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BGNE Hits Record High, SYRS Awaits Catalysts, ALT To Report Data In Q4

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 9, 2017.

GAINERS

1. Altimmune Inc. (ALT)

Gained 14.10% to close Monday's (Oct.9) trading at $2.59.

News: No news

Recent event:

-- On September 20, 2017, the Company announced that its phase II clinical study of NasoVAX, its intranasally administered recombinant flu vaccine, is open for enrolment. The study is expected enrol 60 healthy adults, between the ages of 18 and 49, who will receive a single intranasal dose of vaccine or placebo.

Near-term catalysts:

-- Data from the phase II clinical study of NasoVAX is expected in the first quarter of 2018.
-- Initial clinical data from a Phase 1 study of HepTcell, ongoing in the UK and South Korea, are expected this quarter (Q4, 2017). HepTcell is an immunotherapeutic with a potential cure for chronic hepatitis B.
-- A bridging study of SparVax-L, a lyophilized anthrax vaccine, is expected to begin this quarter, with topline data anticipated in the first quarter of 2018.
-- A Phase 1 trial of NasoShield, a next-generation intranasal, single-dose, first-in-class anthrax vaccine, is expected to begin during the 1Q-2018, with topline data anticipated in the 2Q-2018.

2. Prima BioMed Ltd (PBMD)

Gained 12.02% to close Monday's trading at $2.22.

News: No news

Pipeline:

The Company's lead product candidate is IMP321, which is under Phase IIb study in metastatic breast cancer, dubbed AIPAC, and phase I study in metastatic melanoma, known as TACTI-mel.

Near-term catalysts:

-- The final immune monitoring and activity data (safety run-in phase) from the AIPAC study expected by the end of 2017.
-- Further dose escalation, safety and activity data from the TACTI-mel trial are anticipated to be presented at the World Immunotherapy Congress on October 31, 2017.
-- Preclinical data of IMP761, which is being developed for autoimmune diseases, are expected to be presented this year.

3. BeiGene Ltd. (BGNE)

Gained 9.10% to close Monday's trading at $113.29.

News: No news

Pipeline:

The Company's most advanced drug candidate is BGB-3111. A head-to-head phase III trial designed to determine whether the quality of response with BGB-3111 in patients with Waldenström's macroglobulinemia is superior to that of AbbVie's Imbruvica is underway. The other oncology clinical drug candidates are BGB-A317, BGB-283 and BGB-290.

4. Loxo Oncology Inc. (LOXO)

Gained 7.24% to close Monday's trading at $94.01.

News: No news

Pipeline:

The Company's lead product candidate is Larotrectinib. It is currently being evaluated in a phase I study in adult subjects with advanced solid tumors, phase II 'basket' trial in adult/adolescent patients with solid tumors harboring TRK fusions, and phase I/II trial in pediatric patients with advanced solid or primary CNS tumors.

The other clinical programs in the pipeline are LOXO-292, which is under a phase I trial in patients with advanced solid tumors, and LOXO-195, which is under a phase 1/2 trial in patients with TRK fusion cancers who have progressed while receiving another TRK inhibitor or are intolerant to another TRK inhibitor.

Near-term Catalysts:

--Initial clinical data of two patients enrolled in phase I clinical trial of LOXO-292 as a single agent in patients with advanced solid tumors are expected to be presented on October 18, 2017.
-- Data, including additional patient follow-up from the Larotrectinib trials are expected to be announced before the end of 2017.
-- Submit NDA for Larotrectinib for the treatment of solid tumors with NTRK-fusion proteins in late 2017 or early 2018.

5. Syros Pharmaceuticals Inc. (SYRS)

Gained 7.18% to close Monday's trading at $17.16.

News: No news

Pipeline:

The Company's drug candidates are SY-1425, in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, in a Phase 1 clinical trial for patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

Near-term catalysts:

-- Initial clinical data from phase II clinical trial of SY-1425 are expected to be reported in the fourth quarter of 2017.
-- Preliminary clinical data from phase I clinical trial of SY-1365 is expected in 2018.

