GLYC On The Move, ATNX Rises On KX2-391 Deal, Three Cheers For PTI

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

1. Proteostasis Therapeutics Inc. (PTI)

Gained 161.28% to close Tuesday's (Dec.12) trading at $6.14.

News: The Company reported positive study results across all three of its cystic fibrosis pipeline programs.

They include data from a 28-day phase II clinical trial of PTI-428 in cystic fibrosis patients receiving Vertex Pharmaceuticals' Orkambi as their background therapy; initial data from the first five subjects in an ongoing phase I study of PTI-801 in cystic fibrosis patients on Orkambi background therapy and data from a phase I study of PTI-808 in healthy volunteers.

The Company also announced that it has completed a healthy volunteer co-administration study of PTI-428, PTI-808 and PTI-801, with the results indicating that the compounds were generally well-tolerated and could potentially be amenable for once a day dosing.

Related Reading

PTI Faces Busy December

After-hours News:

The Company announced that it intends to offer and sell 7 million shares of its common stock in an underwritten public offering.

2. Vital Therapies Inc. (VTL)

Gained 15.15% to close Tuesday's trading at $5.70.

News: The Company has been selected for addition to the NASDAQ Biotechnology Index, which will become effective prior to the open of U.S. markets Monday, December 18, 2017.

The Company's lead investigational product is ELAD, a cell-based therapy for the treatment of acute forms of liver failure.

Near-term catalyst:

-- Top-line data from phase III trial of ELAD System in subjects with severe alcoholic hepatitis are expected in the third quarter of next year.

As of October 24th, the trial was 79% enrolled based on its target of at least 150 subjects. If it is decided more than 150 subjects are needed to reach 55 deaths under the event-driven design of the trial, the top line data could be delayed.

3. GlycoMimetics Inc. (GLYC)

Gained 14.87% to close Tuesday's trading at $16.45.

News: The Company reported updated data from its phase 1/2 trial of GMI-1271 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and in older adults with newly diagnosed AML.

At a median follow up of 6.6 months, for patients with R/R AML treated at the Phase 2 dose, the clinical remission was 43% and median overall survival was 9.4 months. This compares favorably to a median overall survival of up to 5.4 months reported for historical, matched controls treated with mitoxantrone, etoposide and cytarabine (MEC) alone.

At a median follow up of 10.5 months, for older patients with newly diagnosed AML, the clinical remission rate were 68% and median overall survival was 15.8 months. This compares favorably to a historical median overall survival of approximately 12 months in matched controls treated with standard care.

4. Syros Pharmaceuticals Inc. (SYRS)

Gained 12.66% to close Tuesday's trading at $9.52.

News: No news.

The stock had lost nearly 32% of its value yesterday, 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 does not plan to 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 is being 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.

5. Athenex Inc. (ATNX)

Gained 10.13% to close Tuesday's trading at $15.87.

News: The Company has teamed up with Spain's largest drugmaker Almirall to further develop and commercialize KX2-391 for the treatment of actinic keratosis and other skin conditions in the United States and Europe.

Athenex's KX2-391, also known as KX-01, is in phase III development as a topical medicinal product for the treatment of actinic keratosis.

As part of the deal, Athenex will receive an up-front fee and near-term payments of up to $55 million, and is entitled to receive launch and additional indications milestones for $65 million, in addition to sales performance milestones estimated to be $155 million.

6. Bellerophon Therapeutics Inc. (BLPH)

Gained 7.66% to close Tuesday's trading at $2.05.

News: No news

Clinical trials & Near-term catalysts:

-- A phase III program evaluating INOpulse in the treatment of Pulmonary Arterial Hypertension, dubbed INOvation-1, is underway. Interim analysis and the top-line results for the study are expected to be available in 2018. -- A second phase III study of INOpulse in Pulmonary Arterial Hypertension, dubbed INOvation-RW, is planned for initiation in the second half of 2018, with top-line results anticipated in 2019. -- A phase IIb study for INOpulse in Idiopathic Pulmonary Fibrosis, called iNO-PF, is expected to commence in early 2018, with readout expected by the end of 2018.

7. Presbia PLC (LENS)

Gained 7.63% to close Tuesday's trading at $2.54.

News: No news

Pipeline:

The Company's lead product candidate 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.

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.

8. Impax Laboratories Inc. (IPXL)

Gained 7.21% to close Tuesday's trading at $17.85.

News: No news

Recent events:

-- On November 9, 2017, the Company reported Q3, 2017 financial results.

Adjusted net income was $16.7 million or $0.23 per share in the third quarter 2017, compared to $26.1 million or $0.37 per share in the prior year period, primarily due to lower product revenue caused by buyer consolidation and additional competition. Total revenues in the third quarter 2017 were $206.4 million, a decrease of 9.4%, compared to $227.9 million in the prior year period.

For full year 2017, the Company expects adjusted net income per share of $0.60 to $0.65.

-- On December 8, the Company received tentative FDA approval for its generic version of Coreg CR extended-release capsules, 10, 20, 40 and 80 mg to manage mild to moderate congestive heart failure. The final approval will be given upon the expiration of marketing exclusivity on May 7, 2018.