Revance up premarket on deal with Teoxane for dermal fillers

Revance Therapeutics (NASDAQ:RVNC) is up 3% premarket on signing a U.S. distribution agreement with TEOXANE SA, a Swiss-based private company for the latter’s Resilient Hyaluronic Acid (RHA) technology.

Under the distribution agreement, Revance will gain immediate and exclusive rights to commercialize TEOXANE’s RHA line of fillers in the U.S., starting with the FDA-approved RHA 1, RHA 2, RHA 3, and RHA 4 products, which include lidocaine.

Additionally, the agreement contains a right of first negotiation to access TEOXANE’s cosmeceutical line that incorporates its propriety RHA technology.

In consideration, Revance has agreed to issue 2.5M common shares to TEOXANE SA.

Revance targets the introduction of the TEOXANE RHA fillers in Q2 2020, followed by the launch of DAXI.

https://seekingalpha.com/news/3530940-revanceplus-3-premarket-on-deal-teoxane-for-dermal-fillers

Akcea and Ionis launch late-stage study ATTR cardiomyopathy study

Ionis Pharmaceuticals (NASDAQ:IONS) and majority-owned affiliate Akcea Therapeutics (NASDAQ:AKCA) initiate a Phase 3 clinical trial, CARDIO-TTRansform, evaluating cardiovascular (CV) outcomes in transthyretin-mediated amyloid cardiomyopathy (ATTR cardiomyopathy) patients receiving AKCEA-TTR-Lrx.

The primary endpoints of the 750-subject study are a composite of CV mortality and clinical events from baseline to week 120 and the change from baseline at week 61 in six-minute walk test distance.

The estimated primary completion date is January 2024.

https://seekingalpha.com/news/3530942-akcea-and-ionis-launch-late-stage-study-attr-cardiomyopathy-study

T2 Bio up premarket on preliminary Q4 results

On a preliminary basis, T2 Biosystems (NASDAQ:TTOO) expects Q4 revenue of ~$3.0M, including ~$1.5M in product sales. It also closed 10 T2Dx contracts in the quarter.

$4.8M in new capital raised via its at-the-market stock sales agreement. $11.0M in cash and equivalents at year-end.

Shares up 7% premarket on light volume.

https://seekingalpha.com/news/3530949-t2-bio-up-7-premarket-on-preliminary-q4-results

LogicBio Therapeutics collaborates with Takeda for LB-301

LogicBio Therapeutics (NASDAQ:LOGC) announces a research collaboration with Takeda Pharmaceutical (OTCPK:TKPHF) to further develop LB-301 for the treatment of Crigler-Najjar syndrome.

Under the agreement, Takeda will provide funding for the research program and will have an exclusive option to negotiate an exclusive, worldwide license to LogicBio’s LB-301 program.

LB-301 is a recombinant adeno-associated viral vector with a uridine disphosphate-glucuronosyltransferase-1 gene leveraging GeneRide genome editing platform for the treatment of Crigler-Najjar syndrome.

https://seekingalpha.com/news/3530926-logicbio-therapeutics-collaborates-takeda-for-lbminus-301

Roche in-licenses tech platform from Amunix Pharma for non-cancer therapies

Privately held Amunix Pharmaceuticals has out-licensed its T cell engager technology platform, XTEN, to Roche (OTCQX:RHHBY) aimed at discovering and developing non-oncology therapeutics against undisclosed targets.

Under the terms of the agreement, Roche will pay Amunix $40M upfront, up to $1.5B in milestones and royalties on net sales.

https://seekingalpha.com/news/3530928-roche-in-licenses-tech-platform-from-amunix-pharma-for-non-cancer-therapies

BridgeBio teams up with Catalent in gene therapy development/manufacturing

BridgeBio Pharma (NASDAQ:BBIO) inks a collaboration agreement with Catalent (NYSE:CTLT) for gene therapy development and manufacturing at the latter’s Harmans, MD facility. Specifically, the partnership is aimed at supporting clinical and commercial demand for the former’s gene therapy candidates BBP-631, BBP-812, for congenital adrenal hyperplasia and Canavan disease.

Financial terms are not disclosed.

https://seekingalpha.com/news/3530932-bridgebio-teams-up-catalent-in-gene-therapy-development-manufacturing

LogicBio Therapeutics submits IND for LB-001

LogicBio Therapeutics (NASDAQ:LOGC) has submitted an Investigational New Drug (IND) application with the FDA to initiate a Phase 1/2 trial of LB-001, a recombinant adeno-associated viral vector with human methylmalonyl-COA mutase gene for the treatment of methylmalonic acidemia (MMA).

Additional details regarding the trial size, endpoints, and timelines will be disclosed once the FDA accepts the IND. The Company plans to initiate a Phase 1/2 trial in pediatric MMA patients in H1 2020, with preliminary data expected in H2.

LogicBio also highlighted key recent and upcoming milestones:

Initiated Retrospective Natural History Study in MMA. This study is designed to evaluate disease progression in pediatric patients with severe MMA.

Reported positive data on Next Generation Capsid Development program at European Society of Gene and Cell Therapy Annual Meeting.

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.

https://seekingalpha.com/news/3530933-logicbio-therapeutics-submits-ind-for-lbminus-001