Plus   Neg

ARRY's COLUMBUS Turns Heads, ZFGN On Course, MNOV UP 66% YTD


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

1. Array BioPharma Inc. (ARRY)

Gained 15.54% to close Tuesday's (Feb.6) trading at $16.28.

News: The Company provided an update on the progress of its key clinical development programs.

In a phase III trial evaluating a combination of Encorafenib 450 mg daily and Binimetinib 45 mg twice daily (COMBO450), dubbed COLUMBUS, the median overall survival (mOS) was 33.6 months in patients with BRAF-mutant melanoma compared to 16.9 months for patients treated with Roche's Zelboraf as a monotherapy.

The New Drug Applications for Encorafenib and Binimetinib are already under FDA review - with a decision date set for June 30, 2018.

Another ongoing phase III trial, known as BEACON, is evaluating the triplet combination of Encorafenib, Binimetinib, and Cetuximab, in patients with BRAF-mutant metastatic colorectal cancer.

This triplet combination has demonstrated an 8 month median progression-free survival (mPFS) with a 48% confirmed overall response rate, including 3 complete responses in patients with BRAF-mutant colorectal cancer, according to the updated BEACON study results.

The Company announced that it has strengthened its immuno-oncology strategy to develop Binimetinib in combination with PD-1/PD-L1 checkpoint inhibitors through collaborations with Bristol-Myers Squibb, Merck and now Pfizer.

2. MediciNova Inc. (MNOV)

Gained 13.76% to close Tuesday's trading at $10.75. The stock is up 66% year-to-date.

News: No news

Recent event:

-- On Feb.1, 2018, the Company reported additional positive clinical data from its phase 2b trial of MN-166, also known as Ibudilast, in progressive multiple sclerosis, dubbed SPRINT-MS.

3. Menlo Therapeutics Inc. (MNLO)

Gained 13.12% to close Tuesday's trading at $34.74.

News: No news

Recent event:

On January 29, 2018, the Company announced the closing of its IPO of 8.05 million shares of common stock at a public offering price of $17.00 each, including the full exercise of underwriters' option to purchase additional shares.


The Company's lead drug candidate is Serlopitant, and phase III trials for the treatment of pruritus associated with prurigo nodularis are expected to be initiated in the first half of 2018.

Serlopitant is also under phase II studies for the treatment of pruritus associated with atopic dermatitis, pruritus associated with psoriasis, and refractory chronic cough.

4. Urogen Pharma Ltd. (URGN)

Gained 12.78% to close Tuesday's trading at $51.00.

News: No news

Recent events:

On January 18, 2018, the Company priced its public offering of 1.46 million ordinary shares at a price of $41.00 each for gross proceeds of about $60.0 million. The offering closed on January 23, 2018.

Clinical Trials & Near-term Catalysts:

-- The Company's lead drug candidate is MitoGel, which is in a phase III trial for the treatment of low-grade upper tract urothelial carcinoma, dubbed OLYMPUS. Top line data from this trial are expected to be available in the third quarter of 2018.

The other clinical programs are:

-- VesiGel, for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC), which has completed phase IIa study. A phase IIb study of VesiGel is planned for the first half of 2018.
-- Vesimune, for the treatment of Carcinoma In-Situ (CIS), a high-grade form of NMIBC, which has completed phase Ib study. A phase II study of Vesimune is planned for the first half of 2018.
-- Botugel, a novel intravesical sustained release formulation of botulinum toxin for Overactive Bladder (OAB) and Interstitial Cystitis (IC). In October 2016, the Company licensed the BotuGel program to Allergan for further development. A phase II trial of Botugel in Overactive Bladder, initiated by Allergan in November 2017, is underway.

5. Zafgen Inc. (ZFGN)

Gained 12.73% to close Tuesday's trading at $8.41.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase II trial of ZGN-1061 in patients with type 2 diabetes has completed enrollment. Top line data are expected mid-year 2018.
-- An investigational new drug (IND) application-enabling work for ZGN-1258 for Prader-Willi Syndrome has commenced. If all goes well as planned, ZGN-1258 may advance into Phase 1 clinical development by the end of this year.

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