NKTR's Pivot Data Pleases Investors, OPHT Catches Eyes, CALA Craters, Wave Rises

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 13, 2017.

Gainers

1. Nektar Therapeutics (NKTR)

Gained 14.15% to close Monday's (Nov.13) trading at $37.10.

News: Initial results from dose-escalation stage of a phase 1/2 study evaluating Nektar Therapeutics' investigational medicine NKTR-214 plus Bristol-Myers Squibb's (BMY) blockbuster immunotherapy drug Opdivo prove encouraging.

In PIVOT-02, the dose-escalation stage of the study, important response rates across all three tumor types - melanoma, renal cell carcinoma and non-small lung cancer - in both PD-L1 positive and PD-L1 negative patients, were observed. There were no treatment discontinuations due to adverse events or study deaths, noted the companies.

-- Response rate was 63% in advanced treatment-naïve stage IV melanoma patients and disease control rate was 91%. -- Response rate was 14% in stage IV, I-O naïve renal cell carcinoma patients, with disease control rate of 100%.

2. Ophthotech Corp. (OPHT)

Gained 11.89% to close Monday's trading at $3.20.

News: No news

Recent event:

-- On November 8, 2017, the Company reported better-than-expected Q3, 2017 financial results.

The net income for the quarter ended September 30, 2017 was $189.1 million or $5.25 per share compared to a net loss of $60.9 million or $1.71 per share for the same period in 2016. Collaboration revenue was $206.7 million for the recent third quarter compared to $1.7 million for the same period in 2016.

Analysts polled by Thomson Reuters were expecting an EPS of $3.06 and revenue of $121 million for Q3, 2017.

3. Wave Life Sciences Ltd. (WVE)

Gained 8.99% to close Monday's trading at $24.85.

News: No news

Near-term catalysts:

-- Data from a global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping are expected in Q3, 2018. -- Topline data from PRECISION-HD program, which includes two phase 1b/2a global clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington's disease, are anticipated in 1H 2019.

4. Tandem Diabetes Care Inc. (TNDM)

Gained 8.39% to close Monday's trading at $2.97.

News: No news

Recent event:

On October 26, 2017, the Company reported strong third quarter financial results.

On a non-GAAP basis, sales for Q3, 2017 were $23.7 million compared to $20.7 million for the same period of 2016. Non-GAAP gross margin for the recent third quarter was 39% compared to 26% for the comparable year-ago period.

For full year 2017, non-GAAP sales are estimated to be in the range of $95 million to $100 million. Non-GAAP sales were $88.5 million in 2016.

5. Dova Pharmaceuticals Inc. (DOVA)

Gained 7.74% to close Monday's trading at $24.92.

News: No news

Pipeline:

-- The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

Recent event:

-- On September 22, 2017, the Company announced the submission of NDA for Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

LOSERS

1. Calithera Biosciences Inc. (CALA)

Lost 28.72% to close Monday's trading at $11.72.

News: The Company reported data from its phase 1/2 study of CB-839, combined with Opdivo in patients with advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer.

The overall response rate was 19% and overall disease control rate was 44% in melanoma patients. The melanoma patients were progressing on a checkpoint inhibitor at study entry.

The overall response rate was 21% in renal cell carcinoma IO naïve cohort with disease control rate of 74%.

2. Immunomedics Inc. (IMMU)

Lost 19.35% to close Monday's trading at $10.00.

News: The Company presented an update on its single-arm Phase 2 study of IMMU-132 in patients with metastatic triple-negative breast cancer.

By local radiologist assessment, the objective response rate was 34%, including three complete responses and 34 partial responses.

Near-term catalyst:

-- Results of the independent central blinded review along with sensitivity analyses of prior treatment regimens of the phase II study of IMMU-132 in patients with metastatic triple-negative breast cancer are scheduled for presentation on December 7, 2017. -- Submit BLA for IMMU-132 for metastatic triple-negative breast cancer in the first quarter of 2018.

3. Syndax Pharmaceuticals Inc. (SNDX)

Lost 15.92% to close Monday's trading at $8.50.

News: The Company announced results from its phase 1b/2 study of Entinostat in combination with Merck's Keytruda in patients with non-small cell lung cancer, dubbed ENCORE 601. The data included that of patients with PD-(L)1 refractory disease, as well as PD-(L)1 naïve patients.

The observed overall response rate was 10% in patients who had progressed on prior anti-PD-1 or PD-(L)1 therapy and 24% in patients naïve to PD-1 or PD-(L)1 therapy. The ENCORE 601 is an open-label, Phase 1b/2 clinical trial consisting of 4 cohorts - patients with non-small cell lung cancer (NSCLC) who have not previously received a PD-1 antagonist (cohort 1); patients with NSCLC who have progressed on a PD-1 antagonist (cohort 2); patients with advanced melanoma who have progressed on a PD-1 antagonist (cohort 3); and microsatellite stable colorectal cancer who have not previously been treated with a PD-1 antagonist (cohort 4).

Near-term catalyst:

-- Report full phase II data from the NSCLC and melanoma cohorts of the ENCORE 601 trial in the first half of 2018.

4. Fluidigm Corp. (FLDM)

Lost 14.89% to close Monday's trading at $4.46.

News: No news

Recent event:

-- On November 2, 2017, the Company reported third quarter 2017 financial results. Non-GAAP net loss for the third quarter of 2017 narrowed to $8.6 million or $0.25 per share from $10.9 million or $0.38 per share in the third quarter of 2016. Total revenue for the third quarter was $24.7 million, an increase of 12% from $22.2 million in the third quarter of 2016.

For the fourth quarter, the Company expects total revenue in the range of $25.5 million to $28.5 million. Total revenue for the fourth quarter of 2016 was $25.1 million.

5. Celyad SA (CYAD)

Lost 14.05% to close Monday's trading at $45.97.

News: No news

Recent event:

-- On October 3, 2017, the Company announced exciting early clinical results of the first dose-level in the hematological arm of its THINK trial.

THINK is a multinational open-label phase I study of CYAD-01 in seven refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).

According to the results reported on October 3, 2017, complete response was observed in the patient with relapsed refractory acute myeloid leukemia. This is the very first time a relapsed, refractory AML patient has reached a MLFS (Morphological Leukemia-Free Status) with gene-engineered T cells without pre-conditioning lymphodepletion nor additional other concurrent treatment to CYAD-01 administration.