Saturday, January 24, 2015
- Redwood City, CA-based Avinger (Pending:AVGR) is set for its IPO of 4,615,384 shares of common stock at $12 - 14.
- The commercial stage medical device company develops image-guided, catheter-based systems used by doctors to treat patients with peripheral arterial disease (PAD). Its current products include the Lightbox imaging console and a family of catheters (Wildcat, Kittycat, Ocelot) which allow physicians to penetrate a total blockage in an artery (chronic total occlusion). A key product in development is the Pantheris, an image-guided atherectomy device that allows physicians to remove arterial plaque in PAD patients with precision.
- Financial performance:
- 2014 (9 mo.) ($000): Revenues: 8,140 (-14.9%); Operating Expenses: 21,250 (-36.1%); Net Loss: (23,829) (+23.9%); CF Ops: (15,748) (+52.9%).
- 2013: Revenues: 12,964 (+51.4%); Operating Expenses: 41,731 (+9.1%); Net Loss: (39,901) (-17.8%); CF Ops: (40,655) (-15.4%).
- The FDA approves NPS Pharmaceuticals' (NASDAQ:NPSP) Orphan Drug-designated Natpara (parathyroid hormone) to control hypocalcemia (low blood calcium) in patients with hypoparathyroidism, a rare disease that affects ~60K people in the U.S.
- Natpara will now enjoy a seven-year period of market exclusivity for this indication as stipulated under Orphan Drug status.
- Previously: PDUFA approaches for NPS Pharma's Natpara (Jan. 22)
Friday, January 23, 2015
- The FDA approves Novartis' (NYSE:NVS) Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals ages 10 through 25.
- This approval, including Pfizer's clearance in October, covers the last remaining uncovered main serogroup of N. meningitidis bacteria that causes meningococcal disease: A, B, C, W and Y.
- Previously: Pfizer seeks regulatory approval for meningitis vaccine (June 17, 2014)
- Previously: Novartis submits BLA for vaccine (June 17, 2014)
- The FDA allows the marketing of Dexcom's (NASDAQ:DXCM) Share mobile app that enables diabetics to share data from a continuous glucose monitor (CGM) in real time from an Apple mobile device thereby enabling caregivers to remotely monitor a patient's blood sugar levels.
- The Dexcom Share system displays data from the G4 Platinum CGM System via two apps: one installed on the patient's mobile device and the other installed on the mobile device of another person. The real-time data is transmitted to a web-based storage location where the app "follower" can download and display also in real time.
- The device is classified as Class II which means a premarket submission was not required.
- The Board of Directors of Mallinckrodt (MNK +1.5%) approves an open-ended $300M share repurchase program.
- CEO Mark Trudeau says, "Funding additional initiatives and seeking attractive business development opportunities remain top priorities as we continue to pursue a range of focused growth strategies. This authorization reflects our strong financial position and commitment to a disciplined capital allocation strategy while reaffirming our confidence in the company's outlook and long-term potential. It also gives us the flexibility to execute share repurchases in a measured and opportunistic manner over time."
- Hellerup, Denmark-based Ascendis Pharma A/S (Pending:ASND) is set for its IPO of 5M ordinary shares at $16 - 18.
- The clinical stage biopharmaceutical company develops long-acting prodrugs to address significant unmet medical needs. Its lead product candidate is TransCon human growth hormone (TransCon hGH), a once-weekly treatment for growth hormone deficiency currently in Phase 2.
- Other pipeline products are TransCon Treprostinil for pulmonary arterial hypertension, TransCon Insulin (in partnership with Sanofi) for diabetes and TransCon Ranibizumab (in partnership with Genentech) for ophthalmic indications.
- The company's products are based on its proprietary TransCon technology which extends a drug's action in the body.
- Dublin, Ireland-based Presbia PLC (Pending:LENS) is set for its IPO of 4,166,667 shares of common stock at $11 - 13.
- The commercial stage ophthalmic device company markets a proprietary optical lens implant called Flexivue Microlens for the treatment of presbyopia which is the age-related loss of near vision. The device is implanted in a minimally invasive procedure, does not compromise the patient's far vision and is invisible to the naked eye once in place. It is CE Mark-approved in the European Union but not cleared for sale in the U.S. It plans to submit a Premarket Approval Application (PMA) to the FDA in late 2017.
- Financial performance:
- 2014 (9 mo.) ($000): Revenues: 125 (+131.5); Operating Expenses: 11,058 (+133.1%); Net Loss: (12,718) (-94.7%); CF Ops: (7,375) (-101.3%).
- 2013: Revenues; 98 (+3.2%); Operating Expenses: 7,268 (+101.2%); Net Loss: (9,462) (-87.5%); CF Ops: (4,821) (-58.4%).
- Philadelphia, PA-based Spark Therapeutics (Pending:ONCE) is set for its IPO of 5.5M shares of common stock at $15 - 17.
