The Week Ahead In Biotech: Biogen, Alexion And Vertex FDA Decisions, Multiple Conference Presentations On The Deck

Biopharma stocks advanced in the truncated week ended June 4 amid the broader market strength. The American Society for Clinical Oncology meeting got underway during the week, headlining the biotech news flow of the week.

In an unexpected M&A move, Morphosys AG MOR announced a deal to buy cancer biopharma Constellation Pharmaceuticals, Inc. CNST.

SCYNEXIS, Inc. SCYX shares failed to gain any traction following FDA approval for its oral treatment of vaginal yeast infection. Liminal BioSciences Inc LMNL and Alkermes plc ALKS, which had binary events during the week, were given favorable verdicts.

Novo Nordisk A/S' NVO semaglutide injection, 2.4 mg once weekly, was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition, for use in addition to a reduced-calorie diet and increased physical activity.

Adamis Pharmaceuticals Corp ADMP gained over 44% for the week after an NIH study revealed its in-licensed drug Tempol was found effective against COVID-19 infection in lab testing.

Here are the key biotech catalytic events that an investor should look forward in the unfolding week.

Healthcare Conferences

American Society of Clinical Oncology, or ASCO, Annual Meeting: June 4-8
American Transplant Congress, ATC: June 4-9
European Renal Association – European Dialysis and Transplant Association, or ERA-EDTA, Congress: June 5-8
The Goldman Sachs 42nd Annual Global Healthcare Conference: June 8-11
The Federation of Clinical Immunology Societies, FOCIS, Meeting: June 8-11
European Hematology Association, or EHA, 2021 Meeting: June 9-17

PDUFA Dates

The FDA is set to decide on Biogen Inc.'s BIIB controversial investigational Alzheimer's candidate, aducanumab, by Mon., June 7. Oppenheimer analyst Jay Olson sees equal probabilities of aducanumab receiving approval or facing rejection.

The shares are likely to move 21% higher if the FDA hands down a positive verdict or 11% lower on the receipt of a complete response letter, he said.

The regulatory agency will also announce by Monday, June 7, its decision on Alexion Pharmaceuticals, Inc.'s ALXN supplemental new drug application for Ultomiris for paroxysmal nocturnal hemoglobinuria in children and adolescents.

Vertex Pharmaceuticals Incorporated's VRTX awaits FDA word on the sNDA for Trikafta, its triple combo regimen for cystic fibrosis in children. The PDUFA goal date is Tuesday, June 8.

The FDA could announce by Tuesday, June 8, its decision on Pfizer Inc.'s PFE biologic license application for 20-valent pneumococcal conjugate (20vPnC) vaccine.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

ASCO Presentations

AbbVie Inc. ABBV: Extended long-term data from the Phase 3 RESONATE-2 study evaluating single-agent Imbruvica versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (Monday).

Novartis AG NVS: Results of the Phase 3 VISION study evaluating Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (Monday).

PDS Biotechnology Corp PDSB: Data from the National Cancer Institute-led phase 2 trial of PDS0101 in triple combination for the treatment of advanced HPV-associated cancers (Monday).

Compugen Ltd. CGEN: Data from Phase 1 clinical trial evaluating COM701 as a monotherapy and in combination with Bristol-Myers Squibb Co.'s BMY Opdivo in solid tumor.

Gossamer Bio, Inc. GOSS: Preliminary clinical and biologic results of GB1275, alone and with Keytruda in advanced solid tumors (Monday).

Oncternal Therapeutics, Inc. ONCT: Updated interim clinical data, from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial (Monday).

ATC Presentations

Eledon Pharmaceuticals, Inc. ELDN: Phase 1 data on the safety, tolerability and pharmacokinetics of AT -1501 in healthy volunteers (Monday).

ERA-EDTA Presentations

Chinook Therapeutics Inc KDNY: Interim data from Part 3 of the phase 1b study of BION-1301 in patients with IgA nephropathy (Tuesday)

FOCIS Meeting Presentations

Precigen, Inc. PGEN: Interim data from the AG019 Phase 1b/2a clinical trial in Type 1 diabetes (Thursday).

