CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency
Swiss pharma firm CSL Vifor, a subsidiary of Australia’s CSL Ltd. (CSL.AX, CSLLY.PK), announced Monday that the U.S. Food and Drug Administration (FDA) has granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
CSL Vifor has granted American Regent an exclusive right to develop, manufacture and market Injectafer in the United States.
The FDA approval was supported by CSL Vifor’s randomized placebo-controlled study, CONFIRM-HF (NCT01453608), which evaluated the efficacy and safety of ferric carboxymaltose in adult patients with symptomatic heart failure and iron deficiency.
The treatment over a 1-year period resulted in a significant and sustainable improvement in exercise capacity in this patient population.
DigitalBridge Group Continues To Gain
Shares of DigitalBridge Group, Inc. (DBRG) are progressing more than 8 percent on Monday morning trade, continuing an uptrend since the mid of May. There have been no corporate announcements today to influence the stock movement.
Currently, shares are at $13.95, up 8.64 percent from the previous close of $12.84 on a volume of 967,190.
EPAM Down 18% After Reducing Q2, FY Guidance
Shares of EPAM Systems, Inc. (EPAM), a digital transformation services company, are losing 18 percent on Monday morning trade after the company announced that it is reducing its second-quarter and full-year financial outlook. The company said the reduced outlook is due to lower spending in the ‘build’ segment of the global IT services market and slower pipeline conversions and a decrease in the total pipeline.
EPAM is currently trading at $211.05, down 18.72 percent or $48.60, in its regular trading session. The stock opened its trading at $216.74 after closing Friday’s trading at $259.65. The stock has traded between $210.60 and $462.99 in the past 52-week period.
The company expects second-quarter earnings to range from $1.75 to $1.82 per share, compared with the previous guidance of $1.82 to $1.90 per share.
The second quarter revenue is expected in a range of $1.160 billion – $1.170 billion, reflecting a year-over-year decrease of 2.5% at the midpoint of the range compared with the previous guidance of $1.195 billion to $1.205 billion.
The company expects the full-year earnings to range from $7.28 to $7.68 per share, compared with the previous guidance of $8.11 to $8.31 per share.
The full-year revenue is expected to range from $4.650 billion to $4.800 billion, reflecting a year-over-year decrease of 2% at the midpoint of the range, compared with the previous guidance of $4.950 billion to $5.000 billion.
U.S. Factory Orders Climb Slightly Less Than Expected In April
The Commerce Department released a report on Monday showing new orders for U.S. manufactured goods increased by slightly less than expected in the month of April.
The report said factory orders rose by 0.4 percent in April after climbing by a downwardly revised 0.6 percent in March.
Economists had expected factory orders to climb by 0.5 percent compared to the 0.9 percent advance originally reported for the previous month.
The increase in factory orders came as orders for durable goods jumped by 1.1 percent in April after surging by 3.3 percent in March. Orders for transportation led the way higher, spiking by 3.7 percent.
Meanwhile, the report said orders for non-durable goods edged down by 0.1 percent in April after tumbling by 1.8 percent in March.
The Commerce Department also said shipments of manufactured goods fell by 0.4 percent in April following a 0.6 percent decrease in March.
At the same time, inventories of manufactured goods increased by 0.5 percent in April after sliding by 0.8 percent in the previous month.
With shipments falling and inventories climbing, the inventories-to-shipments ratio rose to 1.50 in April from 1.48 in March.
Day One Biopharma Up 13% On New Data For Tovorafenib
Shares of Day One Biopharmaceuticals, Inc. (DAWN) are up 13% on the Monday morning trade after the company announced new data from the registrational Phase 2 FIREFLY-1 trial for Tovorafenib (DAY101).
DAWN is trading on the Nasdaq at $15.42, up 13.38% or $1.82 per share. It has traded between $6.40 and $28.35 in the past 52-week period.
The company announced an overall response rate of 67% and a clinical benefit rate of 93% in 69 heavily pre-treated RANO-HGG evaluable patients in a pediatric low-grade glioma trial.
In addition, the Company announced a rolling NDA submitted to the FDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma.
Driver killed in early morning crash in north Denver
A driver was killed in a single-vehicle crash before dawn Monday in north Denver, police said.
The crash happened near the intersection of West 52nd Street and Sheridan Boulevard before 3:40 a.m., according to a Denver Police posting on Twitter.
Paramedics pronounced the driver dead at the scene. Police were investigating. No other information, including the identity of the victim, was released.
Amedisys Climbs 14% After Announcing Unsolicited Acquisition Proposal From Optum
Amedisys, Inc. (AMED) shares are gaining more than 14 percent on Monday morning trade after the company announced the receipt of an unsolicited acquisition proposal from Optum, a diversified health services company. The offer is to acquire Amediys’s common stock in an all-cash transaction for $100 per share.
Amedisys said it is currently engaging in exploratory discussions with Optum. At the same time, the company said it remains bound by the terms of the merger agreement with Option Care Health.
Currently, AMED is at $91.21, up 14.77 percent from the previous close of $79.47 on a volume of 1,992,522.