Wed, May 20, 1:14 PM
- Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
- Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
- SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
- iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
- Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
- Related ticker: (PFE +0.4%)
Mon, Mar. 2, 8:48 AM
- Micro cap Athersys (NASDAQ:ATHX) jumps 20% premarket on robust volume in response to its announcement of an exclusive partnership and license agreement with Chugai Pharmaceutical Co. (OTCQX:RHHBY) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.
- Under the terms of the agreement, Chugai is responsible for the development and commercialization of MultiStem for the indication in Japan. Athersys will receive an upfront cash payment of $10M, development and regulatory milestones of up to $45M, sales milestones of up to $150M and tiered double-digit royalties on net sales.
- MultiStem is currently in Phase 2 development for ischemic stroke in the U.S. and Europe.
Tue, Feb. 10, 10:05 AM
- Pfenex (PFNX +25.9%) and Hospira (HSP +0.1%) team up to develop and commercialize PF582, Pfenex's lead biosimilar candidate to Genentech's (OTCQX:RHHBY +0.8%) Lucentis (ranibizumab), which logged ~$4B in sales last year.
- Under the terms of the collaboration, Pfenex will receive an upfront payment of $51M, once the agreement clears antitrust review, and up to $291M in development and sales milestones plus tiered double-digit royalties on commercial sales.
- The companies will share the Phase 3 equivalence clinical trial costs. Hospira will be responsible for manufacturing and commercializing PF582 worldwide.
Fri, Jan. 16, 6:14 AM
- Looking to gain access to an experimental drug to treat spinal muscular atrophy, Roche (OTCQX:RHHBY) has agreed to buy privately-held Trophos.
- The acquisition is the latest in a spate of deals by Roche, following its purchase of a $1B stake in Foundation Medicine and licensing agreement with Genome pioneer J. Craig Venter.
- Under the terms of the agreement with Trophos, the French firm's shareholders will receive an upfront payment of €120M ($140M), plus further payments based on predetermined milestones worth up to €350M.
- OTCQX:RHHBY -2.2% premarket
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Wed, Jan. 7, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Dec. 19, 2014, 8:44 AM
- ImmunoGen (NASDAQ:IMGN) plummets 40% premarket on robust volume in response to Roche's (OTCQX:RHHBY) announcement that its Phase 3 trial evaluating Kadcyla (trastuzumab emtansine) failed to significantly improve progression-free survival as a first-line therapy in breast cancer patients.
- Kadcyla was developed based on ImmunoGen's ADC technology which uses tumor-targeting antibodies to deliver an ImmonGen cell-killing agent to cancer cells.
- Previously: Roche cancer drug fails label expansion trial (Dec. 19, 2014)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Nov. 17, 2014, 9:07 AM| Comment!
Nov. 17, 2014, 8:57 AM
- Celldex Therapeutics (NASDAQ:CLDX) is up 20% premarket on robust volume in response to its announcement of interim data from is Phase 2 clinical trial assessing the safety and efficacy of rindopepimut in patients with EGFRvIII-positive glioblastoma (GBM). The results demonstrate signs of clinical activity including groups both naive and refractory to Avastin (bevacizumab) (OTCQX:RHHBY).
- Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor-specific oncogene EGFRvIII. Patients in this category have a worse prognosis that the overall glioblastoma population and poor long term survival prospects.
- In the bevacizumab-naive group, the primary endpoint is progression-free survival at six months (PFS-6). The value for the rindopepimut arm is 27% compared to 11% in the control arm (p=0.048). Statistically significant overall survival (OS) benefit: rindopepimut median: 12.0 months versus control median of 8.8 months (p=0.0208). Hazard ratio: 0.47.
- In the bevacizumab-refractory group, rare but prominent anti-tumor activity did not meet the hurdle for expanded accrual. Noteworthy OS compared to historical values. Rindopepimut plus bevacizumab was well-tolerated, no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit.
