Today - Tuesday, July 26, 2016
- Thinly traded nano cap Cesca Therapeutics (KOOL +69.6%) is up on a healthy 20x surge in volume. No particular news accounts for the move, although one frequently sees this kind of unexplained action before a public offering of equity. A few days ago, the company filed an updated S-3 for a $30M mixed shelf offering.
- In May, shares jumped on the announcement of positive data from a pilot study of its Acute Myocardial Infarction Rapid Stem Cell Therapy ((AMIRST)).
- Previously: Results from single-patient heart attack study of Cesca's stem cell therapy sends shares up over 100% (May 19)
- Neogenomics (NEO -0.4%) Q2 results: Revenues: $63.1M (+158.6%); Operating Income: $2.2M; Net Income: $0.4M; Loss Per Share: ($0.07); Non-GAAP EPS: $0.04; Quick Assets: $21.8M (-6.8%); CF Ops: $12.1M.
- 2016 Guidance: Revenue: $242M - 252M; Adjusted EBITDA: $35M - 40M; Adjusted Net Income: $8M - 13M; Adjusted EPS: $0.08 - 0.13.
- Cynosure (CYNO +2.4%) Q2 results: Revenues: $110.3M (+31.8%); Operating Income: $10.5M (+38.2%); Net Income: $6.3M (+16.7%); EPS: $0.27 (+12.5%); Non-GAAP EPS: $0.36 (+20.0%); Quick Assets: $170.4M (+18.3%).
- No guidance given.
- AbbVie (ABBV -0.3%) and privately held X-Chem enter into a multi-target drug discovery partnership with the aim of identifying novel small molecule inhibitors of promising new targets in addition to those already validated but difficult to address. AbbVie has an exclusive option to license active hits and leads generated during the collaboration and is responsible for all further development and commercialization.
- Financial terms are not disclosed.
- MiMedx Group (MDXG -2.8%) Q2 results: Revenues: $57.3M (+25.4%); Operating Income: $3.6M (-36.8%); Net Income: $2M (-63.0%); EPS: $0.02 (-60.0%); Non-GAAP EPS: $0.05 (unch); Quick Assets: $23.8M (-24.4%).
- Q3 Guidance: Revenue: $62M - 64M.
- FY16 Guidance: Revenue: $243.5M - 248M; Adjusted EPS: $0.21 - 0.23.
- FibroGen (FGEN +0.6%) and development partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) announce the dosing of the first patient in Phase 3 studies in Japan assessing roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD). The event triggers a $10M milestone payment to FibroGen from Astellas. The Phase 3 trials follow two successful Phase 2s there.
- FibroGen is collaborating with Astellas on the development and commercialization of roxadustat for anemia in CKD patients in Japan, the Commonwealth of Independent States, the Middle East and South Africa. FibroGen is partnering with AstraZeneca (AZN -0.2%) in the U.S., China and other markets.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's Procrit].
- Thinly traded micro cap BioTelemetry (NASDAQ:BEAT) is up 7% premarket on light volume in response to its announcement that its has received 510(k) clearance from the FDA for its next generation Mobile Cardiac Outpatient Telemetry device.
- The product, called the MCOT Patch, is a four-lead, two-channel system based on the same technology as the current MCOT, but with a more convenient form factor.
- Thinly traded micro cap Cardiome Pharma (NASDAQ:CRME) is off 42% premarket on robust volume in response to its announcement that its has priced its public offering of 10M shares of common stock at $3.00 per share. Underwriters over-allotment is an additional 1.5M shares. Closing date is July 29.
- Net proceeds will fund the in-licensing of dalbavancin, including milestone payments related to pricing reimbursement and launches, and general corporate purposes.
- The FDA approves Tandem Diabetes Care's (NASDAQ:TNDM) t:slim Insulin Pump for use in children as young as six years old. The previous age limit was 12 years.
- The expanded pediatric indication does not require any changes to the existing user interface, which has the look and feel of a typical consumer device.
