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ZFGN Awaits Data, SLDB Makes Solid Gains, RCKT On Fire, SGEN Snaps Up CASC

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

1. Cascadian Therapeutics Inc (CASC)

Gained 70.51% to close Wednesday's (Jan.31) trading at $10.06.

News: The Company has agreed to be acquired by Seattle Genetics Inc. (SGEN) for $10.00 per share in cash, which equates to a total value of approximately $614 million.

Cascadian's lead drug candidate is Tucatinib, under pivotal trial in patients with locally advanced or metastatic HER2-positive breast cancer, dubbed HER2CLIMB. A phase 1b/2 trial known as TULiP that is evaluating Tucatinib in combination with an aromatase inhibitor and CDK4/6 agent for patients with hormone receptor-positive and HER2-positive (HR+/HER2+) metastatic breast cancer, and a phase 2 study of Tucatinib in combination with Herceptin for patients with HER2+/RAS wild type metastatic colorectal cancer, known as MOUNTAINEER, are also underway.

2. Zafgen Inc. (ZFGN)

Gained 21.16% to close Wednesday's trading at $6.87.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase II trial of ZGN-1061 in patients with type 2 diabetes has completed enrollment. Topline 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.

3. Solid Biosciences Inc. (SLDB)

Gained 13.87% to close Wednesday's trading at $25.62.

News: No news

Recent event:

-- On January 30, 2018, the Company completed its IPO of 8.98 million shares of its common stock, priced at $16.00 each, including full exercise of underwriters' overallotment option.

The shares began trading on the Nasdaq Global Select Market on January 26, 2018.

Clinical Trials & Near-term Catalyst:

The Company's lead product candidate is SGT-001 for the treatment of Duchenne muscular dystrophy (DMD).

A phase I/II study of SGT-001 in ambulatory and non-ambulatory adolescents and children with DMD, dubbed IGNITE DMD, is underway. A pre-specified interim analysis of preliminary data is expected in the first half of 2019.

4. ImmunoGen Inc. (IMGN)

Gained 10.34% to close Wednesday's trading at $9.18.

News: H.C. Wainwright analyst Debjit Chattopadhyay has initiated coverage on Immunogen with a Buy rating and a price target of $18.00.

Pipeline:

The Company's lead product candidate is Mirvetuximab soravtansine, under a phase III trial as a single agent for the treatment of platinum-resistant ovarian cancer, dubbed FORWARD I, and under a phase 1b/2 study as combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer, known as FORWARD II.

Also in the pipeline are IMGN779 and IMGN632.

IMGN779 is under a phase I trial in adult patients with relapsed/refractory CD33-positive Acute Myeloid Leukemia while IMGN632 recently advanced into phase I testing in patients with CD123-positive hematological malignancies, including acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm.

Near-term Catalyst:

The Company is scheduled to report its 2017 operating results and provide a brief update on its business on February 9, 2018.

5. Rocket Pharmaceuticals Inc. (RCKT)

Gained 10.19% to close Wednesday's trading at $19.04.

News: No news

Recent events:

-- On January 5, 2018, Rocket's common stock began trading on the NASDAQ Global Market, following its reverse merger with Inotek Pharmaceuticals Corp.
-- On January 24, 2018, the Company priced its public offering of 5.5 million shares of its common stock at $13.25 each. The gross proceeds to Rocket from the offering are expected to be $72.87 million.

Clinical Trials & Near-term Catalysts:

-- A phase 1/2 trial of LVV-based gene therapy for Fanconi Anemia (FA), is underway . Additional patient data are expected this year, with a registration study anticipated to start in 2019.
-- Also in the pipeline are three LVV-based programs in preclinical development for the indications of Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD) and Infantile Malignant Osteopetrosis (IMO).
-- The LAD-I program is expected to advance into the clinic in 2018, with the PKD and IMO programs to follow in 2019.

6. Juniper Pharmaceuticals Inc. (JNP)

Gained 9.72% to close Wednesday's trading at $7.90.

News: The Company announced that it is exploring strategic alternatives in order to enhance shareholder value. Rothschild has been engaged as independent financial advisor to assist Juniper and its Board of Directors in evaluating potential strategic alternatives.

