|Over a month ago|
LogicBio Therapeutics reports Q1 EPS (41c), consensus (48c) » 17:3405/1105/11/20
Reports Q1 revenue $1.02M…
Reports Q1 revenue $1.02M vs. $0 last year. The company said, "LogicBio has been actively monitoring the COVID-19 pandemic and its impact globally. LogicBio's objectives have remained the same throughout the pandemic: to support the safety of its team members and their families and continue its research and development activities to develop genetic medicines that have the potential to durably treat rare diseases in pediatric patients with significant unmet medical need. Since mid-March, the Company's non-laboratory employees have been working remotely to comply with social distancing and "stay at home" orders as well as applicable guidelines from the U.S. Centers for Disease Control and Prevention. LogicBio's laboratory employees, whose work must be performed on premises, have been working in shifts to continue in-house research and manufacturing activities on a decreased basis. LogicBio has also ceased all business travel for its employees and plans to maintain these or similar restrictions on its business activities until LogicBio believes that its employees can fully resume such activities in accordance with federal, state and local requirements and guidelines."
|Over a quarter ago|
LogicBio Therapeutics provides update on IND for trial of MMA patients » 16:1803/1603/16/20
In January, the company…
In January, the company announced the submission of an IND to support the initiation of a Phase 1/2 clinical trial in pediatric patients with MMA, which the FDA placed on clinical hold. Subsequently, we received a letter from the FDA specifying its questions related to the clinical hold. The clinical hold was based on questions that were clinical and nonclinical in nature, including questions related to the studies conducted for our IND filing, but did not relate to chemistry, manufacturing, and controls. The company expects to have interactions with the FDA regarding their questions through mid-2020, after which we plan to provide guidance on the anticipated timing for the initiation of the Phase 1/2 clinical trial for LB-001. Cash, cash equivalents and investments were $50.6M as of December 31, 2019. Based upon the current operating plan, which takes into account expenditures that are contingent based on corporate developments, the company believes that cash and cash equivalents and short-term investments as of December 31, 2019 will enable the company to fund operating expenses and capital expenditure requirements into Q1 of 2021.
Fly Intel: After Hours Movers » 18:4102/1002/10/20
AMKR, FLDM, OMF, RNG, XPO, BHF, STE, S, TMUS, OII, AVRO, GNSS, ELY, APPS, RLGT, RPD, CHGG, MELI, BRX, MIME, AIN, MOH, VRNS, IIVI, KMPR, LOGC, XERS, RVNC, TBPH, ADVM
UP AFTER EARNINGS: Amkor…
UP AFTER EARNINGS: Amkor (AMKR) up 16.7%... Fluidigm (FLDM) up 13.2%... OneMain Holdings (OMF) up 3.8%... RingCentral (RNG) up 3.4%... XPO Logistics (XPO) up 2.6%... Brighthouse Financial (BHF) up 2.0%... Steris (STE) up 2.0%. ALSO HIGHER: Spring (S) up 54.0%, T-Mobile (TMUS) up 7.7% after getting judge's approval to complete merger... Oceaneering (OII) up 3.8% after getting light well intervention contract from BP... Avrobio (AVRO) up 2.2% after positive initial data on its Cystinosis program. DOWN AFTER EARNINGS: Genasys (GNSS) down 7.7%... Callaway Golf (ELY) down 6.6%... Digital Turbine (APPS) down 6.4%... Radiant Logistics (RLGT) down 6.3%... Rapid7 (RPD) down 5.4%... Chegg (CHGG) down 4.3%... MercadoLibre (MELI) down 3.9%... Brixmor Property (BRX) down 3.8%... Mimecast (MIME) down 3.7%... Albany International (AIN) down 3.0%... Molina Healthcare (MOH) down 2.6%... Varonis (VRNS) down 2.4%... II-VI (IIVI) down 1.7%... Kemper (KMPR) down 1.4%. ALSO LOWER: LogicBio (LOGC) down 26.3% after FDA placed clinical hold on submission of LB-001... Xeris Pharma (XERS) down 7.5% after equity offering... Revance Therapeutics (RVNC) down 5.3% after convertible debt offering... Theravance Biopharma (TBPH) down 5.2% after equity offering... Adverum Biotech (ADVM) down 3.7% after equity offering. Movers as of 18:30ET.
