The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.
1. Miragen Therapeutics Inc. (MGEN)
Lost 15.75% to close Thursday’s (Jan.10) trading at $3.53.
News: The Company announced new encouraging clinical data in patients with three different types of blood cancers treated with its drug candidate Cobomarsen. The decline in stock price had nothing to do with study results.
In the phase I Cobomarsen clinical trial in Cutaneous T-cell Lymphoma, 50% of cutaneous T-cell lymphoma patients treated with 300mg IV infusion achieved objective response lasting for greater than four months (ORR4).
In the phase I trial of Cobomarsen for HTLV-1 Associated Adult T-cell Leukemia/Lymphoma, there was evidence of disease stabilization in five adult T-cell leukemia/lymphoma patients.
In the phase I trial of Cobomarsen in patients with diffuse large B-cell lymphoma (DLBCL), there was an early indication of response in one patient.
2. PAVmed Inc. (PAVM)
Lost 14.66% to close Thursday’s trading at $0.99.
News: The Company has been told by the FDA that data from a properly structured clinical study is necessary to review the 510(k) application for CarpX.
CarpX is a minimally invasive device designed to treat carpal tunnel syndrome. PAVmed has been working closely with the FDA over the past year to secure U.S. regulatory clearance of CarpX through the FDA’s 510(k) pathway, which is based on demonstrating substantial equivalence (SE) to a previously cleared predicate device.
The 510(k) for CarpX carpal tunnel device was submitted to the FDA by the Company in November 2017.
3. Regulus Therapeutics Inc. (RGLS)
Lost 11.29% to close Thursday’s trading at $1.11.
News: No news
The Company’s lead investigational microRNA therapeutic is RG-012 for the treatment of Alport syndrome, currently in phase II study, dubbed HERA.
Under an amended agreement, signed in November of 2018, Regulus granted Sanofi a worldwide exclusive license to develop and commercialize RG-012 for all indications, including Alport syndrome.
The other microRNA therapeutic in clinical testing is RGLS4326, being developed for the treatment of autosomal dominant polycystic kidney disease.
The Company voluntarily paused the phase I study for RGLS4326 last July due to unexpected observations in its 27-week mouse chronic toxicity study. That toxicity study was terminated, and a new 27-week chronic mouse toxicity study for RGLS4326 was initiated in September.
The preliminary results of a planned interim data analysis from the new mouse chronic toxicity study of RGLS4326 after 13 weeks of dosing was announced on January 4, 2019. The interim data analysis has shown no adverse or other significant findings across the range of doses tested and is intended to support re-initiation of Phase I RGLS4326 study after consultation with FDA, according to the Company.
4. Atossa Genetics Inc. (ATOS)
Lost 10.63% to close Thursday’s trading at $1.43.
News: No news
On January 9, the Company announced successful completion and final results from its phase I dose-escalation study of topical Endoxifen in healthy male subjects, which sent the stock up over 30% to $1.60.
The topical Endoxifen is being developed to treat or prevent several health conditions in both men and women. For men, topical Endoxifen is being developed to prevent and treat gynecomastia, a condition which refers to male breast enlargement and accompanying pain. For women, topical Endoxifen is being developed to treat mammographic breast density or MBD.
— A phase II study of topical Endoxifen in women with mammographic breast density (MBD) is underway, with study completion expected in the second quarter 2019.
5. Translate Bio Inc. (TBIO)
Lost 9.43% to close Thursday’s trading at $6.15.
News: No news
Clinical Trials & Near-term Catalysts:
–A phase I/II clinical trial of MRT5005, consisting of both a single-ascending-dose (SAD) part and multiple-ascending-dose (MAD) part, in patients with cystic fibrosis is underway. The first patient dosing in the MAD part is expected to begin in early 2019. Interim data from this trial is expected in the second half of 2019. — Screening of patients with OTC deficiency for phase I/II clinical trial of MRT5201 is expected to begin in the first half of 2019.