Thursday, February 11, 2016
- In a regulatory filing, DaVita Healthcare Partners (NYSE:DVA) discloses that it has received a Civil Investigative Demand (CID) from the U.S. Attorney's Office for the Northern District of Texas regarding a False Claims Act investigation into allegations that it submitted false claims to the government for prescription drug reimbursement dating back to January 1, 2006. The company intends to cooperate fully with the inquiry.
- Previously: DaVita unit subject to False Claims Act inquiry (Nov. 18, 2015)
- Previously: DaVita receives subpoenas from HHS (Feb. 12, 2015)
- Previously: DaVita pays $400M to settle whistleblower suit (Oct. 23, 2014)
- Zimmer Biomet Holdings (NYSE:ZBH) receives 510(k) clearance for its Unite3D Bridge Fixation System, used to provide stability in foot and ankle joint fusion surgery. The device, which features the company's proprietary OsseoTi porous metal technology, is made with a 3D printer which produces a design that mimics the architecture of cancellous (spongy) bone. It also features an osteoconductive matrix that promotes biological integration.
- Alnylam (NASDAQ:ALNY) Q4 results ($M): Net Revenues From Collaborators: 7.6 (-68.3%); Operating Expenses: 100.1 (+43.6%); Quick Assets: 1,281.0 (+45.3%).
- Net Loss: (90.7) (-323.8%); Loss Per Share: (1.07) (-282.1%): Non-GAAP Loss Per Share: (1.07) (-282,1%).
- Pipeline up to eight programs. Patisiran regulatory submission on track for 2017. At least 10 major clinical data readouts on tap for this year.
- 2016 Guidance: Cash balance greater than $850M.
- Shares are flat after hours on modest volume.
- Arcadia Biosciences (NASDAQ:RKDA) President & CEO Eric Rey will step down from his executive and board member roles in order to devote himself to a full recovery from a coronary stent procedure. He will serve as as consultant during the search for and orientation of his successor. VP of business development Roger Salameh will serve as interim CEO until a permanent replacement for Mr. Rey is appointed.
- U.K. finance blogger Betaville reports hearing i-bank Moelis is "trying to broker a deal" between WebMD (WBMD +4.5%) and drugstore giant Walgreens Boots. Walgreen is said to have "already submitted an indicative offer."
- The FT reported in January WebMD is exploring a sale of all or part of its business. However, soon afterwards, the company stated it's "not currently in any negotiations to be acquired."
- Q4 results arrive on the afternoon of Feb. 23.
- IPO AveXis (NASDAQ:AVXS) is faring a bit better than fellow IPO Proteostasis Therapeutics (NASDAQ:PTI) although down 13% from its $20 offer price on light turnover of 760K shares.
- AveXis priced its debut at the midpoint of its proposed range of $19 - 21 so, all things considered, not too bad for a bad day for an IPO. Proteostasis is changing hands at more than 52% below its original midpoint of $12 - 14.
- Previously: AveXis on deck for IPO (Feb. 8)
- Embattled upstart blood-testing firm Theranos received a warning letter last month from Walgreens Boots Alliance (WBA -1.9%) that it may end their relationship unless it can quickly fix the problems at its Newark, CA laboratory. Apparently, Theranos' largest customer has given it until the end of the month to resolve the issues cited in a government audit.
- Theranos is running the tests normally performed at the Newark site at its Arizona facility. Its director, however, does not have a medical degree nor is pathology board-certified. The company says it has hired a new director who has the appropriate credentials, but has not publicly named the person.
- If WBA pulls the plug, Theranos will struggle to recover, say analysts. If this happens, it would a stunning collapse for the company and founder Elizabeth Holmes, who was the world's youngest female self-made billionaire based on her stake in the firm that was valued as high as $9B.
