Today - Wednesday, April 1, 2015
- The FDA accepts for review the New Drug Application (NDA) for Repros Therapeutics' (NASDAQ:RPRX) Androxal (enclomiphene citrate) for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Androxal is designed to treat the underlying cause of secondary hypogonadism, insufficient stimulation of the testes by the pituitary gland.
- Lightly-traded nano cap Nymox (NYMX +46.4%) jumps on an 11x surge in volume. Investors appear to be anticipating positive results from a Phase 2 trial evaluating NX-1207 in low risk localized prostate cancer. Final data collection should happen this month.
- The company also announced that it is undertaking further analyses of its pivotal U.S. Phase 3 trials (NX02-0017 and NX02-0018) of NX-1207 for the treatment of benign prostate hyperplasia (BPH) or enlarged prostate. Shares plunged in November when the company reported that NX-1207 performed no better than placebo at Month 12. Management expects to report new long-term data in Q2 or Q3.
- Previously: Nymox plummets after failure of BPH trials (Nov. 3, 2014)
- Micro cap CytoSorbents (CTSO -28.7%) plummets on a 10x surge in volume in response to the company's softer guidance on direct sales for the first half. During yesterday evening's earnings call, CEO Dr. Philip Chan said, "In an effort to create an outstanding core sales team, we have been in process of restructuring our direct sales force. We felt it necessary to replace a number of existing sales representatives with others who were better equipped to sell our therapy and to better support international sales. This has created a significant gap in sales coverage in our direct sales territories and has resulted in lower direct sales. Although painful, we believe these changes are necessary and will have a positive effect in the second half of 2015. Q1 2015 sales are expected to show ~45% yoy growth and be slightly lower than Q4 2014. Investors should expect near-term growth will be driven predominantly by distributor and strategic partner sales. We believe that growth in direct sales will resume in the second half of 2015."
- The company generates all of its product revenue from CytoSorb, an immunotherapy for the prevention or mitigation of multiple organ failure.
- Q1 Guidance: Product revenue: $700K - 725K.
- NuVasive (NUVA -3%) CEO Alex Lukianov was forced to resign after an internal investigation found that he failed to comply with the firm's expense reimbursement and other policies. According to Director Jack Blair, the amounts involved are immaterial to the company's financial results but Mr. Lukianov's actions "in this regard were not representative of the high standards by which NuVasive operates. We believe this leadership transition is appropriate and in the best interests of the Company and all of our stakeholders."
- Board member Greg Lucier will take over a Chairman and interim CEO until a permanent chief executive is hired.
- Medtronic (MDT -2.1%) initiates a new clinical program, called SPYRAL HTN, to evaluate its next-generation renal denervation technology. It will begin with two global studies designed to address the issues in its earlier SYMPLICITY HTN-3 Phase 3 trial, which failed to achieve its primary and secondary efficacy endpoints.
- In the new studies, each enrolling 100 patients with moderate-to high-risk hypertension, physicians will use the company's Symplicity Spyral catheter and Symplicity G3 radiofrequency (RF) generator, both investigational in the U.S. and Japan. In SPYRAL HTN-OFF MED, the primary objective is to isolate the effect of renal denervation on blood pressure (BP) reduction. In SPYRAL HTN-ON MED, patients not achieving adequate BP control despite taking anti-hypertensive drugs will comprise the treatment group. Based on the successful outcomes of the two studies, the company will design a pivotal Phase 3 trial that will support regulatory applications in the U.S. and Japan.
- Renal denervation, using RF energy to ablate nerves in the wall of the renal artery, is an approved procedure to control resistant hypertension. Destroying the nerves in the artery interrupts the renal sympathetic nervous system and reduces BP. Its efficacy, though, has been questioned. About a year ago, Medtronic announced that SYMPLICITY HTN-3, failed to demonstrate efficacy compared to a sham control. The company believes that the trial design was the culprit, specifically the medication parameters, patient population and procedural variability. It believes that these issues will be corrected in the new trials.
- The FDA designates Idera Pharmaceuticals' (IDRA -2.4%) lead product candidate, IMO-8400, an Orphan Drug for the potential treatment of diffuse large B-cell lymphoma. IMO-8400 is an antagonist of endosomal Toll-like receptors (TLRs) 7,8 and 9. TLRs are a class of proteins that play a key role in the innate immune system. They employ a type of pattern recognition to identify pathogenic molecules. In certain diseases, TLRs are over-activated which leads to chronic inflammation and disease progression. Inhibiting their activity, therefore, may have a clinical benefit.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Thinly-traded relatively-recent IPO Immune Design (IMDZ +18.1%) moves up on 22% higher volume, albeit on turnover of only 71K shares, in response to its announcement of positive data from three Phase 1 trials of its two lead product candidates, CMB305 and G100.
