AVRO Up 21% In 3 Days, KZIA For The Long Haul, Big Test Awaits CHRS
The following are some of today’s top gainers in the pharma/biotech sector.
1. Coherus BioSciences Inc. (CHRS)
Gained 20.13% to close Wednesday’s (Jul 18) trading at $17.90.
News: In a SEC filing, the Company has disclosed that all outstanding issues related to the marketing authorisation application of CHS-1701 filed with the European Medicines Agency have been resolved.
CHS-1701 is a biosimilar candidate for Amgen Inc.’s (AMGN) blockbuster treatment, Neulasta.
The Company expects an opinion from the CHMP this month. Following a CHMP opinion, the European Commission usually announces its decision within 67 days.
Coherus’ Marketing Authorization Application for CHS-1701 was accepted by the European Medicines Agency in November 2016.
In the U.S., the resubmitted NDA for CHS-1701 is under FDA review, with a decision expected on November 3, 2018.
If approved, CHS-1701 will be the Company’s first drug to receive regulatory approvals.
Mylan’s Fulphila, which received FDA approval last month, is the first biosimilar to Neulasta to have won regulatory nod.
2. AVROBIO Inc. (AVRO)
Gained 16.85% to close Wednesday’s trading at $33.91.
News: No news
AVROBIO is a phase II clinical stage gene therapy company focused on developing gene therapies to treat rare diseases.
The Company went public on the Nasdaq Global Select Market on June 21, 2018, offering its shares at a price of $19.00 each.
— AVR-RD-01 for the treatment of Fabry disease, currently under an investigator-sponsored Phase 1 clinical trial and company-sponsored Phase 2 clinical trial.
— AVR-RD-02 for the treatment of Gaucher disease for which Phase 1/2 clinical trials are planned.
— AVR-RD-03 for the treatment of Pompe disease, under preclinical testing
AVR-RD-04 for the treatment of cystinosis for which Phase 1/2 clinical trials are planned.
3. Kazia Therapeutics Limited (KZIA)
Gained 13.68% to close Wednesday’s trading at $3.62.
News: No news
On July 13, the Company announced that it successfully negotiated a divestment of its next generation anti-tropomyosin (ATM) discovery research program to TroBio Therapeutics Pty Ltd (TroBio), a privately-held biotechnology company based in Sydney, Australia.
— GDC-0084, currently in phase II trial for brain cancer
— Cantrixil, currently in phase I trial for ovarian cancer.
Further safety and efficacy data from phase I study of Cantrixil in ovarian cancer is expected in Q4, 2018.
Read-out from dose optimization component of phase II study of GDC-0084 in brain cancer is expected in early 2019.
4. Nemaura Medical Inc. (NMRD)
Gained 13.10% to close Wednesday’s trading at $2.85. The stock has gained 27% over the last two days.
The Company is developing sugarBEAT for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system. SugarBEAT consists of a disposable skin-patch connected to a rechargeable transmitter, and mobile app displaying glucose readings.
On July 17, the Company placed an initial order with its designated UK-based contract manufacturer for 12,500 sugarBEAT rechargeable transmitters, which will be supplemented with approximately 100,000 skin-patches per month, also manufactured in the UK, in preparation for the anticipated sugarBEAT product launch in the coming months.
5. Translate Bio Inc. (TBIO)
Gained 8.38% to close Wednesday’s trading at $14.10.
News: No news
The Company went public on the Nasdaq Global Select Market as recently as June 28, 2018, offering its shares at a price of $13.00 each.
— MRT5005, for the treatment of cystic fibrosis, or CF, under a Phase 1/2 clinical trial
— MRT5201, for the treatment of ornithine transcarbamylase, or OTC, a genetic disease, which is expected to enter Phase 1/2 clinical testing in the first half of 2019.
by RTTNews Staff Writer
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