- Previously: Walgreens halts openings of new Theranos centers (Oct. 24, 2015)
- Previously: Theranos' $350M Safeway deal on the rocks (Nov. 11, 2015)
- Previously: Theranos in more hot water (Jan. 27)
- IPO Proteostasis Therapeutics (NASDAQ:PTI) is getting some rude treatment in its first day of trading. Shares are down 25% from the discounted price of $8 on turnover of 1.4M. The debut price was cut 38% from the (midpoint) of original expected range of $12 - 14.
- Previously: Proteostasis prices IPO well below range at $8; trading commences today (Feb. 11)
- Vanda Pharmaceuticals (VNDA -4.9%) Q4 results: Revenues: $31.8M (+106.5%); R&D Expense: $8.7M (+81.3%); SG&A: $28.9M (+67.1%); Operating Loss: ($14.9M) (-121.4%); Net Loss: ($14.8M) (-121.2%); Loss Per Share: ($0.35) (-119.8%); Non-GAAP Loss Per Share: ($0.23) (+36.1%).
- FY2015 results: Revenues: $109.9M (+118.9%); R&D Expense: $29.1M (+51.6%); SG&A: $84.5M (-0.1%); Operating Loss: ($40.2M) (+300.0%); Net Loss: ($39.9M) (-297.5%); Loss Per Share: ($0.94) (-270.9%); Non-GAAP Loss Per Share: ($0.45) (+80.4%); Quick Assets: $143.2M (+10.3%).
- 2016 Guidance: Net product sales from both HETLIOZ and Fanapt: $143M - 153M; HETLIOZ® net product sales: $73M - 78M; Non-GAAP Operating expenses: $125M - 135M; 2016 year end cash: $123M - 143M.
- Thinly traded nano cap NanoViricides (NNVC +15.5%) is up on increased volume in early trading in response to its announcement of an agreement with the University of Pittsburgh Medical Center's Eye Center's Ophthalmic Microbiology Laboratory for the testing of its drug candidates in standard animal models of ocular virus infections.
- The tests will be performed to assess their efficacy and potency as anti-viral agents in ocular viral infections. If successful, the company plans to file an Investigational New Application (IND) with the FDA for clearance to start clinical trials.
- The firm's nanoviricide drug candidates are designed to specifically attack virus particles and dismantle them. A nanoviricide is created by attaching a virus-binding ligand (derived from the virus's cell surface receptor) to a flexible polymer. Pipeline candidates include drugs for H5N1 bird flu, seasonal influenza, HIV, Epidemic Kerato-Conjunctivitis, hepatitis C, rabies, dengue fever and Ebola.
- Cyanotech (CYAN -1.7%) FQ3 results: Revenues: $7.5M (-22.7%); Operating Expense: $2.8M (-20.0%); Operating Income: $0.3M (-75.0%); Net Loss: ($0.3M) (-160.0%); Loss Per Share: ($0.04) (-150.0%); Quick Assets: $2M (-9.1%).
- No guidance given.
- Update: Shares are down 24% on a 28x surge in volume about one hour before the close.
- Genocea Biosciences (GNCA +1.8%) Q4 results: Revenues: $0.2M (-33.3%); R&D Expense: $6.5M (-25.3%); SG&A: $3.8M (+46.2%); Operating Loss: ($10.1M) (+7.3%); Net Loss: ($10.3M) (+12.0%); Loss Per Share: ($0.37) (+43.9%).
- FY2015 results: Revenues: $0.7M (+133.3%); R&D Expense: $28M (+18.1%); SG&A: $14M (+44.3%); Operating Loss: ($41.4M) (-24.7%); Net Loss: ($42.5M) (-20.4%); Loss Per Share: ($1.74) (+23.3%); Quick Assets: $106.4M (+125.9%).
- No guidance given.
- Invacare (IVC +5.2%) Q4 results: Revenues: $283.3M (-11.0%); SG&A: $78.5M (-11.4%); Net Loss: ($2.9M) (+56.7%); Loss Per Share: ($0.09) (+57.1%); Non-GAAP Loss Per Share: ($0.06) (+50.0%).