- In two parallel Phase 1s, CMB305's prime boost components, LV305 and G305, were well tolerated and demonstrated immunogenicity.
- G100 demonstrated an acceptable safety profile alone or in combination with local radiation in a Phase 1 study as well as additional evidence of clinical efficacy.
- Abstracts for each of the three trials have been submitted for presentation at the American Society of Clinical Oncology (ASCO) meeting May 29 - June 2.
- Although the market's slump is a key contributor, Acheogen (AKAO -20.4%) would still be under pressure today in response to its announcement during yesterday's webcast that it plans to initiate another Phase 3 study evaluating its lead product candidate, plazomicin, for the treatment of complex urinary tract infections. Top line results won't be available until H2 2017. The longer timeline appeared to surprise investors.
- For what it's worth, Needham & Co. maintained its Buy recommendation, but lowered its price target to $15.
- Receptos (RCPT -3.7%) completes patient enrollment in its RADIANCE Phase 3 study evaluating ozanimod (RPC1063) in patients with relapsing multiple sclerosis (RMS). The randomized, double-blind trial will assess whether ozanimod is superior to Biogen's (BIIB -2.7%) Avonex (interferon beta-1a) in reducing the annualized relapse rate in patients after two years of therapy.
- Ozanimod is an oral, once-daily selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for the treatment of autoimmune diseases. It diminishes the activity of autoreactive lymphocytes (white blood cells) which is the cause of many types of autoimmune disorders.
- In a Phase 2 RMS trial, it achieved its primary endpoint of reduction in MRI brain lesion activity.
- Baxter International (BAX -0.6%) secures CE Mark clearance for its automated peritoneal dialysis (APD) device, Homechoice Claria. The system features two-way connectivity so clinicians have visibility to monitor the patient's home dialysis treatments and adjust prescriptions accordingly. Peritoneal dialysis is a home-based therapy option for end-stage renal disease patients.
- The company plans to launch the product in select European and Asian countries in H1.
- Micro cap Organovo (NYSEMKT:ONVO) is up 10% premarket on average volume in response to its announcement that it presented data on in vitro three-dimensional kidney tissue at the Experimental Biology conference in Boston.
- The 3D tissue, fabricated using the company's NovoGen bioprinter, consists of multiple tissue-relevant cell types arranged to recapitulate the renal tubular/interstitial interface, specifically polarized renal proximal tubular epithelial cells and a living interstitial layer of renal fibroblasts and endothelial cells.
- Analyzing the tissue on a slide under a microscope showed evidence of formation of microvascular structures and stable maintenance of the layered architecture for at least two weeks.
- Trillium Therapeutics (NASDAQ:TRIL) prices its public offering of 1,522,395 common shares and 1,077,605 non-voting convertible preferred shares at $19.50 per share. Underwriters over-allotment is an additional 228,359 common shares. Closing date is April 7. Net proceeds will fund the develop of product candidates, working capital and general corporate purposes.
- Cellceutix (OTCPK:CTIX) secures a stock purchase agreement with Aspire Capital Fund, LLC under which it has committed to buy up to $30M of CTIX common stock over the next three years at market prices. The timing of the purchases is at the sole discretion of Cellceutix.
- Aspire previously provided the company with $30M in equity capital in two similar transactions.
- Myriad Genetics (NASDAQ:MYGN) and AstraZeneca (NYSE:AZN) expand their companion diagnostic collaboration using Myriad's BRACAnalysis CDx test to prospectively identify patients with metastatic pancreatic cancer who may respond to treatment with AZN's Lynparza (olaparib).
- BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variants of BRCA1 and BRCA2 genes using genomic DNA from whole blood specimens. The FDA approved it in December 2014 as a companion diagnostic for Lynparza for ovarian cancer.
8:49 AM| Comment!
- Retractable Technologies (RVP +1.8%) Q4 results: Revenues: $10.7M (+42.7%); COGS: $6.4M (+25.5%); Operating Expenses: $3.5M (-7.9%); Operating Income: $0.8M (+157.1%); Net Income: $0.5M (+129.4%); EPS: $0.02 (+133.3%).
- FY2014 results: Revenues: $34.5M (+12.0%); COGS: $22.5M (+9.8%); Operating Expenses: $14.2M (-12.3%); Operating Loss: ($2.2M) (+62.7%); Net Loss: ($3.3M) (+53.5%); Loss Per Share: ($0.12) (+53.8%); Quick Assets: $22.2M (-19.6%).
- No guidance given.
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