GNC +13% on report of buyout

GNC Holdings (NYSE:GNC) is on watch after Bloomberg reports the company may be taken private by Harbin Pharmaceutical Group.

Harbin invested $300M in GNC last year.

Shares of GNC are up 13.46% premarket to $2.36 vs. the 52-week range of $1.32 to $4.47.

https://seekingalpha.com/news/3507704-gnc-plus-13-percent-report-buyout

Novartis off to strong start with Zolgensma

Novartis’ (NYSE:NVS) gene therapy Zolgensma (anasemnogene abeparvovec-xioi) generated $160M in sales in Q3, well above analysts’ projections of ~$98M, its first full quarter on the market.

The FDA approved Zolgensma, priced at a hefty $2.1M per patient, in May for children younger than two years old with spinal muscular atrophy.

On a call with reporters today, CEO Vas Narasimhan said that 99% of eligible patients were receiving the gene therapy, on average within 30 days of requesting it.

To address payer concerns over the price, the company is offering outcomes-based deals where a portion of the cost is refunded if Zolgensma proves ineffective in addition to an option to pay for the treatment in five equal installments over five years.

https://seekingalpha.com/news/3507714-novartis-strong-start-zolgensma

FDA OKs expanded label for Heron’s Cinvanti

Heron Therapeutics (NASDAQ:HRTX) is up 4% premarket on light volume in response to the FDA nod for a 130 mg single-dose IV regimen for Cinvanti (aprepitant) for patients receiving moderately emetogenic (nausea and vomiting-inducing) chemo.
https://seekingalpha.com/news/3507730-fda-oks-expanded-label-herons-cinvanti-shares-ahead-4-percent-premarket

Fresenius down 7% premarket on bribery probes

Fresenius Medical Care AG & Co. KGaA (NYSE:FMS) slumps 7% premarket on light volume in apparent response to reports in Germany that Frankfurt prosecutors are investigating alleged bribery by certain company employees during the period between 2007 and 2016.

Bribes worth “many millions” were allegedly paid in 17 countries, mostly to doctors and state employees as provisions or consultancy fees. “Questionable” payments were also made in eight additional countries.

In March, unit Fresenius Medical Care paid $231.7M to the U.S. Department of Justice and SEC to settle corruption charges.

https://seekingalpha.com/news/3507767-fresenius-7-percent-premarket-bribery-probes

FDA OKs expanded use of Novo’s Fiasp insulin

The FDA approves the use of Novo Nordisk’s (NVO +1.6%) Fiasp (insulin aspart injection) 100 u/mL in insulin infusion pumps for patients with type 1 or type 2 diabetes.
https://seekingalpha.com/news/3507778-fda-oks-expanded-use-novos-fiasp-insulin-shares-2-percent

Trovagene up 79% on encouraging onvansertib data

Nano cap Trovagene (TROV +79%) is up on a healthy 38x surge in volume in response to positive preliminary data from a Phase 1b/2 clinical trial evaluating lead asset onvansertib, combined with chemo regimen FOLFIRI and Roche’s Avastin (bevacizumab), for the second-line treatment of patients with KRAS mutation-positive metastatic colorectal cancer.

Decreases in KRAS mutational burden were observed in all four patients who completed the first cycle of treatment with the onvansertib regimen.

Up to 44 subjects will participate in the study. The estimated completion date is May 2021.

https://seekingalpha.com/news/3507804-trovagene-79-percent-encouraging-onvansertib-data

Boston Sci launches offer for up to $1B of outstanding debt

Boston Scientific (BSX +0.1%) commences a tender offer for up to $1B of its outstanding debt from four issues of Senior Notes due 2022 – 2028 yielding 3.375 – 4.125%. The offer will expire at midnight Eastern Standard Time on November 19.
https://seekingalpha.com/news/3507806-boston-sci-launches-offer-1b-outstanding-debt