ACHV Focuses On Achievement, IMGN Strikes Chord With JAZZ, FDA Snubs ACOR

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 29, 2017.

GAINERS

1. Achieve Life Sciences Inc. (ACHV)

Gained 37.69% to close Tuesday's (Aug.29) trading at $3.69.

News: No news

Recent events:

On August 16, 2017, the Company announced that it has initiated Cytisine Clinical Development Program in the U.S.

Cytisine has been approved and marketed in Central and Eastern Europe as a smoking cessation treatment for more than 15 years.

Near-term catalysts:

In preparation to initiate a pivotal Phase 3 trial in the United States, Achieve expects to conduct the following clinical studies this year.

-- Evaluation of the effect of food on the bioavailability of cytisine - enrollment has started, the first subjects have been dosed and data analysis expected to be completed in Q4 2017. -- Assessment of repeat-dose pharmacokinetic (PK) parameters and pharmacodynamics expected to commence in Q4 2017.

2. Ovid Therapeutics Inc. (OVID)

Gained 21.48% to close Tuesday's trading at $8.71.

News: No news

The Company made its debut on the NASDAQ Global Select Market on May 5, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's pipeline includes OV101, a potential treatment for Angelman syndrome and Fragile X syndrome, and TAK-935/OV935 for treatment of adults with rare epilepsies.

A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome, and a phase 1b/2a clinical trial of TAK-935/OV935 in adults with rare epilepsies are underway.

Near-term catalysts:

-- The top line data from the phase I trial evaluating OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are expected to be available in the second half of 2017. -- Data from the phase 1b/2a clinical trial of TAK-935/OV935 are expected next year.

3. Juno Therapeutics Inc. (JUNO)

Gained 20.09% to close Tuesday's trading at $43.81. This is the second straight day of gain for the stock.

News: Brokerage firm Wedbush has upgraded the rating on Juno's stock to Outperform from Neutral and has raised the target price to $42 up from $24.

Juno's stock rose more than 18% yesterday as a sympathy play on Kite Pharma's acquisition by Gilead. Like Kite Pharma, Juno is also focused on developing CAR T-cell therapies to cure cancer.

4. ImmunoGen Inc. (IMGN)

Gained 17.34% to close Tuesday's trading at $7.58.

News: The Company has entered into a strategic collaboration and option agreement with Jazz Pharma to develop and commercialize antibody-drug conjugate products.

The programs covered under the agreement include IMGN779 for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, IMGN632 for hematological malignancies expected to enter clinical testing before the end of the year and an additional program that will be designated.

As per the agreement terms, Jazz will pay ImmunoGen an upfront payment of $75 million, up to $100 million in development funding over seven years to support the three ADC programs and potential future opt-in fees, milestones and royalties.

5. Fate Therapeutics Inc. (FATE)

Gained 13.98% to close Tuesday's trading at $3.67.

News: No news

Near-term catalysts:

-- The Company plans to initiate enrollment in its phase II efficacy stage of PROTECT study next month.

PROTECT is a phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies undergoing matched unrelated donor mobilized peripheral blood HCT. The PROTECT study is intended to evaluate ProTmune to prevent acute graft-versus-host disease (GvHD).

-- A phase I study of FATE-NK100, the Company's first-in-class adaptive memory natural killer (NK) cell product candidate for advanced acute myeloid leukemia is underway.

-- The Company looks forward to initiating a phase I trial of FATE-NK100 for the treatment of women with ovarian cancer resistant to, or recurrent on, platinum-based treatment, and another phase I study of FATE-NK100, including in combination with monoclonal antibody therapy, in subjects with advanced solid tumor malignancies.

6. Aeglea Biotherapeutics Inc. (AGLE)

Gained 12.73% to close Tuesday's trading at $3.72.

News: No news

Pipeline:

Aeglea is currently recruiting patients for its ongoing phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency. Two phase I trials of AEB1102 in cancer patients with advanced solid tumors and with hematological malignancies are underway.

Upcoming event:

The Company will present a corporate update at the Wells Fargo Healthcare Conference being held September 6 - 7 in Boston, MA.

7. Protagonist Therapeutics Inc. (PTGX)

Gained 12.32% to close Tuesday's trading at $16.77.

News: No news

Near-term catalysts:

-- Interim analysis of phase 2b trial of PTG-100 in ulcerative colitis patients is expected in early 2018 - with top-line results anticipated for the second half of 2018. -- Results from a phase 1 clinical study of PTG-300 in normal healthy volunteers are anticipated in the second half of 2017. PTG-300 is being developed as a potential treatment for patients with chronic iron overload in rare diseases such as beta-thalassemia. -- PTG-200, which is being co-developed by Janssen Biotech, for inflammatory bowel disease is expected to enter Phase 1 clinical testing before the end of 2017.

8. Sangamo Therapeutics Inc. (SGMO)

Gained 11.30% to close Tuesday's trading at $12.80.

News: No news

Pipeline:

SB-525, under phase 1/2 clinical trial in adults with hemophilia A; SB-318 for Mucopolysaccharidosis (MPS) I; SB-913 for MPS II and SB-FIX for Hemophilia B, all of which are under phase 1 clinical trials.

Near-term catalyst:

-- Preliminary data from phase I/II study of SB-525 in Hemophilia A are expected by the end of this year or early 2018.

9. Puma Biotechnology Inc. (PBYI)

Gained 10.57% to close Tuesday's trading at $94.15.

News: No news

Recent events:

On July 17, 2017, the FDA approved NERLYNX (neratinib), formerly known as PB272, for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. The drug became commercially available by prescription in the United States on July 31, 2017.

Near-term catalysts:

-- NERLYNX is under review in the European Union, and the CHMP is expected to issue an opinion in the first quarter of 2018. -- NERLYNX is also being explored in the third-line disease setting, and a phase III trial of the drug in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments is underway. The primary analysis of progression free survival from the trial is expected to be available during the first half of 2018.

10. Altimmune Inc. (ALT)

Gained 10.29% to close Tuesday's trading at $2.68.

News: No news

Recent event:

On August 21, 2017, the Company submitted an Investigational New Drug application to the FDA in preparation for phase II trial of its recombinant flu vaccine for NasoVAX. Data from the trial is expected sometime in the first quarter of 2018.

LOSERS

1. Acorda Therapeutics Inc. (ACOR)

Lost 24.32% to close Tuesday's trading at $19.45.

News: The FDA has refused to accept for review the Company's New Drug Application seeking approval of INBRIJA for treating symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

In its Refusal to File letter, the FDA has noted that the NDA is not sufficiently complete to permit a substantive review for two reasons - first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record.

2. AVEO Pharmaceuticals Inc. (AVEO)

Lost 12.24% to close Tuesday's trading at $3.37.

News: No news

Recent event:

On August 28, 2017, the Company's FOTIVDA (Tivozanib) was approved in the European Union for the treatment of advanced renal cell carcinoma.

The drug is not approved in the U.S. yet. It was issued a Complete Response letter by the FDA in June 2013.

2. KalVista Pharmaceuticals Inc. (KALV)

Lost 8.72% to close Tuesday's trading at $6.07.

News: No news

Near-term catalyst:

Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

3. uniQure N.V. (QURE)

Lost 7.49% to close Tuesday's trading at $7.91.

News: No news

Near-term catalysts:

An investigational new drug application for AMT-130 in Huntington's disease is expected to be filed in 2018.

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.

4. AveXis Inc. (AVXS)

Lost 6.05% to close Tuesday's trading at $91.11.

News: No news

Near-term catalysts:

-- A pivotal study trial of AVXS-101 in SMA Type 1 in the U.S. is expected to be initiated later in the third quarter of 2017, pending agreement from the FDA. -- A phase 1/2a trial of AVXS-101 in SMA Type 2 in the U.S. is also expected to be initiated later in the third quarter of 2017, pending agreement from the FDA.