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Monday, July 22, 2019

Vistagen cut to Neutral from Buy by Chardan

Target to $0.70 from $22

Rapt Therapeutics sets IPO terms

Rapt Therapeutics (RAPT) will offer 5M common shares at $14 – 16 per share in its IPO. Underwriters over-allotment will be an additional 750K shares.
Certain stockholders have indicated an interest in buying $25M of the offering.

Livongo Health boosts IPO price

Livongo Health (LVGO) has upsized its IPO of 10.7M common shares to $24 – 26 per share from $20 – 23.
Current investor Kinnevik Online AB has indicated an interest in acquiring ~$20M of the offering.

DaVita up premarket on guidance boost

DaVita (NYSE:DVAannounces preliminary Q2 results and updated FY 2019 guidance.
Q2 Operating income is expected between $460M and $465M.
In the Company’s U.S. dialysis and related lab services segment, the Company expects to report:
Non-acquired treatment growth of 2.1%, with 7,520,587 treatments in second quarter.
Q2 Revenue per treatment of ~$350, an increase of ~$1.60 from Q1 2019.
Second quarter cost per treatment decrease of ~$9 from Q1 2019.
The Company is updating its FY 2019 adjusted operating income guidance to a range of $1.64B to $1.70B from $1.54B to $1.64B.
Final Q2 financial results will be provided on August 1, 2019, at 5:00 p.m. ET.
Share are up 5% premarket on light volume.

Dosing underway in study of Cyclacel’s sapacitabine in certain blood cancers

Nano cap Cyclacel Pharmaceuticals (NASDAQ:CYCC) is up 8% premarket on light volume following its announcement that the first patient has been dosed in a Phase 1/2 clinical trial evaluating oral sapacitabine, a nucleoside analogue prodrug, combined with AbbVie’s oral Venclexta (venetoclax), a BCL-2 inhibitor, in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).
The primary endpoint of the 40-subject study is the response rate at year two.

Late-stage study underway for FibroGen’s pamrevlumab in pulmonary fibrosis

FibroGen (NASDAQ:FGEN) has dosed first patient in the ZEPHYRUS Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
Approx. 565 subjects will be enrolled into the global study. The primary endpoint is the change in forced vital capacity from baseline. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering, extension treatment with pamrevlumab.
Pamrevlumab is an antibody developed to inhibit the activity of connective tissue growth factor.

Vanda Pharma receives FDA update for HETLIOZ

Vanda Pharmaceuticals (NASDAQ:VNDA) has received a notification from the FDA stating that as part of its ongoing review of sNDA for HETLIOZ (tasimelteon) for the treatment of Jet Lag Disorder, the agency has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.
No deficiencies were disclosed and this notification does not reflect a final decision.
The FDA had assigned a PDUFA target date for completion of its review by August 16, 2019.
Vanda anticipates receiving additional communication from the FDA identifying specific deficiencies in the sNDA.