Gainers & Losers Of June 5: LOXO, CLSN, RDUS, GLYC, JUNO...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 5, 2017.

GAINERS

1. Loxo Oncology Inc. (LOXO)

Gained 43.16% to close Monday's (June 5) trading at $70.12.

News: Encouraging interim clinical data from all three ongoing Larotrectinib (LOXO-101) clinical trials in patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday.

The three ongoing clinical trials with Larotrectinib are:

-- A phase 1/2 study in pediatric patients with advanced solid or primary Central Nervous System tumors, dubbed SCOUT. -- A phase II study in patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3, dubbed NAVIGATE -- A phase I study in adult subjects with advanced solid tumors that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.

According to the Company, Larotrectinib demonstrated 76 Percent Objective Response Rate in TRK Fusion adult and pediatric cancers. Loxo expects to submit a New Drug Application for Larotrectinib to the FDA in late 2017 or early 2018.

2. Celsion Corp. (CLSN)

Gained 24.06% to close Monday's trading at $3.30.

News: The Company reported encouraging clinical data from the first fourteen patients who have completed treatment in the OVATION Study.

The OVATION Study is a phase Ib dose escalating clinical trial combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.

Of the fourteen patients treated to date in the entire study, 2 patients demonstrated a complete response, 10 patients demonstrated a partial response and 2 patients demonstrated stable disease. This translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR").

3. Radius Health Inc. (RDUS)

Gained 10.46% to close Monday's trading at $38.75.

News: The Company announced positive data from a fully enrolled ongoing Phase 1 study of Elacestrant (RAD1901) in patients with estrogen receptor positive (ER+) breast cancer on Sunday.

The Company noted that Elacestrant single agent Objective Response Rate was 23% in heavily pre-treated patients with advanced ER+ breast cancer at the cutoff date of April 28, 2017. In the 400 mg patient group with mature data, median PFS was 4.5 months and Clinical Benefit Rate at 24 weeks was 42%.

4. bluebird bio Inc. (BLUE)

Gained 8.50% to close Monday's trading at $91.30.

News: The updated results from the ongoing Phase 1 clinical study of bb2121 in 18 patients with relapsed/refractory multiple myeloma are found to be promising. bb2121 is co-developed by bluebird and Celgene.

-- In the phase I study, dubbed CRB-401, 100% of the 15 evaluable patients in active dose cohorts achieved an objective response while the overall response rate across all cohorts is 89%.

-- 73% of evaluable patients in active dose cohorts achieved a very good partial response or better, with 27% complete response rate across active dose cohorts. There were no disease progression and dose-limiting toxicities in active dose cohorts.

5. Summit Therapeutics plc (SMMT)

Gained 6.74% to close Monday's trading at $11.40.

News: The Company presented new preclinical data on Ridinilazole for the treatment of Clostridium difficile infection at ASM Microbe 2017.

"The positive preclinical data presented at ASM Microbe highlight the potency of Ridinilazole against a wide range of C. difficile clinical isolates from patients with CDI," commented Dr David Roblin, President of Research and Development of Summit.

Ridinilazole is all set to enter phase III clinical trials during the first half of 2018. The drug candidate has successfully completed a Phase 2 proof of concept clinical trial where it demonstrated statistical superiority against Vancomycin, an FDA approved treatment for CDI.

6. TiGenix NV (TIG)

Gained 6.23% to close Monday's trading at $18.75.

News: No news

The Company's lead product candidate is Cx601 for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn's disease. Cx601 has been filed for regulatory approval in Europe. Cx601 has been licensed to Takeda Pharmaceuticals International AG for the exclusive development and commercialization outside of the US.

Near-term catalysts:

-- The Company will submit responses to the Cx601 Marketing Authorization Application Day 180 List of Outstanding Issues during the month of August. -- A global pivotal Phase III trial for the U.S. registration of Cx601 is expected to begin this year.

LOSERS

1. Merus N.V. (MRUS)

Lost 14.49% to close Monday's trading at $18.18.

News: No news

Recent event:

On May 17, 2017, the Company reported promising results from phase 1/2 study of MCLA-128 in patients with HER2-positive metastatic breast cancer.

Near-term catalysts:

-- An Investigational New Drug application of MCLA-117 for a Phase 1 trial is planned for submission to the FDA during the second half of 2017. -- During the second half of 2017, Merus expects to report topline data from its Part 2 of Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications. -- During the second half of 2017, Merus expects to report interim results from its Phase 1 clinical trial evaluating MCLA-117 in patients with AML. -- By the end of 2017, Merus expects to file a CTA (Clinical Trial Assessment) for a planned Phase 1/2 clinical trial of MCLA-158 in patients with colorectal cancer.

2. GlycoMimetics Inc. (GLYC)

Lost 14.47% to close Monday's trading at $11.05.

News: The updated data from phase 2 portion of the Company's ongoing Phase 1/2 clinical trial of its drug candidate GMI-1271 for the treatment of patients with acute myeloid leukemia show high remission but low mortality rates than historical controls.

The Company said that among the 54 relapsed/refractory AML patients, the overall response rate (complete remission/complete remission with incomplete marrow recovery, or CR/CRi) was 41 percent, which is higher than historical controls. But the 60-day induction related mortality rate was 7 percent, which is lower than historical controls.

Among the 25 newly diagnosed elderly patients (age 60 and older) participating in the trial, the overall response (CR/CRi) rate was 68 percent and the 60-day mortality rate was 8 percent.

3. NewLink Genetics Corp. (NLNK)

Lost 12.39% to close Monday's trading at $11.03.

News: The Company's phase II trial of Indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer did not meet its pre-specified endpoints.

The trial failed to meet the pre-specified endpoints of progression-free survival, overall survival or objective response rate.

4. Juno Therapeutics Inc. (JUNO)

Lost 10.74% to close Monday's trading at $23.40.

News: The Company reported high durable response rates in patients with relapsed or refractory CD19+ aggressive non-Hodgkin lymphoma in the phase I trial of JCAR017, dubbed TRANSCEND. But investors are disappointed to learn that 18% (8/44) of patients experienced severe neurotoxicity and 2% (1/44) experienced severe cytokine release syndrome in core analysis group.

5. AnaptysBio Inc. (ANAB)

Lost 10.49% to close Monday's trading at $22.43.

News: No news

Near-term catalysts:

-- Top-line results from a phase 2a clinical trial for ANB020 in adult patients with severe peanut allergy are anticipated during the second half of 2017. -- Top-line results from a phase 2a clinical trial for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis are anticipated during the second half of 2017. -- Top-line results from a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 is being administered in single and multiple doses, through subcutaneous and intravenous routes of administration are expected during the second half of 2017. AnaptysBio plans to initiate Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, using ANB019 during 2018.