CDNA Soars On Medicare Decision, BOLD Data In Sep., NBRV Slumps Before LEAP

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 24, 2017.

GAINERS

1. CareDx Inc (CDNA)

Gained 33.02% to close Thursday's (Aug.24) trading at $2.86.

News: AlloSure, the Company's noninvasive test that detects active rejection in kidney transplant patients has qualified for Medicare coverage effective October 9th, 2017.

Commenting on the development, Peter Maag, Chief Executive Officer, said, "We see the coverage decision by the MolDX team as a great signal for the support of kidney transplant patients and an acknowledgement of the unmet medical need. About 80% of kidney transplant patients are covered by Medicare, so many patients will have access to AlloSure, a new milestone in precision medicine in transplantation."

2. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 26.58% to close Thursday's trading at $2.81.

News: No news

Recent event:

On August 3, 2017, the Company reported fiscal 2017 third quarter results.

The net loss for the three months ended June 30, 2017 narrowed to $5.3 million or $0.07 per share from $19.4 million or $0.32 per share in the comparable year-ago period.

Revenue for the three months ended June 30, 2017 rose to $9.4 million from $40 thousand for the three months ended June 30, 2016. This increase is driven by the upfront payments received from collaboration agreements with Amgen, and these payments will be recognized as revenue over the next several quarters, the Company noted.

The Company had cash of $75.1 million at June 30, 2017.

3.Corvus Pharmaceuticals Inc. (CRVS)

Gained 12.85% to close Thursday's trading at $14.67.

News: No news

Pipeline:

The Company's lead drug candidate is CPI-444, which is under Phase 1/1b study, being evaluated both as a single agent and in combination with Roche's Tecentriq in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC). The Company presented positive results from the study on June 6, 2017.

Near-term catalyst:

-- Additional data from the Phase 1/1b study of CPI-444 are expected to be presented at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting in November 2017.

4. XOMA Corp. (XOMA)

Gained 12.47% to close Thursday's trading at $8.93.

News: No news

Recent event:

On August 8, 2017, the Company reported Q2, 2017 financial results.

Net income for the second quarter of 2017 was $0.3 million or $0.02 per share compared to a net loss of $15.2 million or $2.52 per share for the second quarter of 2016. Revenue for the recent second quarter rose to $10.9 million from $0.4 million in the comparable year-ago quarter. The increase was due primarily to a $10 million milestone payment earned under the Company's license agreement with one of its pharmaceutical partners.

On June 30, 2017, XOMA had cash and cash equivalents of $12.5 million and $10 million included in accounts receivable from a milestone earned in May 2017 from one of its licensees, which was received in July 2017.

5. Tonix Pharmaceuticals Holding Corp. (TNXP)

Gained 11.25% to close Thursday's trading at $3.66.

News: No news

Recent event:

On August 14, 2017, the Company reported Q2, 2017 financial results.

Net loss for the recent second quarter was $4.8 million or $0.65 per share compared to a net loss of $9.8 million or $4.97 per share for the second quarter of 2016.

Pipeline:

The Company's lead drug candidate is Tonmya, a sublingual formulation designed for bedtime administration in the treatment of post traumatic stress disorder, under phase III testing; TNX-601, an oral formulation for daytime dosing targeted as a 1st line monotherapy for PTSD, under preclinical testing, and TNX-801, a smallpox-preventing vaccine, also under pre-clinical testing.

Near-term catalysts:

--Outcome of interim analysis from the phase III trial of Tonmya in military-related PTSD (posttraumatic stress disorder) in the United States, dubbed HONOR, are due 1H18. -- Top-line results from the HONOR study are expected in the second half of 2018.

6. Audentes Therapeutics Inc. (BOLD)

Gained 11.16% to close Thursday's trading at $20.72.

