News

May 22 2018

Zosano Appoints Steven A. Elms to Board of Directors

May 22 2018

FREMONT, Calif., May 22, 2018 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”) a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced that Steven A. Elms, Managing Partner at Aisling Capital, has been appointed to the Company’s Board of Directors. Aisling was a lead investor in the follow-on financing that Zosano recently completed in early-April.

“On behalf of our entire Board, I am pleased to welcome Steven as a member of our Board of Directors,” commented John Walker, Chief Executive Officer and Chairman of the Board. “Steven’s investment banking and Wall Street experience make him an ideal addition to our Board. He adds to the strong industry experience already represented on our Board with his working knowledge of M&A, financings and the full range of capital market transactions. We look forward to having his perspective available as we advance our strategic opportunities.”

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May 21 2018

Harmony Biosciences Receives Breakthrough Therapy And Fast Track Designations For Pitolisant

May 21 2018

PLYMOUTH MEETING, Pa.May 21, 2018 /PRNewswire/ — Harmony Biosciences, LLC (Harmony), today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA). Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. These designations signal FDA’s interest in the development program for pitolisant and provide opportunities for frequent interaction with the Agency, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review.

“We are very pleased that the FDA has granted pitolisant Breakthrough Therapy and Fast Track designations and believe it reflects the Agency’s interest in this investigational product to potentially address an important unmet medical need for patients with narcolepsy,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “We look forward to working with the FDA throughout the submission and review of an NDA for this first-in-class molecule with a novel mechanism of action to treat adult patients with narcolepsy with or without cataplexy.”
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May 14 2018

ADMA Biologics Retires Approximately 8.6 Million Shares Previously Issued to Biotest

May 14 2018

RAMSEY, N.J. and BOCA RATON, Fla., May 14, 2018 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ:ADMA) (“ADMA” or the “Company”) announced today that it has negotiated the receipt and immediate retirement of approximately 8.6 million shares of its non-voting common stock previously issued to Biotest Pharmaceuticals Corporation (“BPC”) and its former parent, Biotest AG (collectively, “Biotest”), as consideration for the waiver and release of certain ADMA rights under the Master Purchase and Sale Agreement, dated as of January 21, 2017, among ADMA and Biotest and certain of their subsidiaries (the “Master Purchase Agreement”).

“We believe the retirement of the non-voting common stock simplifies ADMA’s capital structure, while reducing our total common stock outstanding by approximately 19%, from 45.3 million shares to 36.7 million shares,” stated Adam Grossman, ADMA’s President and Chief Executive Officer.

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May 14 2018

Zosano Reaches Another Enrollment Milestone in M207-ADAM Long-term Safety Study

May 14 2018

FREMONT, Calif., May 14, 2018 (GLOBE NEWSWIRE) — Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced that the 250TH subject has enrolled and received M207 in the M207-ADAM study (the “Study”), a long-term safety study for the acute treatment of migraines. Enrollment in the Study will close on May 18th; however, the investigators will continue enrolling subjects that are scheduled or currently in the run-in period.

“The M207-ADAM study continues to progress at a brisk pace. Importantly, our observed pain freedom and pain relief score at two hours are consistent with the data reported in our pivotal efficacy study,” said Dr. Donald Kellerman, Zosano’s VP, Clinical Development and Medical Affairs. “The 250TH enrolled subject is an important milestone in the study. We believe that at least 150 subjects will complete six months of evaluation in the Study and 50 will complete one year.  The Study is on track to have more than 50 subjects complete one year of evaluation by the end of March 2019.”

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May 10 2018

Lilly Announces Agreement To Acquire ARMO BioSciences

May 10 2018

INDIANAPOLIS and REDWOOD CITY, Calif., May 10, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and ARMO BioSciences, Inc. (NASDAQ: ARMO) today announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction. ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors.

The acquisition will bolster Lilly’s immuno-oncology program through the addition of ARMO’s lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Pegilodecakin is currently being studied in a Phase 3 clinical trial in pancreatic cancer, as well as earlier-Phase trials in lung and renal cell cancer, melanoma and other solid tumor types. ARMO also has a number of other immuno-oncology product candidates in various stages of pre-clinical development.

