Boston Therapeutics (OTCQB:BTHE) hopes to begin a pivotal Phase 3 trial, by the second or third quarter of 2014, of a chewable tablet that is designed to be taken before meals to reduce post-meal elevation of blood glucose in Type 2 diabetics.
“Our PAZ320 drug is a potential adjunct to metformin in patients living with Type 2 diabetes,” CEO David Platt says in an interview with BioTuesdays. “We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes.”
See BT for rest of article……..
William Blair & Co. has initiated coverage of Novadaq Technologies (NASDAQ:NVDQ; TSX:NDQ) with an “outperform” rating and “aggressive growth” company profile, ahead of the company’s annual investor meeting in New York on Monday.
“We believe this could be a positive catalyst for the stock and expect the company will discuss several of its developing opportunities with investors,” writes analyst Margaret Kaczor.
These includes the opportunity for Luna, its newly launched wound care product, compelling usage and clinical results within surgery, specifically general surgery and gynaecology, and the financial impact of signing its recent international distributor agreement with Swissray Asia.
Ms. Kaczor said Novadaq is the only company on the domestic market with a fluorescence imaging technology for use during surgery and diagnostic imaging. “We believe that the company is in only its first stage of growth as it works to penetrate the $2 billion-plus long-term market opportunity.”
She said that supporting the market opportunity for its technology is a “winning formula of compelling clinical data as well as a decline in overall patient care costs through the reduction of surgical complications.”
Shares of Novadaq closed at $16.20 on Thursday. She said that at eight times her 2015 sales target of $89-million, up 70% year-over-year, the stock trades above other fast-growing medical technology names. Her “outperform” rating is based on her belief that “adoption will remain strong, which should drive upside to estimates.”
November 12, 2013 by leonardzehr · Leave a Comment
A new sales and marketing venture with a unit of Mission Pharmacal gives DARA BioSciences (NASDAQ:DARA) a formidable leg up in the oncology supportive care sector to address ongoing areas of medical need.
A 20-person national sales team contracted from Mission’s Alamo Pharma Services will promote DARA’s products, including Soltamox, Gelclair, and Bionect, as well as three Mission products—Ferralet 90 for anemia, BINOSTO for osteoporosis, and Aquoral for chemotherapy/radiation therapy-induced dry mouth. The Alamo sales reps will work under the direction of two DARA sales managers.
“This dedicated sales force can provide a formidable product portfolio that addresses many of the common challenges and side effects that cancer patients deal with on a daily basis, including oral mucositis, loss of bone density, radiation dermatitis, dry mouth, anemia, and long-term adherence to tamoxifen,” DARA’s CEO and CMO, Dr. David Drutz, says in an interview with BioTuesdays........
....See BioTuesdays for rest of this week's feature article...
November 1, 2013 by stephenkilmer · Leave a Comment
Stifel Nicolas has initiated coverage of TherapeuticsMD (NYSE MKT:TXMD) with a “buy” rating and $8 price target, saying the company has three products set to deliver data catalysts and potential approvals every six months starting in late 2015. The stock closed at $4.22 on Thursday.
“We believe the TherapeuticsMD portfolio represents the first innovation the hormone market has seen in nearly 10 years and could fill a very important void that was left in hormone replacement therapies (HRT) since the NIH-sponsored Women’s Health Initiative clipped the opportunity,” writes analyst Annabel Samimy.
“With new research supporting its effort and a market that has been left fragmented, under-promoted, and served primarily by the unregulated compounding market, we believe the environment is ripe for TherapeuticsMD’s offering,” she added.
The annual compounding market for HRT is currently estimated at over $1.5-billion, while the market for regulated branded and generic products has fallen to about $500-million.
Ms. Samimy said the FDA and legislators are now putting in place major restrictions to this compounding market, leaving an open door for TherapeuticsMD to introduce the first clinically-studied, well-regulated bioidentical combination HRT as a leading alternative.
“We see a potential launch in late 2016, with a conservative peak of $236-million” in sales, she added.
She said the company also has developed a low-dose progesterone for secondary amenorrhea, which potentially offers a better side-effect profile, and could launch in late-2015. This would be followed in mid-2016 by an estradiol vaginal suppository, providing ease of administration and lower systemic exposure. She pegs peak sales at $139-million and $53-million, respectively.
NeoStem (NASDAQ:NBS) is on track to complete enrollment later this year in a Phase 2 clinical trial of a bone marrow-derived cell therapy to treat patients for acute myocardial infarction, with a data readout six-to-eight months later.
“AMR-001 represents the first compound in a class of cell therapies to have a highly defined cell population and an identified biologically effective therapeutic dose, both of which tie back to the biological mechanism of action that the outcomes of the current study are intended to demonstrate,” chairman and CEO Dr. Robin Smith says in an interview with BioTuesdays.
Dr. Smith explains that NeoStem’s AMR-001 drug candidate brings a natural repair system, consisting of enriched CD34+ cells, to the heart in order to preserve heart function following a stent placement in patients with a type of heart attack known as ST segment elevation myocardial infarction (STEMI).
