logo
Plus   Neg
Share
Email

SPRO To Report Data In Q3, ITRM Takes Steady And SURE Steps, PBYI On Watch

pharma-daily-080918-lt.jpg

Today's Daily Dose brings you news about stock offerings of Restoration Robotics and NeoGenomics; Spero's clinical trial catalyst to watch in Q3; update on Iterum's SURE study; Viking and Puma's anticipated milestones.

Read on...

Iterum Therapeutics plc (ITRM) has initiated the first of three phase III clinical trials of Oral Sulopenem in uncomplicated urinary tract infections.

In the trial, dubbed SURE, oral sulopenem etzadroxil combined with probenecid in a bilayer tablet is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections. Top-line results from this study are expected in the second half of 2019.

Iterum is planning to initiate two additional phase III clinical trials later this year that will utilize both oral and intravenous Sulopenem in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

The Company expects to file its new drug applications with the FDA by the end of 2019 and has received QIDP designations for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI.

ITRM closed Thursday's trading at $8.88, up 4.10%.

NeoGenomics Inc. (NEO) has priced its underwritten public offering of 9.8 million shares of its common stock at a public offering price of $12.75 per share.

The underwriters have a 30-day option to purchase up to 1.47 million additional shares of common stock. The offering is slated to close on or about August 14, 2018, and gross proceeds from the offering are expected to be approximately $125 million.

On July 24, the Company reported its results for the second quarter of 2018.

Looking ahead to full year 2018, the Company reaffirmed its revenue outlook in the range of $260 million to $272 million. GAAP Diluted EPS is expected to be $0.01 to $0.06 per share compared to previous guidance of a loss of $0.13 to $0.08 per share.
The Company expects Adjusted diluted EPS to be $0.12 to $0.17 per share compared to previous guidance of $0.16 to $0.20 per share.

NEO closed Thursday's trading at $13.07, down 3.47%.

Puma Biotechnology Inc. (PBYI) has reported a narrower loss for the second quarter of 2018 on strong commercial progress.

Net loss for the recent second quarter was $44.3 million or $1.17 per share on net product revenue of $50.8 million from sales of NERLYNX. This compared with a net loss of $77.8 million or $2.10 per share on nil revenue in the year-ago quarter.

Anticipated key milestones over the next 12 months:

-- European Commission decision on Neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer in the third quarter of 2018.
-- Data from a phase III trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer, dubbed NALA trial in the second half of 2018 or first half of 2019.
-- Seek regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in the second half of 2018 and first half of 2019.
-- Report additional data from phase II study of Neratinib in extended adjuvant treatment of HER2-positive early stage breast cancer, dubbed CONTROL, in the fourth quarter of 2018, and
-- Report additional data from the Phase II trial of Neratinib in patients with a wide variety of solid tumors with activating EGFR, HER2 or HER4 mutations, dubbed SUMMIT, in the fourth quarter of 2018 and first half of 2019.

PBYI closed Thursday's trading at $48.65, up 0.72%.

Restoration Robotics Inc. (HAIR) has offered to sell 10 million shares of common stock to the public at a price of $1.50 each.

The Company has also granted the underwriters a 30-day option to purchase up to 1.5 million additional shares of common stock. The offering is expected to close on August 14, 2018, subject to customary closing conditions.

Restoration Robotics is a medical device company developing and commercializing the ARTAS Robotic Hair Restoration System.

On July 30, the Company announced financial results for the second quarter ended June 30, 2018.

Net loss for the second quarter of 2018 was $6.2 million or $0.21 per share compared with a net loss of $5.0 million or $3.09 per share for the second quarter of 2017. Revenue in the second quarter of 2018 was $5.5 million, a decrease of 5% compared to $5.8 million in second quarter 2017. The year-over-year decline was driven by a decrease in system and upgrade revenues.

HAIR closed Thursday's trading at $1.72, down 6.52%.

Spero Therapeutics Inc. (SPRO) has a clinical trial catalyst to watch out for this quarter related to its lead product candidate SPR994.

SPR994 for the treatment of complicated urinary tract infection is under an ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial.

In early July, Spero announced positive results from an interim analysis of its ongoing single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial of SPR994. The data demonstrated that SPR994 was well tolerated with a pharmacokinetic and pharmacodynamic profile that supports the advancement of SPR994 into a pivotal Phase 3 clinical trial at a 300 mg dose administered three times per day.

The MAD portion of the trial is continuing to dose escalate to determine the maximum tolerated dose (MTD), and Spero expects to report final MAD data in the third quarter of 2018.

Following a pre-phase III meeting with the FDA in the second half of 2018, Spero plans to initiate a pivotal Phase 3 clinical trial of SPR994 for the treatment of complicated urinary tract infection (cUTI) around year-end 2018 in support of a new drug application.

SPRO closed Thursday's trading at $11.30, down 1.57%.

Viking Therapeutics Inc. (VKTX) has a couple of catalysts to watch out for in the coming months.

The Company has completed enrollment in the Phase 2 trial of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated LDL cholesterol, and looks forward to reporting the results from this study in the fall.

Dosing of patients in a Phase 1 clinical trial of VK2809 in GSD Ia is expected to begin in the third quarter of 2018.

GSD Ia is a rare genetic disease that results in an excess accumulation of glycogen and lipids in the liver, potentially leading to hepatic steatosis, hepatic adenomas, and hepatocellular carcinomaina.

IND-enabling work for VK0214 in X-linked adrenoleukodystrophy (X-ALD) has been initiated, and an IND seeking to conduct a proof-of-concept study in X-ALD is expected to be filed in 2019.

VKTX closed Thursday's trading at $9.89, down 4.72%.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Follow RTT