- Thinly traded micro cap Tokai Pharmaceuticals (NASDAQ:TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
- Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
- Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
- Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)
- Thinly traded nano cap Viking Therapeutics (NASDAQ:VKTX) is up 19% premarket on light volume in response to its announcement of positive preclinical results for product candidate VK0214 in a rare nervous system disorder called X-linked adrenoleukodystrophy (X-ALD), a disease caused by the deterioration of fatty covering of nerves (myelin) which reduces the ability of the nerves to relay information to the brain. It also damages the outer layer of the adrenal glands which leads to the shortage of certain hormones (adrenocortical insufficiency). It occurs in ~1 in 17,000 births.
- The results were generated in a proof-of-concept mouse model of X-ALD. VK0214 rapidly reduced plasma very long chain fatty acid (VLCFA) levels by more than 25% compared to controls after six weeks of treatment. VLCFAs are elevated in X-ALD sufferers due to metabolic defects.
- Complete data will be presented at an upcoming scientific meeting.
- VK0214 is an orally available thyroid receptor beta agonist that selectively regulates the expression of genes believed to be relevant to the presence of X-ALD.
- Bristol-Myers Squibb (NYSE:BMY) and Janssen Biotech (NYSE:JNJ) will collaborate in a Phase 2 clinical trial assessing the combination of BMY's Opdivo (nivolumab) and Janssen's immunotherapy JNJ-64041757 in patients with non-small cell lung cancer (NSCLC).
- JNJ-64041757 is an antigen-presentation therapeutic based on Live Attenuated Double-Deleted Listeria monocytogenes bacteria strains engineered to induce an immune response against NSCLC tumors. It is currently in Phase 1 development for lung cancer.
- Opdivo is indicated for the treatment of NSCLC with progression on or after platinum-based chemo.
- Baxter International (NYSE:BAX) Q2 Results ($M): Total Revenues: 2,585 (+4.4%); Hospital Products: 1,620 (+6.2%); Renal: 965 (+1.7%).
- Fluid Systems: 586 (+13.1%); Integrated Pharmacy Solutions: 563 (+2.7%).
- Net Income: 1,212 (+265.1%); Non-GAAP Net Income: 256 (+139.3%); EPS: 2.19 (+265.0%); Non-GAAP EPS: 0.46 (+142.1%).
- 2016 Guidance: Sales Growth: 1 - 2%; EPS: $8.87 - 8.94 from $8.94 - 9.06.
- Q3 Guidance: Sales Growth: 2 - 3%; EPS: $0.25 - 0.29.
- Centene (NYSE:CNC) Q2 Results ($M): Total Revenues: 10,897 (+97.9%); Premium and Service: 10,276 (+98.2%).
- Net Income: 169 (+92.0%); EPS: 0.97 (+34.7%); Non-GAAP EPS: 1.29 (+69.7%); CF Ops (6 mo.): (225) (-157.0%).
- Health Benefits Ratio: 86.6% (-2.1%).
- Total Membership: 11,430,800 (+147.8%); Total At-Risk Membership: 8,615,100 (+94.2%).
- 2016 Guidance: Total Revenues: $39.4B - 40.0B; EPS: $2.65 - 3.00; Non-GAAP EPS: $4.20 - 4.55; Health Benefits Ratio: 87.0 - 87.5%.
- Shares are up 2% premarket on light volume.
- Eli Lilly (NYSE:LLY) Q2 Results ($M): Total Revenues: 5,404.8 (+8.6%); Animal Health: 859.8 (+2.3%).
- Net Income: 747.7 (+24.5%); Non-GAAP Net Income: 908.8 (-4.8%); EPS: 0.71 (+26.8%); Non-GAAP EPS: 0.86 (-4.4%).
- Key Product Sales: Humalog: 701.9 (+7.3%); Cialis: 630.5 (+11.0%); Alimta: 607.1 (-8.6%); Forteo: 367.6 (+11.9%); Humulin: 332.3 (+5.0%); Cymbalta: 236.5 (-13.7%); Strattera: 224.6 (+17.1%); Zyprexa: 210.7 (-16.9%); Trulicity: 201.3 (+354.4%); Erbitux: 180.6 (+34.2%); Cyramza: 147.0 (+67.6%); Effient: 135.1 (+4.9%).
