Benzinga | Nov 8, 2020 12:47PM EST

The Week Ahead In Biotech: Earnings, Conference Presentations And IPOs

Biotech stocks turned around with the broader market in the week ended Nov. 6, as investors warmed to the idea of a split Congress and a change of guard at the White House.

The week witnessed a flurry of earnings from several smid-cap companies. Bluebird bio Inc. (NASDAQ:BLUE) shares came under pressure after it announced a push back in the timeline for the regulatory filing for its gene therapy to treat sickle cell disease.

Biogen Inc. (NASDAQ:BIIB) was also in the news over an FDA roadblock regarding its Alzheimer's drug aducanumab. On the M&A front, Merck & Co. Inc. (NYSE:MRK) announced a $2.75 billion deal to buy oncology-focused biopharma VelosBio Inc.

Here are the key biotech events to watch out for in the unfolding week:

Conferences

American College of Rheumatology, or ACR, Convergence 2020: Nov. 5-9

Credit Suisse 29th Annual Virtual Healthcare Conference: Nov. 9-10

35th Annual Meeting of The Society for Immunotherapy of Cancer, or SITC: Nov. 9-14

American Academy of Ophthalmology, or AAO, 2020 Virtual meeting: Nov. 13-15

American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, Digital Experience: Nov. 13-16

American Heart Association, or AHA, Scientific Sessions 2020: Nov. 13-17

PDUFA Dates

The FDA is set to rule on strong>Supernus Pharmaceuticals Inc's (NASDAQ:SUPN) NDA for SPN-812 (vilaxazine hydrochloride) for the treatment of attention deficit hyperactivity disorder. (Sunday)

Sanofi SA (NASDAQ:SNY) awaits FDA nod for its BLA for sutimlimab as a treatment option for hemolysis in adult patients with cold agglutinin disease. (Saturday)

SITC Presentations

Gossamer Bio Inc. (NASDAQ:GOSS): Preliminary results from KEYNOTE-A36, a Phase 1/2 study of GB1275, alone and with Merck's Keytruda or chemotherapy in specified advanced solid tumors (poster presentation Monday)

Corvus Pharmaceuticals Inc. (NASDAQ:CRVS): updated data from its Phase 1 study of CPI-006 to provide a novel immunotherapy approach for patients with COVID-19 (poster and oral presentations Monday)

I-Mab ADR (NASDAQ:IMAB): Phase 1 dose escalation trial data from its CD47 program, lemzoparlimab, codenamed TJC4, in relapsed or refractory malignancy and preclinical data for TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent

Iovance Biotherapeutics Inc. (NASDAQ:IOVA): new interim Phase 2 data for the tumor infiltrating lymphocyte therapy LN-145 in combination with Keytruda in head and neck squamous cell carcinoma (poster presentation)

MacroGenics Inc. (NASDAQ:MGNX): updated data from the Phase 1 dose expansion study of tebotelimab in combination with margetuximab in a cohort of patients with advanced HER2-positive tumors (poster presentation)

Genocea Biosciences Inc. (NASDAQ:GNCA): emerging safety and activity data from GEN-009-101, a phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 checkpoint inhibitors in advanced solid tumors (Monday, poster presentation at SITC and an investor call)

Other presenters at the SITC meeting include:

Fate Therapeutics Inc. (NASDAQ:FATE)

Celldex Therapeutics Inc. (NASDAQ:CLDX)

Amgen Inc. (NASDAQ:AMGN)

Leap Therapeutics Inc. (NASDAQ:LPTX)

Arcus Biosciences Inc. (NYSE:RCUS)

Nektar Therapeutics (NASDAQ:NKTR)

OncoSec Medical Inc. (NASDAQ:ONCS)

Repligen Corporation (NASDAQ:RGEN)

Checkmate Pharmaceuticals Inc. (NASDAQ:CMPI)

Agenus Inc. (NASDAQ:AGEN)

