03.04.2018 03:11:21
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SLS Gets A Shot In The Arm, BLFS Full Of Life, MNOV Soars On NASH Trial Data
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. SELLAS Life Sciences Group Inc. (SLS)
Gained 150.72% to close Monday's (Apr.2) trading at $8.65.
News: The Company announced positive interim data from its phase 2b independent investigator-sponsored clinical trial of NeuVax in combination with Roche's Herceptin in HER2 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences.
According to a pre-specified interim analysis, conducted by an independent Data Safety Monitoring Board, there was a clinically meaningful difference in median disease-free survival in favor of NeuVax plus Herceptin in the overall study population consisting of 275 HER2 1+/2+ breast cancer patients with positive nodes and/or 'triple-negative' breast cancer.
The NeuVax + Herceptin combination produced a clinically meaningful and also statistically significant efficacy in triple negative breast cancer (TNBC) cohort. The addition of NeuVax to Herceptin did not result in any additional cardiotoxicity compared to Herceptin alone, noted the Company.
The Data Safety Monitoring Board has asked the Company to expeditiously seek regulatory guidance from the FDA for further development of the combination of NeuVax plus Herceptin in triple negative breast cancer.
2. BioLife Solutions Inc. (BLFS)
Gained 20.47% to close Monday's trading at $6.18.
News: The Company announced first quarter 2018 preliminary revenue of $3.8 million, which represents 61% growth over the first quarter of 2017 and 22% sequential growth over the fourth quarter of 2017.
The revenue includes sales of BioLife's proprietary CryoStor and HypoThermosol biopreservation media products.
Looking ahead to 2018, the Company expects biopreservation media revenue to range between $14.5 million to $15.5 million, representing growth of approximately 32% to 41% over 2017. This is an increase from the Company's previous guidance for 2018 revenue of $13.6 million to $14.7 million.
Near-term Catalyst:
The Company is slated to report first quarter 2018 financial results in the 2nd week of May.
3. MediciNova Inc. (MNOV)
Gained 18.88% to close Monday's trading at $12.15.
News: The Company announced that it is terminating its phase II clinical trial of MN-001 in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with hypertriglyceridemia early based on the significant positive results from an interim analysis.
The interim analysis of the phase II study demonstrated that that MN-001 significantly reduced mean serum triglycerides, a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment. There were no clinically significant safety or tolerability issues during the study.
4. Innovate Biopharmaceuticals Inc. (INNT)
Gained 18.70% to close Monday's trading at $32.50.
News: No news
Pipeline:
The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).
Near-term Catalyst:
-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.
5. Allena Pharmaceuticals Inc. (ALNA)
Gained 18.60% to close Monday's trading at $13.07.
News: No news
Pipeline:
The Company's drug candidates include ALLN-177, under a phase III trial in patients with enteric hyperoxaluria, dubbed URIROX-1, and a Phase 2 basket trial in adolescents and adults with primary hyperoxaluria or enteric hyperoxaluria and hyperoxalemia, dubbed Study 206; ALLN-346, intended for patients with hyperuricemia and moderate to severe chronic kidney disease, under a preclinical program.
Near-term Catalysts:
-- The interim data from Study 206 is expected to be announced in the second half of 2018. -- The topline data from URIROX-1 is expected to be announced in the second half of 2019.
Recent event:
The Company went public on the NASDAQ Global Select Market on November 2, 2017, offering its shares at a price of $14.00 each.
6. Aethlon Medical Inc. (AEMD)
Gained 17.65% to close Monday's trading at $1.40.
News: No news
Recent event:
-- On Feb.1, 2018, the Company announced results for its fiscal third quarter ended December 31, 2017.
The net loss was approximately $1.22 million or $0.08 per share for the December 2017 quarter on revenues of $74,813. This compared with a net loss of about $1.21 million or $0.15 per share and nil revenue in the December 2016 quarter.
The Company, which had a cash balance of roughly $5.6 million at year-end 2017, raised approximately $1.4 million over the month of January 2018 through a combination of cash from warrant exercises and sales under the Company's At-The-Market financing agreement.
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Aktien in diesem Artikel
Allena Pharmaceuticals Inc Registered Shs | 0,00 | 0,00% | |
Biolife Solutions Inc | 25,60 | 0,00% | |
MediciNova Inc | 298,00 | 0,00% |