21.09.2018 02:49:54
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ALT Up 514% In 2 Days, CRBP Well Stocked, ACAD Soars On FDA Review
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. Altimmune Inc. (ALT)
Gained 59.36% to close Thursday's (Sep.20) trading at $26.23.
News: No news
Pipeline:
Altimmune is a clinical-stage immunotherapeutics company having three clinical product candidates in its pipeline namely, NasoVAX, a phase II seasonal influenza vaccine candidate, HepTcell, a phase I immunotherapeutic candidate for the potential cure of chronic hepatitis B, SPARVAX-L, a phase II Anthrax vaccine, and NasoShield, a next generation Anthrax vaccine, under phase I study.
Recent events:
-- On September 14, the Company effected a 1 for 30 reverse stock split. -- On September 4, the Company announced additional positive data from a Phase 2a study of its NasoVAX intranasal influenza vaccine candidate. The results demonstrated a statistically superior mucosal immune response providing a first line of defense against infection; a durable serum immune response at six months compared to over 50% decline with Fluzone, a licensed injectable influenza vaccine, and a continued clean safety profile.
Near-term Catalyst:
Immunogenicity data for two-dose cohort from the phase I study of NasoShield under investigation as a potential vaccine against anthrax is expected to be available in the fourth quarter of this year.
2. Corbus Pharmaceuticals Holdings Inc. (CRBP)
Gained 53.62% to close Thursday's trading at $7.95.
News: The Company announced that it has licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 compounds targeting the endocannabinoid system from Jenrin Discovery LLC.
The pipeline includes CRB-4001, Jenrin's 2nd generation, peripherally-restricted, CB1 inverse agonist targeting liver, lung, heart and kidney fibrotic diseases. CRB-4001 is expected to enter phase I testing next year.
3. Therapix Biosciences Ltd. (TRPX)
Therapix Biosciences is a specialty clinical-stage pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders.
Gained 34.91% to close Thursday's trading at $5.72.
News: No news
Clinical Trials & Near-term Catalysts:
-- The first patient in a phase IIb, placebo-controlled 12-week clinical trial for THX-110 in Tourette syndrome, which will be conducted in Germany, is expected to be enrolled by the end of the third quarter. Top line results are expected in the first half of 2020. -- A phase IIa sponsor-initiated trial with THX-110 in Obstructive Sleep Apnea is underway, with top line results expected in the first half of 2019.
The other ongoing studies are a phase IIa investigator-initiated trial with THX-110 for the treatment of chronic pain, a pre-clinical study evaluating THX-130 in a rodent model for cognitive impairment related to traumatic brain injury; pre-clinical study of THX-150 for the treatment of infectious diseases, and a pre-clinical study of THX-160 for the treatment of pain.
4. ACADIA Pharmaceuticals Inc. (ACAD)
Gained 26.56% to close Thursday's trading at $19.11.
News: The FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of the Company's Nuplazid for patients with Parkinson's disease psychosis.
Nuplazid received FDA approval in April 2016. It is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson's disease psychosis.
The net product sales of Nuplazid were $124.9 million in full-year 2017, and $105.9 million in the first half of 2018.
5. Xenetic Biosciences Inc. (XBIO)
Gained 17.62% to close Thursday's trading at $2.47.
News: No news
Clinical Trials & Near-term Catalysts:
-- A phase II clinical trial evaluating MABp1 (Bermekimab) in patients with moderate to severe Atopic Dermatitis is underway. -- A phase II clinical study evaluating Bermekimab in patients with moderate to severe Hidradenitis Suppurativa is underway. -- A physician-sponsored clinical research study being conducted to examine the safety of Bermekimab in combination with Onivyde and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients suffering from cachexia is ongoing. Clinical results from this study are expected to be reported later in 2018.
6. Conatus Pharmaceuticals Inc. (CNAT)
Gained 17.37% to close Thursday's trading at $5.54.
News: No news
Clinical Trials & Near-term Catalysts:
-- Top-line results from a phase IIb clinical trial of Emricasan in patients with NASH Cirrhosis and severe portal hypertension, dubbed ENCORE-PH, are expected in the fourth quarter of 2018. -- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF, is ongoing. Top line results are expected in the first half of 2019. -- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF, is underway. Top-line results are expected in the second half of 2019.
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