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Wednesday, January 15, 2020

FDA accepts Bristol-Myers Squibb’s application for lung cancer combo

Under Priority Review status, the FDA has accepted Bristol-Myers Squibb’s (NYSE:BMY) marketing application for Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK mutations.
The agency’s action date is May 15.
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FDA accepts Neovasc’s Reducer application; shares up

Nano cap Neovasc (NASDAQ:NVCN) is up 26% premarket on light volume in reaction to its announcement that the FDA has accepted for review its marketing application for its Reducer device for the treatment of refractory angina.
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Accelerate Diagnostics down on soft guidance

Accelerate Diagnostics (NASDAQ:AXDX) expects 2020 revenues of $16 – 18M, up 72 – 94% from 2019 but well below consensus of ~$28M.
CEO Jack Phillips will be presenting this forecast and a business overview at JPM20 today.
Shares down 27% premarket on light volume.
JPM20 presentation
Source: Press Release
#JPM20
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J&J files application in Europe for expanded use of Spravato

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies has filed a supplemental marketing application in Europe, called a Type II variation, seeking approval to use Spravato (esketamine) nasal spray as an acute short-term treatment, together with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults experiencing a moderate-to-severe depressive episode of major depressive disorder (MDD) who have suicidal ideation with intent.
Spravato is currently approved (December 2019) in the EU for adults with treatment-resistant MDD, in combination with an SSRI or SNRI, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
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FDA accepts Clovis application for new use of Rubraca; shares up

Under Priority Review status, the FDA has accepted Clovis Oncology’s (NASDAQ:CLVS) supplemental marketing application seeking approval to use Rubraca (rucaparib) to treat adult men with recurrent, metastatic BRCA1/2 mutation-positive castration-resistant prostate cancer. The agency’s action date is May 15.
The PARP inhibitor was approved in the U.S. in December 2016 for ovarian cancer.
Shares up 13% premarket on robust volume.
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Iovance advances pivotal lifileucel study

Iovance Biotherapeutics (NASDAQ:IOVA) announces that the last patient has completed dosing in cohort 4 of its Phase 2 registration-enabling study, C-144-01, evaluating cell therapy lifileucel (LN-144) in metastatic melanoma patients, a Fast Track, Regenerative Medicine Advanced Therapy and Orphan Drug indication.
The primary endpoint of the 164-subject trial is objective response rate (ORR) up to month 54 (every six weeks for six months, then every three months thereafter).
The company says it remains on track to file a U.S. marketing application in Q4.
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Twist Bio teams up with Schrödinger in drug discovery

Twist Bioscience (NASDAQ:TWST) collaborates with Schrödinger, Inc., to discover new antibody therapeutics against G-protein coupled receptor (GPCR) targets.
Under the terms of the agreement, Schrödinger will use its physics-based computational platform to model functional antibody segments that bind to a particular GPCR receptor.
Twist Biopharma, a division of Twist Bioscience, will use its silicon-based DNA synthesis platform to generate a large number of defined antibody sequences that can then be taken into proof-of-concept and preclinical development.
The companies will collaborate on any commercial opportunities generated by the work together.
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