- FY2015 results: Revenues: $1,142.3M (-10.1%); SG&A: $319.8M (-16.7%); Net loss: ($26.5M) (+61.5%); Loss Per Share: ($0.82) (+61.9%); Non-GAAP Loss Per Share: ($0.62) (+61.0%); Quick Assets: $60.1M (+54.5%).
- No guidance given.
- Acorda Therapeutics (ACOR -3.5%) Q4 results: Revenues: $130.9M (+11.0%); R&D Expense: $44M (+69.9%); SG&A: $53M (-6.2%); Operating Income: $3.9M (+225.0%); Net Income: $9.2M (+999%); EPS: $0.21 (+999%); Non-GAAP EPS: $0.28 (-39.1%).
- FY2015 results: Revenues: $492.7M (+22.7%); R&D Expense: $149.2M (+103.0%); SG&A: $205.6M (+1.9%); Operating Income: $34M (-6.6%); Net Income: $11.1M (-37.3%); EPS: $0.25 (-40.5%); Non-GAAP EPS: $1.05 (-39.7%); Quick Assets: $353.3M (+14.9%).
- 2016 Guidance: AMPYRA Net Revenue: $475M - 485M; R&D Expense: $165M - 175M; SG&A Expense: $195M - 205M.
- Quintiles Transnational Holdings (Q) Q4 results: Revenues: Revenues: $1,521.7M (+7.8%); SG&A: $244.1M (+8.4%); Operating Income: $178M (+12.0%); Net Income: $104.6M (+18.3%); EPS: $0.85 (+23.2%); Non-GAAP EPS: $0.90 (+26.8%).
- FY2015 results: Revenues: $5,737.6M (+5.1%); SG&A: $921M (+4.4%); Operating Income: $646.6M (+9.5%); Net Income: $387.2M (+8.6%); EPS: $3.08 (+13.2%); Non-GAAP EPS: $3.33 (+23.3%); Quick Assets: $977.2M (+12.7%).
- 2016 Guidance: GAAP Net Income: $432M - 454M; Adjusted Net Income: $454M - 473M; GAAP EPS: $3.52 - 3.70; Adjusted EPS: $3.70 - 3.85; Constant currency service revenue growth: 7.0 - 8.5%.
- Shire plc (NASDAQ:SHPG) Q4 results ($M): Total Revenues: 1,715.7 (+8.9%); Product Sales: 1,623.7 (+8.2%).
- Key Product Sales: Vyvanse: 453.3 (+18.2%); Lialda/Mezavant: 201.4 (+9.0%); Elaprase: 147.1 (+2.7%); Cinryze: 143.3 (+0.6%), Firazyr: 125.2 (+22.9%).
- Net Income: 280.6 (-87.1%); Non-GAAP Net Income: 587.6 (+13.2%); EPS: 0.473 (-87.1%); Earnings per ADS: 0.1419 (-87.1%); Non-GAAP Earnings per ADS: 0.2971 (+12.8%); CF Ops: 761.8 (-70.2%).
- 2016 Guidance: Product Sales Growth: 11 - 14%; Non-GAAP Earnings/ADS Growth: 7 - 10%.
- Shares are up 3% premarket on increased volume.
- The first patient has been enrolled in a Phase 2 clinical trial evaluating Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) injection in women with cervical cancer. The study will assess the use of Lymphoseek in sentinel lymph node biopsy during cervical cancer surgery in support of its current label in lymphatic mapping.
- The trial will enroll up to 40 subjects. Each will receive a single dose of Lymphoseek administered around the tumor 1 - 2 hours before surgery. The primary endpoint is the per-patient false negative rate. According to clinicaltrials.gov, the estimated study completion date is August of this year.
- Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor. These have the highest probability of harboring cancer cells.
- Citing the need to reduce operating expenses and conserve cash as U.S. competitors erode JUXTAPID (lomitapide capsules) sales, Aegerion Pharmaceuticals (NASDAQ:AEGR) intends to cut 25% of its workforce by the end of Q2. The company will have ~230 employees after the reduction.
