BLUE To Face FDA Next Month, SNSS Catches Eyes, ADVM On Watch
Today’s Daily Dose brings you news about the earnings date of Adverum, near-term catalyst of bluebird bio, Predictive Oncology’s private placement of common stock, and analyst rating of Sunesis Pharma.
1. Adverum Bio to provide Update On ADVM-022 Next Week
Adverum Biotechnologies, Inc. (ADVM) is slated to host a conference call and webcast to highlight significant progress in the development plans for ADVM-022 in wet AMD, recent business progress, and report fourth quarter 2020 financial results on March 1, 2021.
Adverum is a clinical-stage gene therapy company developing therapies to treat ocular and rare diseases. The company’s lead gene therapy candidate ADVM-022 is under phase I trial in wet AMD, dubbed OPTIC, and in phase II trial in patients with diabetic macular edema, dubbed INFINITY.
ADVM closed Tuesday’s trading at $13.33, up 6.64%.
2. bluebird bio To Face FDA On Mar.27
bluebird bio Inc. (BLUE), whose LentiGlobin gene therapy for sickle cell disease has been put on clinical hold by the FDA, has a regulatory catalyst to watch out for next month.
The FDA decision on Ide-cel, proposed for the treatment of patients with relapsed and refractory multiple myeloma, is expected on March 27, 2021. Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.
On February 16, 2021, the FDA imposed a clinical hold on the company’s LentiGlobin gene therapy trials in sickle cell disease due to a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia and a SUSAR of myelodysplastic syndrome in the trial participants.
In light of the clinical hold on LentiGlobin gene therapy trials, the company has temporarily suspended marketing of gene therapy ZYNTEGLO in Europe. This is because ZYNTEGLO is also manufactured using the same BB305 lentiviral vector used in LentiGlobin gene therapy for sickle cell disease.
ZYNTEGLO received conditional marketing authorization from the European Commission for treating patients 12 years and older with transfusion-dependent ß-thalassemia in June 2019. The refined commercial drug product manufacturing specifications for ZYNTEGLO were approved by the European Medicines Agency in October of that year.
The company added that the European Medicines Agency has paused the renewal procedure for ZYNTEGLO’s conditional marketing authorization while the EMA’s pharmacovigilance risk assessment committee will review the risk-benefit assessment for ZYNTEGLO and determine whether any additional pharmacovigilance measures are necessary.
BLUE touched a new all-time low of $24.24 on Tuesday, before closing at $25.62, down 1.73%.
3. Predictive Oncology Raises $17.6Mln In Private Placement
Predictive Oncology Inc. (POAI) has closed its previously announced private placement of common stock and warrants, resulting in gross proceeds of $17.6 million.
An aggregate of 9.04 million shares of common stock and warrants to purchase up to an aggregate of 4.52 million shares of common stock were sold in the private placement, at a purchase price of $1.95 per share of common stock and associated warrant.
Predictive Oncology is a knowledge-driven company focused on applying artificial intelligence (“AI”) to personalized medicine and drug discovery.
POAI closed Tuesday’s trading $1.49, down 10.24%.
4. Sunesis Catches Eyes
Sunesis Pharmaceuticals Inc. (SNSS) jumped more than 20% on Tuesday, following analyst upgrade.
Sunesis Pharma has been upgraded to “Outperform” from “Perform” by Oppenheimer analyst Hartaj Singh with a price target of $12.00.
The company is set to merge with Viracta Therapeutics Inc., a privately held precision oncology company targeting virus-associated malignancies. The combined company will operate under the name Viracta Therapeutics Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol “VIRX.” The transaction is expected to close this quarter. Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.
SNSS closed Tuesday’s trading at $4.28, up 20.22%.
5. Stocks That Gained/Lost the Most in a Day
Solid Biosciences Inc. (SLDB) closed Tuesday’s (Feb.23, 2021) trading at $9.74, up 41.78%.
Savara Inc. (SVRA) closed at $2.06, up 19.08%.
LENSAR Inc. (LNSR) closed at $9.50, up 18.60%.
Guardion Health Sciences, Inc. (GHSI) closed at $0.75, down 27.77%.
NantKwest Inc. (NK) closed at $32.38, down 23.36%.
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