Friday, March 27, 2015
- Thinly-traded nano cap Adamis Pharmaceuticals (NASDAQ:ADMP) craters 35% after hours on robust volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for its lead product candidate, Epinephrine Pre-filled Syringe (PFS), for the emergency treatment of acute anaphylaxis (severe allergic reaction).
- The FDA's questions relate to the general area of Chemistry, Manufacturing and Controls (CMC) and specifically to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim.
- President and CEO Dr. Dennis J. Carlo says, "We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications. Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."
- The company submitted its NDA in May of last year.
- Previously: Adamis submits NDA for adrenaline product (May 29, 2014)
- DaVita Healthcare Partners (NYSE:DVA) announces that its CFO Garry Menzel is leaving the firm to return to the biopharma industry.
- Menzel had become CFO in November 2013. He'll remain with the firm to ensure a smooth transition; CAO James Hilger will serve as interim CFO effective on Monday.
- Menzel was previously COO for Regulus Therapeutics, as well as serving in roles at healthcare investment banking groups at Goldman Sachs and Credit Suisse.
- Brean Capital's Difei Yang says small cap Hyperion Therapeutics (NASDAQ:HPTX) should be on the acquisition radar considering Big Pharma's appetite for rare disease players. The company's revenues are generated by two products, Ravicti (glycerol phenylbutyrate) and Buphenyl (sodium phenylbutyrate), that treat urea cycle disorders, inherited metabolic diseases caused by a deficiency in one of the enzymes or transporters in the urea cycle. Elevated ammonia, a consequence of the failure to convert ammonia to urea, can have serious consequences, such as brain damage, coma and even death.
- Mr. Yang estimates that the company's takeout price at $60 per share. He lists Shire plc (NASDAQ:SHPG), Valeant Pharmaceuticals (NYSE:VRX), and Endo International (NASDAQ:ENDP) as potential suitors. HPTX closed today at just under $43.
- The company booked ~$114M in revenues last year but took a loss of ($6.3M).
- At the 2nd Annual Immunotherapy of Cancer Conference in Munich, Germany, Northwest Biotherapeutics' (NWBO +6.6%) Chief Technology Officer Dr. Marnix Bosch presented data from an Information Arm of 51 patients with glioblastoma multiforme (GBM) treated with DCVax-L. They were treated outside of the company's Phase 3 study because they were not eligible due to evidence of early tumor re-growth following six weeks of standard-of-care treatment with radiotherapy and chemotherapy. The data showed longer-than-expected survival.
- Overall survival data were generated for all 51 patients, but only 46 had MRI images available. Patients in this group were classified as Rapid Progressors (n=20) (patients with a new lesion of at least 1 cm in size or tumor growth at least 25% both at baseline visit and Month 2), Indeterminate (n=25) (evidence of progression at baseline visit followed by stable disease or modest progression/regression) or Pseudo-Progressor (n=1) (Month 2 MRI showed resolution of most of tumor growth seen at baseline visit).
- Median overall survival (OS) of the 51 patients was 18.3 months, with ~30% living beyond two years. Median OS for Rapid Progressors, the ones with the poorest prognoses, was 15.3 months. Median OS for Indeterminates was 21.5 months. The Pseudo-Progressor is still alive (30.1 months to date). The results reflect as much as a 50% improvement over expected OS.
- The Phase 3 trial assessing DCVax-L in GBM is ongoing.
- According to a source close to the matter, Sanofi (SNY +2.2%) intends to launch its long-acting insulin, Toujeo (insulin glargine 300 IU/mL), in the U.S. on Monday, which is consistent with its earlier statement that it planned to launch at the beginning of Q2.
- Toujeo, approved by the FDA on February 25, is a once-daily injection of basal insulin that has three times more insulin per mL than its top-selling Lantus (insulin glargine [rDNA origin] 100 IU/mL).
- Sanofi will have the long-acting insulin market to itself for a while. Novo Nordisk (NVO +0.9%) plans to resubmit its NDA for its offering, Tresiba (insulin degludec), shortly, but approval won't happen until next year at the earliest. Eli Lilly (LLY +0.2%) postponed its NDA for basal insulin peglispro until "after 2016" so it can assess its effects on the liver.
- Previously: Novo Nordisk trys again with Tresiba and Ryzodeg NDA resubmission to FDA (March 26)
- Previously: Side effect of Lilly basal insulin potentially delays regulatory filings past 2016 (Feb. 23)
- Despite being on the agenda at this month's meeting of the European Medicines Agency to review new drugs, committee members reached no decision regarding Bristol-Myers Squibb's (BMY +1.2%) Marketing Authorization Application (MAA) for Opdivo (nivolumab) for the treatment of advanced melanoma. Such delays occur when reviewers feel that they need more time to evaluate the drug. The MAA could be considered again as early as next month. The agency accepted the application for review in September 2014.
