BioShares Biotechnology Clinical Trials (BBC): $23.65, +$0.12, +28.5% YTD
BioShares Biotechnology Products (BBP): $38.47, +$0.21, +17.5% YTD
The dollar strengthened, while U.S. stock index futures edged lower ahead of the interest rate decision by the Federal Reserve at the end of a two-day meeting on Wednesday. Producer price index data is on the economic calendar. European shares fell as uncertainty surrounding the Dutch and French elections weighed on market sentiment, while Asian stocks closed higher mostly. Oil prices slipped as investors waited for key data that may shed light on a global supply glut. Gold was little changed.
STRATA Skin Sciences announced an agreement to license the exclusive US distribution rights for the Ellipse family of products from Ellipse USA. Under the terms of the agreement, STRATA will be the exclusive distributor of Ellipse lasers for three years, with an automatic extension out to a five-year term as long as minimum sales targets are achieved. STRATA will pay an annual license fee as well as a commission for each system sold. As part of the transaction, the majority of sales and marketing professionals from Ellipse USA will be joining STRATA’s team.
Albireo Pharma announced financial results for the year ended December 31, 2016. Albireo reported a net loss of $16.3 million for the year ended December 31, 2016, compared with a net loss of $6.8 million for 2015. As of December 31, 2016, cash and cash equivalents totaled $29.9 million. Based on current operating plans, Albireo expects that its current cash resources will be sufficient to meet its operating requirements at least through mid 2018.
OncoSec Medical Incorporated has entered into a Technology Access Program (TAP) agreement with Inhibrx, LP, a privately held biotherapeutic company. Under the agreement, Inhibrx will use OncoSec’s proprietary gene delivery technologies; the GENESIS™ research generator and proprietary applicators, for preclinical discovery of antibodies.
Transgene announced the dosing of the first patient of the Phase 2 trial evaluating TG4010 in combination with Opdivo® (nivolumab) for the treatment of metastatic non-small cell lung cancer (NSCLC) after failure of one line of platinum-based chemotherapy.
Aurinia Pharmaceuticals announced the pricing of its underwritten public offering of 22,300,000 common shares (the “Offering”). The shares are being sold at a public offering price of US$6.75 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$150.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about March 20, 2017, subject to the satisfaction of customary closing conditions.
Heron Therapeutics will present at the Oppenheimer 27th Annual Healthcare Conference on Tuesday, March 21, 2017, at 10:55 a.m. ET.
Lipocine will present a company overview at the 27th Annual Oppenheimer Healthcare Conference on Tuesday, March 21, 2017 at 4:30 p.m. ET.
Rockwell Medical will hold a conference call to discuss fourth quarter and year end 2016 financial results on Wednesday, March 15, 2017 at 4:30pm Eastern Time.
Biocept announced a collaboration with Catalyst Pharmaceuticals for the provision of Biocept’s Target Selector platform to screen patients diagnosed with LEMS for early onset or recurrence of small cell lung cancer (SCLC). Specifically, Biocept’s liquid biopsy tests will be offered by Catalyst Pharmaceuticals at no cost to all patients enrolled in its ongoing Phase III clinical trial designed to demonstrate the safety and efficacy of Firdapse (amifampridine phosphate) for the treatment of LEMS. These patients will also have access to Biocept’s liquid biopsy testing in the long-term extension study phase of the trial allowing for testing every six months for up to two years to monitor for early signals of SCLC. Terms of the agreement were not disclosed.
Tonix Pharmaceuticals announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application 14/214,433, “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride,” covering the proprietary sublingual formulation of TNX-102 SL. A Notice of Allowance signifies that Tonix will be entitled to receive patent protection until 2034 in the U.S. for the allowed claims when the patent is issued. Tonix expects the patent to be issued within two months.
