(RTTNews) – The following are some of the biotech stocks that made their way onto the Day’s Gainers & Losers’ list of September 6, 2017.
1. Verastem Inc. (VSTM)
Gained 28.13% to close Wednesday’s (Sep.6) trading at $4.92.
News: The Company has expanded its Duvelisib development program to include targeting the treatment of patients with Peripheral T-Cell Lymphoma. Duvelisib has also been granted Fast Track designation by the FDA for the treatment of patients with Peripheral T-Cell Lymphoma who have received at least one prior therapy.
Duvelisib is the Company’s lead drug candidate.
A phase III study of Duvelisib in relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, dubbed DUO, is underway. Duvelisib’s potential is also being explored in patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The Company reported positive results from a phase II study of Duvelisib in patients with indolent non-Hodgkin lymphoma, dubbed DYNAMO, last June.
— Data from the DUO study are expected in the latter part of summer 2017. — Initiation of a phase II study of Duvelisib in patients with relapsed or refractory PTCL is expected by year end.
2. Voyager Therapeutics Inc. (VYGR)
Gained 24.70% to close Wednesday’s trading at $13.63.
News: The Company announced positive results from its ongoing Phase 1b trial of VY-AADC01 in advanced Parkinson’s disease.
The study demonstrated durable, dose-dependent and time-dependent improvements across multiple measures of patients’ motor function after a one-time administration of VY-AADC01. These measures include patient-reported diaries, Parkinson’s disease rating scales, and activities of daily living.
— Initiation of pivotal phase 2-3 program of VY-AADC for advanced Parkinson’s disease expected during late 2017. — Filing of an investigational new drug application for VY-SOD101 for the treatment of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 gene during late 2017 or early 2018.
3. G1 Therapeutics Inc. (GTHX)
Gained 19.74% to close Wednesday’s trading at $25.72.
News: No news
The Company made its debut on the NASDAQ on May 17, 2017, offering its shares at a price of $15.00 each.
Pipeline: The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.
Trilaciclib is under four Phase 2 clinical trials – three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer. G1T38 is under a phase 1b/2a study for the treatment of ER+, HER2- breast cancer. G1T48 is currently in IND-enabling studies, and is on track for Phase 1 clinical development in the fourth quarter of 2017.
— Investigational New Drug application filing for G1T38 in non-small cell lung cancer is expected in the fourth quarter of 2017. — IND filing for G1T48 in ER+, HER2- breast cancer is expected in the fourth quarter of 2017. — Top-line data from a phase 2a study of Trilaciclib in first-line small-cell lung cancer are expected in the first quarter of 2018. — Enrollment for the phase 2a trial of Trilaciclib in second/third-line small-cell lung cancer is expected in the second quarter of 2018. — Preliminary Phase 1b data for G1T38 plus Faslodex in ER+ breast cancer are anticipated in the second quarter of 2018.
4.Sarepta Therapeutics Inc. (SRPT)
Gained 13.75% to close Wednesday’s trading at $46.73.
News: The Company announced positive results from its phase 1/2 first-in-human study of Golodirsen (SRP-4053), conducted in Europe, in 25 boys with confirmed deletions of the Duchenne muscular dystrophy gene amenable to skipping exon 53.
The results demonstrated statistically significant exon skipping, dystrophin production and localization.
5. Zogenix Inc. (ZGNX)
Gained 12.69% to close Wednesday’s trading at $14.65.
News: No news
— The top-line data from Study 1 of phase III program of ZX008 in Dravet Syndrome are expected in the third quarter of 2017. The phase III program consists of two studies 1501 and 1502. The results from the combined patient population of studies 1501 and 1502 would be reported as “Study 1”. — Enrollment of second pivotal phase III of ZX008 in Dravet Syndrome, dubbed Study 1504, is now approximately two-thirds complete. Enrollment in this study is expected to be completed in the third quarter of 2017.
6. Insmed Inc. (INSM)
Gained 8.78% to close Wednesday’s trading at $29.36. This is the second straight day of gain for the stock.
— On September 5, 2017, the Company reported positive top-line results from a phase III study of Amikacin Liposome Inhalation Suspension in adult patients with treatment-refractory nontuberculous mycobacterial, a rare, progressive, destructive lung infection.
— The Company also announced that it has commenced an underwritten public offering of $250 million of shares of its common stock.
1. Pulmatrix Inc. (PULM)
Lost 14.98% to close Wednesday’s trading at $2.10. After rallying over 30% on Tuesday, the stock has given back half the gain.
News: The Company announced that it has partnered with Vectura Group plc to develop PUR0200 for chronic obstructive pulmonary disease (COPD) for the U.S. market.
Pulmatrix’s PUR0200 is a novel dry powder formulation of a currently marketed once daily LAMA bronchodilator Spiriva HandiHaler, for the treatment of chronic obstructive pulmonary disease. PUR0200 is currently being developed in Europe based on PK bioequivalence, and the US development program is being planned.
Pulmatrix intends to seek a pre-IND meeting with the FDA to inform the US clinical development path for PUR0200 in the second half of 2017.
2. Flex Pharma Inc. (FLKS)
Lost 13.81% to close Wednesday’s trading at $3.37.
News: No news
The Company will be making a presentation at
— The Rodman & Renshaw 19th Annual Global Investment Conference on September 11, 2017 at 10:00am ET in New York, NY and — The Cantor Fitzgerald 2017 Global Healthcare Conference on September 25, 2017 at 3:35pm ET in New York, NY.
3. Aptevo Therapeutics Inc. (APVO)
Lost 10.60% to close Wednesday’s trading at $1.94.
News: No news
The Company has two clinical drug candidates – MOR209/ES414 monotherapy in patients with metastatic castration-resistant prostate cancer, under phase I trial, and Otlertuzumab for chronic lymphocytic leukemia, under phase II study.
4. Xenon Pharmaceuticals Inc. (XENE)
Lost 9.37% to close Wednesday’s trading at $2.90.
News: No news
— Filing of an investigational new drug application to initiate a phase 1 first-in-man clinical trial of XEN1101 for the treatment of epilepsy is expected in the fourth quarter of 2017. — Filing of an investigational new drug application for XEN901 for the treatment of rare infantile epileptic encephalopathies and other forms of epilepsy is also slated for the fourth quarter of 2017.
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