….see BIoTuesdays for rest of article….
October 23, 2013 by leonardzehr · Leave a Comment
Canaccord Genuity has raised its price target for “buy-rated” Novadaq Technologies (NASDAQ:NVDQ; TSX;NDQ) to $22 from $18 after the company’s third quarter report beat consensus estimates. The stock closed at $16.18 on Tuesday.
“We continue to believe that Novadaq possesses one of the most attractive, emerging technologies in med-tech, and possesses the largest, least-penetrated collection of target addressable markets in our space,” writes analyst Jason Mills. “We recommend investors add positions at these levels.”
Pointing to the company’s plans to increase its sales rep headcount from 42 reps currently to 150-to-160 over the next few years, Mr. Mills said that in his experience, such a robust sales force expansion can be a strong leading indicator of “glowing” growth in small-cap med tech land, and “we believe it signifies Novadaq’s level of confidence with its SPY growth opportunities.”
He said Novadaq’s new “non-SPY” product development initiatives, including Trapper, surgical marker, and nerve and lymph node localization, “none of which are in our estimates, seem highly synergistic with its fluorescence imaging platform and could drive growth above our current estimates.”
October 17, 2013 by stephenkilmer · Leave a Comment
Analysts at Ladenburg Thalmann and Roth Capital Partners raised their price targets on “buy-rated” Keryx Biopharmaceuticals (NASDAQ:KERX) after positive top-line Phase 3 Zenerex data in chronic kidney disease (CKD) patients was released in an abstract for American Society of Nephrology (ASN) annual meeting by Japanese partner, JT/Torii.
See BioTuesdays for rest of article......
What if it were possible to deliver a broad range of potent cancer drugs more optimally, enhancing both their safety and efficacy?
That’s the question CytRx (NASDAQ:CYTR) hopes to answer this December when it plans to report top-line Phase 2b data from a global clinical trial of its lead drug, aldoxorubicin, as a first-line treatment for soft tissue sarcoma, where tumors develop in soft tissue such as muscle, fat, blood vessels, nerves, tendons and in the lining of joints.
“Our clinical and preclinical evidence thus far supports our belief that aldoxorubicin and our technology platform have the potential to dramatically improve traditional chemotherapy by allowing cancer patients to receive more drug, up to 3.5-to-four times more drug, and have fewer side effects,” president and CEO Steven Kriegsman says in an interview with BioTuesdays.
“Aldoxorubicin is just the tip of the iceberg, since we are making better versions of several anti-cancer drugs,” he adds.......
....see BioTuesdays for the rest of this week's feature on CYTR....
October 10, 2013 by Jennifer Poland · Leave a Comment
Roth Capital Partners has initiated coverage LeMaitre Vascular (NASDAQ:LMAT) with a “buy” rating and 12-month price target of $10. The stock closed at $6.73 on Wednesday.
see BioTuesdays for rest of brief...
October 8, 2013 by leonardzehr · Leave a Comment
After initiating enrollment of a Phase 2b/3 clinical trial of TNX-102 SL in fibromyalgia (FM) patients earlier this month, Tonix Pharmaceuticals Holding (NASDAQ:TNXP) is now setting its sights on a Phase 2a trial of its drug candidate as a treatment for post-traumatic stress disorder (PTSD).
“About 50% of FM and PTSD patients meet the criteria for the other disorder,” CFO Dr. Leland Gershell says in an interview with BioTuesdays. “In FM, patients hurt all over and can’t get restorative sleep; in PTSD, patients experience disturbed sleep and widespread pain.”
Dr. Gershell explains that Tonix’s treatment concept with TNX-102 SL, a sublingual tablet that dissolves under the tongue, is a nightly bedtime therapy designed to improve pain and other daytime symptoms by improving sleep quality.....
...see BioTuesdays for the rest of this week's feature article on TNXP
October 2, 2013 by Jennifer Poland · Leave a Comment
Feltl & Co. has raised its price target for “strong buy-rated” Cancer Genetics (NASDAQ:CGIX) to $30.50 from $17.55, which is based on a multiple of 3.5 times estimated enterprise value/sales for 2015. The stock closed at $19.60 on Tuesday.
A number of recent developments, including the company completing a secondary offering and expanding its relationship with an affiliate of Roche, “further validate CGI’s platform and go-to-market strategy,” writes analyst Ben Haynor.
In addition, Mr. Haynor figures the recent Foundation Medicine (NASDAQ:FMI) IPO, “sets a new benchmark for the valuation of molecular diagnostics firms.”
On the deal with Roche to bring Cancer Genetics’ ExpandDx community hospital program to Central America and the Caribbean, Mr. Haynor said that he has seen this type of relationship expansion before with other Roche collaborators and, and generally speaking, “it seems to us that once Roche begins the initial expansion of a relationship, it tends to grow much larger, so we would be unsurprised to see additional business from Roche in the future.”