Curis Inc. (NASDAQ:CRIS)

Adaptimmune Therapeutics PLC -- ADR (NASDAQ:ADAP)

Xencor Inc. (NASDAQ:XNCR)

ALX Oncology Holdings Inc. (NASDAQ:ALXO)

Spring Bank Pharmaceuticals Inc. (NASDAQ:SBPH)

BioNTech SE -- ADR (NASDAQ:BNTX)

Genmab 10 Sponsored ADR Ord Shs (NASDAQ:GMAB)

Imv Inc. (NASDAQ:IMV)

Cue Biopharma Inc. (NASDAQ:CUE)

Advaxis Inc. (NASDAQ:ADXS)

ACR Meeting Presentations

Navidea Biopharmaceuticals Inc. (NYSE:NAVB): results from the the second interim analysis of its NAV3-31 Phase 2b clinical study in rheumatoid arthritis (Monday, 9 am to 11 am)

Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA): new data from the global Phase 2 clinical trial of mavrilimumab in giant cell arteritis (at the late-breaking abstract session Monday at 11:30 am)

AAO Meeting Presentations

MeiraGTx Holdings PLC (NASDAQ:MGTX): 12-month results from the Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa (Friday at 5:55 pm)

Adverum Biotechnologies Inc. (NASDAQ:ADVM): additional clinical data for Cohorts 1-4 in the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in wet age-related macular degeneration (Friday, 2:15 pm)

ProQR Therapeutics NV (NASDAQ:PRQR): Phase 1b/2 trial results of intravitreal sepofarsen RNA therapy in Leber congenital amaurosis 10

NGM Biopharmaceuticals Inc. (NASDAQ:NGM): detailed Phase 1 safety, tolerability and pharmacokinetics findings from single and multiple intravitreal injections of NGM621 in patients with geographic atrophy (Friday, 10 am)

AHA Presentations

Cytokinetics Inc. (NASDAQ:CYTK) and Amgen Inc. (NASDAQ:AMGN): primary results from the GALACTIC-HFhe Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil in acute heart failure

Related Link: A Pfizer Analyst's 3 Possible Coronavirus Vaccine Readout Scenarios

AASLD Presentations

NGM Biopharmaceuticals Inc. (NASDAQ:NGM): comprehensive data from its 24-week Phase 2 study (Cohort 4) of aldafermin in patients with non-alcoholic steatohepatitis (Friday)

Metacrine Inc. (NASDAQ:MTCR): new Phase 1b data on lead clinical candidate, MET409 for the treatment of NASH

Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL): early data from the Phase 3 MAESTRO study of resmetirom in NASH and data from the MAESTRO-NAFLD-1 open label study (Friday, 4:30-5 pm)

89bio Inc. (NASDAQ:ETNB): Phase 1b/2a multiple ascending dose study of BIO89-100 in NASH

CymaBay Therapeutics Inc. (NASDAQ:CBAY): data from a Phase 2 study of seladelpar in NASH

DURECT Corporation (NASDAQ:DRRX): additional safety and efficacy signals from a Phase 1b study of 4-Week Oral DUR-928 in NASH subjects

Can Fite Biopharma ADR Representing 30 Ord Shs (NYSE:CANF): data from the Phase 2, dose-finding study of the efficacy and safety Of namodenoson in treating NAFLD and NASH

Earnings

Monday

Neos Therapeutics Inc. (NASDAQ:NEOS) (before the market open)

Xeris Pharmaceuticals Inc. (NASDAQ:XERS) (before the market open)

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) (before the market open)

Mersana Therapeutics Inc. (NASDAQ:MRSN) (before the market open)

Seres Therapeutics Inc. (NASDAQ:MCRB) (before the market open)

Recro Pharma Inc. (NASDAQ:REPH) (before the market open)

Urogen Pharma Ltd. (NASDAQ:URGN) (before the market open)

