JMP Securities analyst Jason Butler lowered his price target for Ovid Therapeutics to $11 from $26 to reflect equity dilution following last month’s equity offering. He maintains an Outperform rating on the stock following the company’s quarterly update, noting that the company remains on track to initiate the Phase 3 trial for OV101 in Angelman syndrome in the second half of this year and he anticipates results from the ARCADE trial of OV935 in severe pediatric epilepsies by the end of 2019.
Friday, March 8, 2019
Joint Corp price target raised to $15 from $10 at DA Davidson
DA Davidson analyst Michael Kawamoto raised his price target on Joint Corp to $15 after its Q4 results showed the first quarter of net profitability and another year of 20% comps growth in 2018. The analyst expects the company’s accelerating clinic build-out and efforts to raise its brand awareness to translate into continued margin expansion and earnings growth, keeping his Buy rating on Joint Corp shares.
Amag Pharma Makena data disappointing
AMAG Pharmaceuticals (NASDAQ:AMAG) is down 6% premarket on light volume in response to disappointing results from a Phase 3 clinical trial, PROLONG, evaluating Makena (hydroxyprogesterone caproate injection) for the prevention of preterm birth in women with histories of prior spontaneous singleton preterm deliveries.
The study failed to demonstrate a statistically significant treatment benefit from Makena compared to placebo. Specifically, the rate of preterm delivery in the Makena cohort was 11.0% compared to 11.5% for control (p=0.72). The percentages of patients who met the criteria for the pre-specified neonatal morbidity and mortality composite index were also comparable (5.4% for Makena vs. 5.2% for placebo, p=.84). The safety profiles were similar.
The company says it will conduct additional subgroup analyses (in an effort to find something positive). It plans to submit the data to the FDA and for publication.
The FDA approved the drug in February 2011 to reduce the risk of preterm birth in at-risk pregnant women.
Trovagene set to continue onvansertib-stoked rally
Thinly traded nano cap Trovagene (NASDAQ:TROV) is up 110% premarket on robust volume, poised to add to yesterday’s 31% move after it released its Q4 report after the close on Wednesday.
Investors appear to reacting to its update on onvansertib. According to CEO Dr. Thomas Adams, the PLK1 inhibitor has shown activity (more specifics needed) in more than 88% of evaluable acute myeloid leukemia (AML) patients to date.
Enrollment in a Phase 1b/2 study in metastatic colorectal cancer (mCRC) should start mid-year.
Data readouts from a Phase 2 study in metastatic castration-resistant prostate cancer (mCRPC) should continue throughout the year.
Interim data from its Phase 1b/2 study in AML and Phase 2 trial in mCRPC will be presented in a few weeks at AACR in Atlanta.
On the working capital front, at the end of December 2018, it had $11.5M in cash and equivalents. Operations consumed $13.2M in cash for the year.
Aceto enters ‘stalking horse’ agreement to sell Rising Pharmaceuticals
Aceto announced that it has entered into a “stalking-horse” asset purchase agreement with Shore Suven Pharma, Inc. to sell the assets of Rising Pharmaceuticals and Rising’s subsidiaries for gross cash proceeds of $15 million, plus the assumption of operating liabilities and customer obligations related to the acquired business on a cash-free and debt-free basis. Shore Suven Pharma, Inc. is a joint venture between Suven Life Sciences Limited, an India-based provider of contract research and manufacturing services for the global life sciences industry, and Shore Pharma Investments, LLC, a company founded by Vimal Kavuru to acquire generic drug assets. Mr. Kavuru is a member of Aceto’s board. The proposed sale will be conducted through a Court-supervised process under Section 363 of the Bankruptcy Code, subject to Court-approved bidding procedures, potential receipt of higher and better offers at auction; approval of the sale by the Court; and, the satisfaction of certain other conditions, including a mutual release of claims against certain of the buyer parties and their affiliates.
Regeneron, Sanofi announce FDA Priority Review of sBLA for Dupixent
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application, or sBLA, for Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, or CRSwNP. Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids. The target action date for the FDA decision is June 26, 2019. Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages. Patients may experience severe nasal obstruction with breathing difficulties, nasal discharge, reduction or loss of sense of smell and taste, and facial pain or pressure. Persistent symptoms of CRSwNP have a substantial adverse impact on patients’ health-related quality of life, which can be measured by a composite that includes reduced productivity and activities of daily living, inability to enjoy food, lack of sleep and fatigue. People with co-morbid asthma and CRSwNP tend to have more severe disease and are often more difficult to treat. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids. About 60% of patients in the trials had co-morbid asthma.
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