- 2016 Guidance: Revenue: $20.6B - 21.1B (unch): EPS: $2.68 - 2.78 (unch); Non-GAAP EPS: $3.50 - 3.60.
Monday, July 25, 2016
- The FDA designates Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab) a Breakthrough Therapy, in combination with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy. Several months ago, the European Commission approved it as monotherapy in adults with relapsed/refractory MM whose prior therapy included a proteasome inhibitor [e.g. Takeda's Ninlaro (ixazomib)] and an immunomodulatory agent and have shown disease progression on the last therapy.
- Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA) (or supplemental NDA in this case).
- Celgene (NASDAQ:CELG) eases 3% after hours on robust volume in response to its announcement that it will not seek a new indication for Revlimid (lenalidomide) as maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) who responded to first-line rituximab (Roche's Rituxan) plus R-CHOP chemo.
- The company's decision was based on the results from a randomized Phase 3 study, REMARC, that showed a statistically valid improvement in progression-free survival in the treatment group versus placebo, but no difference in overall survival.
- Revlimid is currently approved for multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma.
- The FDA approves AbbVie's (NYSE:ABBV) VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets, a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK. The new product is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those patients with compensated cirrhosis (Child-Pugh A). It is used without ribavirin in genotype 1b patients and in combination with twice-daily ribavirin in genotype 1a patients.
- The data supporting the application was generated in Phase 3 studies that showed a 100% cure rate in genotype 1b patients after 12 weeks of therapy without ribavirin and a 95% cure rate in genotype 1a patients when used with ribavirin for 12 or 24 weeks.
- HCV-1 is the most prevalent form of HCV infection in the U.S., representing ~74% of cases. About 2.7M Americans are chronically infected with HCV.
- Express Scripts Holding (NASDAQ:ESRX) Q2 results ($M): Total Revenues: 25,222.3 (-1.0%);
- EBITDA: 1,798.1 (+4.9%); Non-GAAP EBITDA: 1,798.1 (+0.2%); Net Income: 720.7 (+20.1%); Non-GAAP Net Income: 998.7 (+2.0%); EPS: 1.13 (+28.4%); Non-GAAP EPS: 1.57 (+9.0%); CF Ops (6 mo.): 1,190.1 (+0.7%).
- Claims Volume: 250.7 (-3.0%);
- 2016 Guidance: Total adjusted claims: 1,260 - 1,290 from 1,255 - 1,295; EBITDA: $7,230 - 7,430 (unch); Operating Income: $5,135 - 5,250 (unch); EPS: $4.45 - 4.55 from $4.53 - 4.61: Non-GAAP EPS: $6.33 - 6.43 from $6.31 - 6.43; CF Ops: $4,600 - 5,100 (unch).
- Expected 2017 retention rate for 2016 selling season: 96 - 98%.
- Shares are off a fraction after hours.
- Gilead Sciences (NASDAQ:GILD) Q2 results ($M): Total Revenues: 7,776 (-5.7%); Product Sales: 7,651 (-5.8%).
- Net Income: 3,497 (-22.2%); Non-GAAP Net Income: 4,177 (-13.8%); EPS: 2.58 (-11.6%); Non-GAAP EPS: 3.08 (-2.2%).
- Key Product Sales: Harvoni: 2,564 (-28.9%); Sovaldi: 1,358 (+5.2%); Truvada: 942 (+11.0%); Atripla: 673 (-13.9%); Stribild: 429 (-4.0%); Viread: 287 (+5.9%).
- 2016 Guidance: Net Product Sales: $29.5B - 30.5B from $30.0B - 31.0B; Non-GAAP Gross Margin: 88-90% (unch); Diluted Impact of Certain Items: $1.47-1.53 from $1.10-1.16.
- Shares are down 4% after hours on robust volume.
