Gainers & Losers Of July 12: CALA, TRVN, GEMP, ALDR, INSY...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 12, 2017.

GAINERS

1. Calithera Biosciences Inc. (CALA)

Gained 11.11% to close Wednesday's (July, 12) trading at $20.00.

News: No news

Pipeline:

The Company's lead product candidate is CB-839, a selective inhibitor of glutaminase, an enzyme required by cancer cells for growth and survival. In preclinical studies, CB-839 has been shown to halt the growth of or kill cancer cells across a range of tumor types.

CB-839 has been evaluated as a monotherapy and in combination with Everolimus and cabozantinib in renal cell carcinoma patients in phase I trials. In the CB-839 phase I monotherapy trial, disease control was achieved in 52% of patients. In the phase I combination with everolimus, disease control was achieved in 93% of patients, and their median progression free survival was 8.5 months.

Near-term catalysts:

-- A phase II trial of CB-839 in combination with Everolimus is planned, and is expected to be initiated in the second half of 2017. -- Initial results from phase I/II trial of CB-839 dosed in combination with Bristol Myers Squibb's Opdivo in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer are expected in the second half of 2017.

2. Trevena Inc. (TRVN)

Gained 10.08% to close Wednesday's trading at $2.62.

News: The Company is slated to make a presentation on its clinical portfolio on Thursday, July 20, 2017.

Pipeline:

The lead product candidate is OLINVO for the management of moderate-to-severe acute pain, which has successfully completed phase III testing. Also in the pipeline are TRV250 for the acute treatment of migraine n Phase 1 development.

Near-term catalysts:

-- Submit NDA for OLINVO for the management of moderate-to-severe acute pain in Q4, 2017. -- Data from phase I trial of TRV250 are expected to be reported in the second half of 2017.

3. Gemphire Therapeutics Inc. (GEMP)

Gained 9.17% to close Wednesday's trading at $14.40.

News: No news

Recent event:

On June 28, 2017, the Company reported positive results from its phase 2b trial of Gemcabene in homozygous familial hypercholesterolemia (HoFH) patients, dubbed COBALT-1.

Near-term catalysts:

-- Top-line results from phase 2b trial of Gemcabene in hypercholesterolemia patients, dubbed ROYAL-1, are expected in the third quarter of 2017. -- Top-line results from phase 2b trial of Gemcabene in subjects with severe hypertriglyceridemia, dubbed INDIGO-1, are targeted for the first quarter of 2018 based on current pace of enrollment. -- Initiate phase 2 clinical development program of Gemcabene in nonalcoholic steatohepatitis, known as AZURE-1, in the second half of 2017 with top-line results targeted for second half of 2018.

4. Flexion Therapeutics Inc. (FLXN)

Gained 8.80% to close Wednesday's trading at $24.11.

News: No news

Pipeline:

The Company's lead product candidate is Zilretta for the treatment of osteoarthritis of the knee, which is under FDA review.

Near-term catalyst:

The FDA decision on Zilretta is slated for October 6, 2017.

5. Achaogen Inc. (AKAO)

Gained 8.59% to close Wednesday's trading at $24.90.

News: No news

Pipeline:

The Company's lead product candidate is Plazomicin, being developed to treat serious bacterial infections due to multidrug-resistant Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE), which has successfully completed phase III trials.

Near-term catalysts:

A New Drug Application for Plazomicin is expected to be submitted to the FDA in the second half of 2017 and a Marketing Authorization Application for the same is planned for submission to the European Medicines Agency in 2018.

6. XBiotech Inc. (XBIT)

Gained 8.30% to close Wednesday's trading at $5.22.

News: No news

Recent events:

-- On June 9, 2017, an Independent Data Monitoring Committee recommended termination of the Company's phase III study of Xilonix for the treatment of colorectal cancer, dubbed XCITE.

The Independent Data Monitoring Committee, which performed its second prospectively planned, unblinded analysis of the XCITE study, found that the findings were not sufficient to meet efficacy or the threshold for continuation of the study. The news had sent XBIT down 66.03% to $3.20 that day.

-- In May of this year, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Xilonix in Europe.

7. Adaptimmune Therapeutics plc (ADAP)

Gained 7.16% to close Wednesday's trading at $5.09.

News: No news

Pipeline:

The Company's lead product candidate is NY-ESO TCR, being developed in partnership with GlaxoSmithKline plc, in multiple Phase 1/2 clinical trials in patients with solid tumors and hematological malignancies including synovial sarcoma, multiple myeloma, melanoma, NSCLC and ovarian cancer.

Also in the pipeline are MAGE-A10 T-cell therapy, under phase I/II study in patients with locally advanced or metastatic non-small cell lung cancer and phase I trials in patients with inoperable or metastatic urothelial cancer, melanoma, or squamous cell carcinoma of the head and neck; AFP for hepatocellular carcinoma, under phase I testing and MAGE-A4, under phase I trials in solid tumors.

LOSERS

1. Alder Biopharmaceuticals Inc. (ALDR)

Lost 17% to close Wednesday's trading at $10.12.

News: The Company has offered to sell 15 million shares of its common stock to the public at a price of $10.00 each.

The underwriters have a 30-day option to purchase up to 2.25 million additional shares of common stock at the public offering price. The offering is expected to close on July 18, 2017.

2. Ocular Therapeutix Inc. (OCUL)

Lost 12.24% to close Wednesday's trading at $6.67.

News: The FDA rejected DEXTENZA, the Company's proposed treatment for ocular pain following ophthalmic surgery.

In its Complete Response Letter, issued on Tuesday, the FDA refers to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility that was completed in May 2017.

3. INSYS Therapeutics Inc. (INSY)

Lost 8.44% to close Wednesday's trading at $12.37.

News: Another former sales representative of the Company has admitted her role in kickback scheme related to Subsys, an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.

The Company is said to have paid medical practitioners thousands of dollars in illegal kickbacks in order to prescribe Subsys, and induce others to prescribe Subsys, over similar medications, defrauding federal healthcare programs.

A probe related to this kickback scheme is being conducted by the U.S. Department of Health and Human Services Office of the Inspector General and the Federal Bureau of Investigation.

Several other individuals connected to Insys, and medical practitioners involved in this painkiller kickback scheme are facing charges.