- The FDA approved Opdivo in December 2014.
- Previously: EMA accepts Opdivo MAA (Sept. 29, 2014)
- Thinly-traded nano cap Great Basin Scientific (GBSN +48.7%) jumps on an 8x surge in volume, albeit on turnover of only 400K shares. No specific news accounts for the move except the obligatory "quick pick" newsletters.
- The molecular diagnostics company has one FDA-approved assay, C. difficile, for its test system, with four more in development.
- 2014 revenues: $1.6M.
- Johnson & Johnson (JNJ +0.5%) and Google (NASDAQ:GOOG) establish a collaboration to develop a robotic-assisted surgery program. Terms are not disclosed.
- J&J Chairman Gary Pruden says, "This collaboration with Google is another important step in our commitment to advancing surgical care."
- Robotic-assisted surgery, led by Intuitive Surgical (ISRG) with its da Vinci systems, is forecasted to grow at a double-digit rate through at least 2020, according to iData Research.
- Applied DNA Sciences (APDN -12.7%) prices its public offering of 3.82M shares of common stock and warrants to purchase 1.528M shares of stock at a combined price of $3. The warrants are exercisable at $3.50 per share and will expire on November 20, 2019.
- Underwriters over-allotment is an additional 573K shares and warrants to purchase up to 229.2K shares. Closing date is April 1.
- Net proceeds will be used for general corporate purposes.
- Minerva Neurosciences (NERV) Q4 results: Revenues: $0; R&D Expense: $3M (+999%); SG&A: $4.5M (+136.8%); Net Loss: ($7.4M) (-252.4%); Loss Per Share: ($0.40) (+2.4%).
- FY2014 results: Revenues: $0; R&D Expense: $42.9M (+999%); SG&A: $12M (+380.0%); Net Loss: ($56.9M) (-999%); Loss Per Share: ($4.47) (-473.1%); Quick Assets: $18.5M (+927.8%).
- No guidance given.
- Medtronic (NYSE:MDT) completes its acquisition of privately-held Sophono, a developer of magnetic hearing implants. Terms are not disclosed. The business will be part of Medtronic's Surgical Technologies division within the Restorative Therapies Group segment.
- Sophono's magnetic bone conduction hearing implants have been placed in more than 4,000 patients in 42 countries. They are indicated for patients at least five years of age with single-sided deafness or conductive, mixed hearing loss.
- According to the World Health Organization, disabling hearing loss affects 360M people worldwide.
- The experimental Ebola vaccines from GlaxoSmithKline (NYSE:GSK) and NewLink Genetics (NASDAQ:NLNK) (NYSE:MRK) appear to be safe, based on interim results in a mid-stage trial in Liberia. The vaccines, administered as a single injection, are being evaluated for safety and efficacy on more than 600 people there. Based on the positive results, the study will now progress to the next phase of efficacy testing where additional volunteers will be injected with one of the vaccines or placebo to see if their immune systems produce anti-Ebola antibodies.
- The Ebola epidemic, its course winding down, has claimed more than 10,000 lives.
- In a shining example of the credibility gap from sell-side analysts, Roth Capital reiterates its Buy recommendation on Ohr Pharmaceutical (NASDAQ:OHRP) with a $30 price target in response to the company's announcement this morning that the Phase 2 study of OHR-102 failed to achieve its primary efficacy endpoint. OHRP shares currently reside at $2.69 in premarket trading on massive volume.
- Previously: Ohr Pharma Phase 2 study of wet-AMD drug fails to hit primary endpoint; shares plummet 55% premarket (March 27)
- Bernstein analyst Ronny Gal lifts his price target 15% for Teva Pharmaceutical Industries (NYSE:TEVA) to $69 (from $60) citing the firm's continued shift to branded drugs, a deeper pipeline and a more global customer base. He also notes that management has a list of 25 preferred acquisition targets, including some in generics (for example, biosimilars) that would yield substantial synergies.
- Onconova Therapeutics (ONTX -0.8%) Q4 results: Revenues: $0.1M (-94.7%); R&D Expense: $10.4M (-14.0%); SG&A: $3.1M (-29.5%); Net Loss: ($13.4M) (+8.2%); Loss Per Share: ($0.62) (+8.8%).
- FY2014 results: Revenues: $0.8M (-83.3%); R&D Expense: $49.4M (-1.6%); SG&A: $15.1M (-10.1%); Net Loss: ($63.7M) (+1.8%); Loss Per Share: ($2.94) (+52.0%); Quick Assets: $43.6M (-56.4%).
- No guidance given.
- BioMarin Pharmaceutical (NASDAQ:BMRN) jumps 10% premarket on higher-than-normal volume as speculation builds that the company could be the next big biotech take out.
- Deutsche Bank raises its price target to $140 from $90; UBS follows suit at $136 from $112.
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