BPC November 18 update

Longeveron LGVN +135% RPD designation; Dicerna DRNA +79% Acquisition by NVO

Price and Volume Movers

Longeveron Inc. (NASDAQ: LGVN) announced that the FDA granted Rare Pediatric Disease (RPD) designation for its drug Lomecel-B to treat Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is currently in a Phase 2 trial. Shares closed up 135% at $6.87.

Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA) announced that it has entered into a definitive agreement with Novo Nordisk (NYSE: NVO) under which Novo Nordisk will acquire Dicerna for $38.25 per share in cash, for a total value of $3.3 billion. Shares closed up 79% at $38.03.

Gilead Sciences, Inc. (NASDAQ: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) announced that Gilead exercised its options to three programs in Arcus's clinical-stage portfolio, including both anti-TIGIT molecules, domvanalimab and AB308, as well as etrumadenant and quemliclustat. Arcus will receive option payments totaling $725 million. Arcus shares closed up 18% at $43.54.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced an underwritten public offering of American Depositary Shares (ADS). Each ADS represents ten ordinary shares. Shares are trading down 11% at $3.44 during after-hours.

Pfizer Inc (NYSE: PFE) has made a $15 million equity investment in Cardiff Oncology Inc (NASDAQ: CRDF) as part of the Pfizer Breakthrough Growth Initiative. Pfizer purchased 2.4 million shares of Cardiff Oncology's shares at $6.22 per share. Cardiff shares closed up 19% at $6.21.

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

AZN – AstraZeneca PLC
AZD7442 (PROVENT)
COVID-19

$56.58
+0.24  +0%
Phase 3 EUA application filed to FDA October 5, 2021. Phase 3 six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths, noted November 18, 2021.
$175.3 billion

BLRX – BioLineRx Ltd.
Motixafortide (BL-8040) - (GENESIS)
Stem-cell mobilization for autologous transplantation

$2.60
-0.04  -2%
NDA Filing NDA filing due 1H 2022.
$123.4 million

BLRX – BioLineRx Ltd.
AGI-134
Solid tumors

$2.60
-0.04  -2%
Phase 1/2 Phase 1/2 data due 1H 2022.
$123.4 million

CNTB – Connect Biopharma Holdings Limited
CBP-201
Atopic dermatitis

$4.50
-0.05  -1%
Phase 2b Phase 2b data met primary endpoint all three doses achieving significant improvements. Also reported for key secondary endpoints including other measures of skin clearance and itch with a 300mg dose every two weeks (Q2W) arm, noted November 18, 2021. Phase 3 trial to initiate in mid-2022.
$258.7 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-721
Hepatitis B

$91.89
+5.00  +6%
Phase 1 Development discontinued, noted November 18, 2021.
$1.9 billion

IONS – Ionis Pharmaceuticals Inc.
Donidalorsen (IONIS-PKK-LRx) - (OASIS-HAE)
Hereditary Angioedema (HAE)

$29.05
-0.71  -2%
Phase 3 Phase 3 trial initiated November 18, 2021.
$4.1 billion

KTRA – Kintara Therapeutics Inc.
VAL-083
MGMT-unmethylated Recurrent Bevacizumab Naïve Glioblastoma Multiforme (GBM) or The Adjuvant

$0.75
-0.01  -1%
Phase 2 Phase 2 top-line data released July 1, 2021. Median overall survival 8.0 months. Phase 2 data noted that In the adjuvant group PFS was 9.5 months and mOS was 16.5 months, noted November 18, 2021.
$36.6 million

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab)
Renal cell carcinoma (RCC)

$79.16
-3.12  -4%
Approved Approved November 18, 2021.
$200 billion

MRKR – Marker Therapeutics Inc.
MultiTAA-Specific T Cells
Lymphoma

$1.23
0.00  0%
Phase 1/2 Phase 1/2 trial ongoing. Phase 1 data to be presented at the 2021 American Society of Hematology (ASH) Annual Meeting December 11-14, 2021.
$102.2 million

PBLA – Panbela Therapeutics Inc.
SBP101
Pancreatic Cancer

$1.97
+0.06  +3%
Phase 1b Phase 1b data presented at ASCO June 4-8, 2021. In cohort 2 (N=7) the objective response rate (ORR) was 71%, and the disease control rate (DCR) was 100%. Phase 1b efficacy data to be presented at ASCO January 20-22, 2022. Randomized trial to be initiated by end of 2021.
$26.5 million

PRQR – ProQR Therapeutics N.V.
QR-1123 - (Aurora)
Autosomal dominant retinitis pigmentosa (adRP)

$7.19
-0.17  -2%
Phase 1/2 Phase 1/2 data reported 3 cases of cataract worsening, with maximum benefit in BCVA observed after 5 weeks and declined thereafter. A mean BCVA benefit of +1.4 letters was reported across all subjects. In doses 75 - 300µg, the mean BCVA benefit was +5 letters, maximum benefit observed was +7 letters, noted November 18, 2021. Phase 2 trial planned for 2022.
$530 million

PRQR – ProQR Therapeutics N.V.
Sepofarsen - (InSight extension trial)
Leber Congenital Amaurosis type 10 (LCA10)

$7.19
-0.17  -2%
Phase 1/2 Phase 1/2 data reported that the vast majority of the treated eyes demonstrated responses on multiple endpoints, noted November 18, 2021.
$530 million

PSTV – PLUS THERAPEUTICS Inc.
Rhenium-186 NanoLiposome ( 186 RNL) - (ReSPECT)
Glioblastoma

$1.50
-0.03  -2%
Phase 1 Phase 1 interim analysis showed that dosing was well-tolerated without dose-limiting toxicities. Patients receiving absorbed dose greater than 100 Gy resulted in a mean of 453.8 days and median OS of 330 days, with 7 of 22 patients remaining alive, noted November 18, 2021. Phase 2/3 study to be initiated mid-2022.
$23 million

PYPD – PolyPid Ltd.
D-PLEX100 - (SHIELD I)
Abdominal (soft tissue) sternal surgical site infections

$6.94
+0.01  +0%
Phase 3 Phase 3 500th patient enrolled, noted November 18, 2021. Phase 3 completion expected 2Q 2022 with top-line results anticipated 2 months thereafter.
$130.2 million