BPC November 23 update

Aptevo APVO +163% Phase 1b data; Vallon VLON +82% Volatility halt

Price and Volume Movers

Aptevo Therapeutics Inc. (NASDAQ: APVO) released data from its Phase 1b expansion trial of APVO436 to treat acute myeloid leukemia (AML). The data noted that in Cohort 1, a high-risk AML patient achieved complete remission after treatment. Shares closed up 163% at $17.03.

Vallon Pharmaceuticals (NASDAQ: VLON) shares were halted today due to high volatility. The action comes after HC Wainwright & Co. initiated coverage with a Buy rating and $12 price target yesterday. Shares closed up 82% at $7.30.

Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced that members of its senior management team will use personal funds to purchase up to a maximum of $2 million of American depositary shares (ADSs) within the next three months. Shares closed up 22% at $7.79.

MediciNova (NASDAQ: MNOV) shares closed up 44% at $4.42 after Zacks Small-Cap research set a $27 valuation on its stock.

Entrada Therapeutics (NASDAQ: TRDA) closed down 21% at $24.13 after Goldman Sachs initiated coverage with a Neutral rating and a $29 price target.

Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) traded on high volume today following interest sparked by a filed Schedule 14A proxy statement for an annual meeting after the market closed on Monday. Shares closed up 76% at $2.34.

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

AADI – Aadi Bioscience Inc.
FYARRO
PEComa​

$22.50
-0.41  -2%
Approved Approved November 23, 2021.
$470.1 million

ADAG – Adagene Inc.
ADG116
Solid Tumors

$8.69
-0.31  -3%
Phase 1 Phase 1 data of ADG-116 monotherapy (ADG116-1003) to be presented at ESMO-IO December 6, 2021. Phase 1 data of combination cohorts, ADG116 with toripalimab and ADG106 due 2022.
$473.4 million

AMYT – Amryt Pharma plc
FILSUVEZ (Oleogel-S10)
Epidermolysis Bullosa

$9.55
-0.27  -3%
PDUFA PDUFA goal date extended by three months to February 28, 2022.
$607.4 million

APVO – Aptevo Therapeutics Inc.
APVO436
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)

$13.07
+1.12  +9%
Phase 1b Phase 1 interim data from Phase 1/1b trial released May 26, 2021. Favorable safety profile and no severe neutropenia. Phase 1b part 2 enrollment and dosing have commenced, noted November 12, 2021. Preliminary data from Phase 1b extension noted one complete remission, noted November 23, 2021. Data to be presented at ASH December 13, 2021.
$64 million

OCUP – Ocuphire Pharma Inc.
Nyxol Eye Drops - (MIRA-3)
Reversal of Mydriasis (RM)

$4.35
+0.21  +5%
Phase 3 Phase 3 trial enrollment of first patient noted November 23, 2021. Phase 3 top-line results expected in early 2022.
$75.3 million

ORMP – Oramed Pharmaceuticals Inc.
ORMD-0801 - (ORA-D-013-1)
Type 2 Diabetes

$20.21
+1.29  +7%
Phase 3 Phase 3 trial reached 75% enrollment noted November 23, 2021. Phase 3 top-line data due 2022.
$768.7 million

RHHBY – Roche Holding AG ADR
Mosunetuzumab - (GO29781)
Follicular lymphoma

$48.41
+0.08  +0%
Phase 1/2 Phase 1b/2 results to be presented at ASH December 11-13, 2021.
$330.8 billion

RHHBY – Roche Holding AG ADR
Polivy (polatuzumab vedotin) - (POLARIX)
Diffuse Large B-Cell Lymphoma

$48.41
+0.08  +0%
Phase 3 Phase 3 trial met primary endpoint - August 9, 2021. Phase 3 data to be presented in as a late-breaker at ASH December 14, 2021.
$330.8 billion

RHHBY – Roche Holding AG ADR
Glofitamab (Glofit) + Polatuzumab Vedotin (Pola)
Diffuse Large B-Cell Lymphoma (DLBCL)

$48.41
+0.08  +0%
Phase 1/2 Phase 1b/2 data to be presented at ASH December 12, 2021.
$330.8 billion

RHHBY – Roche Holding AG ADR
Cevostamab
Relapsed/Refractory Multiple Myeloma (RRMM)

$48.41
+0.08  +0%
Phase 1 Phase 1 updated results to be presented at ASH December 11, 2021.
$330.8 billion

SYBX – Synlogic Inc.
SYNB1618 - (SynPheny-1)
Phenylketonuria (PKU)

$2.59
-0.05  -2%
Phase 2 Phase 2 interim analysis demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, September 20, 2021. Phase 2 data reported a 40% reduction in D5-Phe absorption after a meal challenge, a 20% reduction in mean fasting plasma Phe across all subjects, and a >250 µM mean reduction in fasting plasma Phe, noted November 23, 2021. Additional Phase 2 data due in 1H 2022.
$180.5 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-1900
Migraine

$0.50
+0.03  +6%
Phase 2 Phase 2 trial enrollment to begin in 1H 2022.
$222 million