OCUL Catches Eyes, IMGN, CLLS Rise After ASH Data, Catalyst Ahead For RETA

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

1. Reata Pharmaceuticals Inc. (RETA)

Gained 12.64% to close Wednesday's (Dec.13) trading at $25.22.

News: No news

Pipeline:

The Company's lead product candidates are Bardoxolone methyl and Omaveloxolone.

Recent event:

On December 11, 2017, the Company revealed interim data from the ongoing phase 1b portion of the REVEAL study.

The REVEAL study is a phase 1b/2 trial to evaluate Omaveloxolone in combination with existing immunotherapies for the treatment of metastatic melanoma.

According to the Company, the ongoing REVEAL trial data suggests that Omaveloxolone may have activity in patients who are refractory to checkpoint inhibitors, which is an emerging and large unmet need.

The dose escalation phase of the study will be continued to identify the optimal dose, and upon completion, the Company will decide the next steps in the clinical development program for Omaveloxolone in melanoma.

Clinical Trials & Near-term catalysts:

-- A phase III trial of Bardoxolone methyl in a severe genetic form of chronic kidney disease caused by Alport syndrome is underway. Top line data is expected in the first half of 2019. -- A phase III trial of Bardoxolone methyl for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, is underway. Data from CATALYST are expected to be available during the second half of 2018. -- A phase II trial of Bardoxolone methyl for the treatment of other rare forms of chronic kidney disease, dubbed PHOENIX, is ongoing, with data expected in second half of 2018. -- A registrational trial of Omaveloxolone in Friedrich's ataxia is underway - with topline expected in the second half of 2019.

2. ImmunoGen Inc. (IMGN)

Gained 12.05% to close Wednesday's trading at $6.79.

Pipeline:

The Company's lead product candidate is Mirvetuximab soravtansine, under a phase III trial as a single agent for the treatment of platinum-resistant ovarian cancer, dubbed FORWARD I, and under a phase 1b/2 study as combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer, known as FORWARD II.

Also in the pipeline are IMGN779 and IMGN632.

IMGN779 is under a phase I trial in adult patients with relapsed/refractory CD33-positive Acute Myeloid Leukemia while IMGN632, being developed for hematologic malignancies, is expected to enter into phase I study before the end of the year.

Recent event:

-- On December 9, 2017, the Company presented new data from its ongoing Phase 1 study of IMGN779 at the 59th American Society of Hematology (ASH) Annual Meeting. The data demonstrated favorable safety profile and anti-leukemia activity of IMGN779.

3. Enanta Pharmaceuticals Inc. (ENTA)

Gained 11.99% to close Wednesday's trading at $53.98.

News: No news

Recent event:

-- On November 20, 2017, the Company reported financial results for its fiscal fourth quarter and year ended September 30, 2017.

Net income for the recent fiscal fourth quarter was $36.5 million, or $1.86 per common share on total revenue of $75.9 million. This compared with a net loss of $1.8 million or $0.09 per common share and total revenue of $12.8 million for the corresponding period in 2016.

The increase in revenue for the quarter was due to $65.0 million in milestone payments for the U.S. and EU approvals of AbbVie's new HCV regimen under the tradenames MAVYRET and MAVIRET, respectively.

Near-term catalysts:

-- Initiate a phase II study of EDP-305 in primary biliary cholangitis by the end of 2017. -- Initiate a phase I study of EDP-938 for respiratory syncytial virus by the end of 2017.

4. Cellectis S.A. (CLLS)

Gained 11.57% to close Wednesday's trading at $26.80.

News: The Company along with Pfizer Inc. (PFE)/Servier reported encouraging preliminary results from two phase I studies of UCART19 in adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The data are from two phase I studies namely CALM, which tested UCART19 in adult patients with R/R B-ALL, and PALL, which tested UCART19 in pediatric patients with high-risk R/R B-ALL.

The first-in-human data demonstrated the safety and tolerability of UCART19, resulting in an 83% complete remission rate across the adult and pediatric patient population, noted the Company.

5. Progenics Pharmaceuticals Inc. (PGNX)

Gained 9.87% to close Wednesday's trading at $6.12.

News: No news

Recent events:

-- On October 31st, the Company completed the rolling submission of its New Drug Application for AZEDRA in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. -- On November 2, 2017, the Company reported Q3, 2017 financial results.

The Company incurred a net loss of $15.4 million, or $0.22 per share on revenue of $2.7 million in the recent third quarter. This compared with a net income of $36.3 million, or $0.52 per share and revenue of $53.9 million in the year-ago period. Revenue is derived from royalty and milestone payments from its RELISTOR collaboration with Valeant.

6. Mersana Therapeutics Inc. (MRSN)

Gained 9.83% to close Wednesday's trading at $18.66.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on June 28, 2017 at an offering price of 15.00 per share.

Clinical trials & Near-term catalysts:

-- Interim safety results from phase I trial of lead oncology drug candidate XMT-1522 in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer are expected around the end of this year. -- Initiated a phase I dose escalation and expansion study of XMT-1536, a potential first-in-class Dolaflexin ADC targeting NaPi2b-expressing tumors, on December 12, 2017.

7. Ocular Therapeutix Inc. (OCUL)

Gained 9.84% to close Wednesday's trading at $4.69.

News: No news

Clinical trials & Near-term catalysts:

-- Meet with the FDA in early 2018 to review plans to resubmit its NDA for DEXTENZA for the treatment of post-surgical ocular pain. --Resubmit its NDA for DEXTENZA in the first half of 2018. --A phase III clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension is underway - with top line efficacy data expected in the second half of 2018. -- A pilot human clinical trial with an intracameral product candidate, OTX-TIC, which is a bioresorbable travoprost-containing hydrogel depot delivered via a fine-gauge needle injection for patients who have moderate to severe glaucoma, initiated in Q3, 2017, is underway. -- Advance OTX-TKI into phase I testing outside the United States in the first half of 2018.

8. Voyager Therapeutics Inc. (VYGR)

Gained 9.43% to close Wednesday's trading at $14.62.

News: No news

Near-term catalysts:

-- Pivotal phase 2/3 program of VY-AADC01 in advanced Parkinson's disease patients to begin during late 2017 and dosing of the first patient is expected during the first half of 2018. -- Identify a lead clinical candidate for the treatment of Friedreich's ataxia during 2018. -- Advance VY-SOD101 for monogenic form of ALS, VY-HTT01 for Huntington's disease and VY-FXN01 for Friedreich's ataxia towards IND filing in 2018.