News: No news

Near-term catalysts:

-- Commence enrollment in a phase I/II study of AT132 of X-Linked Myotubular Myopathy patients less than five years of age, dubbed ASPIRO, in the third quarter of 2017. -- Report preliminary data from a pre-phase 1 prospective, non interventional clinical assessment study to evaluate children living with X-Linked Myotubular Myopathy, known as INCEPTUS, in September 2017. -- Report preliminary clinical data from ASPIRO by the end of 2017. -- Commence enrollment in phase I/II study of AT342 for Crigler-Najjar Syndrome patients greater than one year of age, dubbed VALENS, in the third quarter of 2017. -- Report preliminary data from a phase I/II run-in study of AT342, dubbed LUSTRO, in October 2017. -- Report preliminary clinical data from VALENS by the end of 2017. -- File IND with the FDA for AT307 in CASQ2-CPVT, a rare monogenic disease that is characterized by life-threatening arrhythmias that may lead to sudden cardiac death. -- File IND with the FDA for AT982 in Pompe Disease in the first half of 2018.

7. Intra-Cellular Therapies Inc. (ITCI)

Gained 10.49% to close Thursday's trading at $15.90. This is the second straight day of gain for the stock.

News: On August 23, 2017, the Company announced a positive regulatory update related to its drug candidate Lumateperone in schizophrenia.

Lumateperone has been evaluated in 2 phase III studies in schizophrenia, and the results of both the studies were positive.

In May of this year, the Company met with the FDA and sought guidance on the acceptability of the two positive clinical trials as the basis for the submission of a new drug application for the treatment of schizophrenia. That time, the FDA requested additional information to confirm that the findings observed in nonclinical animal toxicology studies of Lumateperone are not indicative of a safety risk associated with long term exposure in humans. The news sent the stock down over 24% to $10.49 on May 1, 2017.

The Company prepared responses to the FDA's request for additional information and were submitted for review.

The FDA has completed the review and has deemed the responses regarding the nonclinical findings to be sufficient. So, the Company is moving forward with its long-term safety study of Lumateperone and intends to submit the NDA for the treatment of schizophrenia by mid-2018.

Lumateperone is also being studied in phase III trials in bipolar depression and in agitation associated with dementia, including Alzheimer's disease.

8. Immunomedics Inc. (IMMU)

Gained 9.88% to close Thursday's trading at $10.68.

News: No news

Pipeline:

The Company's pipeline include Sacituzumab govitecan, also known as IMMU-132, under phase II trials in select types of solid cancers including metastatic triple-negative breast cancer, small-cell lung cancer, non-small-cell lung cancer, urothelial cancer and certain other cancers and Labetuzumab govitecan, or "IMMU-130, which is also under phase II testing, for the treatment of metastatic colorectal cancer.

Key Upcoming Events:

-- Interim Phase 2 results with IMMU-132 in patients with metastatic urothelial cancer will be presented at the European Society for Medical Oncology 2017 Congress in September. -- Enrollment of metastatic triple-negative breast cancer patients in a phase III confirmatory trial of IMMU-132 is expected in early fourth quarter of calendar 2017. -- The final results of IMMU-132 in mTNBC that will form the basis of the BLA submission are anticipated later this year.

LOSERS

1. Nabriva Therapeutics AG (NBRV)

Lost 8.97% to close Thursday's trading at $8.02.

News: No news

Near-term catalysts:

-- Top-line data from 1st phase III trial of Lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia, dubbed LEAP 1, expected to be reported next month (September). -- Top-line data from 2nd phase III trial of Lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia, dubbed LEAP 2, expected to be reported in Q1, 2018.

2. Verastem Inc. (VSTM)

Lost 7.04% to close Thursday's trading at $3.30.

News: No news

Near-term catalysts:

-- Data from phase III study evaluating Duvelisib in relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, dubbed DUO, are expected in the latter part of summer 2017.

Duvelisib's potential is also being explored in patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The Company reported positive results from a phase II study of Duvelisib in patients with indolent non-Hodgkin lymphoma, dubbed DYNAMO, last June.

3. Mustang Bio Inc. (MBIO)

Lost 5.43% to close Thursday's trading at $10.98, retracing some of yesterday's gain.

News: Mustang Bio, a Fortress Biotech (FBIO) company commenced trading on the NASDAQ Global Market on August 22, 2017.

Near-term catalysts:

-- Initiate construction on a proprietary CAR T manufacturing facility later this year. -- Read out phase I data from its lead CAR T therapies MB-101 in glioblastoma and MB-102 in acute myeloid leukemia in early 2018.