BioShares Biotechnology Clinical Trials (BBC): $21.66, -$0.19, +17.7% YTD
BioShares Biotechnology Products (BBP): $36.49, -$0.06, +11.4% YTD
U.S. stock index futures were little changed as focus shifted to monthly payrolls report due later in the day for further cues on the health of the economy. European markets fell as mining and financial stocks slipped, while Asian stocks ended on a mixed note. Gold prices rose as bids for safe-haven assets picked up after the United States fired dozens of cruise missiles at a Syrian airbase, escalating tensions with Russia and Iran. Oil prices hit a one-month high on concerns that the conflict could spread in the oil-rich region.
Bellerophon Therapeutics released clinical data from a poster presented at the 37th Annual Meeting for the International Society for Heart and Lung Transplantation (ISHLT) in San Diego, CA on April 6th. The poster Effects of Ambulatory Inhaled Nitric Oxide on Exercise Induced Increases in Pulmonary Pressures featured data from an investigator led study of INOpulse® in patients with pulmonary arterial hypertension (PAH).
Catalyst Biosciences announced the pricing of an underwritten public offering of units for gross proceeds of $18 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Catalyst. Ladenburg Thalmann & Co., a subsidiary of Ladenburg Thalmann Financial Services, is sole book-running manager in connection with the offering.
Aurinia Pharmaceuticals announced the outcome of discussions with both the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active lupus nephritis (LN). Pursuant to these discussions, the Company believes that the confirmatory data that can be generated from the single Phase III clinical trial (AURORA) and the recently completed AURA-LV (AURA) Phase IIb study should support regulatory submissions in the US, Europe and Japan.
Bioblast Pharma announced the cancellation of its previously announced underwritten public offering of the Company’s securities due to adverse market conditions. H.C. Wainwright had been serving as the underwriters for the proposed offering. The offering was conducted pursuant to a registration statement Form F-1 filed with the SEC. The Company will provide a business update in the near future that deals with its financing plans and clinical development program for patients with Ocular Pharyngeal Muscular Dystrophy (OPMD) using its investigational proprietary intravenous (IV) form of trehalose 90 mg/mL solution.
STRATA Skin Sciences announced a reverse stock split of its shares of common stock at a ratio of 1-for-5. At the opening of trading on April 7, 2017, STRATA’s common stock will begin trading on a split-adjusted basis and the number of shares of STRATA’s common stock outstanding will decrease from approximately 10.9 million pre-split shares to approximately 2.2 million post-split shares. STRATA’s new CUSIP number will be 86272A 206, and its common stock will continue to trade on The Nasdaq Capital Market under the symbol “SSKN.”
Merck announced that the FDA has issued a CRL regarding Merck’s sNDA for JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin HCl) and JANUMET XR (sitagliptin and metformin HCl extended-release). With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss next steps with the FDA.
Kura Oncology a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the first patient has been dosed in its Phase I clinical trial of KO-947, a potent and selective small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2).
AbbVie, in cooperation with Neurocrine Biosciences, announced detailed results from a Phase IIb clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo. The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo.
Medivir AB announced the completion of the Phase II clinical study of the topical, skin-directed histone deacetylase (HDAC) inhibitor, remetinostat, in patients with early stage CTCL. The trial included 60 patients with the mycosis fungoides (MF) variant of CTCL, who were randomized to receive either 0.5% remetinostat gel BID, 1% remetinostat gel QD or 1% remetinostat gel BID for between 6 and 12 months. The primary end-point of the study was the proportion of patients with either a complete or partial confirmed response to therapy, assessed using the Composite Assessment of Index Lesion Severity (CAILS). Based on an intent-to-treat analysis, patients in the 1% remetinostat gel BID arm had highest proportion of confirmed responses (8/20, 40%), including 1 complete response. The response rates in the other two arms were 5/20 (25%) and 4/20 (20%) in the 0.5% BID arm and the 1% QD arm respectively, and did not include any complete responses. Across all the dose groups, remetinostat was well-tolerated without signs of systemic adverse effects, including those associated with systemic HDAC inhibitors.
Galapagos announced a share capital increase arising from warrant exercises. Galapagos issued 247,070 new ordinary shares on 6 April 2017, for a total capital increase (including issuance premium) of €4,033,858.30. Pursuant to the warrant exercise program of Galapagos’ executive committee, executive committee members automatically are committed to exercise a minimum number of warrants, subject to certain conditions. In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 warrants. Two other executive committee members exercised an aggregate number of 10,000 warrants. In addition to Onno van de Stolpe, one other board member exercised 5,400 warrants.
PeptiDream announced that it has entered into a multi-target discovery and optimization collaboration with US-based Janssen Pharmaceuticals, one of the JanssenPharmaceutical Companies of Johnson & Johnson. Under the agreement, facilitated by Johnson & Johnson Innovation, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to identify macrocyclic/constrained peptides against multiple metabolic and cardiovascular targets of interest selected by Janssen, and to optimize hit peptides into therapeutic peptides or small molecule products. Janssen also holds an exercisable option to peptide-drug conjugate (PDC) use and applications. Janssen will have the right to develop and commercialize all compounds resulting from the collaboration. Under the terms of the agreement, PeptiDream would receive an undisclosed upfront payment and research funding and is eligible to receive preclinical, clinical, and commercialization milestone payments potentially totaling up to $1.15 billion. In addition, PeptiDream is eligible to receive royalties on sales of any products that arise from the collaboration.
VWR announced that it has acquired MESM Ltd., a provider of laboratory and medical equipment and ancillary supplies to clinical trials worldwide.
Flexion Therapeutics announced that Yamo Deniz, MD, has been named Chief Medical Officer. This appointment strengthens the company’s leadership with an industry veteran who brings extensive experience leading medical and clinical development teams at major biotechnology and pharmaceutical companies.
Barclays analyst Geoff Meacham increased his price target of Incyte to $185 from $135, citing the IDO landscape is increasingly tilting in favor of Incyte’s epacadostat and increased confidence in the upcoming FDA approval and differentiation of Olumiant (baricitinib) following checks with rheumatologists.
Mizuho analyst Irina Koffler increased her price target of Ironwood Pharmaceuticals to $22 from $21, citing a more bullish outlook on the IW-3718 refractory GERD program.
Leerink analyst Geoffrey Porges decreased his price target of Biogen to $290 from $300, citing the FDA granted approval to Roche’s Ocrevus (Ocrelizumab) for the treatment of both relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS).