| 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:
In its Q2 earnings release, Vir Biotechnology Inc (NASDAQ:VIR) and its partner GSK plc (NYSE:GSK) said that they do not plan to file a marketing application for sotrovimab for COVID-19 at this time.
The company also said it does not intend to pursue the U.S.-based Phase 3 COMET-STAR prophylaxis trial, citing evolving COVID-19 landscape and FDA discussions.
Discussions with the FDA remain ongoing regarding the appropriate path forward for sotrovimab in the U.S.
Aethlon Medical Inc (NASDAQ:AEMD) said it is commissioning a new in vitro binding experiment to confirm that the Hemopurifier effectively captures the current strain of the monkeypox virus.
In 2008, the company conducted an in vitro study demonstrating that the Hemopurifier effectively bound and removed the monkeypox virus.
The study indicated that the Hemopurifier removed 44% of the monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours.
SAB Biotherapeutics (NASDAQ:SABS) will discontinue its work with the U.S. Department of Defense (DoD) under a prototype research and development agreement.
The conclusion will allow the company to focus on its core priorities and expand its current pipeline.
The FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck & Co Inc's (NYSE:MRK) type 2 diabetes drug Januvia/Janumet (sitagliptin).
The agency said that to avoid a shortage and to help ensure patients have access to an adequate supply, the FDA said it would not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.
Evotec SE's (NASDAQ:EVO) subsidiary, Just - Evotec Biologics Inc, has expanded a multi-year partnership with Alpine Immune Sciences Inc (NASDAQ:ALPN) for ALPN-303 for systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases.
Just - Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303.
Bristol Myers Squibb Co (NYSE:BMY) and 2seventy bio Inc (NASDAQ:TSVT) have announced topline results from KarMMa-3 Phase 3 trial of Abecma (idecabtagene vicleucel) for multiple myeloma.
The interim analysis demonstrated a statistically significant improvement in progression-free survival.
Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens.
Centessa Pharmaceuticals plc (NASDAQ:CNTA) has decided to discontinue the development of ZF874 following a recent report of an adverse event involving elevated liver enzymes (AST/ALT) in a PiMZ subject dosed with 5 mg/kg in the Phase 1 study.
Based on the results observed, the company concluded that ZF874 was unlikely to achieve the desired target product profile.
Gemini Therapeutics Inc (NASDAQ:GMTX) and privately held Disc Medicine Inc have entered into a merger agreement in an all-stock transaction.
The combined company will focus on advancing Disc's pipeline of hematology programs, including multiple patient studies for its clinical-stage programs bitopertin and DISC-0974.
The combined company will operate under the Disc Medicine moniker, trade on the Nasdaq Global Market under the 'IRON' ticker, and be led by Disc Medicine's CEO, John Quisel.
Caladrius Biosciences Inc's (NASDAQ:CLBS) merger partner, Cend Therapeutics Inc has announced a trial collaboration with Roche Holdings AG (OTC:RHHBY).
Under the terms of the agreement, Roche will be responsible for the operational management of the trial, while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study.
VYNE Therapeutics Inc (NASDAQ:VYNE) has announced results from the Phase 2a segment of Phase 1b/2a trial evaluating FMX114 for mild-to-moderate atopic dermatitis.
The study did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index.
Aridis Pharmaceuticals Inc's (NASDAQ:ARDS) inhaled treatment of its fully human monoclonal antibody cocktail AR-701 resulted in no detectable SARS-CoV-2 virus in the lungs of infected non-human primates.
The candidate also protected their lungs from disease.
AR-701 was effective in non-human primates as a prophylactic or therapeutic treatment regimen.
Verona Pharma plc (NASDAQ:VRNA) announced an underwritten public offering of 10 million American Depositary Shares.
Mirum Pharmaceuticals Inc (NASDAQ:MIRM) priced its previously announced underwritten public offering of 3.5 million shares at $23/share, with gross proceeds of $80 million.
Karuna Therapeutics Inc (NASDAQ:KRTX) priced an upsized, underwritten public offering of 3.5 million shares at $215/share, for approximately $750 million gross proceeds.
Adamis Pharmaceuticals Corp (NASDAQ:ADMP): After market close.
Ascendis Pharma A/S (NASDAQ:ASND): After market close.
Eyenovia Inc (NASDAQ:EYEN): After market close.
DiaMedica Therapeutics Inc (NASDAQ:DMAC): After market close.
TRACON Pharmaceuticals Inc (NASDAQ:TCON): After market close.
BioCardia Inc (NASDAQ:BCDA): After market close.
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): After market close.
Posted In: ADMP AEMD ALPN ARDS ASND BCDA BMY CLBS CNTA CYCC DMAC EVO EYEN GMTX GSK IBB KRTX MIRM MRK RHHBY
