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 (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. (PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate. Avenue Therapeutics Inc. (ATXI) shares fell from $11 to just under $4 after the FDA rejected its opioid pain drug on safety concerns.
Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (VRTX) and Cyclerion Therapeutics Inc. (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: October 18-21.
- The Prostate Cancer Foundation's 27th Annual Scientific Retreat: October 20-23.
- IDWeek 2020: October 20-25.
- American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: October 22-25 (early programs scheduled for October 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: October 24-25.
PDUFA Dates
Zosano Pharma Corp. (ZSAN)'s NDA for its migraine drug Qtrypta has a PDUFA action date of October 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. (SPPI)'s BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is October 24.
Clinical Readouts
- Pfizer Inc. 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) 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) 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 October 22.
- Mustang Bio Inc. (MBIO), 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 October 23.
EORTC-NCI-AACR Symposium Presentations
- Cyclacel Pharmaceuticals Inc. (CYCC): Phase 1 safety, pharmacokinetic and pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent kinase inhibitor, in patients with advanced cancer. The presentation is being held October 24.
- Revolution Medicines Inc. (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. The presentation is being held October 24.
- Aileron Therapeutics Inc. (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. The presentation is being held October 24.
- Turning Point Therapeutics Inc. (TPTX): First-in-human safety, pharmacokinetics, and preliminary efficacy of TPX-0022 in patients with advanced solid tumors harboring genetic alterations in MET. The presentation is being held October 24.
- Syros Pharmaceuticals Inc. (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. The presentation is being held October 24.
Earnings
- Abbott Laboratories (ABT) reporting earnings Wednesday, October 21, before the market open.
- Biogen Inc. (BIIB) reporting earnings Wednesday, October 21, before the market open.
- Edwards Lifesciences Corp. (EW) reporting earnings Wednesday, October 21, after the market close.
- Quest Diagnostics Inc. (DGX) reporting earnings Thursday, October 22, before the market open.
- Neurometrix Inc. (NURO) reporting earnings Thursday, October 22, before the market open.
- West Pharmaceutical Services Inc. (WST) reporting earnings Thursday, October 22, before the market open.
- Plus Therapeutics Inc. (PSTV) reporting earnings Thursday, October 22, after the market close.
IPO Quiet Period Expiry
- Taysha Gene Therapies Inc. (TSHA).
- Prelude Therapeutics Inc. (PRLD).
- PMV Pharmaceuticals Inc. (PMVP).
- Orphazyme A S ADR (ORPH).
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