02.02.2019 03:38:21
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Week Ahead In Pharmaceuticals: 6 Stocks To Watch (EOLS, AVRO, SGMO...)
(RTTNews) - The week saw yet another Alzheimer's drug bite the dust. The investigational drug Crenezumab, being developed by Roche and AC Immune (ACIU), was under two phase III trials in early Alzheimer's disease. On January 30, the companies announced that they were discontinuing the two Crenezumab trials as the compound was unlikely to meet the primary endpoint. Since the announcement of the news, shares of AC Immune have lost 62% of their value.
AVEO Pharmaceuticals Inc. (AVEO) is another stock that lost over 60% of its value in the week. On January 31, the Company announced that it has been asked by the FDA not to submit a New Drug Application for FOTIVDA for renal cell cancer with just the preliminary overall survival (OS) results from its phase III TIVO-3 trial. The regulatory agency has sought additional survival data.
However, it was not all doom and gloom for pharma stocks in the week.
SCYNEXIS Inc. (SCYX) gained as much as 94% in the week, following positive results from the first interim efficacy analysis of its ongoing FURI study. FURI is a phase III study of investigational drug Ibrexafungerp (formerly SCY-078) in patients with refractory or intolerant fungal disease.
Now, here are some of the pharma/biotech stocks to watch out for in the week starting February 4.
1. AVROBIO Inc. (AVRO)
AVROBIO is a clinical-stage gene therapy company developing gene therapies to potentially cure rare diseases like Fabry disease, Gaucher disease, Cystinosis, and Pompe disease.
The Company's lead drug candidate is AVR-RD-01, an ex vivo lentiviral gene therapy being investigated as single-dose therapy for Fabry disease.
Last October, the Company reported encouraging data from the investigator-sponsored phase I study and the AVROBIO-sponsored phase II trial of AVR-RD-01 in Fabry disease, dubbed FAB-201.
Watch out for…
Enrollment in both the FAB-201 clinical trial and investigator-sponsored phase I study of AVR-RD-01 in Fabry disease continues, and an update on the trials is scheduled to be presented at WORLDSymposium on February 5, and February 6, respectively.
AVRO closed Friday's trading at $13.42, up 7.70%.
2. Catalyst Biosciences Inc. (CBIO)
Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications.
The Company's lead drug candidate is Marzeptacog alfa (activated) a potent, subcutaneously administered, next-generation Factor VIIa therapy being developed for prophylaxis in hemophilia A or B with inhibitors.
The phase II portion of phase II/III program of Marzeptacog alfa is enrolling patients.
Watch out for…
The most up to date data from the ongoing Phase 2/3 trial of marzeptacog alfa (activated) (MarzAA) for the treatment of hemophilia A or B with inhibitors is scheduled for presentation at the European Association for Haemophilia and Allied Disorders (EAHAD) on February 8, 2019.
CBIO closed Friday's trading at $8.37, down 4.78%.
3. Evolus Inc. (EOLS)
Evolus is a medical aesthetics company.
Watch out for…
The Company just secured FDA approval for its lead product for the treatment of glabellar lines, also known as frown lines, in adult patients.
Jeuveau/DWP-450 is an injectable formulation of a 900 kilodalton, or kDa, Botulinum toxin Type A complex, produced by Clostridium botulinum.
Currently, Allergan plc's (AGN) Botox is the neurotoxin market leader and the only other approved 900 kDa botulinum toxin type A complex in the United States.
Jeuveau is expected to be available throughout the United States at physician offices starting in Spring 2019.
EOLS closed Friday's trading at $18.34, up 12.17%. In after-hours, the stock was up 14.56% to $21.35.
4. Protalix BioTherapeutics Inc. (PLX)
Protalix is a biopharmaceutical company focused on developing drugs for Fabry disease, Cystic Fibrosis, and others.
The Company's lead product candidate is Pegunigalsidase alfa for the treatment of Fabry disease, under a phase III trial, dubbed BRIGHT.
Watch out for…
The preliminary pharmacokinetic data from the BRIGHT study is slated to be presented at the 15th Annual WORLDSymposium 2019 on February 7, 2019.
PLX closed Friday's trading at $0.55, up 13.17%.
5. Sangamo Therapeutics Inc. (SGMO)
Sangamo is a clinical stage biotechnology company focused on developing genomic therapies. A leader in the research and development of zinc finger proteins, or ZFPs, the Company uses its platform technologies in genome editing, gene therapy, gene regulation, and cell therapy.
The Company's clinical trial candidates are:
-- SB-318 in a phase l/ll clinical trial for the treatment of patients with mucopolysaccharidosis type I (MPS I, Hurler syndrome), dubbed EMPOWERS. -- SB-913 in a phase I/II clinical trial for the treatment of mucopolysaccharidosis Type II (MPS II, also known as Hunter syndrome), dubbed CHAMPIONS. -- SB-525 in a phase I/II clinical trial for people with hemophilia A, or factor VIII (FVIII) deficiency. -- SB-FIX in a phase I/II clinical trial for patients with hemophilia B. -- ST-400 and BIVV-003 in phase I/II clinical trial for the treatment of people with sickle cell disease and beta-thalassemia, respectively.
Watch out for…
Update on safety and biochemical changes at up to 24 weeks from 6 adult patients in the CHAMPIONS study will be presented on February 7, 2019.
Preliminary safety and biochemical changes at up to 4 weeks from first 3 adult patients are expected to be presented on February 7, 2019.
SGMO closed Friday's $12.48, up 6.76%.
6. Sienna Biopharmaceuticals Inc. (SNNA)
Sienna Biopharma is a clinical-stage biopharmaceutical company developing topical products in medical dermatology and aesthetics.
The most advanced product in the pipeline is SNA-001 for the reduction of light-pigmented hair under three pivotal trials - with 1064 nm wavelength laser, 810 nm and with the 755 nm wavelength lasers. Each trial is enrolling about 70 subjects.
Watch out for…
Top-line data from the pivotal trials are expected in early February 2019.
SNNA closed Friday's trading at $2.83, up 5.60%.
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Aktien in diesem Artikel
AC Immune SA | 2,57 | 0,98% | |
Evolus Inc Registered Shs | 10,50 | 2,94% | |
Sangamo Therapeutics Inc | 2,44 | 5,88% | |
Sienna Biopharmaceuticals Inc Registered Shs | 0,00 | 0,00% |