The Week Ahead In Biotech: ASCO Presentations Front And Center, FDA Decisions Due For Scynexis, Liminal And Alkermes

After having declined through the first half of the week, biotech stocks staged a recovery to close higher in the trading week ended May 28. Broader market sentiment and company-specific news flow dictated stock moves during the week.

Ahead of Memorial Day, the Food and Drug Administration handed down several positive verdicts. Among the drugs approved were Bristol-Myers Squibb Company's BMY Zeposia for ulcerative colitis, Amgen, Inc.'s AMGN KRAS G12C-inhibitor sotorasib for non-small cell lung cancer, and Biohaven Pharmaceutical Holding Company Ltd.'s BHVN migraine treatment.

Eton Pharmaceuticals, Inc. ETON, meanwhile, faced a rejection, as the regulator turned down its new drug application for dehydrated alcohol injection as a treatment option for methanol poisoning.

Provention Bio, Inc. PRVB had a mixed week, as it rallied strongly Tuesday in reaction to the briefing document released ahead of the Adcom meeting. The stock retreated by as much following the Adcom verdict. Investors did not quite relish the company's statement that, despite the positive FDA panel vote, approval for its type 1 diabetes treatment could still be delayed due to issues raised by the regulator regarding the comparability of the pharmacokinetic profile.

Pieris Pharmaceuticals, Inc. PIRS was among the biggest gainers of the week following its pact with Roche Holding AG's RHHBY Genentech unit. Meanwhile, Larimar Therapeutics, Inc. LRMR shares suffered a massive sell-off after an early-stage study of Friedreich ataxia treatment was put on hold.

Here are the key catalysts for the unfolding week.


The Jefferies Virtual Healthcare Conference: June 1-4
European League Against Rheumatism, or EULAR, 2021 Virtual Conference: June 2-5
12th C1-Inhibitor Deficiency and Angioedema Workshop: June 3-6
American Society of Clinical Oncology, or ASCO, Annual Meeting: June 4-8


The FDA is scheduled to rule on Alkermes plc's ALKS resubmitted new drug application for ALKS 3831, a combo drug comprising olanzapine and samidorphan, as a treatment option adults with schizophrenia and bipolar I disorder. The prescription drug user fee act, or PDUFA, date – the date by which the FDA is required to announce its decision – has been fixed for Tuesday, June 1.

SCYNEXIS, Inc. SCYX awaits FDA verdict on its NDA for ibrexafungerp by the PDUFA goal date of Tuesday, June 1. Ibrexafungerp is being evaluated for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infections. The therapeutic candidate is to get Brexafemme as its trade name.

The FDA has fixed a PDUFA goal date of Saturday, June 5, for deciding on Liminal BioSciences Inc.'s LMNL biologic license application for Ryplazim or plasminogen. The investigational asset is being evaluated for treating patients with clinical signs and symptoms associated with congenital plasminogen deficiency.

Clinical Readouts/Data Presentations

EULAR Meeting Presentations

Kezar Life Sciences, Inc. KZR: Final data from MISSION Phase 1b trial, the 25-week safety and tolerability study investigating up to 75-mg weekly dosing of KZR-616 in 47 patients with systemic lupus erythematous (Wednesday, June 2, 4:30 p.m.)

Aurinia Pharmaceuticals Inc. AUPH: Supportive interim analysis of its AURORA 2 Phase 3 continuation study that is evaluating Lupkynis for the treatment of lupus nephritis

ASCO Presentations

Here's a list of companies presenting at the conference, and the list is not comprehensive.

Seagen Inc. SGEN: updated results of the EV-103 and EV-201 clinical trials for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer and additional data from the HER2CLIMB trial of Tukysa (tucatinib) in previously treated HER2+ metastatic breast cancer patients.

Magenta Therapeutics, Inc. MGTA: Initial mobilization, collection, engraftment and disease outcome data from Phase 2 study of MGTA-145 plus plerixafor in multiple myeloma

Immunocore Holdings plc IMCR: Data from Phase 3 study comparing tebentafusp vs. investigator's choice in first line metastatic uveal melanoma

Jounce Therapeutics, Inc. JNCE: Data from Phase 1 study of JTX-8064 as monotherapy and in combination with anti-PD-1 in adult patients with advanced solid tumors

BeyondSpring Inc. BYSI: Data from Phase 1 study of Plinabulin, in combination with Bristol-Myers Squibb's Opdivo and Yervoy in the treatment of 2nd and 3rd line small cell lung cancer

Sensei Biotherapeutics, Inc. SNSE: Data from combination study of SNS-301 with Merck & Co., Inc.'s MRK Keytruda in patients with advanced squamous cell carcinoma of the head and neck

Vincerx Pharma, Inc. VINC: Phase 1 dose-escalation safety and efficacy data for VIP152 in relapsed/refractory chronic lymphocytic leukemia and Richter syndrome

Alkermes: Data from ARTISTRY-1 and ARTISTRY-2 clinical trials evaluating nemvaleukin alfa (nemvaleukin) in solid tumors

Allogene Therapeutics, Inc. ALLO: first presentation of data from the dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma

Bolt Biotherapeutics, Inc. BOLT: Preliminary results from a Phase 1/2 study of BDC-1001 in patients with advanced HER2-expressing solid tumors.

Deciphera Pharmaceuticals, Inc. DCPH: Updated data from the Phase 1b/2 study of rebastinib in combination with paclitaxel in the endometrial cancer cohort

Delcath Systems, Inc. DCTH: : Preliminary results of FOCUS phase 3 trial of percutaneous hepatic perfusion with melphalan for patients with ocular melanoma liver metastases

Allogene & Cellectis S.A. CLLS: Initial results from patients treated with consolidation dosing of ALLO-501A

Immutep Limited IMMP: Results from a phase 2 study of eftilagimod alpha and Keytruda in patients with PD-L1 unselected metastatic non-small cell lung carcinoma as well as phase 2 study of eftilagimod alpha and Keytruda in patients with PD-L1 unselected metastatic second-line squamous head and neck carcinoma.

