The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference
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 (NYSE: JNJ) 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. (NYSE: PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.
Avenue Therapeutics Inc (NASDAQ: ATXI) 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 (NASDAQ: VRTX) and Cyclerion Therapeutics Inc (NASDAQ: CYCN) 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 (NASDAQ: ZSAN) 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 (NASDAQ: SPPI) BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.
Clinical Readouts
Pfizer Inc. (NYSE: PFE) 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. (NASDAQ: ALNY) 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 (NASDAQ: OMER) 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 (NASDAQ: MBIO), founded by Fortress Biotech (NASDAQ: 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 (NASDAQ: CYCC): 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 (NASDAQ: RVMD): 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 (NASDAQ: ALRN): 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 (NASDAQ: TPTX): 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 (NASDAQ: SYRS): 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 (NYSE: ABT) (Wednesday, before the market open)
Biogen Inc (NASDAQ: BIIB) (Wednesday, before the market open)
Edwards Lifesciences Corp (NYSE: EW) (Wednesday, after the close)
Quest Diagnostics Inc (NYSE: DGX) (Thursday, before the market open)
Neurometrix Inc (NASDAQ: NURO) (Thursday, before the market open)
West Pharmaceutical Services Inc. (NYSE: WST) (Thursday, before the market open)
Plus Therapeutics Inc (NASDAQ: PSTV) (Thursday, after the close)
IPO Quiet Period Expiry
Taysha Gene Therapies Inc (NASDAQ: TSHA)
Prelude Therapeutics Inc (NASDAQ: PRLD)
PMV Pharmaceuticals Inc (NASDAQ: PMVP)
Orphazyme A S ADR (NASDAQ: ORPH)
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