Search This Blog

Friday, January 10, 2020

Nektar up premarket on new Bristol-Myers collaboration

Nektar Therapeutics (NASDAQ:NKTR) is up 3% premarket on light volume in reaction to its revised collaboration agreement with Bristol-Myers Squibb (NYSE:BMY) aimed at advancing the combination of bempegaldesleukin and Opdivo (nivolumab) in a range of new registrational studies.
The new deal will expand the partnership beyond the three pivotal studies in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer.
In addition, a Phase 1/2 study evaluating the combo + Pfizer’s (NYSE:PFE) Inlyta (axitinib) in first-line RCC will be conducted that will support a future pivotal trial.
Study costs will be shared per the terms in the original agreement.
BMY will independently conduct and fund a Phase 1/2 dose optimization and expansion trial assessing the combo in first-line non-small cell lung cancer.
Bempegaldesleukin is a CD122-preferential IL-2 pathway agonist designed to activate and proliferate certain cancer-killing immune cells.

Auris Medical nabs new patent in Europe

Auris Medical Holding (NASDAQ:EARS) is up 12% premarket on receiving a notice of “Intention to Grant” from European Patent Office (EPO) for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System” (Application 11 894 529.3).
The allowed claims cover compounds modulating the sodium potassium chloride co-transporter 1 for use in the oral treatment or prevention of tinnitus.

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.

Akcea and Ionis launch late-stage study ATTR cardiomyopathy study

Ionis Pharmaceuticals (NASDAQ:IONS) and majority-owned affiliate Akcea Therapeutics (NASDAQ:AKCAinitiate 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.

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.

LogicBio Therapeutics collaborates with Takeda for LB-301

LogicBio Therapeutics (NASDAQ:LOGCannounces 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.

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.