BPC November 16 update

GeoVax GOVX +24% Notice of Allowance; OPTN Offering -33%

Price and Volume Movers

GeoVax Labs, Inc. (NASDAQ: GOVX) announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office in regards to its Patent Application No. 16/068,527 entitled "Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen." Shares closed up 24% at $4.78.

Optinose, Inc. (NASDAQ: OPTN) announced a public offering of 25,000,000 shares of its common stock at $1.60 per share, for gross proceeds of $40 million. Shares closed down 33% at $1.59.

Progenity, Inc. (NASDAQ: PROG) traded on high volume today at more than 294 million compared to its daily average of just over 64 million. Shares closed up 39% at $4.80.

Molecular Partners AG (NASDAQ: MOLN) announced the outcome of a planned futility analysis by the Data and Safety Monitoring Board (DSMB) of its Phase 3 ACTIV-3 study of ensovibep to treat mild to moderate COVID-19. The DSMB meeting resulted in an assessment that the trial has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting. Shares closed down 32% at $10.15.

Kezar Life Sciences, Inc. (NASDAQ: KZR) continued to trade up after it released interim results from its Phase 2 portion of its MISSION trial of KZR-616 to treat lupus nephritis (LN) during the after-hours session yesterday. HC Wainwright also adjusted their price target of Kezar today from $12 to $20 with a Buy rating. Shares closed up 38% at $11.59.

Notable earnings releases from today:

NRx Pharmaceuticals (NASDAQ: NRXP)

AIM ImmunoTech Inc. (NYSE: AIM)

MediWound Ltd. (NASDAQ: MDWD)

Legend Biotech Corporation (NASDAQ: LEGN)

Advancers

CompanyPriceChange
BFRI
Biofrontera Inc.
$7.90+2.68  +51.34%
NRXP
NRX Pharmaceuticals Inc.
$6.75+2.25  +50.00%
ADGI
Adagio Therapeutics Inc.
$25.12+6.39  +34.12%
ATNF
180 Life Sciences Corp.
$5.41+0.95  +21.30%
GOVX
GeoVax Labs Inc.
$4.69+0.81  +20.88%
MRNA
Moderna Inc.
$329.63+56.24  +20.57%
ICVX
Icosavax Inc.
$27.55+4.51  +19.57%
VALN
Valneva SE
$59.60+9.7  +19.44%
TYRA
Tyra Biosciences Inc.
$23.87+3.66  +18.11%
PTPI
Petros Pharmaceuticals Inc.
$2.09+0.26  +14.21%

Decliners

CompanyPriceChange
LGVN
Longeveron Inc.
$30.67-11.63  -27.49%
AMTI
Applied Molecular Transport Inc.
$16.33-2.66  -14.01%
NEXI
NexImmune Inc.
$7.94-1.06  -11.78%
IGMS
IGM Biosciences Inc.
$49.63-6.58  -11.71%
CRNX
Crinetics Pharmaceuticals Inc.
$24.40-3.08  -11.21%
AVRO
AVROBIO Inc.
$4.08-0.51  -11.11%
ELYM
Eliem Therapeutics Inc
$13.76-1.72  -11.11%
MRSN
Mersana Therapeutics Inc.
$6.95-0.82  -10.55%
MNOV
MediciNova Inc.
$3.22-0.35  -9.80%
TARS
Tarsus Pharmaceuticals Inc.
$25.00-2.7  -9.75%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AMRN – Amarin Corporation plc
VASCEPA (Icosapent Ethyl)- (PREPARE-IT)
Covid-19

$3.64
-0.21  -5%
Phase 3 Phase 3 trial did not met the primary or secondary endpoints, noted November 16, 2021.
$1.4 billion

BFRI – Biofrontera Inc.
Ameluz (BF-200 ALA) in combination with BF-RhodoLED XL
Actinic Keratosis on face & scalp

$7.90
+2.68  +51%
Phase 1 Phase 1 safety study using 3 tubes of Ameluz; IRB approval obtained; protocol registered with the FDA; clinical site initiation November 16, 2021.
$91.6 million

CDAK – Codiak BioSciences Inc.
exoSTING (CDK-002)
Solid tumors

$13.29
-1.04  -7%
Phase 1/2 Phase 1/2 data reported that treatment was well tolerated with early signs of anti-tumor activity in 8 patients, noted November 16, 2021. Phase 1/2 data regarding Phase 2 dose and objective response rate due in 1H 2022.
$297.2 million

CLRB – Cellectar Biosciences Inc.
iopofosine I-131 (pediatric trial)
High grade gliomas (HGGs) and soft tissue sarcomas

$0.72
-0.03  -4%
Phase 1 Phase 1 data noted that an initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. This includes patients with relapsed HGGs experiencing over 5 months of progression free survival (PFS), noted November 16, 2021.
$44.2 million

GSK – GlaxoSmithKline PLC
Ensovibep (VIR-7831 / GSK4182136) - (ACTIV-3)
Mild to moderate COVID-19

$41.02
-0.58  -1%
Phase 3 Independent Data and Safety Monitoring Board (DSMB) recommended that enrollment to be closed - raised concerns about the magnitude of potential benefit. November DSMB meeting resulted in an assessment that the trial has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting, noted November 16, 2021.
$103.2 billion

LPCN – Lipocine Inc.
LPCN 1144 (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

$1.13
-0.04  -3%
Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. Phase 2 36-week data met with primary endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring. Both treatment arms showed improvement of the observed NASH activity in steatosis, inflammation and ballooning, August 25, 2021. Phase 2 data reported statistically significant reductions of ALT and AST; up to a mean of 24.5 U/L decrease in ALT, and 12.3 U/L decrease in AST, noted November 16, 2021
$99.8 million

OCUL – Ocular Therapeutix Inc.
OTX-TKI
Wet Age-related Macular Degeneration (AMD)

$6.54
-0.34  -5%
Phase 1 Phase 1 continues enrolling, interim data reported that some subjects showed a decrease in intraretinal or subretinal fluid as early as two months in, with the combination showing a decrease as early as a week after treatment, noted November 16, 2021.
$501 million

PFE – Pfizer Inc.
PAXLOVID (ritonavir)
Oral Protease Inhibitor for COVID-19

$54.00
+3.11  +6%
Phase 2/3 Phase 2/3 trial demonstrated a reduction in hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults, in the overall study population through Day 28 no deaths were reported, noted November 5, 2021. EUA rolling submission to the FDA as soon as possible, noted November 5, 2021. Phase 2/3 final data expected in 1Q 2022 or 2Q 2022. EUA requested November 16, 2021.
$303.1 billion