Polarityte Inc (NASDAQ:PTE) (before the market open)

Rubius Therapeutics Inc. (NASDAQ:RUBY) (before the market open)

InspireMD Inc. (NYS: NSPR) (before the market open)

Reata Pharmaceuticals Inc. (NASDAQ:RETA) (before the market open)

TherapeuticsMD Inc. (NASDAQ:TXMD) (before the market open)

Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN) (before the market open)

Sesen Bio Inc. (NASDAQ:SESN) (before the market open)

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) (before the market open)

Allakos Inc. (NASDAQ:ALLK) (before the market open)

Apyx Medical Corp. (NASDAQ:APYX) (before the market open)

Atara Biotherapeutics Inc. (NASDAQ:ATRA) (after the close)

Athersys Inc. (NASDAQ:ATHX) (after the close)

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) (after the close)

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) (after the close)

Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) (after the close)

Forte Biosciences Inc. (NASDAQ:FBRX) (after the close)

Pulse Biosciences Inc. (NASDAQ:PLSE) (after the close)

Neurocrine Biosciences Inc. (NASDAQ:NBIX) (after the close)

Kindred Biosciences Inc. (NASDAQ:KIN) (after the close)

Castle Biosciences Inc. (NASDAQ:CSTL) (after the close)

PDL BioPharma Inc. (NASDAQ:PDLI) (after the close)

Evofem Biosciences Inc. (NASDAQ:EVFM) (after the close)

Cara Therapeutics Inc. (NASDAQ:CARA) (after the close)

CASI Pharmaceuticals Inc. (NASDAQ:CASI) (after the close)

Omeros Corporation (NASDAQ:OMER) (after the close)

ChemoCentryx Inc. (NASDAQ:CCXI) (after the close)

Revance Therapeutics Inc. (NASDAQ:RVNC) (after the close)

Infinity Pharmaceuticals Inc. (NASDAQ:INFI) (after the close)

TapImmune Inc. common stock (NASDAQ:MRKR) (after the close)

Novavax Inc. (NASDAQ:NVAX) (after the close)

Fulgent Genetics Inc. (NASDAQ:FLGT) (after the close)

Myriad Genetics Inc. (NASDAQ:MYGN) (after the close)

Organogenesis Holdings Inc (NASDAQ:ORGO) (after the close)

Rockwell Medical Inc. (NASDAQ:RMTI) (after the close)

Xeris Pharmaceuticals Inc. (NASDAQ:XERS) (after the close)

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX

Tuesday

Fulcrum Therapeutics Inc. (NASDAQ:FULC) (before the market open)

STRATA Skin Sciences Inc. (NASDAQ:SSKN) (before the market open)

Aerpio Pharmaceuticals Inc. (NASDAQ:ARPO) (before the market open)

Altimmune Inc. (NASDAQ:ALT) (before the market open)

BioNTech SE -- ADR (NASDAQ:BNTX) (before the market open)

Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) (before the market open)

Affimed NV (NASDAQ:AFMD) (before the market open)

Zogenix Inc. (NASDAQ:ZGNX) (after the close)

10X Genomics Inc. (NASDAQ:TXG) (after the close)

Adaptive Biotechnologies Corp. (NASDAQ:ADPT)

Clearside Biomedical Inc. (NASDAQ:CLSD) (after the close)

Viela Bio Inc. (NASDAQ:VIE) (after the close)

CTI BioPharma Corp. (NASDAQ:CTIC) (after the close)

Curis Inc. (NASDAQ:CRIS) (after the close)

Clearpoint Neuro Inc. (NASDAQ:CLPT) (after the close)

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) (after the close)

HTG Molecular Diagnostics Inc (NASDAQ:HTGM) (after the close)

Eyenovia Inc. (NASDAQ:EYEN) (after the close)

TRACON Pharmaceuticals Inc. (NASDAQ:TCON) (after the close)

