Amicus Therapeutics FY 2019 top line up 100%

Amicus Therapeutics (FOLD) FY results:

Revenues: $182.2M (+99.8%).

Net loss: ($356.4M) (-2.1%); loss/share: ($1.48) (+21.3%); Quick Assets: $452.7M (-10.2%).

2020 guidance: Galafold revenue: $250M – 260M.

Key Strategic Priorities: Complete Pompe Phase 3 PROPEL study, enroll pediatric studies and advance manufacturing to support 2021 BLA and MAA.

Advance clinical development, manufacturing and regulatory discussions for CLN6 and CLN3 Batten programs.

Progress Pompe gene therapy towards IND and disclose up to two additional IND candidates.

Previously: Amicus Therapeutics EPS misses by $0.10, beats on revenue (March 2)

https://seekingalpha.com/news/3547379-amicus-therapeutics-fy-2019-top-line-up-100

Merck’s Keytruda tops Seattle Genetics’ Adcetris in late-stage lymphoma study

Preliminary data from a Phase 3 clinical trial, KEYNOTE-204, showed that Merck’s (NYSE:MRK) Keytruda (pembrolizumab) statistically significantly improved progression-free survival (PFS) in adults with relapsed/refractory classical Hodgkin lymphoma (cHL) compared to Seattle Genetics’ (NASDAQ:SGEN) Adcetris (brentuximab vedotin), one of the primary endpoints.

The other primary endpoint, overall survival, has yet to be tested.

The data will be presented at a future medical conference and submitted to regulatory authorities.

KEYNOTE-204 is the confirmatory study for Keytruda for cHL, approved in the U.S. in March 2017 on an accelerated basis.

https://seekingalpha.com/news/3547387-mercks-keytruda-tops-seattle-genetics-adcetris-in-late-stage-lymphoma-study

BridgeBio Pharma EPS beats by $0.09

BridgeBio Pharma (NASDAQ:BBIO): Q4 GAAP EPS of -$0.62 beats by $0.09.

Revenue of $13.82M

Press Release

https://seekingalpha.com/news/3547398-bridgebio-pharma-eps-beats-0_09

Dynavax +17% premarket on COVID-19 vaccine plan

Dynavax Technologies (NASDAQ:DVAX) is up 17% premarket after collaborating with the University of Queensland as part of a Coalition for Epidemic Preparedness initiative to develop a vaccine to prevent COVID-19.

The company is providing technical expertise and toll-like receptor 9 agonist adjuvant, CpG 1018, to support this initiative.

CpG 1018 is used in HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]. It provides a well‑developed technology and a significant safety database, accelerating the development of a COVID-19 vaccine.

https://seekingalpha.com/news/3547415-dynavaxplus-17-premarket-on-covidminus-19-vaccine-plan

AnaptysBio EPS beats by $0.45, beats on revenue

AnaptysBio (NASDAQ:ANAB): Q4 GAAP EPS of -$0.75 beats by $0.45.

Revenue of $3M beats by $1M.

Press Release

https://seekingalpha.com/news/3547408-anaptysbio-eps-beats-0_45-beats-on-revenue

Daxor up 86% on coronavirus news

In yet another example of the animal spirits related to any company even mentioning coronavirus, ultra-thinly traded nano cap Daxor (NYSEMKT:DXR) is up 63% premarket, albeit on only 25K shares, in reaction to its announced “engagement” with hospitals and government agencies regarding the use of its blood volume analyzer, BVA-100, in critically ill COVID-19 patients.

It says a clinical trial showed that the use of the device reduced mortality by as much as 66% in patients suffering from respiratory distress and septic shock, adding that it has an inventory of product “ready for deployment.”

https://seekingalpha.com/news/3547412-daxor-up-86-on-coronavirus-news

Analyst action, March 2

Akero Therapeutics (NASDAQ:AKRO) initiated with Buy rating and $33 (52% upside) price target at H.C. Wainwright.

Amarin (NASDAQ:AMRN) initiated with Outperform rating and $23 (57% upside) price target at Cowen and Company. Shares up 2% premarket.

Beam Therapeutics (NASDAQ:BEAM) initiated with Buy rating and $32 (42% upside) price target at Jefferies. Initiated with Outperform rating and $32 price target at Wedbush. Resumed with Overweight ratings at Barclays and JPMorgan. Shares up 2% premarket.

Catalent (NYSE:CTLT) initiated with Hold rating at Deutsche Bank.

Charles River Laboratories (NYSE:CRL) initiated with Buy rating and $190 (22% upside) price target at Deutsche Bank.

IQVIA Holdings (NYSE:IQV) initiated with Buy rating and $190 (36% upside) at Deutsche Bank.

NextCure (NASDAQ:NXTC) initiated with Buy rating and $80 (92% upside) price target at Roth Capital.

PPD (NASDAQ:PPD) initiated with Buy rating and $32 (15% upside) price target at BofA. Initiated with Buy ratings at 12 other shops with price targets ranging from $30.50 – 34. Shares up 2% premarket.

Schrödinger (NASDAQ:SDGR) initiated with Equal Weight rating and $42 (9% downside risk) price target at Morgan Stanley. Initiated with Hold rating at Jefferies and Outperform with a $65 (40% upside) price target at BMO. Shares up 3% premarket.

Masimo (NASDAQ:MASI) upgraded to Outperform with a $183 (12% upside) price target at Raymond James.

SmileDirectClub (NASDAQ:SDC) downgraded to Neutral with a $9 (20% upside) price target at UBS. Shares down 2% premarket.

https://seekingalpha.com/news/3547405-cowen-likes-amarin-in-premarket-analyst-action