- CEO Mary Szela says, "We believe this action better aligns the company's resources with our current strategy and market opportunity with JUXTAPID and our goal of continuing to grow MYALEPT (metreleptin for injection) sales, supports our objective to create a pipeline of therapies to treat patients with rare diseases and positions us to maximize the value of our assets for our shareholders."
- Teva Pharmaceutical Industries (NYSE:TEVA) Q4 results ($M): Total Revenues: 4,881 (-5.6%); Generic Medicines: 2,257 (-8.6%); Specialty Medicines: 2,114 (-5.8%); MS Specialty: 960 (-14.4%); Other Specialty: 1,154 (+2.9%).
- Key Product Sales: Copaxone: 960 (-14.4%); Treanda: 198 (-12.4%); ProAir: 148 (+23.3%).
- Net Income: 485 (-30.9%); EPS: 0.55 (-31.3%); Non-GAAP EPS: 1.28 (-3.8%); CF Ops: 1,615 (-7.8%).
- Q1 Guidance: Revenues: $4.7B - 4.9B; Non-GAAP EPS: $1.16 - 1.20; CF Ops: $1.2B - 1.3B. Full-year guidance will be released after the close of the Actavis Generics transaction.
- Shares are down 3% premarket on light volume.
- Incyte (NASDAQ:INCY) Q4 results ($M): Total Revenues: 243.9 (+96.7%); Jakafi Sales: 182.0 (+71.7%); Operating Expenses: 169.1 (+14.9%); Quick Assets: 707.8 (+17.9%).
- Net Income: 55.2 (+249.6%); EPS: (+231.8%).
- 2016 Guidance: Jakafi Sales: $800M - 815M.
- Conference call this morning at 10:00 am ET.
- Shares are down 16% premarket on light volume.
- Previously: Incyte bags late-stage development of Jakafi for solid tumors; shares down 10% premarket (Feb. 11)
- Incyte (NASDAQ:INCY) terminates its Phase 3 clinical trial assessing Jakafi (ruxolitinib), in combination with chemo agent capecitabine, for the second-line treatment of advanced or metastatic pancreatic cancer after an interim analysis failed to show sufficient efficacy.
- Based on these data and the interim analysis of the Phase 2 sub-study of Jakafi, in combination with Bayer's (OTCPK:BAYRY) STIVARGA (regorafenib), in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all Jakafi studies in solid tumors, including Phase 2 trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
- Data from all the discontinued trials will be analyzed and shared with the scientific community over the next few months.
- Ongoing studies of Jakafi and selective JAK1 inhibitors in hematology will continue as will those assessing selective JAK1 inhibition in solid tumors based on different hypotheses. These include a series of studies evaluating INCB39110 in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) and Incyte's epacadostat and INCB50465. A Phase 1/2 trial will also be conducted assessing INCB39110 plus AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib).
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Shares are off 10% premarket on light volume.
- Innovus Pharmaceuticals (OTCQB:INNV) acquires Austin, TX-based Beyond Human, LLC for $630K in cash. The privately held firm's flagship product is a natural testosterone booster called Beyond T Human. The company generated ~$1.3M in sales in 2014 and ~$2.2M last year.
- According to Innovus, the transaction will add $3M in gross revenues and over $600K in net profits to its operations, once integrated into its platform.
Wednesday, February 10, 2016
- Psychemedics (NASDAQ:PMD): Q4 EPS of $0.03
- Revenue of $6.13M (-9.3% Y/Y)
- Cepheid (NASDAQ:CPHD) promotes EVP and Chief Operating Officer Warren Kocmond to President & COO. His expanded responsibilities now include Global Commercial Operations in addition to Manufacturing, Engineering, Technical Service and Customer Service. He will continue to report to Chairman and CEO John Bishop.
- Genomic Health (NASDAQ:GHDX) Q4 results ($M): Total Revenues: 74.5 (+7.8%); U.S. Revenues: 63.9 (+8.7%); Operating Expenses: 78.0 (+3.9%).
