Tuesday, May 7, 2019
RedHill Biopharma reports Q1 EPS 3c, consensus (35c)
Reports Q1 revenue $1.74M, consensus $2.76M. RedHill is continuing its preparations for the potential U.S. launch of Talicia in the fourth quarter of 2019. RedHill is currently working toward a confirmatory Phase 3 study to support a potential NDA for BEKINDA for acute gastroenteritis and gastritis. This study follows the successful completion of a first Phase 3 study with BEKINDA for acute gastroenteritis and gastritis and guidance provided by the FDA. RedHill plans to initiate a pivotal Phase 3 study with RHB-204 for the treatment of pulmonary NTM infections in the second half of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as a stand-alone, first-line treatment for pulmonary NTM infections caused by Mycobacterium avium complex. RedHill plans to meet with the FDA in the second half of 2019 to discuss the development path toward potential approval of RHB-104, including the design of a confirmatory Phase 3 study.
Voyager Therapeutics Q1 GAAP EPS (81c), may not compare to consensus 58c
Reports Q1 revenue $5.2M, may not compare to consensus $48.28M.
https://thefly.com/landingPageNews.php?id=2904595
https://thefly.com/landingPageNews.php?id=2904595
Akorn says has agreement with creditors, rationalizing pending ANDAs
Akorn said: “We have been working constructively with our creditors and are pleased to have reached an agreement that is expected to provide Akorn time to continue to make progress on operational initiatives and deliver improved results, while also providing the lending institutions with additional transparency, reduced risk and enhanced protections.” Additionally, Akorn said: “In an effort to improve the efficiency of our future R&D spend, we have recently completed a review of our pending ANDAs and have decided to rationalize a number of pending filings. Because of changes in the market size or competitive landscape, the expected commercial opportunity for these ANDAs no longer justifies further investment of time or funds required to obtain the approval.”
Monday, May 6, 2019
Notable companies reporting before tomorrow’s open
Notable companies reporting before tomorrow’s open, with earnings consensus, include Allergan (AGN), consensus $3.55… Henry Schein (HSIC), consensus 76c…
Ultragenyx Q1 ‘in-line’ with sustained Crysvita momentum, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond kept his Overweight rating and $75 price target on Ultragenyx, saying its Q1 results were “fairly in-line” amid continued momentum for its Crysvita program. The analyst is also positive on the “significant news flow” expected for Ultragenyx this year, which includes the U.S. regulatory filing for its UX007 and key gene therapy assets data.
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