Allergan and Editas Medicine announced that Allergan’s wholly-owned subsidiary, Allergan Pharmaceuticals International Limited, and Editas Medicine have entered into a strategic research and development alliance under which Allergan will receive exclusive access and the option to license up to five of Editas Medicine’s genome-editing ocular programs, including its lead program for Leber Congenital Amaurosis (LCA10), which is currently in pre-clinical development.
Pacira Pharmaceuticals reported that a Phase IV study of its injectable treatment Exparel in patients undergoing total knee arthroplasty achieved statistical significance for its co-primary endpoints for postsurgical pain and opioid reduction.
AbbVie announced that priority review has been granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) for its investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes (GT1-6) of the chronic hepatitis C virus (HCV). This priority review follows EMA accelerated assessment and FDA priority review designations in December 2016 and January 2017 respectively. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.
Sanofi, and its specialty care global business unit, Sanofi Genzyme, announced that the UK’s MHRA has granted dupilumab, an investigational treatment for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision means that eligible adults with severe AD can access dupilumab before the drug is granted marketing authorization in the UK.
Pfizer announced that Zavicefta, a novel combination antibiotic for the treatment of patients with certain confirmed or suspected Gram-negative bacterial infections requiring hospitalization, is now available in the U.K. and Germany. Pfizer expects to launch Zavicefta in additional markets outside the U.S. throughout 2017 and 2018. Zavicefta was developed in response to the urgent medical need for new antibiotics for difficult-to-treat Gram-negative bacteria, many of which have become increasingly resistant to currently available antibiotics.
Novartis announced that the FDA has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Reuters reported that Billionaire investor William Ackman walked away from Valeant Pharmaceuticals International with a loss of more than $3 billion as he sold his entire stake in the struggling drug company after trying to rescue it for some 18 months.
Galectin Therapeutics announced preliminary results for severe and refractory atopic dermatitis from a small, open label, investigator-initiated study with GR-MD-02 that has enrolled 3 patients. There were no serious adverse events observed. All three patients showed clinical response as determined by reduction of the Eczema Area and Severity Index (EASI) score at week 12 having received 6 every other week doses, with two patients achieving a 64% and 74% reduction in EASI, respectively, at six weeks after receiving only 3 doses of GR-MD-02 (see graph below). These findings are believed to demonstrate a clinically significant effect of this novel investigational drug in this patient population.
AMO Pharma announced it has entered a collaboration agreement with Ranedis Pharmaceuticals to progress the development of RND-001 for rare genetic diseases, including certain lysosomal storage disorders and other diseases affecting the central nervous system. In addition, Ranedis has granted AMO an exclusive option to acquire the worldwide rights to RND-001 during the collaboration period. Terms of the deal were not disclosed.
Sanofi and Voluntis announced a non-exclusive agreement to deliver digital insulin titration solutions, featuring a mobile phone application designed to help improve decision-making and self-management of type 2 diabetes for people treated with basal insulin. The application will also enable remote monitoring by health care teams. The agreement reinforces the existing alliance between the two companies, established in 2011, by expanding both its scope and geography.
Lung Therapeutics announced the enrollment of the first patient in a Phase I a/b clinical trial for LTI-01, designed to treat loculated pleural effusions. The company had previously received clinical trial approval for the company’s drug candidate, LTI-01, which is being conducted at three sites each in Australia and New Zealand.
RepliCel Life Sciences announced the successful completion of its first-in-human clinical study of the Company’s autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).
MetrioPharm announced positive top-line results from its Phase IIa trial with its proprietary drug compound MP1032 in patients with moderate-to-severe plaque psoriasis.
CRISPR Therapeutics and Casebia Therapeutics, a joint-venture established by CRISPR Therapeutics and Bayer AG for developing CRISPR-based therapeutics in select disease areas, announced they have signed a joint commercial license agreement with MaxCyte.