The Company's core businesses include its CRINONE (progesterone gel) franchise and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development and clinical trials manufacturing to clients. Also in the pipeline are 3 drug candidates based on differentiated intravaginal ring (IVR) technology to address unmet needs in women's health, each of which has demonstrated positive pharmacokinetic data in in vivo animal studies.

7. BeiGene Ltd. (BGNE)

Gained 9.70% to close Wednesday's trading at $135.75.

News: The Company has initiated a global phase III clinical trial of Tislelizumab as a potential second-line treatment in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). This is the third global Phase 3 study of Tislelizumab under BeiGene's strategic collaboration with Celgene Corp. (CELG).

BeiGene and Celgene have a global strategic collaboration for Tislelizumab for solid tumors outside of Asia (except Japan).

Pipeline:

The Company's pipeline includes BGB-3111 (Zanubrutinib), BGB-A317 (Tislelizumab) and BGB-290 (Pamiparib).

Clinical Trials:

A pivotal phase II trial in China of BGB-3111 in relapsed/refractory mantle cell lymphoma; a global phase III trial of BGB-3111 compared to bendamustine and rituximab in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma patients; a global pivotal phase II trial of BGB-3111 in combination with GAZYVA in relapsed or refractory follicular lymphoma patients; and a pivotal phase II trial in China of BGB-3111 in Waldenström's macroglobulinemia; a global phase III trial of BGB-3111 compared to bendamustine and rituximab (BR) in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) patients and a global pivotal phase II trial of BGB-3111 in combination with GAZYVA in relapsed or refractory follicular lymphoma (FL) patients are underway.

BGB-A317 (Tislelizumab) is under a global phase III clinical trial in patients with previously untreated advanced hepatocellular carcinoma; phase III trial in China as a second- or third-line treatment for patients with advanced lung cancer; phase II trial in China in relapsed/refractory classical Hodgkin's lymphoma; a global phase 1a/1b trial in advanced tumors; pivotal phase II trial in China in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer; phase II trial in China in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and a phase II trial in China in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.

BGB-290 is under a global phase I trial in combination with temozolomide in locally advanced or metastatic solid tumors, and under a global Phase 1b/2 trial in combination with radiation therapy and/or temozolomide in glioblastoma.

8. Zai Lab Limited (ZLAB)

Gained 8.49% to close Wednesday's trading at $26.96.

News: No news

Recent event:

The Company went public on the Nasdaq Global Market on September 20, 2017, offering its American depositary shares at a price of $18 each.

Clinical Trials & Near-term Catalysts:

-- The Company's lead drug candidate is Niraparib (ZL-2306), under phase III registration trial for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer.
-- A separate phase III study evaluating ZL-2306 as a first-line maintenance therapy in patients with platinum-responsive ovarian cancer is expected to be initiated in the first half of 2018.
-- A pivotal study of ZL-2306 in small cell lung cancer is expected to be initiated in the first half of 2018.
-- A phase III trial of ZL-2306 in breast cancer is planned for initiation in the first half of 2018.
-- Pharmacokinetic data read-out of ZL-2306 in ovarian cancer is anticipated in the second half of 2018.
-- A phase III trial evaluating FPA144 plus chemotherapy in front-line gastric and gastro-esophageal junction cancers, dubbed FIGHT, is expected to start in China in the second half of 2018.
-- Data read-out from phase II trial of ZL-2301 as a second-line treatment for advanced hepatocellular carcinoma patients in China is expected in the second half of 2018.
-- Data read-out from phase II trial of ZL-3101 in patients with mild to moderate subacute eczema is expected in the second half of 2018.

9. KemPharm Inc. (KMPH)

Gained 7.76% to close Wednesday's trading at $6.25.

News: The Company announced that its President and CEO, Travis Mickle, will make a strategic presentation on the opportunities and outlook for KemPharm's prodrug development platform, utilizing the company's proprietary LAT (Ligand Activated Therapy) platform at The MoneyShow Orlando, one of the largest annual retail investor conferences held in the U.S., on Friday, February 9, 2018.

Near-term Catalysts:

-- The FDA decision on resubmitted New Drug Application for Apadaz, an investigational product candidate that is intended to provide short-term management of acute pain, is expected on February 23, 2018.
-- A pivotal efficacy trial of KP415 for the treatment of Attention Deficit, Hyperactivity Disorder is underway, with top line data anticipated in mid-2018, and complete data set expected to be available prior to the end of the year.

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