SPPI Breathes Easy On Trial Results, PTI Awaits Data In Q4, HAIR Keeps Receding

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 18, 2017.

GAINERS

1. Spectrum Pharmaceuticals Inc. (SPPI)

Gained 36.03% to close Wednesday's (Oct.18) trading at $19.67.

News: The Company presented encouraging interim data from its phase II study evaluating Poziotinib in EGFR Exon 20 mutant non-small cell lung cancer at the 18th IASLC World Conference on Lung Cancer in Japan.

We alerted our premium subscribers to this stock on October 3, 2017 when it was trading around $14.

2. Endocyte Inc. (ECYT)

Gained 12.87% to close Wednesday's trading at $4.91.

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.

3. Impax Laboratories Inc. (IPXL)

Gained 11.14% to close Wednesday's trading at $21.45.

News: Impax is all set to combine with Amneal Pharmaceuticals LLC to form a new, publicly traded holding company called Amneal Pharmaceuticals, Inc.

As a result of the transaction, Amneal Holdings members will own approximately 75% and Impax shareholders will own approximately 25% of the new company's pro forma shares on an as converted basis.

The combined company is expected to have 2018 pro forma adjusted EBITDA of approximately $700 million to $750 million, which includes expected significant cost savings within the first full year of close. The transaction is expected to close in the first half of 2018.

4. Proteostasis Therapeutics Inc. (PTI)

Gained 5.61% to close Wednesday's trading at $2.26.

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. Infinity Pharmaceuticals Inc. (INFI)

Lost 22.22% to close Wednesday's trading at $2.10.

News: No news

Near-term catalyst:

The Company will be reporting clinical and translational data from monotherapy dose-escalation component of its ongoing phase 1/1b study of IPI-549 in patients with advanced solid tumors during an oral session at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 10, 2017.

2. Immune Design Corp. (IMDZ)

Lost 20.12% to close Wednesday's trading at $6.55.

News: No news

Near-term catalyst:

-- Data from phase II study of G100 in combination with Keytruda are expected to be presented in December of this year.

3. Restoration Robotics Inc. (HAIR)

Lost 20.12% to close Wednesday's trading at $6.55.

News: No news

Recent event:

On October 16, 2017, the Company announced the closing of its initial public offering of 3.57 million shares of common stock at a public offering price of $7.00 each. The Company's common stock began trading on The NASDAQ Global Market on October 12, 2017. The Company commercializes the ARTAS Robotic Hair Restoration System, which is CE-marked and FDA cleared.

4. uniQure N.V. (QURE)

Lost 18.85% to close Wednesday's trading at $9.47.

News: The Company presented new preclinical data on AMT-130, its proprietary gene therapy candidate for the treatment of Huntington's disease.

Data from the study demonstrate that following administration of AMT-130 in Huntington's disease mouse models, significant improvements in both motor-coordination and survival were observed, as well as a dose-dependent, sustained reduction in huntingtin protein.

Near-term catalysts:

-- Filing of an investigational new drug application for AMT-130 in Huntington's disease in 2018. -- A comparability protocol also has been finalized, and the Company is planning to meet with U.S. and European regulators in the early fall to further discuss its plans to begin a pivotal program of AMT-060 in hemophilia B in 2018.

5. MannKind Corporation (MNKD)

Lost 13.05% to close Wednesday's trading at $4.13.

News: No news

Recent events:

-- On October 11, 2017, the Company 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 was expected to close on or about October 13, 2017. -- On October 2, 2017, the FDA approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect.

6. Esperion Therapeutics, Inc. (ESPR)

Lost 7.91% to close Wednesday's trading at $48.08.

The ongoing phase III Program for Bempedoic acid includes four global pivotal studies that enrolled almost 3,600 high cardiovascular disease (CVD) risk patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), or who are high risk primary prevention, on optimized background lipid-modifying therapy and with elevated levels of LDL-C.

Top-line results from Studies 1, 3 and 4 are expected in the second quarter of 2018, with top-line results from Study 2 expected in the third quarter of 2018.