Lumos Pharma Inc. (NASDAQ:LUMO) (after the close)

Silk Road Medical Inc. (NASDAQ:SILK) (after the close)

Osmotica Pharmaceuticals PLC (NASDAQ:OSMT) (after the close)

Precision BioSciences Inc. (NASDAQ:DTIL)

Passage Bio Inc. (NASDAQ:PASG)

Gamida Cell Ltd. (NASDAQ:GMDA)

Wednesday

Royalty Pharma PLC(NASDAQ:RPRX) (before the market open)

Ascendis Pharma A/S (NASDAQ:ASND) (after the close)

TELA Bio Inc (NASDAQ:TELA) (after the close)

Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) (after the close)

Trevi Therapeutics Inc. (NASDAQ:TRVI) (after the close)

OpGen Inc. (NASDAQ:OPGN) (after the close)

Salarius Pharmaceuticals Inc (NASDAQ:SLRX) (after the close)

Thursday

Myovant Sciences Ltd. (NYSE:MYOV) (before the market open)

Sol Gel Technologies Ltd. (NASDAQ:SLGL) (before the market open)

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) (before the market open)

ADC Therapeutics SA (NYSE:ADCT) (before the market open)

RedHill Biopharma Ltd. (NASDAQ:RDHL) (before the market open)

ImmuCell Corporation (NASDAQ:ICCC) (after the close)

Aptinyx Inc. (NASDAQ:APTX) (after the close)

Agile Therapeutics Inc. (NASDAQ:AGRX) (after the close)

Achieve Life Sciences Inc. (NASDAQ:ACHV) (after the close)

aTyr Pharma Inc. (NASDAQ:LIFE) (after the close)

Alpine Immune Sciences Inc. (NASDAQ:ALPN) (after the close)

Aytu Bioscience Inc. (NASDAQ:AYTU) (after the close)

Dare Bioscience Inc. (NASDAQ:DARE) (after the close)

Dyadic International, Inc. (NASDAQ:DYAI) (after the close)

Eton Pharmaceuticals Inc. (NASDAQ:ETON) (after the close)

BioNano Genomics Inc. (NASDAQ:BNGO) (after the close)

Helius Medical Technologies Inc. (NASDAQ:HSDT) (after the close)

Thermogenesis Holdings Inc. (NASDAQ:THMO) (after the close)

RA Medical Systems Inc. (NYSE:RMED) (after the close)

Onconova Therapeutics Inc. (NASDAQ:ONTX) (after the close)

Opiant Pharmaceuticals Inc. (NASDAQ:OPNT) (after the close)

Inari Medical In.c (NASDAQ:NARI) (after the close)

Friday

PLx Pharma Inc. (NASDAQ:PLXP) (before the market open)

Meridian Bioscience, Inc. (NASDAQ:VIVO) (before the market open)

IPOs

Atlanta-based Inhibikase Therapeutics Inc. has filed to offer 1.364 million shares of its common stock in an initial public offering, or IPO, to be priced between $10 and $12 apiece. The shares are to be listed on the Nasdaq under the ticker symbol IKT. Inhibikase is a clinical stage pharmaceutical company developing therapeutics for Parkinson's disease.

New York-based IN8bio is offering 4.688 million shares in an IPO at an estimated price range of $15-$17. The oncology-focused biopharma has applied for listing its shares on the Nasdaq under the ticker symbol INAB.

IPO Analysts' Quiet Period Expiry

Aligos Therapeutics Inc. (NASDAQ:ALGS)

Kiromic Biopharma Inc. (NASDAQ:KRBP)

Opthea Spon American Depositary Receipts Representing 8 Ord Shs (NASDAQ:OPT)

Praxis Precision Medicines Inc. (NASDAQ:PRAX)

Tarsus Pharmaceuticals Inc. (NASDAQ:TARS)

Codiak BioSciences Inc. (NASDAQ:CDAK)

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