EHA Meeting Presentations

bluebird bio, Inc. BLUE: Data from its Phase 3 clinical studies of betibeglogene autotemcel (beti-cel), including updated results from the Phase 3 Northstar-2 (HGB-207) and the Phase 3 Northstar-3 (HGB-212) studies, in transfusion-dependent β-thalassemia and data from the Phase 1/2 HGB-206 study of lentiGlobin for sickle cell disease (Friday).

Celyad Oncology SA ADR CYAD: Data from Phase 1 dose-escalation IMMUNICY-1 trial evaluating the shRNA-based anti-BCMA CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma (Friday).

Agios Pharmaceuticals, Inc. AGIO: Data from the Phase 3 study of mitapivat in adults with pyruvate kinase deficiency who are not regularly transfused, as well as data from the Phase 3 study of mitapivat in adults with pyruvate kinase deficiency who are regularly transfused. (Presentations are scheduled for June 15, while the company has scheduled an investor webcast Friday, at 7:30 a.m., to discuss the data.)

Equillium, Inc. EQ: Data from the Phase 1b EQUATE study of itolizumab in acute graft-versus-host disease (Friday).

NexImmune Inc NEXI: Preliminary data from the initial safety cohorts of Phase 1/2 studies of NEXI-001 in acute myeloid leukemia and NEXI-002 in myelodysplastic syndromes (Friday).

IMARA Inc IMRA: Phase 2a clinical trial and Phase 2a open-label extension trial results of IMR-687 in adults with sickle cell disease (Friday).

Forma Therapeutics Holdings Inc FMTX: Updated multiple-ascending dose results and initial open-label extension trial results of FT-4202 Phase 1 trial in sickle cell disease and Phase 2 registrational results of olutasidenib in recurrent/relapsed acute myeloid leukemia (Friday).

BeiGene Ltd BGNE: Results from the interim analysis of the Phase 3 ALPINE trial comparing Brukinsa to AbbVie's Imbruvica in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (Friday).

Protagonist Therapeutics Inc PTGX: Updated data from its Phase 2 clinical study evaluating rusfertide in polycythemia vera (Friday).

Autolus Therapeutics PLC AUTL: Phase 1/2 data for AUTO1 in relapsed/refractory indolent B cell lymphomas (Friday).

Aptose Biosciences Inc APTO: Updated data for separate luxeptinib Phase 1 a/b studies in acute myeloid leukemia and B-cell malignancies (Friday).

Vertex and CRISPR Therapeutics AG CRSP: Data from separate Phase 1/2 studies of CTX001 in transfusion-dependent Β-thalassemia and sickle cell disease (Friday).

Curis, Inc. CRIS: Updated data from the Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes (Friday).

Fortress Biotech FBIO: Data from Phase 3 study of CAEL-101 in AL amyloidosis and updated interim data from the Phase 1/2 clinical trial of MB-106 in B-cell non-Hodgkin lymphoma & chronic lymphocytic leukemia (Friday).

Mustang Bio Inc MBIO: Interim data from the Phase 1/2 clinical trial of MB-106 CD20-targeted CAR T for high-risk B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia (Friday).

X4 Pharmaceuticals Inc XFOR: Initial efficacy and safety data from the Phase 1b clinical trial of mavorixafor, in combination with AbbVie's Imbruvica, in Waldenström's macroglobulinemia patients with MYD88 and CXCR4 mutations (Friday).

Global Blood Therapeutics Inc GBT: Results from an analysis of the Phase 2a HOPE-KIDS 1 Study in children with sickle cell disease, ages 4 to 11 years treated with Oxbryta tablets (Friday).

MEI Pharma Inc. MEIP and Japan's Kyowa Kirin Co Ltd KYKOF: Updated clinical data from a Phase 1b study of zandelisib iin combination with Beigene's Brukinsa in patients with relapsed or refractory B-cell malignancies (Friday).

IPO Quiet Period Expiry

Vera Therapeutics, Inc. VERA

(Photo: National Cancer Institute via Unsplash)