6. Compugen Ltd. (CGEN)

Gained 7.04% to close Monday's trading at $3.80.

News: The Company has discovered CGEN-15032, a novel myeloid and epithelial immunooncology target, which may serve as an immuno-suppressive target within the tumor microenvironment. The Company also announced the extension of its multi-year immuno-oncology research collaboration with Johns Hopkins University.

The research collaboration, originally announced in December 2014, is now expanded to include new additional targets discovered by Compugen which have the potential to serve as a basis for the development of cancer immunotherapy treatments.

7. Aeglea Biotherapeutics Inc. (AGLE)

Gained 7.03% to close Monday's trading at $5.71.

News: No news

Pipeline:

A phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency, and two phase I trials of AEB1102 in cancer patients with advanced solid tumors and with hematological malignancies are underway.

Near-term catalysts:

-- Top-line results from phase I study of AEB1102 in cancer patients with advanced solid tumors are expected in 4Q2017/1Q2018.
-- Top-line results from phase I study of AEB1102 in patients with hematological malignancies are expected in 4Q2017/1Q2018.
-- Top-line results from phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency are anticipated in the second half of 2018.

LOSERS

1. Marinus Pharmaceuticals, Inc. (MRNS)

Lost 18.93% to close Monday's trading at $5.63.

News: No news

Near-term catalysts:

-- Initiate a phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis, later this year.
-- Initiate a phase II study of Ganaxolone IV in patients with status epilepticus later this year.

2. Surgery Partners Inc. (SGRY)

Lost 12.83% to close Monday's trading at $9.85.

Recent event:

On August 8, 2017, the Company reported disappointing Q2, 2017 financial results and trimmed its revenue outlook for the year.

In the second quarter of 2017, the Company's net loss attributable to Surgery Partners was $4.5 million or $0.09 per share compared to net income of $2.1 million or $0.04 per share for the same period last year. Total revenues for the recent second quarter decreased 0.5% to $288.4 million from $289.7 million for the second quarter of 2016.

Looking ahead to full year 2017, the Company expects revenue in the range of $1.18 billion to $1.20 billion, which reflects 7% to 9% growth over 2016. Previously, the Company was expecting 2017 revenue growth of 9% to 11%. The revised outlook of this year reflects the recent softness in healthcare utilization and payor mix shift experienced during the second quarter.

3. Proteon Therapeutics Inc. (PRTO)

Lost 11.32% to close Monday's trading at $2.35.

News: No news

Near-term catalysts:

-- Enrol 24 patients in phase I trial of Vonapanitase in patients with peripheral artery disease before the end of 2017.
-- Complete enrolment of 600 patients in PATENCY-2 in the first quarter of 2018.
PATENCY-2 is Proteon's ongoing pivotal Phase 3 clinical trial of Vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis.

4. Endocyte Inc. (ECYT)

Lost 9.74% to close Monday's trading at $5.19.

News: No news

Recent event:

-- On October 2, 2017, the Company announced a deal with ABX GmbH, in-licensing its proprietary ligand PSMA-617. The transaction provides Endocyte with 177Lu-PSMA-617, a phase III-ready prostate cancer drug. The news sent the stock soaring over 157% that day to $3.63, and it gained another 80% to touch a high of $6.55 the following day.

Endocyte plans to seek regulatory approval to initiate a phase III registration trial of 177Lu-PSMA-617 in early 2018. If all goes well as planned, the Company expects to complete the trial as early as 2020.

5. Synlogic Inc. (SYBX)

Lost 9.16% to close Monday's trading at $16.27.

Synlogic completed its merger with Mirna Therapeutics to become Nasdaq-listed Company on August 28, 2017.

News: No news

Pipeline:

The Company's lead product candidate is SYNB1020 for Hyperammonemia including Urea Cycle Disorder and Hepatic Encephalopathy. A healthy volunteer study with SYNB1020 was initiated in June 2017.

Another investigational product in the pipeline is SYNB1618 for Phenylketonuria, and is under preclinical testing. SYNB1618 is expected to enter into clinical testing in the first half of 2018.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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