Ra Medical receives FDA IDE approval for atherectomy study

The FDA has approved Ra Medical Systems (NYSE:RMED) to initiate an investigational device exemption (IDE) to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.

The trial will enroll up to 100 patients with symptoms of peripheral vascular disease (PAD) (Rutherford Class 2-4).

The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment.

https://seekingalpha.com/news/3532969-ra-medical-receives-fda-ide-approval-for-atherectomy-study

Arcutis Biotherapeutics sets IPO terms

Arcutis Biotherapeutics (ARQT) has filed a preliminary prospectus for its IPO of ~7.8M common shares at $15 – 17 per share.

Underwriters’ over-allotment will be an additional ~1.2M shares.

https://seekingalpha.com/news/3533070-arcutis-biotherapeutics-sets-ipo-terms

Glaxo balantamab mafodotin nabs accelerated review in US for myeloma

The FDA grants Priority Review status to GlaxoSmithKline’s (NYSE:GSK) marketing application for belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma (MM) in patients whose prior therapies included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

Belantamab mafodotin is an immunoconjugate comprised of a humanized anti-B cell maturation antigen monoclonal antibody conjugated to a cytotoxic agent called auristatin F via a non-cleavable linker in-licensed from Seattle Genetics (NASDAQ:SGEN).

https://seekingalpha.com/news/3533065-glaxos-balantamab-mafodotin-nabs-accelerated-review-in-u-s-for-mm

BeiGene’s tislelizumab successful in late-stage lung cancer study

A Phase 3 clinical trial evaluating BeiGene’s (NASDAQ:BGNE) PD-1 inhibitor tislelizumab, combined with two chemo regimens, for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) met the primary endpoint of progression-free survival (PFS) at the planned interim analysis.

Additional data will be submitted for presentation at an upcoming medical conference.

The company plans to file a supplemental marketing application in China.

The China National Medical Products Administration approved tislelizumab last month for Hodgkin lymphoma patients who have received at least two prior lines of therapy.

https://seekingalpha.com/news/3532989-beigenes-tislelizumab-successful-in-late-stage-lung-cancer-study

Eton Pharma teams up with Xellia Pharma for Biorphen

Eton Pharmaceuticals (NASDAQ:ETON) has entered into a co-promotion agreement with Xellia Pharmaceuticals for the promotion of Biorphen (phenylephrine HCl), an only FDA approved ready-to-use formulation of phenylephrine injection indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia.

Xellia’s hospital sales force will immediately begin promoting Biorphen in collaboration with Eton.

The agreement significantly expands Biorphen’s commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.

Xellia will receive a commission on Biorphen sales realized from certain customer accounts.

https://seekingalpha.com/news/3532996-eton-pharma-teams-up-xellia-pharma-for-biorphen

Stealth Bio launches clinical development of SBT-272

Stealth BioTherapeutics (NASDAQ:MITO) initiates a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of SBT-272, its second-generation pipeline compound, in 40 healthy volunteers.

SBT-272 is a peptidomimetic that the company is developing for neurodegenerative diseases involving mitochondrial dysfunction.

https://seekingalpha.com/news/3533001-stealth-bio-launches-clinical-development-of-sbtminus-272

Bellicum Pharma +11% premarket on sale of Houston facility

Bellicum Pharmaceuticals (NASDAQ:BLCM) has entered into an asset purchase agreement under which The University of Texas MD Anderson Cancer Center will acquire Bellicum’s 60,000-square-foot Houston facility for $15M.

As part of the transaction, Bellicum also will enter into a master services agreement. Following completion of the transaction, MD Anderson will operate the Houston facility for its own internal programs as well as to manufacture Bellicum’s GoCAR and other cellular therapy programs.

The sale is expected to close in Q1 2020. Transition activities are underway.

Shares are up 11% premarket.

https://seekingalpha.com/news/3533024-bellicum-pharmaplus-11-premarket-on-sale-of-houston-facility