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Tuesday, November 12, 2019

TG Therapeutics net loss widens in Q3

TG Therapeutics (TGTX +0.4%) Q3 results: Revenues: $0.04M (unch).
Net loss: ($61.9M) (-82.1%); loss/share: ($0.69) (-60.5%); Quick Assets: $72.5M (+5.2%).
Remaining 2019 and Early 2020 Milestones: Initiate a rolling NDA submission for umbralisib to treat adult patients with previously treated marginal zone lymphoma.
Report top-line PFS results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with frontline and previously treated CLL.
Share results from the Phase 2b UNITY-NHL FL cohort with the FDA to determine potential filing opportunities.
Previously: TG Therapeutics EPS misses by $0.35, revenue in-line (Nov. 12)
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Ocular Therapeutix down 7% on Q3 results

Ocular Therapeutix (OCUL -6.5%) Q3 results: Revenues: $0.8M (+60.0%).
Net loss: ($18.8M) (-25.3%); loss/share: ($0.45) (-18.4%); Quick Assets: $65.4M (+20.9%).
Topline data for Phase 3 trial of DEXTENZA for ocular itching associated with allergic conjunctivitis anticipated in H1 2020.
Previously: Ocular Therapeutix EPS beats by $0.01, misses on revenue (Nov. 12)
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Solid Bio down on another clinical hold on Duchenne gene therapy

Solid Biosciences (NASDAQ:SLDB) reports that the FDA has placed its Phase 1/2 clinical trial, IGNITE DMD, evaluating lead gene therapy candidate SGT-001 in Duchenne muscular dystrophy (DMD) patients on clinical hold after a participant experienced a serious adverse event related to the study drug.
The patient, in the second cohort that received a higher dose, experienced complement activation, thrombocytopenia, a decrease in red blood cell count, acute kidney injury and cardio-pulmonary insufficiency. No cytokine- or coagulopathy-related abnormalities were observed. The company says the individual is recovering and is being closely watched by his healthcare team.
A clinical hold stops recruitment and suspends treatment for patients already enrolled.
This is the second clinical hold placed on the study. The first occurred in March 2018 after a participant was hospitalized for decreased platelet count followed by a reduction in red blood cell count and evidence of complement activation.
Shares down 59% premarket on light volume (so far).
DMD-related tickers: SRPT, CAPR, CATB, PFE, WVE
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Lilly’s Taltz tops Humira in psoriatic arthritis study

Eli Lilly (NYSE:LLY) announces positive results from a Phase 3b/4 clinical trial, SPIRIT-Head-to-Head, comparing Taltz (ixekizumab) to AbbVie’s (NYSE:ABBV) Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). The results are being presented at the American College of Rheumatology Annual Meeting in Atlanta.
The study met the primary and all secondary endpoints. Taltz was superior to Humira as measured by the proportion of patients achieving ACR50 (at least a 50% reduction in disease activity) and PASI 100 (complete skin clearance) at week 24, the primary objective (36% vs. 28%, p<0.05).
At week 52, 50% of patients in the Taltz arm and the Humira arm achieved ACR50. 64% of patients receiving Taltz achieved PASI 100 versus 41% of those receiving Humira.
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Amarin up 20% ahead of Ad Com for Vascepa CV benefit claim

Amarin (NASDAQ:AMRN) is up 20% premarket on robust volume in reaction to the release of meeting materials for Thursday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to review and discuss the company’s application for a CV benefit claim for Vascepa (icosapent ethyl) based on results from the large-scale REDUCE-IT study.
Citing the summary (FDA briefing doc, page 103), the FDA review team believes that the benefit-risk profile for CVD risk reduction is favorable.
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Sage Therapeutics EPS misses by $0.07, beats on revenue

Sage Therapeutics (NASDAQ:SAGE): Q3 GAAP EPS of -$3.48 misses by $0.07.
Revenue of $3.57M beats by $1.05M.
Shares -1% PM.
Press Release
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Japan Tobacco halves price of reduced-risk cigarette starter kit

Japan Tobacco is halving the price of starter kits for its Ploom S reduced-risk cigarettes, as it struggles to compete against rival Philip Morris International.

Japan is the world’s biggest market for “heat not burn” products, which emit less smoke than conventional cigarettes, as regular e-cigarettes with liquid nicotine are banned.

From Dec. 1, the recommended retail price of the kit, including the smoking device which heats tobacco sticks, micro USB cable and AC adapter, will be 3,480 yen ($31.90) from 7,980 yen, Japan Tobacco said on Tuesday.
In October, the company said fewer people than it expected were trying out and switching to Ploom S, amid strong competition from Philip Morris’ IQOS, cutting its annual profit outlook.
The company said it now expected full-year operating profit of 505 billion yen, down from a previous forecast of 518 billion. For the third quarter, operating profit fell 26% on the year, to 129 billion yen.
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