- Kite Pharma (NASDAQ:KITE) inks a global license agreement with the University of California for technology to advance the development of off-the-shelf allogeneic T-cell therapies from renewable pluripotent stem cells.
- The technology is an artificial thymic organoid (ATO) cell culture system that replicates the human thymic environment to support efficient and scalable ex vivo differentiation of T cells from primary and reprogrammed pluripotent stem cells due, in large part, to the potential capability of pluripotent stem cell lines to self-renew indefinitely. According to the company, the ATO system is an attractive platform to facilitate additional gene engineering steps to develop off-the-shelf allogeneic T-cell therapies.
- Under the terms of the agreement, Kite has exclusive rights to use the technology to develop and commercialize oncology-focused T-cell products. In connection with the contract, the company has entered into a Sponsored Research Agreement with UCLA to support ongoing preclinical research to optimize the ATO platform. Financial terms are not disclosed.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Allergan's (AGN -0.9%) TRUBERZI (eluxadoline) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).
- In two pivotal studies, patients treated with TRUBERZI experienced significant reductions in the two most bothersome IBS-D-related symptoms: abdominal pain and diarrhea, with sustained relief over six months.
- A final decision from the European Commission (EC) usually takes ~60 days.
- If approved, TRUBERZI will join Ironwood Pharmaceuticals' (IRWD -2.1%) CONSTELLA (linaclotide), approved by the EC in June 2013, as the only medications in the EU licensed to treat IBS-D symptoms.
- Ultra-thinly traded nano cap Ritter Pharmaceuticals (RTTR +16.7%) heads north on 1.6M-share turnover. Shares were up almost 80% before easing. No particular news accounts for the action but a secondary equity offering may be brewing.
- The clinical stage firm develops therapeutics the modulate the human gut microbiome to treat gastrointestinal diseases. Its lead product candidate is RP-G28, a highly purified galactooligosaccharide for the treatment of lactose intolerance. It is designed to stimulate the growth of lactose-metabolizing bacteria in the colon. If approved, it will be the first drug cleared by the FDA for the indication.
- Struggling biosimilar developer EPIRUS Biopharmaceuticals (EPRS +2%) files for protection under Chapter 7 of the U.S. Bankruptcy Code. In accordance with the provisions, the company's assets will be liquidated and claims paid with the proceeds.
- Read now Epirus Signs Profit-Sharing Collaboration With PolPharma Group
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) informs PTC Therapeutics (PTCT -5.3%) that its renewal assessment procedure for the Translarna (ataluren) marketing authorization will not be completed by mid-year as expected, although the company believes that the current marketing authorization to remain in effect until a decision is announced by the European Commission (EC).
- The EC initially approved Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in 2014 subject to annual renewal and certain conditions.
- The company is currently recruiting patients in an open-label 10-subject Phase 2 clinical trial assessing Translarna in boys aged 2 to 5 with DMD. The primary endpoint is the number of participants with abnormal laboratory values and/or treatment-related adverse events at week 56. According to ClinicalTrials.gov, the estimated study completion date is October 2017.
- In Q3 2015, the company submitted a variation to its marketing authorization requesting approval for the use of Translarna in nonsense mutation cystic fibrosis based on a post-hos analysis of its completed Phase 3 study. It no longer expects to receive an opinion from CHMP by mid-year. In addition, there is a substantial likelihood that the results from the ongoing Phase 3 ACT CF trial, expected to be completed in early 2017, will be required for approval.
- Previously: PTC Therapeutics DMD drug gets conditional nod from European Commission (Aug. 4, 2014)
- Soligenix (OTCQB:SNGX -4.6%) announces that it has received $634K in new funding to support the development of OrbeShield (oral beclomethasone 17,21 dipropionate or BDP) as a medical countermeasure for civilian and military use to treat gastrointestinal acute radiation syndrome (GI ARS). The Biomedical Advanced Research and Development Authority (BARDA) chipped in $350K while NIH's National Institute of Allergy and Infectious Diseases (NIAID) contributed $284K.
