Today - Monday, May 4, 2015
- Auris Medical's (EARS +0.9%) development plan for Orphan Drug-designated AM-111 includes two pivotal clinical trials in idiopathic (cause unknown) sudden sensorineural hearing loss ((ISSNHL)), which is the most frequent type of acute sensorineural hearing loss (ASNHL).
- The first trial, called HELIOS, will commence in Q3 and will enroll ~255 patients in Europe and Asia. The second trial, called ASSENT, will be based in the U.S. and commence enrollment in Q1 2016. Both groups will receive a single dose of AM-111 (either 0.4 mg/Ml or 0.8 mg/mL) or placebo. The number of subjects will be comparable with HELIOS. Patients in ASSENT may receive a course of oral corticosteroids as background therapy.
- The company is preparing a third Phase 2 trial, called REACH, that should commence in Q3 2016. In this study, patients with residual hearing who are undergoing cochlear implant surgery will receive AM-111 intraoperatively.
- AM-111 is a biodegradable gel that is administered in a single dose intratympanic injection into the middle ear. From there, the drug diffuses through the round window membrane into the cochlea. Its active ingredient is a synthetic peptide that inhibits the JNK stress kinase coupled to an intracellular transporter.
- In animal models of cochlear stress, AM-111's protective effects have been demonstrated in acute acoustic trauma, acute labyrinthitis, drug ototoxicity, bacterial infection, cochlear ischemia and cochlear implant trauma.
11:09 AM| Comment!
- Aquinox Pharmaceuticals (AQXP +0.4%) hits its enrollment target in a Phase 2 proof-of-concept trial, KINSHIP, evaluating its lead product candidate, AQX-1125, for the treatment of atopic dermatitis.
- The 50-subject randomized, double-blind, placebo-controlled study will assess AQX-1125 in patients with mild-to-moderate atopic dermatitis. The primary endpoint is the change in Total Lesion Symptom Score from baseline after 12 weeks of treatment.
- AQX-1125 is a small molecule activator of SHIP1, a regulating component of the PI3K signaling pathway which, if overactive, produces inflammation.
- Can-Fite BioPharma (CANF) subsidiary OphthaliX (OTCPK:OPLI) signs a non-binding term sheet to acquire Israel-based Improved Vision Systems, a developer of devices to improve sight. It is focused on two types of products: 1) an indoor eye tracking solution which can be attached to a TV, computer screen, etc. that manipulates the projected image in a way that best compensates for the user's clinical impairment and 2) a goggles-based mobile device that generates high definition displays that are manipulated and moved based on the movement of each eye, thereby enabling vision-impaired people to regain their independence and mobility.
- The proposed financial terms are not disclosed.
- Baxter International (BAX +0.6%) files a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking clearance for MM-398 (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. Merrimack Pharmaceuticals (MACK +3.5%), the original developer of MM-398, filed a New Drug Application (NDA) with the FDA in November.
- The companies inked an exclusive development and commercialization deal for MM-398 for ex-U.S. territories in September 2014. PharmaEngine has the rights in Taiwan.
- MM-398 is a nanotherapeutic consisting of the chemo agent irinotecan encapsulated in a liposomal sphere. It is being evaluated as a treatment of chemo-resistant tumors across multiple types of cancer.
- Previously: Merrimack pancreatic cancer product candidate Fast Track'd (Nov. 20, 2014)
- PetMed Express (PETS +2.3%) FQ4 results: Revenues: $50M (+2.9%); COGS: $33.1M (+6.1%); SG&A: $8.9M (-12.7%); Operating Income: $7.8M (+9.9%); Net Income: $5M (+11.1%); EPS: $0.25 (+8.7%).
- FY2014 results: Revenues: $229.4M (-1.7%); COGS: $153.1M (-1.7%); SG&A: $46.3M (-4.5%); Operating Income: $27.6M (-2.1%); Net Income: $17.5M (-2.8%); EPS: $0.87 (-3.3%); Quick Assets: $51.2M (+51.5%); CF Ops: $32M (+137.0%).
- No guidance given.
- Isis Pharmaceuticals (ISIS) enters into an exclusive license agreement with Bayer Healthcare (OTCPK:BAYRY -1%) to develop and commercialize ISIS-FXIrx for the prevention of thrombosis (blood clot).
- Under the terms of the agreement, Isis will receive an upfront payment of $100M and $55M upon the advancement of the program following a Phase 2 trial in patients with compromised kidney function. It is also eligible to receive milestone payments as the product approaches regulatory clearance plus tiered royalties in the low-to-high 20% range on gross margins of ISIS-FXIrx.
- Part of the clinical development program will include an evaluation of ISIS-FXIrx in patients for whom currently available anticoagulants are contraindicated, e.g., patients with a high risk of bleeding due to multiple co-morbidities.
- ISIS-FXIrx is an antisense drug that inhibits Factor XI, a clotting factor produced in the liver.
9:51 AM| Comment!
