Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Bausch Health To Appeal Expected Court Decision On Xifaxan Patents
Bausch Health Companies Inc (NYSE:BHC) said it intends to appeal a decision that would likely invalidate patents related to Xifaxan.
"We are disappointed with today's development. We strongly disagree with any conclusion that our patents are not valid and intend to file an appeal to any such order," said Thomas Appio, CEO of Bausch Health.
Bausch said it expects the court to enjoin Norwich's ANDA until the HE patents expire in 2029. If Norwich removes HE safety data to avoid the patents, the company said it would "vigorously oppose" the move.
European Approval For Abbvie's Rinvoq In Spondyloarthritis
The European Commission has approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib) for active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation who did not respond to nonsteroidal anti-inflammatory drugs.
ImmunityBio's Bladder Cancer Candidate Under FDA Review
The FDA accepted for review ImmunityBio Inc's (NASDAQ:IBRX) marketing application seeking approval for N-803 for BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
The company filed the application based on positive results from a series of studies, including the ongoing QUILT 3.032 trial.
The Prescription Drug User Fee Act target action date is May 23, 2023.
Icosavax Shifts Focus On Bivalent Strategy For COVID-19 Vaccine Candidate After Antigen Instability Issues
Icosavax Inc (NASDAQ:ICVX) announced the results of an end-to-end drug product investigation of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD).
The investigation followed the company's Phase 1/2 topline interim data results.
Results of the investigation confirmed the company's initial hypothesis that the reduced potency observed for IVX-411 was antigen-specific.
Bristol Myers's Opdivo/Yervoy Combo Flunks In Kidney Cancer Trial
Bristol Myers Squibb & Co's (NYSE:BMY) Part A of the Phase 3 CheckMate -914 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for localized renal cell carcinoma did not meet the primary endpoint of disease-free survival.
The study included kidney cancer patients who have undergone full or partial kidney removal and are at moderate or high risk of relapse.
Enanta's COVID-19 Treatment Shows Favorable Action In Healthy Participants
Enanta Pharmaceuticals Inc (NASDAQ:ENTA) has announced topline data from a Phase 1 study of EDP-235 in healthy adult subjects.
EDP-235, a coronavirus 3CL protease inhibitor, is designed to be a once-daily, oral antiviral treatment for COVID-19.
Data from the Phase 1 study demonstrated favorable safety, tolerability, and pharmacokinetics with strong exposure multiples over the EC90.
Sarepta Expects Duchenne Candidate To Go Before FDA This Year
Sarepta Therapeutics Inc (NASDAQ:SRPT) intends to submit a marketing application to the FDA seeking approval for SRP-9001 (delandistrogene moxeparvovec) to treat ambulant individuals with Duchenne muscular dystrophy.
SRP-9001 is an investigational gene therapy developed for Duchenne in partnership with Roche Holdings AG (OTC:RHHBY).
"We look forward to a collaborative review commencing this year and running through the first half of 2023," said Doug Ingram, president & CEO of Sarepta.
Adamis Provides Update On COVID-19 Treatment Study
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) provided an update on its ongoing U.S. Phase 2/3 trial of Tempol as a treatment for COVID-19.
The next Data Safety Monitoring Board (DSMB) meeting to review interim data results has been scheduled for late September.
The DSMB previously met to evaluate the clinical and safety data from interim analyses in March and June 2022, and both times recommended that the study continues without modification.
Offerings
VolitionRx Limited (NYSE:VNRX) commenced an underwritten public offering of its common stock.
On The Radar
PDUFA Dates
Arcutis Biotherapeutics Inc (NASDAQ:ARQT): Roflumilast cream for psoriasis in adults and adolescents.
Earnings
AstraZeneca Plc (NASDAQ:AZN): Before the market open.
ImmunoGen Inc (NASDAQ:IMGN): Before the market open.
AbbVie Inc (NYSE:ABBV): Before the market open.