- Total funding from the two groups will be as high as $33M if all contract options are exercised ($18M has been committed thus far).
- ARS occurs after toxic radiation exposure. It typically damages three organ systems: the bone marrow, GI tract and lungs. Orphan Drug- and Fast Track-tagged OrbeShield is a two-tablet regimen, one releases BDP in the proximal portions of the GI tract and the other releases BDP in the distal portions. BDP has been marketed worldwide since the early 1970s as the active ingredient in inhalation products for the treatment of allergic rhinitis and asthma.
- The FDA lifts its clinical hold on Novartis' (NVS -1%) Phase 1/2 study assessing CGF166 in patients with severe-to-profound hearing loss after the Data Safety and Monitoring Board recommended that the trial continue. The agency stopped the trial in January of this year in accordance with criteria in the study's protocol that required a review of the results. Top-line data should be available in 2017.
- CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene to sensory cells in the inner ear. Novartis licensed it from GenVec (GNVC -2.4%) in January 2010.
- Apricus Biosciences (APRI +0.7%) expands its exclusive distribution deal with Swiss firm Ferring Pharmaceuticals related to topical erectile dysfunction cream Vitaros. The new agreement adds 19 countries plus Hong Kong to Ferring's previous territory of Latin America and (recently) the United Kingdom. The existing marketing authorizations will be transferred to Ferring from Sandoz pursuant to the termination of Sandoz's license.
- Under the new arrangement, Apricus is eligible to receive an additional $3.6M in upfront and pre-commercialization payments as well as up to an additional $1.5M in launch-related milestones. It can earn up to $34M in total milestones when the previous distribution agreement is included. Sales-based royalties will be high single-digit to low double-digit.
- Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
- The FDA has tagged V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
- Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.
- Micro cap Ocular Therapeutix (NASDAQ:OCUL) receives a Complete Response Letter (CRL) from the FDA after reviewing its New Drug Application (NDA) seeking approval of DEXTENZA (dexamethasone insert) 0.4 mg for intracanalicular use in the treatment of ocular pain following ophthalmic surgery.
- The CRL cited deficiencies in manufacturing process and controls observed during an on-site inspection of the company's manufacturing facility. The company says the agency did not identify which deficiencies remain open since its last written response to regulator. No safety or efficacy issues related to DEXTENZA are involved.
- CEO Amar Sawhney, Ph.D., says, "We have previously responded to all requests in an effort to address the manufacturing items raised by the FDA during the application process and we await completion of the review. Labeling discussions with the FDA are ongoing. We remain optimistic that DEXTENZA will be approved once these open manufacturing items are closed. We will continue to work collaboratively with the FDA so they can finalize their review of our NDA and are committed to bringing DEXTENZA to market as rapidly as possible."
- DEXTENZA is designed to deliver dexamethasone, a corticosteroid, to the ocular surface for four weeks. It is placed through the punctum (small opening), a natural opening in the eyelid, into the canaliculus (small channel in the eyelid) where it is resorbed over time.
- Shares are down 4% premarket on robust volume.
- Thinly traded micro cap Tobira Therapeutics (NASDAQ:TBRA) is down 54% premarket on increased volume in response to its announcement that lead product candidate cenicriviroc (CVC) failed to achieve its primary endpoint of a two-point reduction in NAFLD Activity Score in a Phase 2b clinical trial, CENTAUR, in patients with non-alcoholic steatohepatitis (NASH).
- On a positive note, the study did show a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, a secondary endpoint, after one year of treatment (p=0.02).
- According to the company, achieving a two-point reduction in NAFLD Activity Score is not required to support a marketing application. The two endpoints needed are an improvement in fibrosis by at least one stage without worsening of NASH and complete resolution of NASH without worsening of fibrosis. Management intends to meet with regulators later this year to discuss the design of a Phase 3 trial.
- Complete results will be presented at an upcoming medical conference.
- Cenicriviroc is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis.
