Gainers & Losers Of July 5: CALA, NVRO, BPMC, KMPH, FLDM...

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

GAINERS

1. Calithera Biosciences Inc. (CALA)

Gained 11.75% to close Wednesday's (July, 5) trading at $17.60.

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 catalyst:

-- 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.

2. Nevro Corp. (NVRO)

Gained 11.43% to close Wednesday's trading at $81.50.

News: The Company announced preliminary unaudited revenue for the second quarter ended June 30, 2017 and provided revenue guidance for full year 2017.

Preliminary unaudited second quarter worldwide revenue is expected to be in the range of $77.5 to $78.0 million compared to $55.4 million in the second quarter of 2016. The consensus revenue forecast amongst 9 polled investment analysts covering Thomson Reuters is $74.1 million.

The company expects worldwide revenue for the full year 2017 to be in the range of $310.0 to $320.0 million. Wall Street analysts have an average revenue estimate of $316.05 million for the year.

3. Verastem Inc. (VSTM)

Gained 10.96% to close Wednesday's trading at $2.43.

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.

4. Blueprint Medicines Corp. (BPMC)

Gained 9.65% to close Wednesday's trading at $55.98.

News: The Company announced new phase I data for BLU-285 in advanced gastrointestinal stromal tumors.

In patients with PDGFRa-driven advanced gastrointestinal stromal tumors harboring a D842 mutation, BLU-285 demonstrated an objective response rate (ORR) of 60 percent and an estimated 9-month progression free survival (PFS) of 87 percent.

Additional data from the expansion portion of the ongoing Phase 1 clinical trial of BLU-285 may be sufficient to support a New Drug Application for the treatment of patients with PDGFRa D842V-driven gastrointestinal stromal tumors, according to the Company.

The Company also plans to initiate a global, pivotal Phase 3 clinical trial of BLU-285 in the first half of 2018.

The Company is slated to report its Q2, 2017 results next month.

5. Spark Therapeutics (ONCE)

Gained 9.21% to close Wednesday's trading at $65.56.

News: No news

Pipeline:

The Company's most advanced investigational candidate is Voretigene neparvovec, a one-time gene therapy, for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal disease.

Spark completed the rolling submission of Voretigene neparvovec Biologics License Application with the FDA in May of this year.

Also in the pipeline are SPK-7001 in a Phase 1/2 trial for choroideremia, and two hemophilia development programs: SPK-9001 in a Phase 1/2 trial for hemophilia B being developed in collaboration with Pfizer, and SPK-8011, in a Phase 1/2 trial for hemophilia A to which Spark Therapeutics retains global commercialization rights.

Upcoming event:

The Company is scheduled to present updated interim data from its phase 1/2 clinical trial of SPK-9001 for hemophilia B on July 10, 2017.

6. Achillion Pharmaceuticals Inc. (ACHN)

Gained 9.11% to close Wednesday's trading at $5.15.

News: No news

Near-term catalyst:

-- Results from the Company's phase IIb study investigating the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection, with and without cirrhosis, dubbed OMEGA-1, are anticipated during the second half of 2017.

Achillion has an exclusive worldwide collaboration with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson (JNJ) that was signed in May 2015, for the treatment of chronic hepatitis C viral infection.

7. Roka Bioscience Inc. (ROKA)

Gained 8.98% to close Wednesday's trading at $2.79.

News: No news

Recent event:

The Company reported first quarter 2017 financial results in May.

Net loss for the first quarter of 2017 was $7.6 million or $1.53 per share compared with a net loss of $8.2 million, or $4.66 per share in the first quarter of 2016.

Revenue for the recent first quarter was $2.0 million compared with $1.6 million for the first quarter of 2016 and $1.9 million for the fourth quarter of 2016. As of March 31, 2017, the Company had cash and cash equivalents and marketable securities of $16.2 million.

LOSERS

1. KemPharm Inc. (KMPH)

Lost 12.20% to close Wednesday's trading at $3.60.

News: No news

Near-term catalysts:

-- Initiate development of KP484, a new super-extended release (SER) d-MPH being designed for the treatment of ADHD, and file an Investigational New Drug (IND) application for KP484 as early as the third quarter of 2017. -- Initiate pivotal efficacy trial of KP415 for the treatment of ADHD in the second half of this year. -- Human clinical trials of KP201/IR for the short-term treatment of acute pain are anticipated to commence in 1H 2017 - with final intranasal human abuse liability (HAL) study data expected in the second half of this year. -- NDA submission for KP415 for the treatment of ADHD is planned for 2018.

2. Fluidigm Corp. (FLDM)

Lost 8.50% to close Wednesday's trading at $3.77.

News: No news

Recent event: On May 4, the Company reported financial results for the first quarter ended March 31, 2017.

Total revenue for Q1, 2017 was $25.5 million, a decrease of 12% from $29.0 million in the first quarter of 2016 and an increase of 2% from $25.1 million in the fourth quarter of 2016.

Non-GAAP net loss for the first quarter of 2017 narrowed to $9.6 million or $0.33 per share from $11.5 million or $0.40 per share for the first quarter of 2016.

For the second quarter of 2017, the total revenue is projected to be in the range of $22 million to $24 million.

Near-term catalyst:

The Company is slated to report Q2, 2017 results in the first week of August.

3. Cerus Corp. (CERS)

Lost 7.94% to close Wednesday's trading at $2.32.

Cerus is a biomedical products company, and its flagship product is INTERCEPT Blood System, designed to reduce the risk of transfusion-transmitted infections. Cerus relies solely on Fresenius Kabi for the production of INTERCEPT Blood System kits.

News: No news

Recent event:

On June 7, 2017, Cerus announced that the expected Fresenius Kabi platelet additive solution (PAS) shortage, which was announced on May 23, 2017, could be less disruptive to blood center production of INTERCEPT platelets than initially anticipated.

On May 23, 2017, the Company received a notification of a pending U.S. supply shortage of a platelet additive solution (PAS) manufactured and sold by Fresenius Kabi, which could temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets.

Due to the platelet additive solution (PAS) shortage, the Company, in May, lowered its 2017 product revenue guidance to a range of $38 million to $46 million, down from its prior range of $43 million to $48 million.