- Net Loss: (3.2) (+39.0%); Loss Per Share: (0.10) (+50.0%).
- 2016 Guidance: Total Revenues: $320M - 335M; Net Loss: $12M - 18M; Oncotype DX tests delivered: 117.5K - 121K.
- Mylan N.V. (NASDAQ:MYL) acquires Solna, Sweden-based Meda Aktiebolag for $9.9B, including the assumption Meda debt. The cash-and-stock transaction values the Meda equity at $7.2B, with the cash portion at $5.7B.
- The deal will be immediately accretive to Mylan's earnings, adding $0.35 - 0.40 in 2017 and enabling the achievement of non-GAAP EPS of $6.00 a year earlier also in 2017.
- The combined company's 2015 sales were $11.8B with non-GAAP EBITDA of ~$3.8B generated by over 2,000 products sold in more than 165 markets worldwide. Meda's 2015 results were sales of $2.3B and non-GAAP EBITDA of $768M.
- Novartis (NVS +0.5%) inks a pricing deal with Cigna (CI +0.9%) and Aetna (AET +2.5%) for its heart drug Entresto (sacubitril/valsartan) that is based on its ability to reduce the proportion of patients who are admitted to the hospital for heart failure. The performance-based scheme applies to the insurers' commercial business, not Medicare or Medicaid.
- Entresto costs $12.50 per day or $4,560 per year, not the most expensive new drug but higher than expected. The deal specifies a base price and modest rebate that will fluctuate based on the number of hospitalizations and savings to the plan.
- Analysts expect more performance-based drug pricing arrangements going forward since it holds the manufacturer accountable for the product's claimed efficacy. Insurers like the deals because they will save money if the drug's benefits are realized and will pay a premium only in such instances, thereby derisking including the drug in their formularies.
- Teva Pharmaceutical Industries (TEVA +0.3%) will release Q4 and full-year 2015 results tomorrow before the open. Consensus views for the quarter and year are EPS of $1.29 on revenues of $4.8B and EPS of $5.44 on revenues of $19.6B, respectively.
- Thinly traded nano cap Ritter Pharmaceuticals (RTTR +35.5%) is up on increased volume, albeit on turnover of only 107K shares, on no particular news (that I could find).
- Its lead product candidate is Phase 2b-stage RP-G28 for lactose intolerance. An earlier Phase 2 successfully demonstrated RP-G28's efficacy in reducing symptoms of the condition.
- Shares were down ~50% year-to-date before today's move.
- Illumina (ILMN +2.4%) taps board member and former Google executive Jeff Huber to lead Grail, its startup company that is developing a test to detect cancers at their earliest stages.
- Mr. Huber's 12-year Google career involved working on advertising products, Google Maps, Google Earth and the life sciences arm of Google X.
- Grail was started in January with more than $100M in funding from the likes of tech titans Bill Gates and Jeff Bezos. Its aim is to develop a "pan-cancer" screening test that can detect very minute levels of tumor-associated material in the blood called cell-free DNA. The process is called a liquid biopsy in light of its similar diagnostic objective to a tissue biopsy, that is, to detect very early-stage cancer. It will use Illumina's latest sequencing technology to analyze the samples. It expects to initiate a large clinical trial in 2017.
- Illumina invested $40M in Grail's first funding round and owns more than 50% of the company.
- Related tickers: (TROV -1.3%)(TBIO +5.4%)(SQNM +6.5%)(BIOC -0.7%)(CDNA -2.5%)
- The USPTO issues a Notice of Allowance to Matinas BioPharma Holdings (OTCQB:MTNB -0.1%) for its U.S. Patent Application No. 14/609,235 titled, "Cochleates Made with Soy Phosphatidylserine." When issued, the patent will be valid though 2033.
- The patent covers the company's lipid-crystal nano-particle cochleate formulation technology, its proprietary technology for improved drug delivery.
