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 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: 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 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 BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.

Clinical Readouts

Pfizer Inc. 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. 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 Oct. 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 Oct. 23.

Related Link: 9 Biotech Stocks With Material Catalysts In Q4

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 (Oct. 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. (Oct. 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 (Oct. 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 (Oct. 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. (Oct. 24)

Earnings

Abbott Laboratories ABT (Wednesday, before the market open)

Biogen Inc BIIB (Wednesday, before the market open)

Edwards Lifesciences Corp EW (Wednesday, after the close)

Quest Diagnostics Inc DGX (Thursday, before the market open)

Neurometrix Inc NURO (Thursday, before the market open)

West Pharmaceutical Services Inc. WST (Thursday, before the market open)

Plus Therapeutics Inc PSTV (Thursday, after the close)

IPO Quiet Period Expiry

Taysha Gene Therapies Inc TSHA

Prelude Therapeutics Inc PRLD

PMV Pharmaceuticals Inc PMVP

Orphazyme A S ADR ORPH