Avid Bioservices (NASDAQ:CDMO): Q2 GAAP EPS of -$0.03 beats by $0.03.
Revenue of $18.31M (+79.9% Y/Y) beats by $3.97M.
Shares +5.64%.
Monday, December 9, 2019
Phreesia EPS beats by $0.03, beats on revenue
Phreesia (NYSE:PHR): Q3 GAAP EPS of -$0.07 beats by $0.03.
Revenue of $32.84M (+32.6% Y/Y) beats by $3.36M.
Agilent up 4% after hours on Pershing stake
Agilent (NYSE:A) is up 4% after hours on modest volume in apparent reaction to a disclosure by Bill Ackman’s Pershing Square of a stake of ~2.9M shares.
Regeneron down 5% after hours on possible sale of Sanofi stake
Regeneron bispecific antibody encouraging in early-stage myeloma trial
Regeneron Pharmaceuticals (REGN -2.4%) announces positive initial data from an open-label Phase 1/2 dose-escalation study evaluating REGN5458 in multiple myeloma (MM) patients who have exhausted all therapeutic options. The results were presented at ASH in Orlando.
The overall response rate (ORR) in the first two dose arms was 57% (n=4/7), including a 75% ORR (n=3/4) in the higher dose (6 mg weekly) group. Two of the participants in the latter showed no cancer cells in their bone marrow.
On the safety front, no neurotoxicity, dose-limiting toxicities or treatment-related discontinuations were observed. The most common REGN5458-related adverse events were lymphopenia (71%), anemia (57%), thrombocytopenia (43%) and cytokine release syndrome (43%). Serious/life-threatening treatment-related adverse events were observed in five (71%) subjects, including lymphopenia (n=3), hypertension (n=2) and anemia, atrial fibrillation, fatigue, febrile neutropenia, pain in extremity, septic shock and thrombocytopenia (one each).
Additional data should be available in 2020.
REGN5458 is a BCMAxCD3 bispecific antibody designed to bind to BCMA (B-cell maturation antigen) and the CD3 receptor on T cells, bridging them together and activating cancer cell-killing activity of T cells. It is one of six bispecific antibodies that company has in clinical development.
The company has launched another Phase 1 evaluating REGN5459, also a BCMAxCD3 bispecific but with differing binding characteristics, in relapsed/refractory MM.
#ASH19
Regeneron Pharmaceuticals (REGN -2.4%) announces positive initial data from an open-label Phase 1/2 dose-escalation study evaluating REGN5458 in multiple myeloma (MM) patients who have exhausted all therapeutic options. The results were presented at ASH in Orlando.
The overall response rate (ORR) in the first two dose arms was 57% (n=4/7), including a 75% ORR (n=3/4) in the higher dose (6 mg weekly) group. Two of the participants in the latter showed no cancer cells in their bone marrow.
On the safety front, no neurotoxicity, dose-limiting toxicities or treatment-related discontinuations were observed. The most common REGN5458-related adverse events were lymphopenia (71%), anemia (57%), thrombocytopenia (43%) and cytokine release syndrome (43%). Serious/life-threatening treatment-related adverse events were observed in five (71%) subjects, including lymphopenia (n=3), hypertension (n=2) and anemia, atrial fibrillation, fatigue, febrile neutropenia, pain in extremity, septic shock and thrombocytopenia (one each).
Additional data should be available in 2020.
REGN5458 is a BCMAxCD3 bispecific antibody designed to bind to BCMA (B-cell maturation antigen) and the CD3 receptor on T cells, bridging them together and activating cancer cell-killing activity of T cells. It is one of six bispecific antibodies that company has in clinical development.
The company has launched another Phase 1 evaluating REGN5459, also a BCMAxCD3 bispecific but with differing binding characteristics, in relapsed/refractory MM.
#ASH19
Vaping-related cases lead to care guidelines from Intermountain
Hospitals across the country have been grappling with an outbreak of vaping-associated illnesses that still have no confirmed cause.
Utah is one of the states hit hardest by cases of e-cigarette- or vaping-associated lung injury, known as EVALI, with nearly all of those patients treated at the Salt Lake City-based Intermountain Healthcare system.
