Gainers & Losers Of July 6: VSTM, BGNE, ALRN, TXMD, OCUL...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 6, 2017.

GAINERS

1. Verastem Inc. (VSTM)

Extending rally to a second day, the stock gained 41.98% to close Thursday's (July 6) trading at $3.45.

News: No news

Pipeline:

The Company's lead drug candidate is Duvelisib, under phase III development for certain types of hematologic malignancies.

Pending Catalyst:

- Top-line data from its phase III study of Duvelisib in patients with relapsed or refractory Chronic Lymphocytic Leukemia, dubbed DUO, slated to be reported in mid-year 2017, are pending.

2. BeiGene Ltd. (BGNE)

Gained 26.80% to close Thursday's trading at $66.28.

News: Celgene Corp. (CELG) and BeiGene have entered into a strategic collaboration to develop and commercialize BeiGene's investigational BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia.

BGB-A317 is currently in two pivotal trials in China - one in patients with bladder cancer and another in patients with relapsed or refractory classical Hodgkin lymphoma. Global pivotal studies of BGB-A317 are planned for initiation in 2018.

BeiGene is set to receive $263 million in upfront license fees and Celgene will acquire an equity stake of 5.9% in BeiGene, which equals to a $150 million equity investment. BeiGene is eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.

As part of the agreement, BeiGene will acquire Celgene's commercial operations in China and gain an exclusive license to commercialize Celgene's approved therapies in China namely, ABRAXANE, REVLIMID and VIDAZA.

3. ObsEva SA (OBSV)

Gained 13.14% to close Thursday's trading at $8.09.

News: No news

Pipeline:

The Company's most advanced investigational drug is OBE2109, under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM) is also underway.

Also in the pipeline are Nolasiban to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) for low fertility, and OBE022 for the treatment of preterm labor.

Nolasiban advanced to phase III testing as recently as March of this year. The phase III trial, known as IMPLANT2, is being conducted at approximately 50 fertility clinics across Europe, and is expected to enroll about 760 women who have undergone assisted reproduction technology. OBE022 is expected to move into phase II trial later this year.

4. Corium International Inc. (CORI)

Gained 11.95% to close Thursday's trading at $8.90.

News: The Company is slated to present preliminary positive results from its recently completed pilot bioequivalence study of Corplex Donepezil at the Alzheimer's Association International Conference 2017 (AAIC) in London, UK, on July 18, 2017.

Preliminary results from this study were reported on May 11, 2017.

Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer's disease.

In the study, Corplex Donepezil successfully met the criteria for bioequivalence to oral Aricept. Aricept is an approved drug to treat mild to moderate dementia caused by Alzheimer's disease.

Corium is planning to start its pivotal BE study later this year and remains on track to file a Section 505(b)(2) New Drug Application (NDA) for the product candidate in 2018.

5. Aduro Biotech Inc. (ADRO)

Gained 9.17% to close Thursday's trading at $12.50.

News: No news

Pipeline:

The most advanced product in the pipeline is CRS-207, which is under phase II trials in the indications of malignant pleural mesothelioma and gastroesophageal adenocarcinoma.

Another investigational drug is ADU-S100 for the treatment of advanced/metastatic solid tumors or lymphomas. A Phase 1b study of ADU-S100 in combination with Novartis' investigational PDR001 is expected to be initiated in the second half of 2017. A phase 1 monotherapy trial of ADU-S100 in patients with cutaneously accessible metastatic solid tumors or lymphomas is already underway.

Near-term catalysts:

-- Janssen is expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer and determine next steps for ADU-741 in prostate cancer in the second half of 2017. -- Report top-line findings from Phase 1 monotherapy trial of ADU-S100 in the second half of 2017 -- File Investigational New Drug Application for BION-1301, anti-APRIL antibody, in the second half of 2017 -- Initiate Phase 1 multiple myeloma trial with anti-APRIL antibody in the second half of 2017.

