Biotech stocks are in risk off mode and have gone nowhere in 2019. My personal feeling is that biotech stocks are off-limits right now and do not look like good trades in the week ahead.
We have earnings season coming to a close next week. Below are biotech companies that report earnings on Monday, Tuesday, and Wednesday of next week.
Below are stocks with signification data releases coming.
ACH-4471 for paroxysmal nocturnal hemoglobinuria (PNH). Phase 2 interim data due May 17, 2019.
“We made significant progress advancing our portfolio of oral factor D inhibitors in the first quarter of 2019,” said Joe Truitt, President and Chief Executive Officer at Achillion. “Our team completed enrollment in our Phase 2 clinical trial of ACH-4471 for paroxysmal nocturnal hemoglobinuria (PNH) in combination with eculizumab. Interim data from this trial has been accepted for presentation at the New Era of Aplastic Anemia and PNH meeting in Napoli, Italy, on May 17, 2019. Our hypothesis for combination therapy is that if the alternative pathway is adequately inhibited then meaningful patient benefit can be achieved in fundamentally different ways than has been seen with C5 inhibitors alone. In addition, we expect to present the data from the recently completed Phase 2 PNH monotherapy trial at a medical meeting later this year.”
CDX-3379 recurrent/metastatic head and neck squamous cell cancer. Phase 2 data due at ASCO June 1, 2019.
“Celldex presented positive data across multiple programs at AACR in April, including from our promising CDX-1140 program,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “We have successfully cleared a critical hurdle for CD40 agonists, reaching dose levels with good systemic exposure that are biologically active and well tolerated. Importantly, these dose levels exceed the maximum tolerated dose levels reported with other CD40 agonists, which we believe may support enhanced tissue and tumor penetration. We are also pleased with the results to date in our unique combination of CDX-1140 with CDX-301, where CDX-301 amplifies the numbers of dendritic cells in patients prior to their activation with CDX-1140. To this end, we continue to believe that CDX-1140 can play a very important role in cancer immunotherapy, especially in combination with drugs that target other key immune pathways and are actively planning additional combination cohorts to begin later this year.”
“We also recently completed the first stage of the Phase 2 study of CDX-3379 and are pleased that this portion of the study met the clinical criteria that are required to progress the study to the next stage. We look forward to presenting more detailed data from this study at ASCO in early June. We are currently conducting a thorough analysis of the overall CDX-3379 program in collaboration with our clinical advisors to determine the optimal path for this candidate. In conclusion, we continue to make considerable progress across our entire pipeline and look forward to updating shareholders over the course of the year,” said Marucci.
Inclisiran – ORION 3 and cardiovascular disease (ASCVD). Phase 2 open-label data to be presented at National Lipid Association Scientific Sessions on May 18, 2019.
“We are relentlessly focused on the successful completion of Phase 3 studies for inclisiran, so that we can ultimately bring forward the first cholesterol-lowering siRNA medicine with the potential to fundamentally change the treatment of atherosclerotic cardiovascular disease (ASCVD), through potent, durable, and consistent lowering of LDL-C levels via twice-a-year dosing,” said Mark Timney, Chief Executive Officer of The Medicines Company. “We continue to make steady progress during this momentous year for The Medicines Company, moving closer to our goal of realizing the intrinsic value of inclisiran.”
The Independent Data Monitoring Committee (IDMC) for inclisiran’s pivotal Phase 3 trials (ORION-9, ORION-10 and ORION-11) recently completed its sixth planned review of un-blinded safety and efficacy data. The committee again recommended that the trials continue as designed and conducted, without modification. The ORION Phase 3 studies, with 18-months treatment and follow-up, randomized a total of 3,660 patients, receiving either inclisiran or placebo, across ORION-9 (482 patients), ORION-10 (1,561 patients) and ORION-11 (1,617 patients).
At the time of the sixth IDMC review, substantially all randomized patients had been treated with three doses and completed a follow-up visit 60-days after the third dose (of four doses) of study medication, and more than 1,600 subjects had received a fourth dose of inclisiran or placebo. To date, more than 3,000 patient-years of inclisiran safety data have been accumulated in the ORION program.
“The IDMC’s latest recommendation is another important milestone on our path toward expected Phase 3 data readouts in the third quarter and subsequent NDA and MAA submissions,” said Peter Wijngaard, Ph.D., Chief Development Officer of The Medicines Company. “We are now building on this outstanding progress by enrolling patients into ORION-8 as they complete their respective Phase 3 studies.”
ORION-8 is an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran.
The Medicines Company will present interim results on long-term safety and efficacy of inclisiran from the ongoing ORION-3 study during a late-breaking clinical trial session at the National Lipid Association Scientific Sessions in Miami, Florida on May 18, 2019.
ORION-3 is an open-label Phase 2, extension study (of ORION-1) to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran. The study also evaluates safety and efficacy of switching patients treated with evolocumab to inclisiran. Follow up for this latter group is still ongoing and will be presented at a later date.
During the 87th European Atherosclerosis Society Congress in Maastricht, Netherlands, the company will present a combined analysis of data in renal-impaired patients from ORION-1 and ORION-7 during an oral abstract session on May 27, 2019. Data in homozygous familial hypercholesterolemia patients from ORION-2 will be presented during a late-breaking abstract session on the same day.
“In February, we reported topline results from SOPHIA showing that in the Phase 3 trial, progression-free survival was prolonged following treatment with margetuximab and chemotherapy compared to trastuzumab with chemotherapy. We look forward to presenting detailed results at ASCO. In addition, we anticipate submitting a BLA for this program to the FDA in the second half of 2019. If approved by regulators, margetuximab could offer the potential of a new treatment option for patients living with HER2-positive metastatic breast cancer in a third line and beyond setting where there are currently no FDA-approved therapies. In seeking to address unmet needs of patients with HER2-postive cancers beyond breast cancer, we plan to initiate in the second half of 2019 a registration-directed trial to evaluate margetuximab for treating gastric cancer patients in the frontline setting,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.
“Mechanistically, we believe the results achieved in the SOPHIA study have validated our Fc-optimization technology, also used in enoblituzumab, our investigational monoclonal antibody targeting B7-H3,” continued Dr. Koenig. “To date, we have made tremendous progress with our immuno-oncology pipeline of nine clinical product candidates with multiple molecules demonstrating clinical proof of concept to support ongoing and/or planned registration studies.”
EYLEA – PANAROMA for nonproliferative Diabetic Retinopathy. A PDUFA date is set for sBLA May 13, 2019.
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