AERI Faces D-Day, PTI To Report Data In Q4, MACK Makes Peace, MNKD Pulls Back

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 11, 2017.

GAINERS

1. Aerie Pharmaceuticals Inc. (AERI)

Gained 16.17% to close Wednesday's (Oct.11) trading at $64.30.

News: The briefing documents posted by the FDA staff ahead of the panel meeting to review the Company's glaucoma drug candidate Rhopressa looks positive.

The briefing documents are used as the basis for discussion by the FDA panel members. The Company is seeking approval of Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension.

Open-angle glaucoma, which is the most common form of glaucoma, is caused by the slow clogging of trabecular meshwork - the drainage canal of the eye, resulting in increased eye pressure, and is characterized by a wide and open angle between the iris and cornea.

Near-term catalysts:

The FDA panel meeting to review Rhopressa is slated for October 13, 2017. The FDA's final decision on Rhopressa is expected to be announced by February 28, 2018.

2. Voyager Therapeutics Inc. (VYGR)

Gained 15.61% to close Wednesday's trading at $24.00.

News: No news

Recent event:

On September 6, 2017, the Company announced positive results from its ongoing Phase 1b trial of VY-AADC01 in advanced Parkinson's disease.

Near-term catalysts:

-- Initiation of pivotal phase 2-3 program of VY-AADC for advanced Parkinson's disease expected during late 2017. -- Filing of an investigational new drug application for VY-SOD101 for the treatment of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 gene during late 2017 or early 2018.

3. Catabasis Pharmaceuticals Inc. (CATB)

Gained 13.78% to close Wednesday's trading at $2.56.

News: No news

Recent event:

On October 4, the Company reported positive results from open-label extension of Phase 2 MoveDMD trial evaluating Edasalonexent in Duchenne Muscular Dystrophy.

Near-term catalysts:

Catabasis plans to initiate a single global Phase 3 trial with Edasalonexent in patients with DMD regardless of mutation type in the first half of 2018 with top-line results expected in 2020.

4. aTyr Pharma Inc. (LIFE)

Gained 11.50% to close Wednesday's trading at $6.30.

News: No news

Pipeline:

The Company's most advanced drug candidate is Resolaris which is being developed for adult Limb girdle muscular dystrophy 2B; adult Facioscapulohumeral muscular dystrophy (FSHD) and early onset FSHD, which has completed phase IB/2 study. Also in the pipeline is iMod.Fc for interstitial lung diseases and ORCA programs, which is expected to move into phase I testing later this year.

5. Merrimack Pharmaceuticals, Inc. (MACK)

Gained 8.23% to close Wednesday's trading at $14.21.

News: the Company has reached a settlement agreement with Wolverine Flagship Fund Trading Limited, 1992 MSF International Ltd. 1992 Tactical Credit Master Fund, L.P. and Wells Fargo Bank, National Association to resolve the previously disclosed lawsuit captioned Wells Fargo Bank, N.A., et. al. v. Merrimack Pharmaceuticals, Inc. pending in the Court of Chancery in the State of Delaware.

The agreement resolves outstanding litigation associated with Merrimack's asset sale to Ipsen. Merrimack has agreed to commence tender offer to purchase outstanding convertible notes with potential to eliminate all remaining debt.

6. Seattle Genetics Inc. (SGEN)

Gained 6.51% to close Wednesday's trading at $61.47.

News: The Company has announced additional clinical collaborations to evaluate SGN-LIV1A in triple negative breast cancer.

SGN-LIV1A administered in combination with Merck's Keytruda will be evaluated in a phase 1b/2 clinical study in patients with locally advanced or metastatic TNBC. SGN-LIV1A followed by standard chemotherapy (doxorubicin and cyclophosphamide) will be evaluated as a neoadjuvant treatment (prior to surgery) for women with newly diagnosed, locally advanced Stage 2 or 3 HER2-negative breast cancer in the I-SPY 2 TRIAL.

7. Proteostasis Therapeutics Inc. (PTI)

Gained 6.28% to close Wednesday's trading at $2.20.

News: No news

Pipeline:

The Company's drug candidates include PTI-428, PTI-801 and PTI-808 for cystic fibrosis. PTI-428 and PTI-801 are in phase 1/2 clinical development and PTI-808 is under phase I testing.

Near-term catalyst:

-- Initial data from phase 1/2 clinical trials of PTI-428 and PTI-801 are expected in Q4 2017.

LOSERS

1. MannKind Corporation (MNKD)

Lost 18.48% to close Wednesday's trading at $5.47.

News: The Company has announced a registered direct offering of an aggregate of 10.16 million shares of common stock at an offering price of $6.00 per share, for gross proceeds of approximately $61 million. The offering is expected to close on or about October 13, 2017, subject to the satisfaction of customary closing conditions.

2. Chiasma Inc. (CHMA)

Lost 12.07% to close Wednesday's trading at $2.55.

News: No news

Chiasma's lead product candidate is Mycapssa. The NDA for Mycapssa capsules for the maintenance treatment of adult patients with acromegaly was turned down by the FDA last April. The company needs to conduct another clinical trial before Mycapssa could be approved.

Recent event:

The Company initiated a new Phase 3 clinical trial of Mycapssa, dubbed CHIASMA OPTIMAL, last month. The top-line data from the trial are expected by the end of 2019.

A phase III clinical trial to investigate the non-inferiority of Mycapssa to once-a-month injectable somatostatin analogs, dubbed MPOWERED, is underway. The results of this study are expected to support the filing of a Marketing Authorization Application with the European Medicines Agency.

3. Endocyte Inc. (ECYT)

Lost 7.47% to close Wednesday's trading at $4.83.

News: No news

Recent event:

-- On October 2, 2017, the Company announced a deal with ABX GmbH, in-licensing its proprietary ligand PSMA-617. The transaction provides Endocyte with 177Lu-PSMA-617, a phase III-ready prostate cancer drug. The news sent the stock soaring over 157% that day to $3.63, and it gained another 80% to touch a high of $6.55 the following day.

Endocyte plans to seek regulatory approval to initiate a phase III registration trial of 177Lu-PSMA-617 in early 2018. If all goes well as planned, the Company expects to complete the trial as early as 2020.