BPC November 24 update

Biofrontera BFRI +98% Analyst Coverage; Outlook OTLK -19% Offering increase

Price and Volume Movers

The team at BioPharmCatalyst wishes a happy Thanksgiving to all of our readers. Due to the holiday, we will not be sending out our newsletters for the remainder of this week, and only publishing our Weekly Watchlist on Saturday.

Roth Capital initiated coverage on Biofrontera (NASDAQ: BFRI) with a Buy rating and $20 price target. Shares closed up 98% at $5.22.

Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that it will increase the size of the previously announced public offering to 40,000,000 shares at $1.25 per share. The gross proceeds are expected to be $50 million. Shares closed down 19% at $1.27.

Ocuphire Pharma (NASDAQ: OCUP) shares traded up after HC Wainwright & Co. initiated coverage with a Buy rating and a price target of $26. Shares closed up 19% at $4.14.

Kura Oncology, Inc. (NASDAQ: KURA) placed the KOMET-001 Phase 1b study of KO-539 to treat relapsed or refractory acute myeloid leukemia (AML) on partial clinical hold due to a grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome. Shares closed down 16% at $14.02.

MyMD Pharmaceuticals Inc (NASDAQ: MYMD) shares closed up 17% at $7.10 after a form 4 filing reported that the Vice President of Operations bought 15,000 shares of stock on November 23, 2021.

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

AVRO – AVROBIO Inc.
AVR-RD-05
Hunter syndrome / MPS II

$4.08
-0.51  -11%
Phase 1/2 Phase 1/2 trial to commence 2H 2022.
$178.1 million

AVXL – Anavex Life Sciences Corp.
ANAVEX 2-73 - AVATAR
Rett syndrome

$19.45
+0.46  +2%
Phase 2 Phase 2 data due by year end 2021.
$1.5 billion

AVXL – Anavex Life Sciences Corp.
ANAVEX 3-71 (AF710B)
Healthy volunteers

$19.45
+0.46  +2%
Phase 1 Phase 1 top-line data due by year end 2021.
$1.5 billion

AZN – AstraZeneca PLC
ORPATHYS (savolitinib) + TAGRISSO (osimertinib)
Non-small cell lung cancer (NSCLC)

$56.58
+0.24  +0%
Phase 3 Phase 3 trial first patient dosed November 22, 2021.
$175.3 billion

CYDY – Cytodyn Inc
Leronlimab
Non-alcoholic steatohepatitis (NASH)

$1.19
-0.09  -7%
Phase 2 Phase 2 initiation announced June 11, 2020. Phase 2 preliminary findings reported that fatty deposits were lowered in 5 patients by 45% and fibrosis was lowered by 10%, in 4 out of 5 patients, noted November 3, 2021. Additional Phase 2 data reported fat reductions up to 45% along with reductions in fibrosis up to 8%, noted November 24, 2021. Results are expected by mid-December 2021.
$783.3 million

IONS – Ionis Pharmaceuticals Inc.
Vupanorsen (AKCEA-ANGPTL3-LRx) - (TRANSLATE-TIMI 70)
Cardiovascular (CV) risk reduction and hypertriglyceridemia

$29.05
-0.71  -2%
Phase 2b Phase 2b updated data demonstrated that in the dose-ranging study in subjects with elevated non-HDL-C and triglycerides (TG), the study met its primary endpoint, achieving a statistically significant reduction in non-HDL-C at all doses tested at 24 weeks, compared to placebo, noted November 24, 2021.
$4.1 billion

KURA – Kura Oncology Inc.
KO-539 (KOMET-001)
Relapsed or refractory acute myeloid leukemia (AML)

$14.01
-0.01  0%
Phase 1 Phase 1b trial placed on partial clinical hold by the FDA due to a grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML, noted November 24, 2021.
$932.1 million