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Apr 17 2018

Arcus Biosciences Presents Phase 1 Data for AB928 in Healthy Volunteers at 2018 AACR Annual Meeting

Apr 17 2018

HAYWARD, Calif.–(BUSINESS WIRE)– Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, will present data today from its Phase 1 trial for AB928, its dual adenosine receptor antagonist, in healthy volunteers in a poster presentation titled “Clinical Pharmacokinetic-Pharmacodynamic Relationship for AB928, a Dual Antagonist of the A2aR and A2bR Adenosine Receptors,” at the 2018 American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.

“We are extremely encouraged by the results from our ongoing Phase 1 trial of AB928. The compound has been shown to be safe and well tolerated at all doses evaluated and achieves near complete inhibition of A2aR adenosine receptor activation in blood samples from healthy volunteers,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. “Importantly, we achieved this level of inhibition under conditions that we believe are representative of the large concentrations of adenosine found in the tumor microenvironment. These results have informed the selection of the starting dose for our clinical trials of AB928 in combination with other anti-cancer agents, and we look forward to starting these trials shortly.”

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Apr 10 2018

Loxo Oncology and Illumina to Partner on Developing Next-Generation Sequencing-Based Pan-Cancer Companion Diagnostics

Apr 10 2018

STAMFORD, Conn. and SAN DIEGO, April 10, 2018 (GLOBE NEWSWIRE) — Loxo Oncology (Nasdaq:LOXO) and Illumina, Inc. (Nasdaq:ILMN) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication. The co-development partnership will seek approval for a version of the Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for Loxo Oncology’s larotrectinib, which targets NTRK gene fusions, and LOXO-292, which targets RET gene alterations, across tumor types.

TruSight Tumor 170 is a comprehensive, state-of-the-art, next-generation sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumors. The CDx version of TruSight Tumor 170 will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options. This version of TruSight Tumor 170 will run on the NextSeq 550Dx platform.

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Mar 26 2018

Biohaven Announces Successful Achievement of Both Co-Primary Regulatory Endpoints in Two Pivotal Phase 3 Trials of Rimegepant an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

Mar 26 2018

NEW HAVEN, Conn., March 26, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive top-line results from both of its two Phase 3 clinical trials (BHV3000-301 and BHV3000-302) of rimegepant (formerly known as BHV-3000), an oral CGRP receptor antagonist for the acute treatment of migraine. In each trial, rimegepant met the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom (MBS) (Figure 1, Table 1). Even without additional rimegepant dosing, or use of rescue medications, these studies showed an early separation from placebo and a profile of continued improvement over the dosing interval. Overall, efficacy and safety results were consistent across both Phase 3 trials.

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Mar 26 2018

Verona Pharma Reports Positive Top-Line Data from Phase 2b Clinical Trial of RPL554 for Maintenance Treatment of COPD

Mar 26 2018

LONDON, March 26, 2018 (GLOBE NEWSWIRE) —  Verona Pharma plc (AIM:VRP) (Nasdaq:VRNA) (“Verona Pharma” or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today positive top-line data from its Phase 2b study evaluating RPL554, a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 with bronchodilator and anti-inflammatory properties, as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

The study met its primary endpoint, with RPL554 producing a clinically and statistically significant improvement in peak forced expiratory volume in one second (FEV1) at four weeks in patients with moderate-to-severe COPD compared to placebo. Furthermore, the peak FEV1 was significantly improved at all time points over the four weeks of dosing. Secondary endpoints measuring 12 hour average FEV1, COPD symptoms and Quality of Life were also met and support the potential clinical benefits of RPL554 for the treatment of COPD.

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Mar 5 2018

GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence at SUFU 2018

Mar 5 2018

MEMPHIS, Tenn.–(BUSINESS WIRE)–Mar. 5, 2018– GTx, Inc. (Nasdaq:GTXI) today announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence (UI) suggesting a possible treatment effect for women with mixed incontinence. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI.

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