Incyte +2% premarket on Q4 beat

Incyte (INCY) Q4 results:

Revenues: $579.4M (+9.7%); Jakafi: $466.5M (+22.7%); Iclusig: $24.3M (+27.2%); Jakavi product royalty: $65M (+17.5%); Olumiant product royalty: $23.6M (+69.8%).

Net Income: $111M (+60.6%); EPS: $0.51 (+59.4%); non-GAAP Net Income: $141.9M (-0.1%); non-GAAP EPS: $0.65 (-1.5%).

2020 Guidance: Jakafi sales: $1.88B – 1.95B; Iclusig sales: $100M – 105M.

Shares are up 2% premarket.

Previously: Incyte EPS beats by $0.07, beats on revenue (Feb. 13)

https://seekingalpha.com/news/3541664-incyteplus-2-premarket-on-q4-beat

Soligenix up 10% premarket on Fast Track for RiVax in U.S.

The FDA designates Soligenix’s (NASDAQ:SNGX) RiVax (heat stable ricin toxin vaccine) for Fast Track review for the prevention of ricin intoxication.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Shares up 10% premarket on average volume.

https://seekingalpha.com/news/3541668-soligenix-up-10-premarket-on-fast-track-for-rivax-in-u-s

FDA OKs new version of Orthofix app for bone growth stimulators

The FDA approves Orthofix Medical’s (NASDAQ:OFIX) STIM onTrack mobile app version 2.1 for use with its bone growth stimulators.

The app is designed to help patients adhere to their prescriptions and improve their clinical outcomes.

https://seekingalpha.com/news/3541677-fda-oks-new-version-of-orthofix-app-for-bone-growth-stimulators

FDA accepts Seattle Genetics’ tucatinib application, action date August 20

Under Priority Review status and its Real-Time Oncology Review and Orbis Pilot Programs, the FDA accepts Seattle Genetics’ (NASDAQ:SGEN) marketing application for the combination of tucatinib and Roche’s (OTCQX:RHHBY) Herceptin (trastuzumab) and Xeloda (capecitabine) for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting.

The agency’s action date is August 20.

Tucatinib is an oral small molecule tyrosine kinase inhibitor highly selective for HER2.

https://seekingalpha.com/news/3541692-fda-accepts-seattle-genetics-tucatinib-application-action-date-august-20

Apple reopening some Beijing stores

Apple (NASDAQ:AAPL) will reopen some stores in Beijing with limited hours starting February 14.

Last week, Apple extended its store closures in China from February 10 until February 13-15 due to the ongoing coronavirus outbreak.

Apple has 42 stores in the region, but the outbreak has also impacted Foxconn and other key suppliers for the tech giant.

https://seekingalpha.com/news/3541709-apple-reopening-beijing-stores

Analyst action, Feb, 13

Abbott (NYSE:ABT) resumed with Neutral rating and $96 (8% upside) price target at Goldman Sachs. Shares down 1% premarket.

Baxter International (NYSE:BAX) resumed with Buy rating and $104 (14% upside) price target at Goldman.

Boston Scientific (NYSE:BSX) resumed with Neutral rating and $46 (9% upside) price target at Goldman.

Constellation Pharmaceuticals (NASDAQ:CNST) initiated with Buy rating and $50 (44% upside) price target at SunTrust.

Edwards Lifesciences (NYSE:EW) resumed with Neutral rating and $253 (12% upside) price target at Goldman.

Fortress Biotech (NASDAQ:FBIO) initiated with Buy rating and $6 (124% upside) price target at Cantor Fitzgerald. Shares up 5% premarket.

Intuitive Surgical (NASDAQ:ISRG) resumed with Buy rating and $725 (22% upside) price target at Goldman. Shares up 1% premarket.

Medtronic (NYSE:MDT) resumed with Sell rating and $118 (1% upside) price target at Goldman. Shares down 1% premarket.

Stryker (NYSE:SYK) resumed with Buy rating and $248 (15% upside) price target at Goldman.

Varian (NYSE:VAR) resumed with Buy rating and $171 (16% upside) price target at Goldman.

Zimmer Biomet Holdings (NYSE:ZBH) resumed with Buy rating and $177 (12% upside) price target at Goldman.

https://seekingalpha.com/news/3541703-goldman-likes-intuitive-surgical-in-premarket-analyst-action

Bristol-Myers Squibb’s liso-cel fast tracked in U.S. for large B-cell lymphoma

Under Priority Review status, the FDA accepts Bristol-Myers Squibb’s (NYSE:BMY) marketing application for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who have received at least two prior lines of therapy.

The agency’s action date is August 17.

Holders of BMY Contingent Value Rights (CVR) (NYSE:BMY.RT) may see a rally today. Yesterday’s close was $3.36.

https://seekingalpha.com/news/3541632-bristol-myers-squibbs-liso-cel-fast-tracked-in-u-s-for-large-b-cell-lymphoma