Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Reata Completes Regulatory Filing For Omaveloxolone As Treatment Option For Neurodegenerative Movement Disorder
Reata Pharmaceuticals, Inc. RETA said it has completed filing the rolling submission of a new drug application to the U.S. Food and Drug Administration for omaveloxolone for the treatment of patients with Friedreich's ataxia.
The FDA has granted Fast Track Designation and Orphan Drug Designation to omaveloxolone for the treatment of Friedreich's ataxia.
The stock was adding 2.14% to $33.46 in premarket trading.
Eisai Buys Healthcare-Related Digital Software Service Provider Arteryex
Eisai Co. Ltd. ESALY announced that Eisai has acquired a majority of the shares issued by Arteryex Inc., a company that plans and develops software related to digital solutions such as provision of medical information platforms, through purchase of shares and subscription of a third-party allocation of common shares.
While confirming that Arteryex has been made its subsidiary, as of March 31, Eisai said the two companies will work together to develop and provide personal health record-related services for patients, healthcare professionals and society at large.
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SELLAS In-licenses Phase 1 Cancer Drug For Up to $150M, Prices Public Offering At Discount
SELLAS Life Sciences Group, Inc. SLS announced the signing of an exclusive license agreement with GenFleet Therapeutics, with the agreement granting SELLAS rights to develop and commercialize Phase 1 Cancer Drug GFH009 across all therapeutic and diagnostic uses worldwide outside of Greater China.
SELLAS will pay to GenFleet an initial upfront payment of $10 million, and development, regulatory and sales milestone payments of up to $140 million and also tiered royalties based on a percentage of annual net sales of GFH009 ranging from the low to high single digits.
Separately, SELLAS said it has priced its previously announced underwritten public offering of 4.63 million shares of its common stock and accompanying warrants to purchase up to 4.63 million shares of common stock at a combined public offering price of $5.40 per share and accompanying warrant.
The stock was plunging 23.95% to $5.08 in premarket trading.
T2 Biosystems Receives Additional $4.4M In BARDA Funding From Existing Multi-year Contract
T2 Biosystems, Inc. TTOO said the Biomedical Advanced Research and Development Authority provided an additional $4.4 million in funding for the multiple-year, cost-share contract between BARDA and T2 Biosystems. The total potential BARDA funding if all contract options are exercised is $69 million.
The company said it will use the additional funding to advance U.S. clinical trials for the T2Biothreat Panel and T2Resistance Panel and to advance the development of its comprehensive panel for the detection of bloodstream infections and antimicrobial resistance, and next-generation instrument.
The stock was adding 3.01% to 53.99 cents in premarket trading.
Merck Says Regulatory Review Period For Pneumococcal Vaccine In Adolescents Extended By 3 Months
Merck & Co., Inc. MRK said the FDA has extended the PDUFA date of the supplemental biologics license application for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1. The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA. No new studies have been requested by the FDA.
Arca's COVID Drug Does Not Meet Primary Endpoint In Mid-Phase Study
Arca biopharma, Inc. ABIO announced results for ASPEN-COVID-19, a 160 patient Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19. In the clinical trial, both doses of rNAPc2 demonstrated a treatment benefit for patients, however, neither dose achieved statistical significance for the primary efficacy endpoint of change in D-dimer level from Baseline to Day 8 compared to standard of care heparin.
The company said it is now evaluating options for development of its assets, including partnering and other strategic options.
The stock was plunging 24.35% to $1.74 in premarket trading.
Spero Therapeutics, Inc. SPRO reported fourth-quarter revenues that trailed expectations and the loss per share was also wider than expected.
The stock was sliding 24.14% to $6.60 in after-hours trading.
On The Radar
Immutep Limited IMMP will present at the ESMO European Lung Cancer Conference additional data on safety and efficacy of efti along with Merck's Keytruda in second-line confirmed PD-1/PD-L1 refractory, non-small cell lung cancer patients. (Friday)
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