- The clinical stage gene therapy firm develops treatments for orphan diseases. Its lead product candidate is SPK-RPE65, currently in Phase 3 for the treatment of rare blinding conditions called inherited retinal dystrophies (IRDs) which are caused by mutations in the RPE65 gene. The FDA has designated SPK-RPE65 a Breakthrough Therapy and an Orphan Drug for this indication. The company plans to submit its Biologics License Application (BLA) to the FDA in 2016.
- It has established human proof-of-concept using gene therapy to express a therapeutic gene in the liver as part of its SPK-FIX program for the potential treatment of hemophilia B, which is caused by a mutation in the Factor IX (FIX) gene. Last month, it entered into a global collaboration with Pfizer to develop and commercialize SPK-FIX.
- Thinly-traded nano cap Egalet (EGLT +32.7%) has jumped almost 60% since yesterday in response to its announcement of positive results from a Category 3 human abuse liability (HAL) study of Egalet-001 (abuse deterrent extended release oral morphine). The study showed that the abuse potential of Egalet-101 taken orally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).
- Egalet-001's abuse deterrent characteristics are based on the company's Guardian technology which makes the pill extremely hard, difficult to chew and resists common methods of physical and chemical manipulation. For example, it turns to gel when exposed to water.
- The company will disclose the results from additional abuse-deterrent studies later this year.
- Related tickers: (ZGNX +2.3%)(ACUR -1.6%)(ALKS +0.4%)
- Recent IPO Nevro (NVRO +16.5%) moves up on increased volume in response to its announcement that it received a letter from the FDA informing the company that its Premarket Approval Application (PMA) for the Senza spinal cord stimulation system (SCS) is approvable. According the letter, the approval is contingent on the satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza as well as finalization of labeling.
- The Senza system utilizes low frequency spinal cord stimulation, typically between 40 Hz and 60 Hz, to treat chronic pain such as persistent back pain.
- NVRO's chart action today is notable in light of the extended price range, specifically the intraday high of $65.50. This was an opening bell fill of only 2,201 shares. Some unlucky investor either forgot to put limit on his stop order or made the mistake of entering at the market.
- The FDA's Dermatology and Ophthalmic Drugs Advisory Committee will review Kythera Biopharmaceuticals' (KYTH +0.7%) New Drug Application (NDA) for ATX-101 (deoxycholic acid), its injectable drug candidate for the reduction in submental fat or double chin, on March 9.
- The PDUFA date, based on the NDA submission date of May 12 of last year, is May 13.
- Progenics Pharmaceuticals (PGNX -1.9%) doses the first patient in the relaunched Phase 2 study assessing its Fast Track-designated radiotherapeutic Azedra in patients with malignant pheochromocytoma and paraganglioma, two rare neuroendocrine tumors that arise from cells of the sympathetic nervous system.
- The primary efficacy endpoint is the clinical benefit as measured by the proportion of patients with a reduction of all antihypertensive medication by at least 50% for a minimum of six months. The Special Protocol Assessment (SPA) requires that a quarter of the 58 patients (14) achieve the primary endpoint.
- Progenics acquired the rights to Azedra via its 2013 acquisition of Molecular Insight Pharmaceuticals. MIP suspended the trial in 2010 due to lack of funding.
- Previously: Progenics to relaunch Azedra study (Nov. 25, 2013)
- Array BioPharma (NASDAQ:ARRY) acquires worldwide rights to Novartis' (NYSE:NVS) encorafenib, a BRAF inhibitor currently in Phase 3 development for the treatment of melanoma, contingent on the closing of the Novartis/Glaxo transaction that was announced last April.
- Under the terms of the agreement, Array will make a de minimus (minimal) payment to Novartis but no milestones or royalties will be paid by either party. Novartis will provide transitional regulatory, clinical development and manufacturing services. Specifically, it will conduct and fund the Phase 3 Columbus trial through the earlier of June 30, 2016 or the completion of the first visit from the last patient. Array will take responsibility for the trial at this point with Novartis reimbursing Array for out-of-pocket costs in addition to half of Array's full-time equivalent (labor) costs associated with completing the trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined period. For all studies transferred to Array, Novartis will reimburse Array under the same guidelines as it will for the Columbus trial.
- Array agrees to recruit a partner that has experience in global development and commercialization.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting marketing authorization for Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion (CRVO/BRVO).
- Eylea is currently approved in the EU for the treatment of age-related macular degeneration, diabetic macular edema and macular edema following central vein occlusion.
- A final decision by the European Commission usually takes ~60 days.
- Incyte (NASDAQ:INCY) earns a $25M milestone payment from Novartis (NYSE:NVS) triggered by the positive opinion from Europe's Committee for Medical Products for Human Use (CHMP) supporting marketing authorization for Jakavi (ruxolitinib) for the treatment of adults with polycythemia vera.
- The company will record the amount as contract revenue and expects to receive payment this quarter.
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