- The USPTO issues a Notice of Allowance to RedHill Biopharma (RDHL +1.4%) for its patent application titled, "Compositions Comprising Rifabutin, Clarithromycin and Clofazamine and Use Thereof," covering RHB-104, its combination antibiotic candidate under development for the treatment of Crohn's disease, relapsed/remitting multiple sclerosis and rheumatoid arthritis.
- The patent, when issued, will be the fifth for RHB-104 and will be valid through 2029.
- The FDA designates Amarantus BioScience Holdings' (OTCQX:AMBS +11.1%) eltoprazine an Orphan Drug for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
- Phase 2-stage eltoprazine, a small molecule neuromodulator, is a 5HT 1A/1B receptor agonist under development for PD-LID and adult attention deficit hyperactivity disorder (NASDAQ:ADHD).
- PD-LID is an involuntary movement disorder that results from prolonged levodopa-based therapy, the standard-of-care for patients with Parkinson's disease. PD-LID occurs in as many as 80% of PD patients. It is difficult to treat and prevents patients from performing routine daily tasks.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Previously: First patient dosed in Amarantus Bio's mid-stage study of eltoprazine in movement disorder (July 20, 2015)
- The FDA accepts for review KemPharm's (KMPH +8.6%) New Drug Application (NDA) seeking clearance of KP201/APAP, its candidate for the short-term management of acute pain. The agency will assess the NDA under its Priority Review process which shortens the review clock to six months from the standard 10 months.
- KP201/APAP is an immediate release combination of the company's prodrug of hydrocodone, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP). It is an abuse-deterrent formulation which also limits excessive opioid exposure compared to currently available hydrocodone combination products such as Vicodin, Norco and Lortab, all widely prescribed and widely abused.
- KP201/APAP was developed using the company's proprietary Ligand-Activated Technology which creates a prodrug by chemically attaching one or more molecules (ligands) to the parent drug which inactivates it. Once inside the body, the ligand separates from the parent drug which then enables it to deliver its therapeutic effect.
- The FDA designates Cidara Therapeutics' (CDTX -2.1%) CD101 IV an Orphan Drug for the treatment of candidemia (presence of the fungus Candida in the blood) and invasive candidiasis (serious systemic infection caused by Candida).
- Phase 2-stage CD101 IV is an intravenous formulation of a novel molecule in a class of antifungals called echinocandins, called the "penicillin of antifungals" in light of their similar mechanisms of action. Its value proposition is a prolonged half-life which may allow for once-weekly IV therapy. Other echinocandins are typically administered daily.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Mast Therapeutics (MSTX -40.2%) prices its public offering of 29,090,910 units at $0.275 per unit. Each unit consists of one share of common stock and one five-year warrant to purchase one share of common at $0.42. Net proceeds will be ~$7.3M. Closing date is February 16.
- Net proceeds will fund the clinical development and commercialization of vepoloxamer, working capital and general corporate purposes.
- Previously: Mast initiates equity offering (Feb. 9)
- Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) completes its tender offer for all issued and outstanding common shares of Ocata Therapeutics (NASDAQ:OCAT) at $8.50 per share.
- Previously: Astellas extends Ocata Therapeutics tender offer until February 9 (Jan. 22)
- Previously: Astellas Pharma buys Ocata Therapeutics for $8.50 per share in cash (Nov. 10, 2015)
- Thinly traded nano cap Electromed (NYSEMKT:ELMD) is up 47% premarket on increased volume in response to its fiscal Q2 results released after yesterday's close. It earned $0.13 (+160%) per share on revenues of $6.3M (+28%).
- The Simi Valley, CA-based company develops products that provide airway clearance therapy, such as its SmartVest System.
- Previously: Electromed reports FQ2 results (Feb. 9)
- NxStage Medical (NXTM) Q4 results: Revenues: $89.8M (+12.4%); Operating Expense: $38.1M (+7.9%); Operating Loss: ($2.3M) (+48.9%); Net Loss: ($2.7M) (+44.9%); Loss Per Share: ($0.04) (+50.0%).
