NLNK Rallies On Indoximod Data, VRNA Breathes Easy, ALNY Jolted

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of September 7, 2017.

GAINERS

1. NewLink Genetics Corp. (NLNK)

Gained 74.58% to close Thursday's (Sep.7) trading at $13.60.

News: The Company reported encouraging updated data from its phase II trial of investigational drug Indoximod plus Merck & Co.'s Keytruda in advanced melanoma.

There was an improvement over previously reported results presented at the AACR Annual Meeting 2017 for both the Complete Response rate (CR) and the Overall Response Rate (ORR) for patients who received Indoximod plus Keytruda, noted the Company.

According to the updated data, Complete Response (CR) improved to 20% (10/51 patients) from the earlier reported CR of 12% (6/51 patients). The Progression-Free Survival by RECIST criteria was 56% at one year with median PFS (mPFS) of 12.9 months.

2. Verona Pharma plc (VRNA)

Gained 38.96% to close Thursday's trading at $16.80.

News: The Company announced positive top-line results from its Phase 2a clinical trial, in which RPL554 was dosed in addition to Spiriva, one of the most commonly used drugs to treat chronic obstructive pulmonary disease.

According to the trial results, RPL554 when added to Spiriva produced significant and clinically meaningful additional improvement in peak lung function and faster onset-of-action.

3. BioCryst Pharmaceuticals Inc. (BCRX)

Gained 20.36% to close Thursday's trading at $5.97.

News: No news

Recent event:

On September 5, 2017, the Company announced positive results from its phase II clinical trial of BCX7353 in hereditary angioedema, dubbed APeX-1.

APeX-1 was a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. This final analysis evaluated data from all patients in Parts 1, 2 and 3 of the trial.

According to the trial results, there was a 73% reduction in overall attack frequency at 125mg dose.

4. Intra-Cellular Therapies Inc. (ITCI)

Gained 16.50% to close Thursday's trading at $22.10.

News: The Company reported positive results from its open-label safety switching study in which stable patients with schizophrenia switched to Lumateperone from standard-of-care antipsychotic therapy.

According to the trial results, statistically significant improvements from standard-of-care baseline were observed in body weight, cardiometabolic and endocrine parameters in patients with stable symptoms of schizophrenia when switched to Intra-Cellular's Lumateperone and worsened again when switched back to standard-of-care medication.

5. Compugen Ltd. (CGEN)

Gained 15% to close Thursday's trading at $3.45.

News: No news

Upcoming events:

-- Paul Sekhri to take over as the new Chairman of the Board, effective October 2, 2017. -- File IND application for COM701 therapeutic antibody candidate for immuno-oncology towards the end of the first quarter of 2018.

6. XOMA Corp. (XOMA)

Gained 12.60% to close Thursday's trading at $18.05.

News: No news

Recent events:

-- On September 5, 2017, Wedbush analyst upgraded XOMA to Outperform from Neutral with a price target of $19, up from the previous price target of $9.00. -- On August 25, 2017, the Company announced that it licensed the global commercial rights to Gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis.

Gevokizumab is under phase II trials in acne vulgaris; acute coronary syndromes; diabetic nephropathies; giant cell arteritis; labyrinthitis; myositis; osteoarthritis; schnitzler syndrome and scleritis. A phase III study evaluating Canakinumab in combination with standard of care in people with a prior heart attack and inflammatory atherosclerosis is underway.

7. KalVista Pharmaceuticals Inc. (KALV)

Gained 12.33% to close Thursday's trading at $8.20.

News: No news

Near-term catalysts:

-- Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

Another clinical drug candidate is KVD818, a potential for hereditary angioedema therapy, under phase I testing. The phase I trial is nearing completion.

8. Adaptimmune Therapeutics plc (ADAP)

Gained 12.02% to close Thursday's trading at $7.55.

News: GlaxoSmithKline plc (GSK) has exercised its option under a collaboration and license agreement signed in 2014 to exclusively license the right to research, develop, and commercialize Adaptimmune's NY-ESO SPEAR T-cell therapy program.

Adaptimmune will receive up to £48 million (~$61 million) from GSK over the course of the transition period.

9. Aeglea Biotherapeutics Inc. (AGLE)

Gained 11.52% to close Thursday's trading at $4.84.

News: The Company announced that it has dosed two patients in the repeat dose part of its Phase 1/2 clinical trial of AEB1102 or the treatment of patients with Arginase 1 Deficiency. Topline data is expected in second half of 2018.

10. NantHealth Inc. (NH)

Gained 11.47% to close Thursday's trading at $3.79.

News: No news

NantHealth is a personalized healthcare company. It derives revenue from sales of licensed software and maintenance, software-as-a-service, hardware, services, and its universal diagnostics solution GPS Cancer to healthcare providers, payors and self-insured employers. The Company made its debut on the NASDAQ Global Select Market on June 2, 2016, offering its shares at a price of $14.00 each.

LOSERS

1. Alnylam Pharmaceuticals Inc. (ALNY)

Lost 15.68% to close Thursday's trading at $72.53.

News: The Company has suspended dosing in all ongoing Fitusiran studies pending further review of the safety event and development of a risk mitigation strategy, following a fatal thrombotic event in a patient with hemophilia A without inhibitors in the Phase 2 open-label extension (OLE) study of Fitusiran.

Fitusiran clinical studies include the ongoing Phase 2 OLE study of hemophilia A and B patients with and without inhibitors and the ATLAS Phase 3 program, which has recently been initiated but in which patient dosing has yet to begin.

2. Akcea Therapeutics Inc. (AKCA)

Lost 12.19% to close Thursday's trading at $21.39.

News: No news

Recent event:

-- On August 31, 2017, the Company submitted a New Drug Application to the FDA for Volanesorsen, an investigational medicine for the treatment of familial chylomicronemia syndrome (FCS).

Volanesorsen is co-developed by Akcea and Ionis Pharmaceuticals Inc. (IONS).

Near-term catalysts:

--Present results from the Phase 1/2 study evaluating AKCEA-APOCIII-LRx in healthy volunteers and patients with elevated triglycerides in the second half of 2017. --Initiate Phase 2 studies with AKCEA-ANGPTL3-LRx in the second half of 2017, including a study in patients with non-alcoholic fatty liver disease (NAFLD) and metabolic complications and studies in patients with rare hyperlipidemias. -- Initiate a Phase 2b dose-ranging study evaluating AKCEA-APOCIII-LRx in patients with hypertriglyceridemia and established cardiovascular disease in the second half of 2017.

3. Exelixis Inc. (EXEL)

Lost 8.91% to close Thursday's trading at $25.66.

News: No news

Near-term catalysts:

The second interim analysis of the Company's ongoing phase 3 pivotal trial of Cabozantinib in patients with advanced hepatocellular carcinoma, dubbed CELESTIAL, is expected to be completed in the second half of 2017.

A supplemental New Drug Application for CABOMETYX as a treatment for patients with previously untreated advanced renal cell carcinoma was submitted to the FDA on August 16, 2017.

4. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Lost 8.79% to close Thursday's trading at $7.00.

News: No news

Near-term catalysts:

-- Data from phase II open-label extension study of Anabasum for the treatment of systemic sclerosis expected in Q4 2017. -- A phase III study of Anabasum for the treatment of systemic sclerosis expected to commence in Q4 2017. -- Topline data from phase II study of Anabasum in skin-predominant dermatomyositis expected to be reported in Q4 2017.