The following are some of today’s top gainers in the pharma/biotech sector.
1. Akari Therapeutics Plc (AKTX)
Gained 224.18% to close Wednesday’s (Mar.13) trading at $5.90.
News: The FDA has agreed to the Company’s proposed pivotal clinical trial program of Coversin for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The trial is expected to commence in the fourth quarter of 2019.
HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children with the severe disease.
The Company’s lead product candidate is Coversin.
— A phase II trial of Coversin in patients with the skin inflammatory disease Bullous Pemphigoid is underway, with initial data expected this quarter.
— A phase I/II trial of Coversin in patients with atopic keratoconjunctivitis, a sight-threatening surface of the eye condition, is ongoing, with initial data expected in the first quarter 2019.
— A phase III trial of Coversin in naïve paroxysmal nocturnal hemoglobinuria patients and a Phase II trial in patients who are resistant to eculizumab are underway.
— A phase II trial of Coversin in atypical hemolytic syndrome, a severe thrombotic microangiopathy, is ongoing.
2. Guardant Health Inc. (GH)
Gained 27.64% to close Wednesday’s trading at $94.45.
News: The Company reported stellar financial results for the fourth quarter and full year ended December 31, 2018.
Revenue was $32.9 million in the three months ended December 31, 2018, a 64% increase from $20.0 million in the three months ended December 31, 2017. Revenue for the year ended December 31, 2018, was $90.6 million, an 82% increase from $49.8 million in 2017.
Looking ahead, the Company has forecast full-year 2019 revenue to be in the range of $130 million to $135 million, representing 43% to 49% growth over the full year 2018.
3. Conatus Pharmaceuticals Inc. (CNAT)
Gained 25.65% to close Wednesday’s trading at $2.89.
News: The Company announced that it will detail results of ENCORE-PH phase IIb trial evaluating Emricasan in patients with NASH cirrhosis and severe portal hypertension on April 13 at the Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
Last December, the Company announced that the ENCORE-PH trial did not meet the primary endpoint. The study has an ongoing six-month extension with 48-week liver function.
Clinical Trials & Near-Term Catalysts:
In addition to ENCORE-PH, two other phase IIb trials of Emricasan are underway – ENCORE-NF (for NASH Fibrosis) and ENCORE-LF (for Liver Function).
— Top-line results from ENCORE-NF are expected in the first half of 2019.
— Top-line results ENCORE-LF are expected in mid-2019.
— Results following the extension period in ENCORE-PH trial are expected in mid-2019.
4. Diffusion Pharmaceuticals Inc. (DFFN)
Gained 23.20% to close Wednesday’s trading at $6.00.
News: No news
The Company’s lead drug candidate is Trans Sodium Crocinate.
— A phase III study of Trans Sodium Crocinate to target inoperable glioblastoma multiforme brain cancer, dubbed INTACT, is underway. The Company was given FDA clearance last September to conduct a phase II on-ambulance trial of Trans Sodium Crocinate for the treatment of stroke.
5. Natera Inc. (NTRA)
Gained 19.09% to close Wednesday’s trading at $19.84.
News: The Company reported financial results for the fourth quarter and year ended December 31, 2018.
Net loss for the fourth quarter of 2018 narrowed to $31.8 million or $0.51 per share from $47.2 million or $0.90 per share for the same period in 2017. Total revenues for the recent fourth quarter increased 29% to $67.0 million from $52.0 million for the fourth quarter of 2017.
Total revenues for full-year 2018 were $257.7 million compared to $209.6 million for 2017, which represents an increase of 23%.
Looking ahead, the Company anticipates 2019 total revenues of $275 million to $302 million.
6. Hancock Jaffe Laboratories Inc. (HJLI)
Hancock is a company specializing in medical devices that restore cardiac and vascular health.
Gained 19.18% to close Wednesday’s trading at $1.74.
News: The Company announced that it has closed a private placement of 2.36 million shares of its common stock for aggregate gross proceeds of approximately $2.7 million with various accredited investors, including participation by a member of HJLI’s management.
The Company has two lead products candidates – the porcine tissue based VenoValve, which is intended to be surgically implanted in the deep venous system of the leg to treat Chronic Venue Insufficiency; and the CoreoGraft, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery.
— Enrollment for the first-in-human study of VenoValve is ongoing. Hancock Jaffe implanted the first VenoValve in a patient in Bogota, Colombia in February of 2019. An update will be provided once additional patients are enrolled in the study.
— A pre-clinical feasibility study for the CoreoGraft is being conducted at the Texas Heart Institute, and results from the study are expected to be released in June of 2019.
7. Nabriva Therapeutics plc (NBRV)
Gained 15.64% to close Wednesday’s trading at $2.81.
News: No news
— The New Drug Applications for Intravenous CONTEPO for the treatment of complicated-urinary tract infections (cUTIs), including acute pyelonephritis (AP) are under priority review by the FDA, with a decision date set for April 30, 2019.
— The New Drug Applications for oral and IV formulations of Lefamulin for the treatment of community-acquired bacterial pneumonia are also under priority review by the FDA, with a decision expected on August 19, 2019.
8. NuCana plc (NCNA)
Gained 13.73% to close Wednesday’s trading at $15.08.
News: No news
Anticipated Milestones in 2019:
— Report interim data from a phase II study of Acelarin for patients with platinum-resistant ovarian cancer.
— Open a Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.
— Continue enrollment in the Phase III study (Acelarate) of Acelarin as a first-line treatment compared to gemcitabine for patients with metastatic pancreatic cancer.
— Report initial data from the ongoing phase Ib study of NUC-3373 in patients with advanced colorectal cancer in combination with other approved agents with which 5-FU is typically combined, including leucovorin, oxaliplatin, and irinotecan.
— Report interim data from the Phase I study of NUC-7738 in patients with advanced solid tumors.
Source: Read Full Article