- Thinly traded nano cap Bellerophon Therapeutics (NASDAQ:BLPH) is up 35% premarket on increased volume in response to its announcement that Belgian health authorities have approved the commencement of an open-label Phase 2 study assessing INOpulse for the treatment of pulmonary hypertension in patients with chronic obstructive pulmonary disease (PH-COPD). Patient recruiting (10 total) will start this quarter with results expected by year end.
- INOpulse is a drug-device combination system that delivers pulsed doses of nitric oxide. It is portable, suitable for at-home use and automatically adjusts to the patient's breathing patterns to deliver consistent dosing
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Bristol-Myers Squibb's (NYSE:BMY) ORENCIA (abatacept) intravenous infusion (IV) and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of patients with highly active and progressive rheumatoid arthritis (RA) not previously treated with methotrexate. If approved, this will be the first biologic in the EU with this indication.
- The data supporting the application was generated in two Phase 3 studies. The first, AGREE, showed significantly more MTX-naive patients with early rapidly progressing RA treated with ORENCIA IV + MTX achieved low disease activity compared to MTX alone at year 1 (41% vs. 23%; p<0.001). The second, AVERT, showed more patients with moderately to highly active RA achieved remission who received subcutaneous ORENCIA + MTX than those treated with MTX alone (60.9% vs. 45.2%).
- A final decision from the European Commission usually takes ~60 days.
- AbbVie (NYSE:ABBV) and Bristol-Myers Squibb (NYSE:BMY) will collaborate in a Phase 1/2 clinical trial assessing the former's antibody-drug conjugate Rova-T (rovalpituzumab tesirine) and the latter's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) in patients with relapsed extensive-stage small cell lung cancer (SCLC). The objective is to determine if the targeted cell killing and antigen release caused by Rova-T enhances the effect of immunotherapy. Patient recruiting should start later this year.
- Small cell lung cancer, accounting for ~15% of lung cancer cases, is very resistant to treatment. The five-year survival rate is less than 5%.
- Rova-T combines a targeted antibody that selectively binds to delta-like protein 3 (DLL3), expressed in more than 80% of SCLC tumors, with a cytotoxic agent. AbbVie obtained the rights to the product candidate via its acquisition of Stemcentrx.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of a 12-week regimen of AbbVie's (NYSE:ABBV) VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 infection with compensated cirrhosis (Child-Pugh A). The currently approved regimen is 24 weeks for these patients.
- The data supporting the positive opinion was generated in the Phase 3 AGATE-1 study that showed a 97% cure rate (n=57/59) in HCV-4 Child-Pugh A patients treated with VIEKIRAX and RBV for 12.
- The 12-week VIEKIRAX and RBV regimen was previously approved for all HCV-4 patients except those with Child-Pugh A.
- A final decision from the European Commission usually takes ~60 days.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merrimack Pharmaceuticals (NASDAQ:MACK) and commercialization partner Shire plc's (NASDAQ:SHPG) ONIVYDE (irinotecan liposome injection), in combination with the chemo agents fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy.
- The positive opinion was based on the Phase 3 NAPOLI-1 study that showed pancreatic cancer patients treated with ONIVYDE plus 5-FU and leucovorin achieved overall survival of 6.1 months compared to 4.2 months for those receiving 5-FU and leucovorin alone (p=0.012) with a 33% reduction in the risk of death (hazard ratio: 0.67). One in four patients treated with the ONIVYDE regimen survived at least one year.
- ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
- Shire has global development and commercialization rights to ONIVYDE except the U.S. and Taiwan.
- The FDA approved ONIVYDE for this indication in October 2015.
- A final decision from the European Commission usually takes ~60 days.
Friday, July 22, 2016
- Onconova Therapeutics (ONTX -1.5%) has again adjusted pricing for a rights offering it had announced previously.
- The company's distributing 1.5 non-transferable subscription rights for each share of common stock or participating warrants.
- The subscription pricing, previously set for a range of $5.75-$6.25, is now $4.10/unit. Investors who had subscribed previously will receive the adjusted price, and excess payments returned afterward.