On valuation, Mr. Haynor said that investors have shown a willingness to assign premium multiples to “as-a-service” recurring business models like the one employed by Cancer Genetics. ”However, given the fact that is early in the business’ development, we have chosen to take a conservative approach. Our valuation methodology leads us to a $30.50 price target (3.5x 2015 EV/sales) using a multiple inline with its publicly-traded comps as well as the low-end valuation of other molecular diagnostic firms at this point in their growth trajectory.”
October 1, 2013 by Jennifer Poland · Leave a Comment
Roth Capital Partners has initiated coverage of Tonix Pharmaceuticals Holding (NASDAQ:TNXP) with a “buy” rating and 12-month price target of $8.50. The stock closed at $3.65 on Monday.
“The impetus for our buy rating is the potential for TNX-102 SL to navigate through late-stage clinical trials for the treatment of fibromyalgia, receive approval, and drive the company into profitability,” writes analyst Scott Henry.
He is targeting Tonix to file the compound in late 2016, noting that the key differentiation versus current treatments could be improved sleep quality.
He cites a number of drivers for his investment thesis, including expectations that a Phase 2b fibromyalgia trial with TNX-102 SL, which is now enrolling, should be positive based on results of an earlier Phase 2a trial.
“Current treatments for fibromyalgia (disorder predominantly in females that impacts pain, mood and sleep) focus largely on mood (Cymbalta) and pain (Lyrica) components of the disorder,” he said. “We expect that TNX-102 SL could be the first drug to focus on sleep disturbance.”
He said a differentiated fibromyalgia treatment could approach a market share of 20%, which corresponds to peak annual sales potential of about $400-million.
Aethlon Medical (OTCQB:AEMD), sporting FDA approval of an investigational drug exemption (IDE), plans to begin treating patients infected with hepatitis C virus (HCV) early next year in a feasibility study to demonstrate the safety of its Hemopurifier.
The Hemopurifier is a therapeutic filtration cartridge designed for use on existing dialysis and CRRT machines. The device targets the rapid elimination of circulating infectious disease and cancer targets without removing essential blood components required for health.
“Obtaining FDA permission to initiate human studies has been our most important objective for several years,” chairman and CEO Jim Joyce says in an interview with BioTuesdays.
“Previously, in the treatment of HCV-infected individuals, we have demonstrated that our Hemopurifier could eliminate the presence of HCV in as little a seven days when utilized in combination with interferon-based therapy,” Mr. Joyce says.
....See BioTuesdays for rest of today's feature article on AEMD...
That's diabetes market maven Kelly Close being quoted in the SA article. You can see the entire article on Biotuesdays.
Excerpt from today's BioTuesdays feature:
"We’re beginning to see positive data come out, and the flat truth is just that we need more alternatives to injected insulin. MannKind (NASDAQ:MNKD) and its inhaled insulin therapy, AFREZZA, has driven our optimism. It’s taken a long time to get to a second-generation inhaled insulin that is practical, easy to use, and effective, but the data, especially that on hypoglycemia, look good."
Excerpt from today's BioTuesdays feature:
"Transition Therapeutics (NASDAQ:TTHI; TSX:TTH) announced some really exciting data in the summer for TT401, which targets GLP-1 and glucagon receptors for obese diabetic patients and may provide clinical effects superior to those of GLP-1 agonists. [Editor’s note: the proof-of-concept data prompted partner Eli Lilly (NYSE:LLY) to acquire an option on the drug candidate to complete clinical development.] "
Positive data from GlaxoSmithKline’s two pivotal trials of its darapladib cardiovascular drug could provide a huge boost to the utilization of diaDexus’ (OTCQB:DDXS) PLAC test, which is being used on patients in the studies to measure their levels of Lp-PLA2, a biomarker that identifies risk of heart attack and stroke.
“If the darapladib trials are successful, it would mean that the Lp-PLA2 enzyme may be considered a risk factor for cardiovascular disease, which could increase utilization of the test by physicians and result in positive reimbursement decisions,” diaDexus president and CEO, Brian Ward, says in an interview with BioTuesdays.
“The FDA also may require a companion diagnostic for GSK’s drug, and diaDexus has the worldwide distribution rights for the companion diagnostic,” he adds.
SEE BIOTUESDAYS FOR REST OF FEATURE ARTICLE ON DDXS
Cantor Fitzgerald analyst Irina Rivkind says shares of Sucampo Pharmaceuticals (NASDAQ:SCMP) are trading off on a recent downgrade of competitor Ironwood Pharmaceuticals (NASDAQ:IRWD), reflecting news that Ironwood’s Linzess will be priced below Sucampo’s Amitiza.
A Cowen & Co. analyst downgraded shares of Ironwood on Monday, citing the company’s growing expenses and disappointing early sales of its bowel drug Linzess.
Ms. Rivkind writes that the Linzess pricing strategy was the subject of a recent BioCentury article that highlighted Ironwood’s attempts to gain improved reimbursement for Linzess by entering the market at a lower price than Amitiza on launch last December.
“We note that there is nothing new in this BioCentury article........
See BioTuesdays for rest of brief.