panel for myeloid malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN).
Cytokinetics announced the completion of patient enrollment in VITALITY-ALS (Ventilatory Investigation
of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an international Phase III clinical trial of tirasemtiv in patients with ALS. VITALITY-ALS is designed to assess the effects of tirasemtiv versus placebo on slow vital
capacity (SVC) and other measures of skeletal muscle strength in patients with ALS. VITALITY-ALS enrolled more than 700 patients in 81 centers in 11 countries. Results from VITALITY-ALS are expected in the second half of 2017. The company also announced that
enrollment in the open-label extension to VITALITY-ALS is expected to begin in the fourth quarter of this year.
Inspyr Therapeutics announced that the first patient has been treated in a Phase II investigator-sponsored
clinical trial to evaluate the safety and activity of mipsagargin in patients newly diagnosed with prostate cancer. The trial is being conducted at The University of Texas Health Science Center (UTHealth) at Houston with Robert Amato, D.O., Professor and Director,
University of Texas/Memorial Hermann Cancer Centers, as principal investigator. Mipsagargin is a first-in-class agent with a novel mechanism of action that targets prostate-specific membrane antigen (PSMA), a highly expressed enzyme on the surface of prostate
Audentes Therapeutics reported that the first patient has been enrolled in INCEPTUS, a prospective
study designed to characterize the disease presentation in children living with X-Linked Myotubular Myopathy (XLMTM). The study is evaluating subjects prior to potential enrollment in ASPIRO, the planned Phase I/II clinical study intended to evaluate the safety
and preliminary efficacy of AT132, the Audentes product candidate for treatment of XLMTM.
Ambrx announced that their ARX788 US IND is now active. ARX788 is Ambrx’s most advanced internally
developed site-specific ADC targeting Her2. Ambrx ARX788 may hold the potential for a broader patient population than the currently available Her2-targeting therapies. Ambrx will open US sites for the first-in-human (FIH) study which is currently recruiting
patients at several sites in Australia and New Zealand. The primary end point is safety and tolerability. The pharmacokinetics and antitumor activity of ARX788 will also be evaluated.
Perrigo announced that it has agreed to acquire Peachtree City, Georgia-based,
Geiss, Destin & Dunn, a small national distributor of over-the-counter healthcare and consumer goods products to the non-chain retail and institutional markets. The transaction is expected to close by the end of August.
Anthera Pharmaceuticals announced the appointment of William Shanahan, M.D., J.D. as Chief Medical
Officer. In his role as Chief Medical Officer, Dr. Shanahan will bring his experience as a Rheumatologist and in drug development to lead the blisibimod lupus program and Sollpura program, with both programs expected to report out topline data in the fourth
quarter of this year. He will also have responsibility for the development of additional indications for blisibimod in diseases such as IgA nephropathy and cystic fibrosis and for Sollpura in celiac disease and other diseases. In addition, he will bring extensive
experience with FDA and European filings to work closely with our regulatory team in preparing the BLA for both Sollpura and blisibimod.
Indivior announces positive top-line results of the pivotal Phase III clinical trial of RBP-6000 buprenorphine
monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support. These results bring the potentially transformational drug one step closer to market, further
bolstering the Company’s efforts to pioneer life-transforming treatments for people suffering with opioid use disorder.
Medivir AB and
Trek Therapeutics announced that TREKtx has licensed the exclusive rights to develop and commercialize MIV-802 globally, excluding China, Taiwan, Hong Kong and Macau. MIV-802 is a nucleotide polymerase inhibitor under development for the treatment of
hepatitis C virus (HCV) infection. Under the terms of the agreement, Medivir is entitled to receive milestones based on successful clinical development and royalties capped at a mid-teens percentage upon commercialization of MIV-802 containing products. BioPhausia,
a subsidiary of Medivir, is granted options to commercialize MIV-802 containing products in the Nordics and certain Western European countries. Other terms of the transaction were not disclosed.
Rasna Therapeutics announced the successful completion of its merger with the
Active With Me. The combined company intends to change its name to Rasna Therapeutics, Inc. and will trade on the OTC Markets under the symbol “ATVM.” The Company intends to submit an application to change its trading symbol.
WAVE Life Sciences announced that it has appointed Keith Regnante as the company’s Chief Financial
MabVax Therapeutics Holdings announced that the Company’s common stock will begin trading on The Nasdaq
Capital Market under the stock symbol MBVX effective with the market open today. The Company also announces the pricing of a public offering. The offering consists of $8.625 million of common stock and Series F Preferred Stock at $4.81 per share of common
stock or Series F Preferred Stock. One Class A warrant exercisable at $5.55 per share and one Class B warrant exercisable at $6.29 per share are also being issued with each share of common stock or Series F Preferred Stock issued in the offering. Each share
of Series F Preferred Stock is initially convertible into one share of common stock, subject to adjustment for stock splits, stock dividends, recapitalizations, combinations, subdivisions or other similar events. The total expected gross proceeds of the public
offering are $8.625 million before the underwriter’s discount and expenses. The warrants are immediately exercisable and expire August 22, 2019. Neither the warrants nor the Series F Preferred Stock will be separately listed on any securities exchange or other
trading market. Laidlaw & Company (UK) Ltd. acted as the sole book-running manager for the offering.
analyst Ed Arce increased his price target of
Aurinia Pharmaceuticals to $10 from $7, citing Aurinia will indeed initiate a Phase 3 study of voclosporin in early 2017, coupled with the view that the drug still retains an overall profile that is very likely “approvable.”
analyst Louise Chen initiated coverage of
Scynexis with a “buy” rating and $15 price target, citing the potential of SCYX’s pipeline in 2022+ is likely to exceed consensus expectations.
analyst Jim Birchenough upgraded
Avexis to “outperform” from “market perform” and increased his valuation range to $56-$61 from $30-$32, citing impressive data for AVXS101 in type 1 SMA should support meaningful upside potential as details emerge on motor milestone improvement and as
a regulatory and commercial strategy gain visibility.
analyst David Maris initiated coverage of
MediWound with an “outperform” rating and $13-$15 valuation range, citing MediWound represents a compelling investment opportunity as its products, have the potential to revolutionize the treatment of burns and chronic wounds if approved.
analyst David Risinger upgraded
Valeant to “overweight” from “equal-weight” and increased his price target to $42 from $33, citing expect management to successfully renegotiate debt covenants for a small amount, improve operating income & cash flow, and pay down debt.
analyst Jim Birchenough increased his valuation range of
Ionis Pharmaceuticals to $63-$68 from $61-$64, citing leadership in RNA therapeutics has produced a pipeline of about 40 drug candidates with unprecedented predictability and potency of effect, and with high likelihood of clinical, regulatory and commercial
analyst Joshua Schimmer increased his price target of
Nektar Therapeutics to $25 from $21, citing NKTR-214 could change the game for cancer immunotherapy.