- Health Net (HNT) Q1 results: Revenues: $3,889.9M (+28.0%); SG&A: $522.5M (+22.9%); Net Income: $30M (+4.2%); EPS: $0.38 (+5.6%); Quick Assets: $1,018.4M (+38.2%); CF Ops: $860.6M (+176.3%).M
- 2015 Guidance: Total commercial membership: 1.2M; Medicare advantage membership: 270K; Medicaid membership: 1.938M; Dual eligibles: 50K; Total health plan membership: 3.457; commercial revenues: $5.7B; Medicare advantage revenues: $3.1B; State health plans: $6.7B; Dual eligibles: $922M; Total health plan revenues: $16.5B; Total revenues: $17.2B; GAAP EPS: At least $2.70; Combined Western Region and Government Contarct EPS: $3.25 - 3.35 from $3.15 - 3.25.
- Spark Therapeutics (NASDAQ:ONCE) drops 11% premarket on light volume in response to an article published by Bloomberg that says a gene therapy (not Spark's) used to treat patients with a rare form of childhood blindness, called Leber congenital amaurosis (LCA), appears to wane over time. An examination of three patients who received an injection of a corrected copy of the defective gene in one eye showed that the vision in the treated eye improved for as long as three years but than began to deteriorate. In addition, patients lost retinal photoreceptor cells at the same pace as their untreated eyes.
- The findings are not necessarily a setback. It just means that the therapy may require more than one dose.
- As many as 180K people worldwide have LCA, a degenerative disease of the retina. A subset of this population, ~9K people, have an RPE65 gene mutation that causes the problem. This is the group who could benefit from gene therapy.
- Patterson Companies (NASDAQ:PDCO) acquires Animal Health International, a distributor of production animal health products, for $1.1B in cash. The transaction doubles the size of PDCO's veterinary business.
- Concurrently, the company announces the potential sale of its medical rehabilitation business, which generated sales and non-GAAP net income of $468M and $64M, respectively, for the 12-month period ended January 2015. Management says the business, while well-positioned, is not a core part of the firm's long-term growth strategy. The proposed sale price is not disclosed.
- The two deals collectively will be neutral to fiscal 2016 non-GAAP EPS, excluding one-time transaction costs and amortization, but accretive beginning in fiscal 2017.
- Patterson will host a conference call this morning at 11 am ET to discuss the transactions.
8:52 AM| Comment!
- The FDA approves new indications for Medtronic's (NYSE:MDT) StealthStation electromagnetic (EM) surgical navigation system instruments for pediatric and adult cranial and ENT procedures. The clearance provides for additional neurosurgical applications that can benefit from flexible, tip-tracked instruments for both pinned and pin-less procedures. The navigated instruments can be used to aid in the placement of ventricular catheters, shunt systems, connection to Ommaya reservoirs, hematoma drainage, external ventricular drainage catheters, neuroendoscope peel-away catheters and depth-electrodes for epilepsy seizure monitoring.
- The StealthStation system is a proprietary tracking technology that utilizes unique engineering to generate an electromagnetic field around a patient's targeting anatomy, triangulating the position of instruments relative to patient-tracking devices during surgical navigation procedures. It is an aid to precisely locate anatomical structures in either open or percutaneous (through the skin) procedures.
- Laval, Quebec-based Klox Technologies (Pending:KLOX) is set for its IPO of 4.8M shares of common stock at $13 - 15.
- The specialty pharmaceutical firm develops and commercializes products for skin and soft tissue disorders based on its BioPhotonic technology, a novel treatment solution based on light and photo-activated oxygen-rich gel formulations. Its initial focus is dermatology, wound care and oral health.
- Its offering in dermatology is LumiCleanse and LumiBel for the treatment of acne vulgaris and cosmetic skin care. In wound care, it's LumiHeal, a healing treatment consisting of LumiHeal gel and a multi-LED lamp. Its product candidate in oral health is PERIO-1 for the treatment of periodontitis.
- 2014 Financials ($M): Revenues: 3.0 (+999%); Expenses: 10.2 (+29.1%); Net Loss: (8.1) (-5.2%); CF Ops: 8.1 (+222.7%).
- Halyard Health (HYH +0.8%) Q1 results: Revenues: $394.2M (-4.0%); COGS: $262.1M (+2.5%); R&D Expense: $6M (-27.7%); SG&A: $97.2M (+13.7%); Operating Income: $40.9M (-33.7%); Net Income: $21.7M (-47.6%); EPS: $0.46 (-48.3%); Quick Assets: $166.2M (+11.5%); CF Ops: $39.7M (+55.1%).
- 2015 Guidance: Net Sales Growth (on a constant currency basis): up 2 percent in 2015 compared to 2014; Adjusted EPS: $2.30 - 2.50; Medical Devices net sales (on a constant currency basis): Increase 2 - 4%; R&D Expenses: $30M - 35M; Adjusted Effective Tax Rate: 37 - 39%.
7:44 AM| 2 Comments
- Canton, MA-based Collegium Pharmaceutical (Pending:COLL) is set for its IPO of 5.8M shares of common stock at $12 - 14.
- The specialty pharmaceutical firm develops abuse-deterrent products to treat chronic pain and other diseases based on its DETERx platform technology. Its lead product candidate is the Fast Track-designated Xtampza ER, an abuse-deterrent extended release, oral formulation of oxycodone that the company plans to launch in the U.S. in Q1 2016, if approved.
- In the DETERx technology, the active ingredients are combined with fatty acid and waxes to form small spherical beads called microspheres that are filled into a capsule. The microspheres resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- 2014 Financials ($M): Operating Expenses: 17.7 (+10.6%); Net Loss: (17.9) (-10.5%); Cash Burn: (17.9) (-8.5%).
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