- FY2015 results: Revenues: $336.1M (+11.5%); Operating Expense: $146.1M (+5.8%); Operating Loss: ($14.6M) (+34.2%); Net Loss: ($15.3M) (+36.0%); Loss Per Share: ($0.24) (+38.5%); Quick Assets: $59.1M (+11.7%).
- Q1 Guidance: Revenues: $87M - 89M; Net Loss: ($2M - 4M).
- 2016 Guidance: Revenues: $355M - 360M; Net Loss: ($7M - 12M).
- Cocrystal Pharma (OTCQB:COCP) licenses certain patents and know-how from Duke and Emory Universities related to CRISPR-Cas9 technologies, a new gene editing method that many observers believe may finally deliver functional cures to many genetic disorders. The company's aim in this case, though, is to develop a cure for hepatitis B virus (HBV) infection and human papilloma virus (HPV) infection.
- CRISPR-Cas9 is the "next big thing" in biotech because of its unprecedented precision in editing DNA. CRISPR, the acronym for "clustered, regularly interspaced short palindromic repeats," uses RNA to guide the molecular scissors, the Cas9 enzyme, to a specific DNA sequence where it makes a specific cut in the DNA and triggers the cell's DNA repair machinery to address the genetic defect. In other words, its can precisely cut out a mutated section of DNA and replace it with one that functions properly.
- Financial terms are not disclosed.
- Charles River Laboratories (CRL) Q4 results: Revenues: $353.9M (+7.4%); SG&A: $81.5M (+13.2%); Operating Income: $52.3M (+28.2%); Net Income: $33.3M (+16.8%); EPS: $0.69 (+16.9%); Non-GAAP EPS: $1.00 (+23.5%).
- FY2015 results: Revenues: $1,363.3M (+5.1%); SG&A: $300.4M (+11.7%); Operating Income: $206.4M (+16.2%); Net Income: $152M (+17.0%); EPS: $3.15 (+16.7%); Non-GAAP EPS: $3.76 (+8.7%); Quick Assets: $117.9M (-26.3%).
- 2016 Guidance: Revenue growth (constant currency): 9% - 11; GAAP EPS: $3.60 - 3.70; Non-GAAP EPS: $4.07 - 4.17.
- Alkermes (NASDAQ:ALKS) initiates its second of two core Phase 3 clinical trials assessing ALKS 3831 (samidorphan/olanzapine) in schizophrenia. The 540-subject study, called ENLIGHTEN-2, will evaluate the weight gain profile of ALKS 3831 compared to olanzapine [Eli Lilly's (NYSE:LLY) Zyprexa] in schizophrenic patients over a six-month period.
- The first study, ENLIGHTEN-1, is assessing ALKS 3831's antipsychotic efficacy over four weeks.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint in ENLIGHTEN-1 is January 2018. The estimated study completion date is April 2018.
- ALKS 3831 is designed to deliver the efficacy of olanzapine with a better safety profile with less unwanted weight gain and metabolic side effects.
- Previously: Alkermes antipsychotic drug shows durable efficacy and beneficial weight effect in clinical trial (April 6, 2015)
- TransEnterix (NYSEMKT:TRXC) announces that it has completed its response to the FDA regarding its 510(k) application seeking clearance of its SurgiBot System. The company expects approval by the end of March.
- It has also beefed up its balance sheet in preparation for the commercial launch. It raised $18M via equity sales and has established an ATM facility that gives it the option to raise up to $43.6M in equity through June 2017.
- Shares have been on a tear the past two weeks, up over 150%, although profit takers have shares down 18% premarket today (on modest volume).
- The single-port Surgibot system allows the surgeon to be in the sterile field which means he/she can stand beside the patient rather than sit behind a console like Intuitive Surgical's (NASDAQ:ISRG) da Vinci system. It also features a combination of reusable and disposable instruments.
- Previously: Transenterix files 510(k) for SurgiBot System (June 1, 2015)
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