Nov. 13, 2014, 5:02 PM
- In a 479-patient Phase 2 clinical trial, Puma Biotechnology's (NYSE:PBYI) tyrosine kinase inhibitor, PB272 (neratinib), with paclitaxel demonstrated comparable results to Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) plus paclitaxel as a first-line treatment in patients with HER2-positive locally recurrent or metastatic breast cancer.
- The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and the incidence of central nervous system (CNS) metastases, including metastases of the brain.
- PFS and ORR for the neratinib/paclitaxel arm were 16.6 months and 74.8%, respectively versus 16.7 months and 75.1%, respectively for the trastuzumab/paclitaxel arm. The differences were not statistically significant.
- There was a 52.6% reduction in CNS metastases in the neratinib/paclitaxel group compared to the trastuzumab/paclitaxel group (7.4% vs. 15.6%) (p=0.006). The difference was statistically significant.
- The safety results showed a 30% incidence of grade 3 diarrhea in the neratinib/paclitaxel arm compared to 4% in the trastuzumab/paclitaxel arm. When high dose loperamide was administered in another trial, though, the incidence of grade 3 diarrhea dropped to 8% in patients receiving neratinib as monotherapy.
- The results of the study will be presented at a future scientific meeting.
- PBYI is down 7.9% after hours on average volume.
Oct. 16, 2014, 10:43 AM| 1 Comment
Sep. 29, 2014, 7:38 AM
- Shares of micro cap Exelixis (NASDAQ:EXEL) are up 26% premaket on healthy volume in response to positive Phase 3 results for cobimetinib announced today by Roche. Exelixis discovered the drug internally. It entered into a global co-development agreement with Genentech (OTCQX:RHHBY) in late 2006. In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the U.S. It is entitled to an equal share of U.S. profits and losses which will decrease as sales increase and will share equally in U.S. marketing and commercialization costs. It is eligible to receive royalties on ex-U.S. sales.
Aug. 24, 2014, 5:31 PM
- Roche (OTCQX:RHHBY, OTCPK:RHHBF) will pay $74/share for InterMune (NASDAQ:ITMN), a 38% premium to its Friday close and 63% higher than Aug. 12 when news of a potential sale emerged.
- The deal gives Roche access to pirfenidone, which targets idiopathic pulmonary fibrosis, a disease that causes tissue deep in the lungs to become thick and scarred over time. Analysts predict pirfenidone will generate $1B in global sales by 2019.
- Pirfenidone joins Roche’s stable of pulmonary treatments, including Pulmozyme for cystic fibrosis, Xolair for asthma, and in-development asthma drug lebrikizumab. Roche plans to speed pirfenidone’s U.S. start-up and help get insurance coverage for the medicine.
- Press release
Jul. 22, 2014, 5:49 PM
- Shares of Puma Biotechnology (NYSE:PBYI) skyrocket 186% AH on massive volume after the company reported top-line results from its Phase 3 clinical trial evaluating PB272 (neratinib) as a treatment for HER2-positive breast cancer. The study, called ExteNET, enrolled 2,821 patients in 41 countries who had undergone surgery and adjuvant treatment with Herceptin (trastuzumab) (OTCQX:RHHBY). After treatment with trastuzumab, patients were randomized to receive adjuvant treatment with neratinib or placebo for one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS) or death for a period of two years after randomization.
- The primary endpoint was disease-free survival (DFS). The neratinib cohort demonstrated a 33% improvement in DFS versus placebo with a statistically significant hazard ratio of 0.67. The secondary endpoint was DFS including DCIS. In this population, the neratinib cohort demonstrated a 37% improvement compared to placebo.
- Puma plans to file for regulatory approval in the extended adjuvant setting in 1H 2015.
Jul. 14, 2014, 3:44 PM
- Shares of Exelixis (EXEL +21.8%) romp on massive turnover of over 33M shares in response to this morning's report of positive results in a Phase 3 trial of cobimetinib combined with Zelboraf in BRAF-mutated melanoma. Rumors are building that the company is an attractive takeout candidate for Roche (RHHBY +1.1%) in light of Genentech's close relationship with the firm and the $1B potential sales of the combo therapy.
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Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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