The recommendations were published in November by Lancet.
“The power of our guidelines is not only saying this is what we did, but this is how the patients did as a result,” said study lead author Dr. Denitza Blagev, a pulmonary and critical-care physician at Intermountain. “Therefore we feel it’s safe to propose this and suggest this for others to use.”
Blagev credited the health system’s telehealth monitoring program for allowing clinicians to track, collect and share data on 60 Intermountain clinic patients with vaping-related lung illness from June 27 to Oct. 4.
The data allowed researchers to rapidly recognize the outbreak and form a task force.
By reviewing that data collected at multiple sites, the task force learned what treatments patients had received and their outcomes after discharge, providing a clearer picture of what therapies were most effective for specific patients.
STRATEGIES
Use remote monitoring to provide real-time tracking of cases, which can lead to earlier recognition of an outbreak
Design the treatment approach based on the initial severity of the patient’s illness
Create a standardized approach to how patient data is collected
“We developed these practices first by just being really comprehensive about understanding how people were already treating these patients in the system,” Blagev said.
She said the recommendations for treating EVALI patients were broadly consistent with guidance issued by the Centers for Disease Control and Prevention in October.
Those guidelines recommend clinicians in all suspected cases perform a complete patient evaluation and consult with an intensive-care specialist to reduce the risk of respiratory complications for those who initially display mild symptoms.
But the findings also suggest clinicians may be able to take a more individualized approach based on the severity of a patient’s symptoms.
The Intermountain guidelines recommend shorter courses of moderate-dose steroids for patients with milder symptoms.
Outpatients were given oral steroids for an average of six days, while those with more moderate forms of the illness were admitted as inpatients and given steroids intravenously for an average of 10 days followed by an oral steroid regimen for seven days.
The most severe cases were treated in an ICU where they received intravenous steroids for an average of 15 days.
Nearly all patients in the study were given antibiotics.
While most patients started to improve within days, six relapsed and were readmitted.
Blagev said the lessons learned dealing with the current outbreak can help shape responses to future infectious-disease outbreaks.
“I definitely think this can serve as a model for identifying other epidemics and having a concerted system response,” she said.
The biggest challenge in developing the guidelines was that no one yet knows exactly what causes EVALI, Blagev said. CDC investigators recently identified vitamin E acetate, a chemical additive used in vaping products containing THC, as a likely cause.
Dr. Albert Rizzo, chief medical officer for the American Lung Association, said a treatment for the vaping illnesses has likely been hindered by both a lack of standardization in evaluating suspected patients and clinicians’ failure to connect the illnesses and vaping earlier.
He said Intermountain’s guidelines give hospitals a “good start” on forming a process to collect relevant data to guide clinical decisionmaking.
“I think this is a very good first attempt, or maybe the best attempt, at trying to get a handle on a disease that’s really not defined by a specific agent at this point and really not defined by a specific pathology,” Rizzo said.
Precision Bio down 49% on early-stage CAR T data in lymphoma
Precision BioSciences (DTIL -48.9%) slumps on a 12x surge in volume in reaction to updated preliminary data from from the NHL cohort in an ongoing Phase 1 clinical trial evaluating CAR T candidate PBCAR0191. The results were presented at ASH in Orlando.
The overall response rate (ORR) in patients with relapsed/refractory NHL was 66% (n=4/6), including one complete responder, but two other early responders progressed.
The ORR was 33% (n=1/3) at day 28+ in patients with relapsed/refractory B-cell precursor ALL. The response was complete. The two non-responders had poor prognoses at study entry.
On the safety front, no serious adverse events (AEs) or evidence of graft-versus-host disease was observed. There was one serious treatment-related AE (pain at the site of the tumor mass for one day following infusion) and one life-threatening treatment-related AE, lymphopenia (low level of lymphocytes), that lasted for seven days.
Investors may be judging the results compared to Bristol-Myers Squibb’s lisocabtagene maraleucel (JCAR017) which demonstrated a 73% ORR, including a 53% complete response rate, in patients treatment-resistant large B-cell lymphomas.
The company will host an investigator update this evening at 8:15 pm ET to discuss the data.
#ASH19
Subscribe to:
Posts (Atom)