After hosting a call featuring a key opinion leader who treats a “significant number” of patients with moderate-to-severely active thyroid eye disease, Piper Jaffray analyst David Amsellem says he continues to view teprotumumab as a “potentially transformational opportunity” for Horizon Pharma. The commentary on the call “clearly underscores the extent to which systemic corticosteroids are inadequate for these patients,” Amsellem tells investors in a research note. He believes experts views teprotumumab as “potentially paradigm-shifting” and reiterates an Overweight rating on Horizon Pharma with a $33 price target.
Thursday, April 4, 2019
Palatin says results of PL-8177 study met all primary,secondary endpoints
Palatin Technologies announced positive results of a micro-dose study of radiolabeled PL-8177 using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL-8177 is a patented melanocortin receptor 1 agonist with potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The main objective of the study was to demonstrate release of polymer-bound PL-8177 in the lower gastrointestinal tract after oral administration. Top line data showed favorable pharmacokinetics, and demonstrated PL-8177 was released in the lower gastrointestinal tract, supporting oral administration of PL-8177 using the delayed release polymer formulation. A secondary objective of the study was also met, demonstrating that PL-8177 is not systemically absorbed after oral administration. There was no intact PL-8177 or its metabolite detected in plasma after oral administration. The oral formulation was well tolerated and there were no adverse events observed.
Viking Therapeutics to present new data on NAFLD candidate at liver congress
Viking Therapeutics announced that data from the company’s 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated low-density lipoprotein cholesterol, will be presented at the International Liver Congress 2019 being held April 10-14 in Vienna. The Phase 2 study achieved both its primary and secondary endpoints, and demonstrated an “encouraging” safety and tolerability profile for VK2089, Viking’s novel liver-selective thyroid receptor beta agonist. The presentation will include new data from the trial’s low-dose 5 mg cohort treatment arm, which demonstrated statistically significant reductions in liver fat content relative to placebo, as well as statistically significant response rates, defined by the proportion of patients experiencing at least a 30% or 50% relative reduction in liver fat, compared with placebo. VK2809 was well tolerated when dosed at 5 mg daily, and no serious adverse events were reported among patients receiving either VK2809 or placebo.
Natera remains ‘top idea’ following management meetings, says Baird
Baird analyst Catherine Ramsey Schulte maintained an Outperform rating and $24 price target on Natera, saying she continues to recommend Natera as a top idea following recent investor meetings with CEO Steve Chapman and CFO Mike Brophy. The analyst thinks Natera’s core business is healthy and believes transplant and oncology opportunities are only partially valued in the stock today and could drive meaningful upside over the next few years.
Entasis Therapeutics initiates Phase 3 ATTACK trial
Entasis Therapeutics announced the initiation of the ATTACK Phase 3 pivotal clinical trial to evaluate ETX2514SUL, a fixed-dose combination of its broad-spectrum ss-lactamase inhibitor ETX2514 with sulbactam, for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. A. baumannii is a Gram-negative bacterium that causes severe infections and is associated with high mortality, increasing rates of antibiotic resistance and growing significance as a hospital-acquired infection due to limited treatment options. Outbreaks of A. baumannii typically occur in intensive care units and healthcare settings with seriously ill patients and can either cause or contribute to death.
https://thefly.com/landingPageNews.php?id=2888537
https://thefly.com/landingPageNews.php?id=2888537
Perrigo Gets Tentative FDA Approval For Generic Version Of Sernivo® Spray
Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of “Quality, Affordable, Self-Care Products™“, today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Sernivo® (betamethasone dipropionate) Spray 0.05%. Perrigo previously settled its Hatch-Waxman litigation relating to Sernivo® (betamethasone dipropionate) Spray 0.05% brought by Promius Pharma LLC. Terms of the settlement remain confidential.
Annual market sales for the 12 months ending February 2019 were approximately $15 million as measured by IQVIA™.
Twist Bioscience, LakePharma to collaborate for antibody discovery
Twist Bioscience Corporation and LakePharma announced a strategic collaboration to offer antibody discovery and development solutions to pharmaceutical and biotechnology customers. Under the terms of the agreement, LakePharma will have the ability to offer Twist’s proprietary antibody discovery and optimization platforms to their existing and future biopharmaceutical customers as part of their service offerings. One such platform generated is for discovery of novel therapeutic antibodies against a major class of protein drug targets known as GPCRs, which traditionally have been difficult for biologics drug development. GPCRs have been heavily investigated due to their involvement in multiple disease classes, including inflammation, cancer, metabolism, respiratory, and pain. In return, customers of Twist will have access to LakePharma’s integrated discovery and development services.
https://thefly.com/landingPageNews.php?id=2888539
https://thefly.com/landingPageNews.php?id=2888539
Subscribe to:
Posts (Atom)