LogicBio Therapeutics down 26% after FDA update for LB-001 » 18:2002/1002/10/20
Shares of LogicBio…
Shares of LogicBio Therapeutics are down 26.3% at $7.70 after the company announced that the FDA has "placed a clinical hold on the Investigational New Drug submission for LB-001 for the treatment of methylmalonic acidemia pending the resolution of certain clinical and nonclinical questions. The Company submitted the IND in January 2020 to support the initiation of a Phase 1/2 clinical trial in patients with MMA. LogicBio expects that the FDA questions will be provided in writing within 30 days. LogicBio plans to work closely with the FDA to resolve these questions as quickly as possible. "
LogicBio Therapeutics Inc trading resumes 16:3502/1002/10/20
LogicBio Therapeutics Inc trading halted, news pending 16:0002/1002/10/20
LogicBio reported 'two wins' with updates, says Roth Capital » 13:1101/1001/10/20
Roth Capital analyst…
Roth Capital analyst Yasmeen Rahimi called LogicBio Therapeutics' IND submission to initiate a Phase 1/2 trial of LB-001 and its announcement of a research collaboration with Takeda Pharmaceutical (TAK) for a second GeneRide indication "two wins to start the new year right." She views Takeda's decision to fund LB-301 development for the treatment of Crigler-Najjar syndrome as strong validation of the GeneRide platform and thinks this may only be the start of partnership news given that that two other liver indications have showed therapeutic effects from GeneRide preclinically. Rahimi has a Buy rating and $26 price target on LogicBio shares.
LogicBio Therapeutics to move into new headquarters in spring 2020 » 07:3601/1001/10/20
The company said,…
The company said, "Doubling available lab and office space to support GeneRide platform development and capabilities expansion. LogicBio expects to move into new headquarters in Lexington, Mass. in the spring of 2020. LogicBio will be adding vivarium space, internal development capabilities, and will increase its capacity for in-house manufacturing of preclinical material. The expanded lab space will support the continued advancement of a robust pipeline that builds on the modular GeneRide construct. The new facilities will also support continued growth of the capsid program, which aims to develop and license new state-of-the-art viral vectors."
LogicBio to present additional findings from AAV capsid candidates in 2020 » 07:3501/1001/10/20
The company said,…
The company said, "Reported positive data on Next Generation Capsid Development program at European Society of Gene and Cell Therapy Annual Meeting. Data were presented from a set of novel, synthetic adeno-associated virus capsid candidates tested against references AAV2, AAV8, and LK-03. All capsids showed selective tropism and more potent transduction and gene expression than the reference capsids in human hepatocytes of a chimeric FRG mouse model. LogicBio, working in partnership with the Children's Medical Research Institute, intends to advance this research and present additional findings at a scientific conference in 2020."
LogicBio, Takeda announce collaboration to develop LB-301 » 07:0801/1001/10/20
LogicBio Therapeutics (LOGC) announced a research collaboration with Takeda Pharmaceutical Company Limited (TAK) to further develop LB-301, an investigational therapy using LogicBio's proprietary, promoterless, nuclease-free genome editing technology, GeneRide, for the treatment of Crigler-Najjar syndrome. LB-301 is a recombinant adeno-associated viral (AAV) vector with a uridine disphosphate-glucuronosyltransferase-1 gene. The collaboration will bring together LogicBio's propriety platform for genome editing and Takeda's expertise in researching and developing gene therapies. Under the agreement, LogicBio and Takeda will collaborate to further research and develop LB-301. Takeda will provide funding for the research program under the collaboration agreement and will have an exclusive option to negotiate an exclusive, worldwide license to LogicBio's LB-301 program.