Related Link: COVID-19 Vaccine Patent Polarizes The World: What You Need To Know

Agenus Inc. AGEN: New Phase 1 clinical data for AGEN2373 in in patients with advanced solid tumors

Merus N.V. MRUS: Interim analysis of data from the phase 1/2 eNRGY trial of Zenocutuzumab in patients with NRG1+ cancers

Surface Oncology, Inc. SURF: Data from the Phase 1 study of SRF388 in advanced solid tumors

NexImmune, Inc. NEXI: Data from preliminary analysis of a Phase 1/2 study of NEXI-001 for the treatment of relapsed acute myeloid leukemia after allogeneic hematopoietic cell transplantation

TRACON Pharmaceuticals, Inc. TCON: Preliminary data for Uliledlimab in combination with Roche Holding AG's RHHBY Tecentriq in patients with advanced cancer

Clovis Oncology, Inc. CLVS: Updated Phase 1b results from Lucitanib and Opdivo in patients with advanced solid tumors

Heat Biologics, Inc. HTBX: Interim results of viagenpumatucel-L plus Opdivo in previously treated patients with advanced non-small cell lung cancer

Cellectar Biosciences, Inc. CLRB: Data from Phase 2a study of CLR 131 in Waldenstrom's macroglobulinemia

Forma Therapeutics Holdings, Inc. FMTX: Results from a planned interim analysis of a phase 2 study of olutasidenib in relapsed/refractory mIDH1 acute myeloid leukemia

ADC Therapeutics SA ADCT: data from Phase 1b study to evaluate camidanlumab tesirine as monotherapy in patients with advanced solid tumor

Tyme Technologies, Inc. TYME: Data from Phase 2 Study of SM-88 in Ewing's and Other Sarcomas
Epizyme, Inc. EPZM: Results of the phase 1b soft-tissue sarcoma portion of the study of tazemetostat plus doxorubicin as frontline therapy for advanced epithelioid sarcoma

Veru Inc. VERU: Data from Phase 2 study of enobosarm in advanced AR+/estrogen receptor+ breast cancer

Purple Biotech Ltd. PPBT: Initial data from Phase 1/2 study of NT219 in adults with advanced solid tumors and head and neck cancer
Panbela Therapeutics, Inc. PBLA: Additional data from phase 1 trial of SBP101 in pancreatic cancer

Harpoon Therapeutics, Inc. HARP: updated interim Phase 1 data for HPN424 for prostate cancer

Kadmon Holdings, Inc. KDMN: Initial safety data from the Phase 1 clinical trial of KD033 in patients with metastatic or locally advanced solid tumors

G1 Therapeutics, Inc. GTHX: Phase 1 data for Rintodestrant, in combination with palbociclib for ER+/HER2- advanced breast cancer

Adaptimmune Therapeutics plc ADAP: Initial data from its Phase 2 SPEARHEAD-1 trial, with afamitresgene autoleucel in synovial sarcoma and myxoid/ round cell liposarcoma

MacroGenics, Inc. MGNX: Data from Phase 1 dose-escalation study of MGC018 in patients with advanced solid tumors

Fate Therapeutics, Inc. FATE: New FT516 Phase 1 data for B-cell lymphoma

VBI Vaccines Inc. VBIV: Updated Phase 2a portion of the Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma patients,

Aprea Therapeutics, Inc. APRE: Phase 1/2 clinical trial of Eprenetapop in relapsed/refractory gastric, bladder and non-small cell lung cancers

ImmunoGen, Inc. IMGN: Data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate

BeiGene, Ltd. BGNE: Initial data from the Phase 3 study of tislelizumab in second-line advanced unresectable or metastatic esophageal squamous cell carcinoma and initial data from the Phase 2 trial of tislelizumab in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors

Advaxis, Inc. ADXS: Updated data from the Phase 1/2 study evaluating ADXS-503 in combination with Keytruda in patients with metastatic non-small-cell lung cancer

Alpine Immune Sciences, Inc. ALPN: Data from the Phase 1 dose escalation clinical trial of ALPN-202 monotherapy in advanced malignancies

I-Mab IMAB: Data from the Phase 1 study of uliledlimab in combination with Tecentriq in patients with advanced cancer

TG Therapeutics, Inc. TGTX: Data from the study of TG-1701 in chronic lymphocytic leukemia and lymphoma

Oncolytics Biotech Inc. ONCY: Clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.

Salarius Pharmaceuticals, Inc. SLRX: Phase 1 trial of seclidemstat in patients with relapsed/refractory Ewing sarcoma and Phase 1 expansion trial of seclidemstat with and without topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma and select sarcomas

C1-Inhibitor Deficiency & Angioedema Workshop Presentations

KalVista Pharmaceuticals, Inc. KALV: Analysis of pharmacokinetic and pharmacodynamic profile of KVD900 and attack symptom severity from a phase 2 cross-over trial in patients with hereditary angioedema type I and II (Saturday, June 5)

Related Link: Why This Pfizer Analyst Is Sidelined After Beat-And-Raise Q1


CTI BioPharma Corp. CTIC (Tuesday, after the close)

IPO Quiet Period Expiry

Valneva SE VALN
Anebulo Pharmaceuticals, Inc. ANEB
Talaris Therapeutics, Inc. TALS

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EPS Surprise
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