Friday, November 21, 2014
- Geron Corp. (GERN +12%) climbs again today on double normal volume. Shares are up almost 60% since its imetelstat development deal with Johnson & Johnson unit Janssen Biotech was announced on November 13.
- Previously: Geron wins deal to develop blood disorder drug, could get $935M
- CB Pharma Acquisition Corp. (CNLMU) files for an IPO of 4M units priced at $10 per unit. Each unit consists of one share of common stock, one right to purchase 1/10 of a share of common stock on the consummation of an initial business combination and one warrant to purchase 1/2 of one share of common stock at a full-share price of $11.50.
- The firm is a blank check company formed by Coronado Biosciences (CNDO +0.5%). It will seek business combinations via mergers, share exchanges, asset acquisitions, share purchases, recapitalizations or reorganizations.
- It has 18 months from the consummation of this offering to complete its initial business combination (up to 21 months in certain circumstances) or it will liquidate the trust account, distribute the proceeds to shareholders and dissolve.
- Per NASDAQ listing rules, the target business for the initial combination must have a fair market value equal to at least 80% of the value of the trust account.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS (NYSEARCA:IPO)
- November 26 is the PDUFA date for the FDA's decision on Avanir Pharmaceuticals' (AVNR +0.9%) NDA for AVP-825, its investigational drug-device combination for the acute treatment of migraines. Approval is unlikely, though. Earlier this month, the agency issued preliminary written feedback to the company where it questioned the human factor validation data in the submission.
- The FDA submitted its feedback via a Discipline Review Letter, which it employs to convey its preliminary opinion on possible deficiencies in an application. In the letter, the regulator requested that Avanir optimize the product-user interface and conduct additional human factor testing. Also, it stated that its review of the NDA was incomplete and it may have additional comments concerning the submission.
- Human factor testing focuses on the interactions between people and devices. The goal in testing is the evaluate use-related risks and to confirm that patients can use the device safely and effectively.
- Previously: Successful Phase 3 results for Avanir migraine product
- The FDA grants Orphan Drug status to Immunomedics' (IMMU -0.7%) humanized anti-CD20 antibody, veltuzumab, for the treatment of pemphigus, a rare autoimmune disease characterized by blistering of the skin and mucous membranes.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
- Genocea Biosciences (GNCA) enters into a loan and security agreement with Hercules Technology Growth Capital (HTGC) for a term loan of up to $27M.
- Proceeds from the initial draw of $12M will be used to repay the company's existing term loan facility, for working capital and general corporate purposes. Genocea can draw up to an additional $5M at its option through June 30, 2015. Two additional tranches of $5M can be drawn by December 15, 2015 contingent of the achievement of certain clinical and corporate milestones.
- The company also entered into an equity rights agreement whereby Hercules purchased 223,463 shares of Genocea's common stock at $8.95 per share.
- The FDA accepts Cerus Corp.'s (NASDAQ:CERS) IDE supplement to make its Intercept Blood System for plasma available to treat convalescent plasma collected from Ebola survivors for passive immune therapy. Transfusion of blood or plasma from recovered Ebola patients may benefit those with acute Ebola infections, although the plasma may carry undetected pathogens due to prior exposure.
- The trial will begin at Emory University Hospital and the University of Nebraska Medical Center. Emory is equipped to collect Ebola convalescent plasma from recovered patients and perform the Intercept treatment on site. After the CDC tests for Ebola antibodies, the treated plasma will be stored at Emory. It will also supply other Ebola treatment centers, such as the University of Nebraska, with the plasma.
- In an effort to build the supply of convalescent plasma, Cerus and the trial investigators are working with the American Red Cross and America's Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.
- The Bill & Melinda Gates Foundation recently made a $5.7M commitment to support efforts in Ebola-stricken African countries to scale up production and evaluation of potential Ebola therapies, including convalescent plasma treated with pathogen inactivation.
- The Intercept System has been commercially available in Europe for eight years. It is currently under FDA review in the U.S.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of AbbVie's (NYSE:ABBV) Viekirax (a combination of ombitasvir, paritaprevir and ritonavir) plus Exviera (dasabuvir), with or without ribavirin, for patients with chronic HCV genotype 1 infection and Viekirax only, with ribavirin, for patients with HCV genotype 4 infection. A final decision by the European Commission usually takes about 60 days.
