Friday, April 17, 2015
- Advaxis (NASDAQ:ADXS) has filed to sell up to $200M in common stock through future offerings. No details have been given on the drug developer's plans for any proceeds it might raise.
- Advaxis raised $23M through a February stock offering. It had $30.6M in cash at the end of January, and no debt.
- Shares have fallen to $18.30 AH.
- The WSJ and Bloomberg report Teva (TEVA +3.4%) is weighing a bid to acquire fellow generic drug giant Mylan (MYL +5.5%), while adding no decision has been made yet. Shaes of both companies have spiked higher.
- Bloomberg's sources state Teva "hasn't made a formal approach yet," though Mylan is aware of Teva's interest. Many analysts have long expected Teva to go after Mylan, given many perceived top and bottom-line synergies. Teva is currently worth $66.2B, and Mylan $34.3B.
- Perrigo (PRGO -2.8%), which Mylan announced a $28.9B ($205/share) bid for last week, has moved lower on the news.
- Cellectar Biosciences (CLRB -2.7%) commences a proof-of-concept study of I-313-CLR1404 in patients with relapsed or refractory multiple myeloma, an indication for which it is tagged an Orphan Drug by the FDA. The Phase 1 open-label dose escalation trial will assess the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone. It will also clarify a recommended dose for a Phase 2 study.
- I-131-CLR1404 is a small molecule, broad spectrum radiopharmaceutical that combines a proprietary optimized phospholipid ether analog as a cancer-targeting delivery and retention vehicle with the cytotoxic radioisotope I-131. Its intracellular radiation mechanism and targeted delivery makes it applicable to a wide range of tumor types.
12:37 PM| Comment!
- Thinly-traded micro cap Trovagene (TROV +23.9%) enjoys a healthy up move after its announcement that its urine-based Precision Cancer Monitoring (PCM) platform did a better job than tissue biopsies in detecting and monitoring epidermal growth factor receptor (EGFR) T790M mutations in metastatic lung cancer patients. The data were presented today at the European Lung Cancer Conference in Geneva, Switzerland.
- In an interim analysis of 34 patients from an ongoing study, the company's PCM platform detected all the biopsy-positive T790M mutations. The urine-based assay also identified samples as T790M-positive from those who had clinical suspicion of T790M-progressive disease, but were either negative by tissue biopsy or had not yet undergone a tissue biopsy for confirmation.
- Early pharmacodynamic events occurring soon after anti-EGFR therapy were evaluated in the study via daily monitoring of urinary circulating tumor DNA (ctDNA). Initial results demonstrated that immediate changes in EGFR mutational load have the potential to identify patients who respond to anti-EGFR therapy much earlier than with follow-up CT scans.
- Patients with EGFR+ non-small cell lung cancer (NSCLC) are typically treated with EGFR-TKIs (tyrosine kinase inhibitors) because the response rate is as high as 80%. Many patients (~67%) with the secondary mutation T790M acquire resistance to EGFR-TKIs after 6 - 12 months.
- The value proposition of urine-based DNA monitoring compared to tissue biopsy is that it is less invasive, more convenient, quicker, much easier to perform and less expensive.
- The FDA designates RXi Pharmaceuticals' (RXII +2.2%) Samcyprone, a topical gel formulation of diphenylcyclopropenone, an Orphan Drug for the treatment of cutaneous metastases in patients with malignant melanoma Stages IIb to IV.
- Samcyprone is also in development for the treatment of warts and alopecia areata, an autoimmune skin disorder that results in a loss of hair on the scalp and elsewhere on the body.
- RXi licensed Samcyprone from Hapten Pharmaceuticals in late 2014.
- The FDA designates Oncolytics Biotech's (ONCY +5.5%) Reolysin (reovirus variant) an Orphan Drug for the treatment of malignant glioma (brain tumor). This is the second such tag this week. Two days ago, it received Orphan Drug status for gastric cancer.
- Among the benefits of the Orphan Drug label is a seven-year period of market exclusivity for the indication, if approved.
- Discovery Labs (DSCO -16.7%) completes the enrollment of 48 premature infants 29 - 34 week gestational age with respiratory distress syndrome (RDS) in a Phase 2a study evaluating the administration of a single dose of AEROSURF, the company's investigational drug/device product that combines its synthetic KL4 surfactant with its proprietary capillary aerosol generator. The multi-center open-label trial will assess the safety and tolerability of a single dose of KL4 surfactant in premature infants who are receiving nasal continuous positive airway pressure (nCAP) for RDS, compared to infants receiving nCPAP alone. The company will report the results and hold an investor conference in three to four weeks.
- AEROSURF is designed to replace SURFAXIN (lucinactant) Intratracheal Suspension, approved in 2012, which is administered by endotracheal intubation supported by mechanical ventilation, a frequent cause of complications. The company is currently exploring the potential for another firm taking over the commercialization of SURFAXIN via some form of strategic alliance, but if one cannot be consummated, then it will cease marketing the product.
- Anika Therapeutics (ANIK -2.8%) completes the enrollment of 242 patients in its Phase 3 Cingal 13-02 study, an open-label follow-on to Cingal 13-01, to evaluate repeat injections of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide) for the treatment of the symptoms of osteoarthritis of the knee.
