Jun 23, 10:27 AM EDT
Armata gains $2.5M extra funding from DoD for lead program
ARMP
Armata Pharmaceuticals ( ARMP ) traded higher on Tuesday after the Department of Defense provided the company with $2.5M in additional funding to help advance its lead program, an antibacterial agent identified as AP-SA02. The funding relates to an agreement t…
Jun 23, 8:45 AM EDT
Galectin, FDA agree on late-stage trial design for MASH therapy
GALT
Galectin Therapeutics ( GALT ) announced on Tuesday it has reached an agreement with the FDA regarding a Phase 3 program to test its lead asset belapectin in cirrhosis and portal hypertension linked to the liver disease metabolic dysfunction-associated steatoh…
Jun 23, 7:59 AM EDT
Boundless Bio to merge with Serapha Bio in reverse merger; shares surge
BOLD
Boundless Bio ( BOLD ) shares surge over 95% premarket after the company and and Serapha Bio entered into a definitive all-stock merger agreement . Following the transaction, the combined company will operate as Serapha Bio and is expected to trade on Nasdaq u…
Jun 23, 7:34 AM EDT
AbbVie, Enanta announce EU label expansion for hepatitis C therapy, Maviret
ABBVENTA
AbbVie ( ABBV ) and Enanta Pharmaceuticals ( ENTA ) announced on Tuesday that the European Commission has approved a label expansion for their jointly developed hepatitis C therapy, Maviret. Accordingly, the once-daily tablet, previously available in the regio…
Jun 23, 6:06 AM EDT
Sangamo falls after Chapter 11 bankruptcy filing; Eli Lilly and Astellas to acquire key assets
SGMOALPMF
AscentXmedia/E+ via Getty Images Sangamo Therapeutics ( SGMO ) on Tuesday reported that it has commenced voluntary Chapter 11 bankruptcy proceedings in Delaware to facilitate a court-supervised reorganization, concurrent with entering into separate asset sale…
Jun 23, 5:01 AM EDT
AbbVie's Skyrizi wins EU approval for pediatric plaque psoriasis
ABBVABBV:CA
AbbVie ( ABBV ) Tuesday said that the European Commission has approved Skyrizi (risankizumab) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy. Approval wa…
Jun 22, 5:13 PM EDT
MacroGenics gains $24.5M payment from Sanofi for Tzield approval
MGNXSNY
adrian825 Sanofi ( SNY ) is providing MacroGenics ( MGNX ) a $24.5M milestone payment following the recently approved additional indication of Tzield (teplizumab) to delay the decline in endogenous insulin production in children ages 8-17 years recently diagno…
Jun 22, 4:36 PM EDT
Stocks to watch on Monday after hours: MLTX, BBY, and DPZ
DJISP500
Wall Street finished Monday’s session in mixed fashion as renewed uncertainty around weekend U.S.–Iran peace negotiations pressured sentiment, while weakness in major technology names added to downside momentum in growth stocks. The S&P 500 ( SP500 ) ended…
Jun 22, 4:11 PM EDT
MoonLake Immunotherapeutics announces $150M public offering
MLTX
MoonLake Immunotherapeutics ( MLTX ) proposed a public offering of $150M of Class A ordinary shares and, for certain investors, pre-funded warrants. The company expects to grant underwriters a 30-day option to purchase up to an additional $22.5M of Class A ord…
Jun 22, 4:06 PM EDT
uniQure files $150M proposed public offering of ordinary shares
QURE
uniQure ( QURE ) announced on Monday that it has commenced a $150M underwritten public offering of its ordinary shares and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase its ordinary shares. Shares of QURE slipped nearly 3% d…
Jun 22, 4:02 PM EDT
Moderna snaps after six-session winning streak
MRNA
Moderna ( MRNA ) snapped a six-session winning streak on Monday, with shares closing down 7.13% at $59.40. Despite the decline, the stock has been one of the market's standout performers recently. Over the previous six sessions, Moderna surged more than 39%, s…
Jun 22, 11:24 AM EDT
Achieve Life Sciences jumps despite cytisinicline CRL
ACHV
Achieve Life Sciences ( ACHV ) is up ~10% in Monday morning trading despite receiving a Complete Response Letter from the US FDA for cytisinicline, its smoking cessation asset. The company said the agency highlighted remaining manufacturing-related issues rela…
Jun 22, 11:14 AM EDT
Exelixis falls as final analysis of zanzalintinib phase 3 data disappoints
EXELRHHBYBAYRY
Exelixis ( EXEL ) shares are down in Monday morning trading after the biotech announced that a final analysis of one of the phase 3 dual primary endpoints for zanzalintinib for metastatic colorectal cancer didn't meet statistical significance. The STELLAR-303…
Jun 22, 9:56 AM EDT
Unicycive seeks to distinguish OLC in crowded CKD hyperphosphatemia market
UNCYSNYFMS
sasirin pamai/iStock via Getty Images While there are already several drugs approved to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, Shalabh Gupta isn't fazed. As CEO of Unicycive Therapeutics ( UNCY ), Gupta, an MD by tra…
Jun 22, 9:45 AM EDT
Praxis gains FDA Breakthrough Therapy Status for elsunersen for encephalopathy
PRAX
musmus culus/iStock via Getty Images The US FDA has awarded Praxis Precision Medicines ( PRAX ) Breakthrough Therapy Designation for elsunersen for seizures associated with SCN2A developmental and epileptic encephalopathy. The asset already has Breakthrough Th…
Jun 22, 7:07 AM EDT
Apogee jumps 52% on $10.9B AbbVie buyout deal
ABBVAPGE
AbbVie ( ABBV ) has agreed to acquire Apogee Therapeutics ( APGE ) in an all-cash deal valued at $135.11 per share, adding Apogee’s portfolio of clinical-stage treatments for inflammatory and immunological diseases to its pipeline. The transaction values Apoge…
Jun 22, 6:55 AM EDT
RGNX gains sharply after report of FDA turnaround on rare-disease treatment
RGNX
skynesher/E+ via Getty Images Regenxbio ( RGNX ) shares rose as much as 37% in premarket trading on Monday after the Wall Street Journal reported that the FDA has agreed to reverse the rejection of the firm’s rare-disease drug. Regenxbio plans to refile its ap…