercial activities of Igalmi (dexmedetomidine) sublingual film and expansion of clinical development efforts of BXCL501 in agitation in patients with Alzheimer's Disease.

Full execution of this financing would result in a cash runway into 2025 for the Company.

SpringWorks Inks Trial Collaboration With Regeneron For Nirogacestat In Multiple Myeloma

SpringWorks Therapeutics Inc SWTX has entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals Inc REGN to evaluate nirogacestat in combination with Regeneron's REGN5458 in patients with relapsed or refractory multiple myeloma.

Regeneron is responsible for the clinical development and will assume all costs associated with the study, other than expenses related to the manufacturing and supply of nirogacestat and certain costs related to intellectual property rights.

Amgen's Stelara-Based Biosimilar Shows Comparable Efficacy, Safety Profile For Psoriasis

Amgen Inc AMGN announced preliminary results from a Phase 3 study of ABP 654 compared to Janssen Biotech Inc's Stelara (ustekinumab) in moderate to severe plaque psoriasis. 

The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and Stelara. 

The safety profile of ABP 654 was comparable to Stelara.

ABP 654 is being developed as a biosimilar candidate to Stelara

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