6. Aileron Therapeutics Inc. (ALRN)

Gained 8.04% to close Thursday's trading at $13.30.

News: No news

Recent event:

Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 $15.00 per share.

Pipeline:

The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

LOSERS

1. TherapeuticsMD Inc. (TXMD)

Lost 14.34% to close Thursday's trading at $4.60.

News: No news

Recent event:

The Company was issued a Complete Response Letter for its New Drug Application for TX-004HR on May 8, 2017.

TX-004HR, also known as Yuvvexy, is an applicator-free vaginal estradiol softgel for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women. The lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial was the reason for the FDA giving thumbs down to TX-004HR.

Near-term catalyst:

-- The NDA for TX-001HR, its investigational oral bio-identical combination of estradiol and progesterone for vasomotor symptoms in menopausal women is expected to be submitted to the FDA as early as the third quarter of 2017.

2. NantKwest Inc. (NK)

Lost 11.87% to close Thursday's trading at $6.98.

News: No news

Pipeline:

The Company is a pioneer in NANT cancer vaccine, the first combination immunotherapy protocol designed to deliver metronomic low dose radiation and chemotherapy with molecularly informed tumor associated antigen vaccines and natural killer cells.

The vaccine is intended to induce cancer cell death and at the same time protect and enhance a patient's immune response against cancer cells with lower toxicity and higher efficacy in comparison with current standards of care.

Recent events:

-- On June 6, 2017, the Company announced that in addition to the previously announced Pancreatic Cancer Vaccine, it is working to initiate multiple clinical trials across a wide range of cancer types which include: Lung, breast, head and neck cancer, colon, melanoma, ovarian, urothelial, Hodgkins and non-Hodgkins lymphoma, sarcoma, and Merkel cell carcinoma. -- The FDA authorized the Investigational New Drug (IND) Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients on May 9, 2017.

3. Immunomedics Inc. (IMMU)

Lost 9.33% to close Thursday's trading at $8.31.

News: No news

Recent event:

On June 29, 2017, the Company announced that its stockholders approved an amendment and restatement of its Company's certificate of incorporation to increase the number of authorized shares of capital stock from 165,000,000 shares to 260,000,000 shares.

To know more about IMMU, read our Company Spotlight column.

4. Cidara Therapeutics Inc. (CDTX)

Lost 8.11% to close Tuesday's trading at $6.80.

News: No news

Near-term catalyst:

A phase II trial of CD101 IV in candidemia, dubbed STRIVE, is ongoing. This study is comparing the safety and efficacy of CD101 IV to standard-of-care therapy, Caspofungin with an optional step-down to oral fluconazole. The top line data from the STRIVE study are anticipated in the fourth quarter (Q4, 2017).

Upcoming event:

Jeffrey Stein, the Company's president and chief executive officer, will be participating in a panel discussion at the 2017 Infectious Diseases Summit being held July 13-14 in Baltimore, Maryland.

5. InVivo Therapeutics Holdings Corp. (NVIV)

Lost 7.84% to close Thursday's trading at $2.35.

News: No news

The Company's lead product candidate is Neuro-Spinal Scaffold, an investigational device, currently being evaluated in a pivotal study for the treatment of patients with spinal cord injury, dubbed INSPIRE.

The Company expects to complete enrollment in the INSPIRE study during the third quarter of this year.

6. Presbia PLC (LENS)

Lost 7.62% to close Thursday's trading at $2.06.

News: No news

Pipeline:

The Company's lead product candidate is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision.

Near-term catalyst:

The Company expects to seek approval of Presbia Flexivue Microlens in the fourth quarter of this year.

7. Ocular Therapeutix Inc. (OCUL)

Lost 6.68% to close Thursday's trading at $9.50.

News: No news

Near-term catalyst:

The FDA decision on Ocular's Dextenza, proposed for treatment of ocular inflammation and pain following cataract surgery, is slated for July 19, 2017.

The FDA had refused to approve Dextenza last July, raising concerns pertaining to manufacturing process and controls.