- Units are composed of a share of common stock and 0.75 of a warrant, which is exercisable to purchase a share of common stock at $4.92 for five years from issuance.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Exelixis (EXEL +0.9%) and licensee Ipsen's (OTCPK:IPSEY) Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma in adult patients who have been previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
- Cabozantinib inhibits enzymes called tyrosine kinases, which play roles in the proliferation and survival of cancer cells.
- Exelixis owns commercialization rights in the U.S. and Canada while Ipsen has the rights elsewhere except Japan. The FDA approved it in April.
- Carbozantinib is also marketed in the U.S. under the brand name Cometriq for the treatment of medullary thyroid cancer, an indication approved by the FDA in November 2012.
- A final decision from the European Commission usually takes ~60 days.
- Previously: Exelixis inks cabozantinib commercialization deal with Ipsen valued as high as $855M; shares up 9% after hours (Feb. 29)
- Johnson & Johnson (NYSE:JNJ) upgraded to Buy from Hold by Argus Research. Price target raised to $145 (16% upside) from $130.
- Humana (NYSE:HUM) upgraded to Buy from Hold by Jefferies. Price target raised to $210 (22% upside) from $199.
- Teva Pharmaceutical Industries (NYSE:TEVA) upgraded to Buy from Hold by HSBC. Price target raised to $65 (19% upside) from $61.
- Relypsa (NASDAQ:RLYP) downgraded to Neutral from Buy by Citigroup. Price target raised to $32 (0% upside) from $25.
- Evoke Pharma (NASDAQ:EVOK) downgraded to Hold from Buy by Noble Financial. Downgraded to Hold from Buy by Brean Capital. Downgraded to Neutral from Buy by Rodman & Renshaw.
- Merck (NYSE:MRK) downgraded to Market Perform from Outperform with a $62 (5% upside) price target by BMO Capital.
- St. Jude Medial (NYSE:STJ) downgraded to Neutral from Outperform by Wedbush. Price target raised to $84 (3% upside) from $70.
- Teva Pharmaceutical Industries (TEVA) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $60 (10% upside) from $70.
- OncoSec Medical (NASDAQ:ONCS) initiated with Buy rating and $6 (253% upside) price target by Rodman & Renshaw.
- Invivo Therapeutics Holdings (NASDAQ:NVIV) initiated with Buy rating and $23.25 (254% upside) price target by Ladenburg Thalmann.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $105 (14% upside) price target by Baird.
- Selecta Biosciences (Pending:SELB) initiated with Buy rating and $23 (64% upside) price target by Stifel Nicolaus.
- Syros Pharmaceuticals (NASDAQ:SYRS) initiated with Neutral rating and $10 (11% downside risk) price target by H.C. Wainwright.
- Voyager Therapeutics (NASDAQ:VYGR) initiated with Buy rating and $33 (161% upside) price target by Stifel Nicolaus.
- AveXis (NASDAQ:AVXS) initiated with Market Perform rating by Wells Fargo.
- Celgene (NASDAQ:CELG) initiated with Buy rating and $150 (40% upside) price target by Stifel Nicolaus.
- ReWalk Robotics (NASDAQ:RWLK) initiated Overweight rating and $10 (49% upside) price target by Piper Jaffray.
- Amgen (NASDAQ:AMGN) files a Biologics License Application (BLA) with the FDA seeking approval of romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
- Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
- The company is co-developing the product with Belgium's UCB (OTCPK:UCBJF)(OTCPK:UCBJY).
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the use of Gilead Sciences' (NASDAQ:GILD) Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk. The strategy is known as pre-exposure prophylaxis.
- The European Commission (EC) approved Truvada in 2005 for the treatment of HIV-1 infection in adults, in combination with other antiretroviral agents. It generated ~$3.6B in sales for Gilead over the past year, ~30% in Europe (~$1.1B). A prophylaxis claim will significantly expand the market for the drug.
- A final decision from the EC usually takes ~60 days.
- GILD is up a fraction pre-market.
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