- The FDA tagged Viekirax a Breakthrough Therapy and granted priority review of AbbVie's NDA in June.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:CNAT) (NASDAQ:ACHN)
- Previously: Enanta declines HCV drug co-development option with AbbVie
- Previously: AbbVie presents HCV/HIV and liver transplant HCV data
- Amedica Corp. (NASDAQ:AMDA) prices its public offering of 11.4M units at $1.14 per unit. Each unit consists of one share of common stock and one warrant to purchase one share of common stock at $1.48. Underwriters over-allotment is 1.7M shares of common stock and/or 1.7M warrants. Closing date is November 26, 2014.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Boehringer Ingelheim's Ofev (nintedanib) for the treatment of patients with ideopathic pulmonary fibrosis. A final decision from the European Commission usually takes about 60 days.
- The FDA approved Ofev last month.
- Previously: Good day for sufferers of IPF
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Celgene's (NASDAQ:CELG) Otezla (apremilast) for two indications: 1. the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or who are contraindicated for or are intolerant to, other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA); 2. alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. A final decision from the European Commission usually takes about 60 days.
- Apremilast is a PDE4 inhibitor specific for cyclic AMP (cAMP). PDE4 inhibition results in increased cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.
- The FDA approved Otezla in March.
- Previously: FDA approves Otezla
- Previously: Otezla label expansion cleared in the U.S.
- Related tickers: (NYSE:PFE) (NYSE:SNY) (OTCQB:SNYNF) (NYSEMKT:PLX) (NASDAQ:SHPG)
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Genzyme's (NYSE:SNY) (OTCQB:SNYNF) Cerdelga (eliglustat) capsules for the treatment of certain adults with Gaucher disease type 1. A final decision by the European Commission usually takes about 60 days.
- The FDA approved Cerdelga in August. It was the first oral therapy approved as a first-line treatment for Gaucher.
- Previously: FDA approves new drug for Gaucher's disease
- Related tickers: (NYSE:PFE) (NYSEMKT:PLX) (NASDAQ:SHPG)
7:27 AM| Comment!
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting regulatory approval for Novartis' (NYSE:NVS) secukinumab for the first-line systemic treatment of adult patients with moderate-to-severe plaque psoriasis. A final decision by the European Commission usually takes about 60 days.
- Secukinumab is an interleukin-17A inhibitor and will be sold under the brand name Cosentyx. It will compete with Amgen's (NASDAQ:AMGN) Enbrel (etanercept) which generated $4.6B in sales the past four quarters. In clinical trials, secukinumab demonstrated superiority to etanercept in skin clearance measurements.
- Last month, an FDA advisory committee voted unanimously in favor of approval for secukinumab for the same indication.
- Previously: Ad Comm backs approval of secukinumab
- Sirona Dental Systems (SIRO +1.4%) FQ4 results: Revenues: $290M (+4.1%); COGS: $130.1M (-3.8%); R&D Expense: $16.5M (+7.8%); SG&A: $87.6M (+6.1%); Operating Income: $58.3M (+21.7%); Net Income: $42.7M (+18.0%); EPS: $0.76 (+16.9%).
- FY2014 results: Revenues: $1,171.1M (+6.3%); COGS: $529.4M (+3.8%); R&D Expense: $64.6M (+7.3%); SG&A: $350.9M (+5.4%); Operating Income: $238.1M (+11.9%); Net Income: $175.7M (+19.7%); EPS: $3.13 (+19.9%); Quick Assets: $382.8M (+58.4%); CF Ops: $248.4M (+7.0%).
- 2015 Guidance: Revenue growth: 6 - 8% ; non-GAAP EPS: $3.95 - 4.05.
6:36 AM| Comment!
- Valeant Pharmaceuticals (NYSE:VRX) has slashed its stake in Allergan (NYSE:AGN) to 0.1% from 9.7%, three days after Actavis (NYSE:ACT) trumped its offer for the Botox maker.
- Pershing Square and Valeant have now sold all 2.2M Allergan in PS Fund 1, a shell fund that was set up by the two to act as a joint acquisition vehicle.
- VRX -0.8% AH