The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

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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.


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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%

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