Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Veru Suggested By FDA To Submit Emergency Use Request For Sabizabulin In COVID-19
In a Pre-EUA meeting, the FDA said Veru Inc VERU should submit a request for FDA emergency use authorization (EUA) for sabizabulin in hospitalized COVID-19 patients.
The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for EUA submission and marketing application submission.
The FDA also agreed that the current safety data available for sabizabulin is sufficient to support the safety portion of a request for EUA submission.
Shares are up 24.3% at $9.68 during the premarket session.
Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19
The FDA approved Eli Lilly And Co's LLY Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Olumiant remains under EUA status for hospitalized pediatric patients between the ages of two and 18 years-old requiring supplemental oxygen, mechanical ventilation, or ECMO.
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Sanofi-AstraZeneca Say New Nirsevimab Data Reinforce Efficacy Against RSV
Sanofi SA SNY and AstraZeneca plc's AZN prespecified pooled analysis of nirsevimab in respiratory syncytial virus (RSV) demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% against medically attended lower respiratory tract infections due to RSV in infants.
In a separate pooled post-hoc analysis, nirsevimab exhibited RSV neutralizing antibodies approximately 50-fold higher than baseline at Day 151 post-dose.
Bioasis, Neuramedy Ink Licensing Pact For Neurology-Focused Candidate
Bioasis Technologies Inc BIOAF has entered into a research collaboration, and license agreement with Korea-based Neuramedy Co Ltd focused on disease-modifying treatments for Parkinson's disease and other synuclein-related diseases.
Under the agreement terms, Neuramedy has obtained worldwide rights to research, develop and commercialize an XB3TM version of its antibody, Tomaralimab, currently in development for Parkinson's and Multiple System Atrophy.
Bioasis will receive an upfront payment and may receive an additional $72 million in milestone payments and a royalty on net sales.
Genentech's Tiragolumab/Tecentriq Fails On Progression-Free Survival In PD-L1-High Metastatic Lung Cancer
Genentech, a unit of Roche Holdings AG RHHBY, announced results from its Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab in PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).
The trial evaluated tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment in 534 NSCLC patients.
The study did not meet its co-primary endpoint of progression-free survival.
At this first analysis, the other co-primary endpoint of overall survival was immature, and the study will continue until the next planned analysis.
Arcellx Starts Dosing In Multiple Myeloma CAR-T cell Therapy Trial
Arcellx Inc ACLX has dosed the first patient in its open-label, multicenter ACLX-001 Phase 1 trial of its novel ARC-SparX program in patients with relapsed or refractory multiple myeloma.
ARC-SparX is a universal cell therapy platform comprised of SparX (soluble protein antigen-receptor X-linkers) proteins engineered to target BCMA on myeloma cells and Antigen Receptor Complex cells dosed separately.
Initial data from the ACLX-001 Phase 1 study is expected in 2023.
NexImmune, Yale, JDRF Ink Research Pact For Type 1 Diabetes
NexImmune Inc NEXI, Yale, and JDRF have begun a two-year project exploring NexImmune's AIM nanoparticles combined with a murine surrogate of teplizumab against diabetes antigen-specific T cells.
The $600,000 grant, funded by JDRF to Yale, is a part of its Cures research portfolio, which includes therapies to prevent type 1 diabetes.
FDA Extends Review Period For Amicus's Pompe Disease Candidate Application
The FDA has extended the review period by 90 days for Amicus Therapeutics Inc's FOLD marketing applications of cipaglucosidase alfa and miglustat, the two components of AT-GAA.
The revised PDUFA action dates for miglustat and cipaglucosidase alfa are Aug. 29 and Oct. 29, respectively.
The FDA extended the PDUFA dates to allow additional time to review the information submitted by Amicus as part of its ongoing reviews.
The extension of the review timeline was not related to requests for any additional clinical data.
Inovio Announces CEO Transition
Inovio Pharmaceuticals Inc INO appointed Jacqueline Shea as President and Chief Executive Officer, effective immediately.
Dr. Shea succeeds Dr. Joseph Kim.
Shea joined the company in March 2019 as Chief Operating Officer.
INO shares closed 18.9% lower at $2.02 during after-hours trading.
Eiger, AnGes Ink Exclusive Partnership for Regulatory Approval, Commercialization Of Lonafarnib In Japan
Eiger Biopharmaceuticals Inc EIGR and AnGes Inc have entered into an agreement for the regulatory approval, marketing, and distribution of Zokinvy (lonafarnib) for progeria (premature aging in children) and processing-deficient progeroid laminopathies in Japan.
Under the agreement terms, AnGes is responsible for obtaining and maintaining regulatory approval for Zokinvy in Japan and will be the exclusive partner for distribution and commercialization.
Eiger will receive upfront and milestone payments up to $1.5 million and earn revenue from the sale of Zokinvy to AnGes.
Exicure Inc XCUR has agreed to sell 26.02 million shares at $0.1937 per share in a private placement in public equity financing for gross proceeds of approximately $5 million.
Shares were trading 35.09% higher at $0.14 on Wednesday morning, according to Benzinga Pro.
Trevena Inc TRVN: Before the market open.
Pieris Pharmaceuticals Inc PIRS: Before the market open.
PDS Biotechnology Corp PDSB: Before the market open.
Xeris Biopharma Holdings Inc XERS: Before the market open.
Evotec SE EVO: Before the market open.
Genmab A/S GMAB: During market trading.
Cyclacel Pharmaceuticals Inc CYCC: After market close.
TFF Pharmaceuticals Inc TFFP: After market close.
BioCardia Inc BCDA: After market close.
TRACON Pharmaceuticals Inc TCON: After market close.
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