Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
---|
Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
---|
Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
---|
Here's a roundup of top developments in the biotech space over the last 24 hours.
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) has agreed to acquire Checkmate Pharmaceuticals Inc (NASDAQ: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 Inc (NASDAQ: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
The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN)-Daiichi Sankyo's (OTC: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 Pharmaceuticals Inc (NASDAQ: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.
India's Central Drugs Standard Control Organisation has approved Navidea Biopharmaceuticals Inc's (NYSE: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 Inc (NASDAQ: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 Therapeutics Inc (NASDAQ:SWTX) has entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals Inc (NASDAQ: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 Inc (NASDAQ: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
Johnson & Johnson (NASDAQ:JNJ)
Posted In: ACAD AMGN AZN BTAI CMPI DSNKY IBB JNJ MRNA NAVB REGN SWTX