BioShares Biotechnology Clinical Trials (BBC): $21.64, -$0.13, +17.5% YTD
BioShares Biotechnology Products (BBP): $36.47, +$0.02, +11.4% YTD
Futures pointed to a modestly lower start for Wall Street as focus shifted towards earnings season which kick starts on Thursday. Data on import and export prices occupies the day’s economic calendar. Federal budget from the U.S. Treasury Department is also on the economic radar. European equities trended higher buoyed by gains in the shares of financials and carmakers, while stock markets in Asia recorded a mixed trading day. The yen recorded broad gains against major currencies and gold steadied after hitting a five-month peak. Oil extended gains after Saudi Arabia was said to be pushing its fellow OPEC members and some rivals to prolong supply cuts beyond June.
On April 5, 2017, Prothena Therapeutics Limited and Prothena Biosciences Limited, wholly owned subsidiaries of Prothena Corporation, entered into a Letter Agreement with Boehringer Ingelheim Biopharmaceuticals GmbH ("BI"), effective as of March 31, 2017, under which BI reserved for Prothena capacity to manufacture and supply bulk drug substance of NEOD001 (Prothena’s investigational monoclonal antibody for the potential treatment of AL amyloidosis), PRX003 (Prothena’s investigational monoclonal antibody for the potential treatment of inflammatory diseases, including psoriasis and psoriatic arthritis) and possibly additional biologics, and Prothena made commitments for the purchase of Products from BI.
Immune Pharmaceuticals announced a reverse stock split of its shares of common stock at a ratio of 1-for-20. Beginning with the opening of trading on April 13, 2017, the Company’s common stock will continue to trade The Nasdaq Capital Market ("Nasdaq") under the symbol "IMNP," but will trade on a split-adjusted basis under a new CUSIP number 45254C 200. The reverse stock split was approved by the Company’s stockholders at the Company’s 2016 Annual Meeting on December 20, 2016.
Novan announced positive topline results from the Company’s Phase II clinical trial with SB208, a topical, silicone based-gel under development for the treatment of infections caused by dermatophytes such as Trichophyton rubrum, or T. rubrum. Novan is developing SB208 as a broad-spectrum antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis. Novan’s SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect (p <0.05) compared to vehicle in a clinical trial in patients with tinea pedis, or athlete’s foot. Clinical activity against dermatophytes was measured by incidence of a negative fungal culture after two weeks of treatment.
Neurocrine Biosciences announced that the FDA has approved INGREZZA (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD. Following the news, Leerink analyst Paul Matteis increased his price target to $68 from $65; Jefferies analyst Biren Amin increased his price target to $65 from $58.
Synergy Pharmaceuticals announced that the USPTO has issued three new patents covering TRULANCE (plecanatide). The first patent relates to the method for manufacturing TRULANCE and will expire March 1, 2032. The two other patents relate to formulations and methods of using TRULANCE for treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) at 3mg or 6 mg dose; both of these patents will expire September 15, 2031.
Protalix BioTherapeutics announced positive results from the Company’s Phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF). Sixteen patients were enrolled in the study, all of whom completed the study. alidornase alfa is a plant cell-expressed, chemically-modified recombinant DNase enzyme resistant to inhibition by actin, which the Company has specifically designed to enhance the enzyme’s efficacy in CF patients.
BioCryst Pharmaceuticals announced today plans to explore a new oral liquid formulation of BCX7353 for the treatment of acute attacks in patients with hereditary angioedema (HAE). The Company has received initial regulatory approvals in Europe to initiate the ZENITH-1 exploratory clinical trial this summer.
Oncolytics Biotech announced its initial registration pathway and clinical development plan for REOLYSIN, its proprietary immuno-oncology viral agent. The Company’s clinical development plan has two main objectives. The primary objective is to obtain regulatory approval for REOLYSIN as quickly as possible and is based on the compelling metastatic breast cancer survival data recently presented at the American Academy of Cancer Research (AACR) Annual Meeting, in Washington, D.C. The second objective is to expand REOLYSIN into commercially valuable new treatment areas that include immunotherapy and immunomodulatory (IMiD) agents in collaboration with pharmaceutical partners.
Dicerna Pharmaceuticals announced that it has closed its previously announced stock purchase transaction for the sale of redeemable convertible preferred stock to a syndicate of current and new investors led by Bain Capital Life Sciences, under which the Company received gross proceeds of $70.0 million. Under terms of the Preferred Stock purchase agreement, Adam M. Koppel, M.D., Ph.D., a managing director of Bain Capital Life Sciences, has joined Dicerna’s Board of Directors, which has been expanded to nine seats.
Neuralstem announced that a new cohort of four patients will be added to its ongoing Phase I human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair chronic spinal cord injury (cSCI). The amended protocol was approved by the FDA and the Institutional Review Board at the study site, University of California San Diego (UCSD). NSI-566 is Neuralstem’s lead stem cell therapy candidate.
Five Prime Therapeutics announced that it has completed enrollment in the initially planned 30-patient cohort of the Phase II part of the ongoing clinical trial evaluating cabiralizumab in patients with tenosynovial giant cell tumor, diffuse type, also known as pigmented villonodular synovitis (PVNS), an aggressive tumor confined to the synovium.
Kadmon Holdings announced the publication of clinical data from its completed Phase II open-label clinical trial of KD025, its oral Rho-associated coiled-coil kinase 2 (“ROCK2”) inhibitor, in patients with moderate to severe psoriasis. In the study, KD025 treatment improved clinical scores and skin pathology in psoriasis patients via concurrent modulation of the pro- and anti-inflammatory immune cell response. The results were published this week in the Cutting Edge section of the Journal of Immunology.
Cytori Therapeutics announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Cytori currently intends to use the net proceeds of the offering for working capital and general corporate purposes, including funding of the HABEO and ATI-0918 development programs. Maxim Group is acting as sole book-running manager for the offering.
Axovant Sciences announced that it has commenced an underwritten public offering of $100 million of its common shares. In connection with this offering, Axovant expects to grant the underwriters a 30-day option to purchase up to an additional $15 million of its common shares in the offering on the same terms and conditions. J.P. Morgan Securities and Morgan Stanley are acting as joint book-running managers for the offering.
Cellectar Biosciences announced it has appointed John Friend, II, M.D. as vice president and chief medical officer effective April 17, 2017.
Piper Jaffray analyst Steven Breazzano initiated coverage of Prothena with an “overweight” rating and $69 price target, citing a favorable view of the company’s lead drug, NEOD001 for AL amyloidosis.
Aegis analyst Robert LeBoyer initiated coverage of Neurotrope with a “buy” rating and $31 price target, citing the company is developing Bryostatin-1 as a stimulator of PKCε, an early regulator of brain cell growth and repair.
Ladenburg Thalman analyst Kevin DeGeeter initiated coverage of Cidara Therapeutics with a “buy” rating and $11.25 price target, citing CDTX has a balanced portfolio of infectious disease therapeutics led by an experienced management team with a track record of successful clinical development and returning value for shareholders.
Piper Jaffray analyst initiated coverage of Tesaro with an “overweight” rating and $180 price target, citing a LT bullish view of the PARPi class, and TSRO’s recently approved Zejula (niraparib) in ovarian cancer is poised to become a major blockbuster driven by broad use in multiple solid tumors.