- Results will be available mid-year. The data will be used to support labeling for repeat injections of Cingal.
- Results from a 636-patient Phase 3 trial published in the online edition of the American Journal of Psychiatry demonstrate the efficacy of brexpiprazole for the treatment of acute schizophrenia. Patients were randomized to receive fixed doses of brexpiprazole (0.25 mg, 2 mg or 4 mg) or placebo.
- The primary endpoint was the change in PANSS (Positive and Negative Syndrome Scale) total score from baseline to Week 6. The changes in scores for the three doses of brexpiprazole cited above were -14.90, -20.73 and -19.65, respectively, compared to placebo's -12.01 (the lower the score the greater the improvement). The difference in score for the 0.25 mg dose did not reach statistical significance but the other two were highly statistically significant.
- The study also met key secondary endpoints related to improvements in behavioral measurements.
- Brexpiprazole is being co-developed by Otsuka Holdings (OTCPK:OTSKY) and Lundbeck A/S (OTCPK:HLUYY). The New Drug Application (NDA) is currently under review by the FDA. The PDUFA date is in July. Analysts regard it as a blockbuster with potential peak annual sales greater than $1B.
- Nano cap Rosetta Genomics (ROSG +6.3%) bucks the market's down move in early trading. Shares are up 27% from Tuesday's close of $3.24. Yesterday, the company announced that it received a Notice of Allowance from the USPTO covering the methods and materials of its second generation Cancer Origin Test, which uses more markers and identifies a larger spectrum of cancers than the first generation product.
- Based on an assessment by the independent Data Monitoring Committee, a Phase 3 clinical trial, CheckMate-057, evaluating Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) versus docetaxel was stopped early after the study met its primary efficacy endpoint. Patients with advanced non-squamous non-small cell lung cancer who received Opdivo demonstrated superior overall survival compared to those who received docetaxel. The company intends to share the data with health authorities soon.
- Opdivo is a PD-1 inhibitor approved for certain types of melanoma as well as metastatic non-small cell lung cancer with progression on or after platinum-based chemo.
- Sunshine Heart (NASDAQ:SSH) reports that the FDA has reviewed it submission regarding the suspended Counter HF study and requested the receipt of minor protocol changes in order to approve the resumption of patient enrollment. The most significant of the changes pertains to the company's proposal to incorporate a Physician Subject Selection Committee. The agency did not indicate that it had concerns over the safety of the C-Pulse Heart Assist System. Also, the Data Safety Monitoring Board reviewed Counter HF's data and recommended continuing the trial.
- The four deaths that were reported om March 6 have all been adjudicated by an independent Clinical Events Committee as being non-device related.
- Shares are up 3% premarket on light volume.
- Previously: Sunshine Heart suspends enrollment in C-Pulse trial after four deaths (March 6)
- Nano cap Novogen (NASDAQ:NVGN) jumps 14% premarket on increased volume in response to its announcement of its collaboration with the Feinstein Institute for Medical Research in New York to develop treatments for brain cancer.
- The core of the partnership is the company's super-benzopyran (SBP) drug technology platform, which has demonstrated the ability to kill the full spectrum of cancer cells in a tumor.
- The research will focus on three main areas: 1) the development of the lead SBP drug candidate, TRXE-009, for the treatment of primary and secondary brain cancer in adults and children, including glioblastoma and medullobastoma; 2) the potential ability of the SBP technology to deliver a new approach to chemotherapy by converting cancer stem cells into stem cells displaying normal stem cell behavior; 3) the development of drug candidates as radio-sensitizers designed to augment the effectiveness of radiotherapy in treating brain cancers.
- TRXE-009 is a pan-acting anti-cancer cytotoxic molecule that is scheduled to enter clinical development in early 2016 for the treatment of melanoma. Its ability to deliver it to brain cancer tissue in adequate amounts remains to be confirmed. In vitro, it has been effective against adult glioblastoma and pediatric glioma and medulloblastoma cells.
- Based on an interim analysis of its ongoing AURA study, AstraZeneca's (NYSE:AZN) experimental cancer drug, AZD9291, demonstrated a median progression-free survival (PFS) of 13.5 months in patients with advanced epidermal growth factor receptor mutation positive (EGFR+) non-small cell lung cancer (NSCLC) who also have the T790M mutation. T790M-positive NSCLC patients with disease progression do not have effective treatment options. Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors (TKI) like erlotinib (Roche's Tarceva) or gefitinib (AZN's Iressa).
- The updated data also show an overall response rate of 54% (80 mg dose) and a median duration of response of 12.4 months. The data were presented at the European Lung Cancer Conference in Geneva, Switzerland.
- NSCLC is the most common form of lung cancer. The T790M mutation is responsible for up to 67% of EGFR TKI resistance in patients with advanced EGFR+ NSCLC.
- The company plans to submit its regulatory application in the U.S. this quarter. Management believes peak sales could reach $3B per year.
- Pernix Therapeutics Holdings (NASDAQ:PTX) sets the terms of its $130M (up from $120M) aggregate principal amount 4.25% Convertible Senior Notes due 2021. The conversion rate is 87.2030 shares per $1,000 principal amount or $11.47 per share. Closing date is April 22.
- The bulk of the capital, ~$81M, will be used to fund the Zohydro ER acquisition.
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