LENS Comes Into Focus, MESO, TIG Ink Deal, NBRV Leaps Forward

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. Presbia PLC (LENS)

Gained 19.91% to close Monday's (Dec.18) trading at $2.59.

Pipeline:

The Company's lead product is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world. It is not approved in the U.S. yet.

News: The Company has received an investment proposal of up to $5 million from Orchard Capital Corporation. Actions are also being taken to reduce its cash burn rate by eliminating pre-FDA approval marketing, manufacturing and engineering expenses related to the post-FDA approval U.S. commercial launch of the Presbia Flexivue Microlens.

The Company is also exploring other financing options and plans to finalize the capital raise by mid-February 2018.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017, with approval expected in 2018.

2. Mesoblast Limited (MESO)

Gained 15.33% to close Monday's trading at $6.32.

News: The Company has granted TiGenix NV (TIG) an exclusive global patent license to use adiposederived mesenchymal stem cells in the local treatment of fistulae.

TiGenix's lead product candidate Cx601 is an allogeneic expanded adipose-derived mesenchymal stem cell product for the treatment of complex perianal fistulas in Crohn's disease patients. Cx601 is under regulatory review in Europe and under phase III testing in the U.S.

As part of the deal, Mesoblast will receive up to €20 million (approximately USD$24 million) in payments, with €5 million upfront, €5 million within 12 months, and up to €10 million in product regulatory milestones. Additionally, Mesoblast will receive single digit royalties on net sales of Cx601.

Clinical Trials & Near-term Catalysts:

-- A phase III trial using MSC-100-IV in children with steroid refractory acute Graft-versus-host disease (GVHD) is expected to complete enrollment this quarter. The trial's 28-day primary endpoint data is expected in Q1 CY2018 and the 100-day survival result is expected in Q2 CY2018. -- A phase III trial using MPC-06-ID in patients with chronic low back pain is expected to complete enrollment in early Q1 CY2018. -- A phase III trial evaluating MPC-150-IM in NYHA Class IV patients with advanced heart failure is underway, with the 6-month primary endpoint of the study expected in Q1 CY2018 and full 12-month results expected in Q3 CY2018. -- A phase III trial evaluating MPC-150-IM in NYHA Class III patients with advanced heart failure is ongoing, with enrollment expected to be completed in 2H CY2018.

3. Nabriva Therapeutics plc (NBRV)

Gained 13.04% to close Monday's trading at $5.76.

News: The Company's addition to the NASDAQ Biotechnology Index became effective today.

Pipeline:

The Company's lead drug candidate is Lefamulin for the treatment of patients with moderate to severe community-acquired bacterial pneumonia (CABP).

Clinical Trials & Near-term Catalysts:

-- A phase III trial, which evaluated the safety and efficacy of intravenous (IV) to oral Lefamulin in patients with community-acquired bacterial pneumonia, dubbed LEAP 1, was successfully completed in September of this year. -- Another phase III trial evaluating the efficacy and safety of oral Lefamulin compared to oral moxifloxacin in patients with moderate CABP, dubbed LEAP 2, is underway. This trial completed enrollment target of 738 patients early this month. The topline clinical results from LEAP 2 trial are expected to be available in the spring of 2018.

4. Arsanis Inc. (ASNS)

Gained 11.34% to close Monday's trading at $12.47.

News: No news

Recent event:

--On November 16, 2017, the Company went public on the NASDAQ Global Market offering its shares at a price of $10 each.

Clinical trials & Near-term catalysts:

-- The Company's investigational lead product candidate is ASN100, which is currently in a Phase 2 clinical trial for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients. -- The trial is expected to be completed in December 2018.

5. Apellis Pharmaceuticals Inc. (APLS)

Gained 11.19% to close Monday's trading at $14.51.

News: No news

Recent event:

The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.

Clinical Trials:

The Company's lead drug candidate is APL-2.

APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris.

6. Syros Pharmaceuticals Inc. (SYRS)

Gained 10.01% to close Monday's trading at $9.89.

News: No news

The stock had lost nearly 32% of its value on December 11, 2017, following the initial clinical data from the Company's ongoing phase II trial of SY-1425 in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), presented at the ASH.

Since the data support the continued development of SY-1425 in combination with other therapies, the Company will not pursue further development of SY-1425 as a single agent. Enrollment in the phase II study of SY-1425 as a single-agent in the cohort of newly diagnosed AML patients who are not suitable candidates for standard chemotherapy has been stopped.

Clinical Trials & Near-term catalysts:

-- A phase II study evaluating SY-1425 in combination with chemotherapy drug Vidaza (azacitidine) in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy is underway. -- Syros recently added a cohort in relapsed or refractory AML and higher-risk MDS patients to evaluate SY-1425 in combination with anti-cancer drug Darzalex (daratumumab) and expects to begin enrolling patients in that cohort in early 2018. -- The initial clinical data from the two combination cohorts are expected in 2018.