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The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

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The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

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 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

Aldeyra Therapeutics Inc. (NASDAQ: ALDX): new clinical utility data from the Phase 2 allergen chamber clinical trial of reproxalap in allergic conjunctivitis

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

 

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