BPC February 22 update

Otonomy OTIC misses key late-stage trial goal - shares fall 44%

Price and Volume Movers

Otonomy, Inc. (NASDAQ:OTIC) announced its Phase 3 clinical trial of Otividex in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. Shares slumped to close down 44% to $3.00.

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares closed down 34% to $4.58 on news the FDA has advised the company that data from its Phase 3 trial of NurOwn in patients with Amyotrophic lateral sclerosis does not provide the threshold of substantial evidence to support a Biologics License Application (BLA). The FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission. The company announced in November 2020 that the trial did not meet the primary endpoint.

Celsion Corporation(NASDAQ:CLSN) shares closed up 48% to $2.81 following its announcement that it received Fast Track designation from the FDA for GEN-1, currently in Phase 2 development for the treatment of advanced ovarian cancer. Fast Track Designation (FTD) is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.

Viatris Inc. (NASDAQ:VTRS) shares closed down 15% following its announcement of revenue guidance below analyst expectations, noting that it expects 2021 to be their trough year in terms of revenue. The company was formed in 2020 following the merger between Mylan and Pfizer’s Upjohn business.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Corvus Pharmaceuticals, Inc. (CRVS): $4.57; +22%.

Annovis Bio, Inc. (ANVS): $33.17; +15%.

Aridis Pharmaceuticals, Inc. (ARDS): $7.25; +12%.

Longeveron Inc. (LGVN): $6.80; +10%.

Athira Pharma, Inc. (ATHA): $23.69; +10%.

DECLINERS:

GeoVax Labs, Inc. (GOVX): $5.51; -19%.

Immunome, Inc. (IMNM): $31.20; -18%.

Altimmune, Inc. (ALT): $19.56; -15%.

VistaGen Therapeutics, Inc. (VTGN): $2.55; -14%.

Ovid Therapeutics Inc. (OVID): $2.99; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
OTEZLA
Plaque psoriasis

sNDA Filing sNDA filing announced February 22, 2021.
$130.4 billion

AMGN – Amgen Inc.
Tezepelumab - NAVIGATOR
Asthma

Phase 3 Phase 3 trial met primary endpoint - November 10, 2020.
$130.4 billion

AXGN – Axogen Inc.
Avance Nerve Graf ( RECON )
Severed peripheral nerves

Phase 3 Phase 3 preliminary report of trial data due 2Q 2022.
$913.9 million

FREQ – Frequency Therapeutics Inc.
FX-322
Acquired Sensorineural Hearing Loss (SNHL)

Phase 2a Phase 2a data due late-1Q 2021.
$1.6 billion

GSK – GlaxoSmithKline PLC
Adjuvanted COVID-19 vaccine
COVID-19 vaccine

Phase 2 Phase 2 initiation announced February 22, 2021. Phase 3 trial to commence 2Q 2021 if data from Phase 2 trial are positive.
$85.8 billion

INCY – Incyte Corporation
Ruxolitinib
Steroid-refractory chronic GVHD (Graft versus host disease)

PDUFA priority review PDUFA date under priority review June 22, 2021.
$17.3 billion

ITCI – Intra-Cellular Therapies Inc.
Lumateperone ITI-007-402
Bipolar depression

sNDA Filing sNDA filing announced February 22, 2021.
$2.8 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

Phase 3 Phase 3 U.K. interim data released January 28, 2021. 89.3% efficacy rate (95.6% effective against original COVID-19 strain and 85.6% against UK variant strain). Phase 2b South African trial noted 60% effective in HIV-negative patients, 49.4% in overall population. Phase 3 U.S. trial data due early April 2021.
$13.9 billion

OTIC – Otonomy Inc.
OTIVIDEX
Ménière's disease

Phase 3 Phase 3 trial did not achieve the primary endpoint.
$140.1 million

REGN – Regeneron Pharmaceuticals Inc.
Libtayo - Cemiplimab
Non-small cell lung cancer (NSCLC)

Approved FDA approval announced February 22, 2021.
$48.7 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002) - JUNIPER
Upper limb spasticity

Phase 2 Phase 2 top-line data released February 22, 2021. One of two co-primary endpoints met (one missed due to reduced enrollment).
$1.8 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-812 (pediatric)
ADHD

PDUFA CRL announced November 9, 2020. NDA filing resubmitted February 8, 2021. PDUFA date two month review - estimate April 8, 2021.
$1.3 billion

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent platinum resistant ovarian cancer

Phase 3 Phase 3 DSMB review recommended trial to continue as planned - February 22, 2021. Next review 3Q 2021 with completion of enrollment at the end of 2021 or in early 2022.
$94.9 million

XENE – Xenon Pharmaceuticals Inc.
XEN1101
Adult Focal Epilepsy

Phase 2 Phase 2b data due 3Q 2021.
$707.8 million