Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.
The week was a quiet one from the perspective of news flow. Johnson & Johnson JNJ 0.62% was in the news for both right and wrong reasons. The company's Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.
Pfizer Inc. PFE 3.86%, meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.
Avenue Therapeutics Inc ATXI 1.79% shares fell from $11 to just under $4 after FDA rejected its opioid pain drug on safety concerns.
Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated VRTX 1.3% and Cyclerion Therapeutics Inc CYCN 0.67% shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.
The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds.
Here are the key catalysts for the unfolding week.
Conferences
American College of Chest Physicians' CHEST Annual Meeting 2020, being held virtually: Oct. 18-21
The Prostate Cancer Foundation's 27th Annual Scientific Retreat: Oct. 20-23
IDWeek 2020: Oct. 20-25
American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25 (early programs scheduled for Oct. 19-21)
32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: Oct. 24-25
PDUFA Dates
Zosano Pharma Corp's ZSAN 3.08% NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.
The FDA is set to rule on Spectrum Pharmaceuticals, Inc.'s SPPI 2.52% BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.
Clinical Readouts
Pfizer Inc. PFE 3.86% is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.
Alnylam Pharmaceuticals, Inc. ALNY 1.01% will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.
Omeros Corporation OMER 0.52% is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for Oct. 22.
Mustang Bio Inc MBIO 1.88%, founded by Fortress Biotech FBIO, is scheduled to present at the Prostate Cancer Foundation's annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23.
Related Link: 9 Biotech Stocks With Material Catalysts In Q4
EORTC-NCI-AACR Symposium Presentations
Cyclacel Pharmaceuticals Inc CYCC 3.23%: Phase 1 safety, pharmacokinetic and pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent kinase inhibitor, in patients with advanced cancer (Oct. 24)
Revolution Medicines Inc RVMD 1.77%: interim data from the Phase 1b/2 clinical trial evaluating the combination of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic mutations. (Oct. 24)
Aileron Therapeutics Inc ALRN 1.55%: proof-of-concept data from the Phase 1b study of ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced toxicities, such as severe anemia, neutropenia and thrombocytopenia, in patients with p53-mutated small cell lung cancer, who are being treated with the chemotherapy topotecan (Oct. 24)
Turning Point Therapeutics Inc TPTX 0.69%: First-in-human safety, pharmacokinetics, and preliminary efficacy of TPX-0022 in patients with advanced solid tumors harboring genetic alterations in MET (Oct. 24)
Syros Pharmaceuticals Inc SYRS 2.07%: initial data from the ongoing dose escalation portion of its Phase 1 clinical trial of SY-5609, its highly selective and potent oral CDK7 inhibitor, in patients with select solid tumors. (Oct. 24)
Earnings
Abbott Laboratories ABT 2.24% (Wednesday, before the market open)
Biogen Inc BIIB 0.22% (Wednesday, before the market open)
Edwards Lifesciences Corp EW 0.07% (Wednesday, after the close)
Quest Diagnostics Inc DGX 1.81% (Thursday, before the market open)
Neurometrix Inc NURO 1.19% (Thursday, before the market open)
West Pharmaceutical Services Inc. WST 0.27% (Thursday, before the market open)
Plus Therapeutics Inc PSTV 4.28% (Thursday, after the close)
IPO Quiet Period Expiry
Taysha Gene Therapies Inc TSHA 3.56%
Prelude Therapeutics Inc PRLD 8.85%
PMV Pharmaceuticals Inc PMVP 0.31%
Orphazyme A S ADR ORPH 0.92%
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.