Fortress Biotech announced the launch of a new subsidiary, Cyprium Therapeutics to develop novel therapies for the treatment of Menkes disease and related copper metabolism disorders. As part of its formation, Cyprium has entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health (NIH), to advance the clinical development of Phase III candidate CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD have entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in Menkes patients, and to be used in combination with CUTX-101.
Aytu BioScience announced the publication of a peer-reviewed journal article demonstrating the clinical utility of the Company’s MiOXSYS System for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in men. The article, titled, "Clinical Relevance of Oxidation-Reduction Potential in the Evaluation of Male Infertility," will be published in the high profile medical journal Urology, the "Gold Journal", and is currently available online ahead of print.
Cellectar Biosciences announces the Japanese Patent Office has granted a composition of matter patent for the company’s optical imaging phospholipid drug conjugates (PDCs), CLR 1501 and CLR 1502.
Reuters reported that Alexion Pharmaceuticals said it has initiated a company-wide restructuring that will affect about 7 percent of its workforce.
Anthera Pharmaceuticals announced the pricing of an underwritten public offering of 30,000,000 shares of its common stock at a price of $0.50 per share and two tranches of warrants to purchase an aggregate of 60,000,000 shares of its common stock. The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company, are expected to be $15.0 million. If exercised in full for cash, the warrants could result in additional gross proceeds of up to $31.5 million to the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock and/or warrants offered in the public offering. The offering is expected to close on or about March 17, 2017, subject to customary closing conditions. The initial per share exercise price of the Tranche 1 warrants is $0.55 and the initial per share exercise price of the Tranche 2 warrants is $0.50, each subject to adjustment as specified in the warrants. The Tranche 1 and Tranche 2 warrants will become exercisable on any day on or after the date that the Company publicly announces through the filing of a Current Report on Form 8-K that it will have sufficient authorized shares of common stock (the “Exercisable Date”) and will expire five years following the Exercisable Date and six months following the Exercisable Date, respectively. Rodman & Renshaw, a unit of H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.
CTI Biopharma announced in an 8-K that Louis A. Bianco resigned as the Executive Vice President, Finance and Administration, Chief Governance Officer and Secretary of CTI BioPharma Corp. effective immediately. Bruce J. Seeley, the Company’s Executive Vice President, Chief Commercial Officer, will serve as the principal financial officer of the Company, effective immediately, and will assume the title of Executive Vice President, Chief Commercial and Administrative Officer and Secretary.
Following Bellicum’s earnings, Jefferies analyst Biren Amin decreased his price target to $19 from $22; SunTrust analyst Peter Lawson decreased his price target to $28 from $30.
Piper Jaffray analyst Edward Tenthoff initiated coverage of Kadmon Holdings with an “overweight” rating and $7 price target, citing Kadmon is a fully-integrated biotech company that is developing novel therapies to treat cancer, autoimmune, fibrotic and orphan diseases.
JP Morgan analyst Whitney Ijem initiated coverage of Acceleron Pharma with a “neutral” rating and $33 price target, citing the company’s lead candidate, luspatercept, developed in collaboration with CELG, has shown clear efficacy/safety in the treatment of anemia.
Following Amphastar’s earnings, Raymond James analyst Elliot Wilbur downgraded the stock to “outperform” from “strong buy” and decreased his price target to $18 from $21; BMO analyst Gary Nachman decreased his price target to $16 from $18; Piper Jaffray analyst David Amsellem decreased his price target to $20 from $22.
Guggenheim analyst Louise Chen initiated coverage of Opko Health with a “buy” rating and $25 price target, citing expect upwards earnings revisions to levels not reflected in consensus and multiple expansion (from diagnostic to hybrid diagnostic/pharma multiple) to drive shares higher.
BMO analyst Gary Nachman decreased his price target of Valeant to $15 from $19, citing Pershing announced it sold its entire stake in VRX, mainly attributed to a disproportionately large amount of time and resources required to manage the investment and a decision to realize a large tax loss and dedicate more time to the rest of the portfolio.