BPC September 14 update

RedHill Biopharma RDHL -33% Phase 2/3 fail; Calliditas CALT -6% AH PDUFA date extended

Price and Volume Movers

RedHill Biopharma Ltd. (NASDAQ: RDHL) released top-line data from its Phase 2/3 trial of opaganib to treat severe COVID-19 pneumonia. The study did not meet its primary endpoint. Analysis of the top-line data is ongoing, and RedHill intends to discuss the data with regulators to determine the next steps. Shares closed down 33% at $4.97.

Calliditas Therapeutics AB (NASDAQ: CALT) announced that the FDA has extended the PDUFA date for its New Drug Application (NDA) for Nefecon to treat IgA nephropathy to December 15, 2021. In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data. Shares closed down 13% at $24.48 and are currently trading down 6% after-hours at $23.05.

Virpax Pharmaceuticals Inc. (NASDAQ: VRPX) announced the pricing of a public offering of 6.67 million shares of its stock at $6.00 per share. Gross proceeds of the offering amount to $40.02 million. Shares closed down 37% at $6.16.

NanoViricides, Inc. (NYSE: NNVC) announced that it has completed the process of licensing the human Coronavirus field for drug development and commercialization from TheraCour Pharma, Inc. NanoViricides will not make any upfront cash payments to TheraCour, however, milestone payments of $4 million cash and 700,000 shares of preferred stock are included in the deal. NanoViricides is currently working on two preclinical COVID-19 lead drug candidates, NV-CoV-2- and NV-CoV-2-R. Shares closed up 19% at $4.83.

Avalo Therapeutics, Inc. (NASDAQ: AVTX) announced a public offering of its shares in after-hours trading today. The terms of the offering have not been released. Shares are down 13% at $2.24 in after-hours trading.

Advancers

CompanyPriceChange
CRVS
Corvus Pharmaceuticals Inc.
$5.32+3.06  +135.40%
IPHA
Innate Pharma S.A.
$8.10+2.35  +40.87%
CYDY
Cytodyn Inc
$2.01+0.37  +22.56%
SURF
Surface Oncology Inc.
$7.10+1.09  +18.14%
ATNM
Actinium Pharmaceuticals Inc. (Delaware)
$7.83+1.15  +17.22%
EVLO
Evelo Biosciences Inc.
$8.34+1.03  +14.09%
MGTA
Magenta Therapeutics Inc.
$7.79+0.92  +13.39%
CNTB
Connect Biopharma Holdings Limited
$23.06+2.51  +12.21%
TRVN
Trevena Inc.
$1.36+0.14  +11.48%
FULC
Fulcrum Therapeutics Inc.
$30.83+3.14  +11.34%

Decliners

CompanyPriceChange
PTGX
Protagonist Therapeutics Inc.
$17.53-28.6  -62.00%
TCRR
TCR2 Therapeutics Inc.
$9.99-5.73  -36.45%
ELYM
Eliem Therapeutics Inc
$18.77-5.27  -21.92%
JANX
Janux Therapeutics Inc.
$27.39-6.96  -20.26%
ICVX
Icosavax Inc.
$33.06-6.4  -16.22%
IPSC
Century Therapeutics Inc.
$24.76-4.49  -15.35%
GRTS
Gritstone bio Inc.
$11.50-2.04  -15.07%
VERV
Verve Therapeutics Inc.
$59.88-9.99  -14.30%
INAB
IN8bio Inc.
$7.00-1.09  -13.47%
TNYA
Tenaya Therapeutics Inc.
$20.85-3.2  -13.31%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACHV – Achieve Life Sciences Inc.
Cytisine - ORCA-2
Smoking cessation

$8.28
+0.31  +4%
Phase 3 Phase 2 data showed smokers who had previously failed Chantix demonstrated an abstinence rate of 51.3% with cytisinicline compared with 15.8% with placebo (p= 0.009). Phase 3 data due 1H 2022.
$78.3 million

APRE – Aprea Therapeutics Inc.
Eprenetapopt (APR-246) + pembrolizumab
Solid tumors

$5.06
+0.22  +5%
Phase 1/2 Phase 1/2 data to be presented at ESMO September 20, 2021.
$107.2 million

ATAI – ATAI Life Sciences N.V.
PCN-101
Treatment Resistant Depression

$16.42
+1.19  +8%
Phase 2a Phase 2a trial initiated September 14, 2021. Phase 2a top-line data due at end 2022.
$2.5 billion

AXSM – Axsome Therapeutics Inc.
MoSEIC meloxicam-rizatriptan (AXS-07)
Migraine

$29.72
+1.19  +4%
PDUFA PDUFA date April 30, 2022.
$1.1 billion

CALT – Calliditas Therapeutics AB
Nefecon (NefIgArd)
IgA nephropathy

$23.06
+0.82  +4%
PDUFA priority review PDUFA priority review date extended to December 15, 2021.
$603.5 million

CHRS – Coherus BioSciences Inc.
Toripalimab (CHOICE-01)
Non-small cell lung cancer (NSCLC)

$17.56
+1.53  +10%
Phase 3 Phase 3 PFS primary endpoint reached at interim analysis. Final PFS and additional interim OS data are expected 2021.
$1.3 billion

DVAX – Dynavax Technologies Corporation
VLA2001-304 + alum and CpG 1018
COVID-19 vaccine

$14.89
+0.45  +3%
Phase 3 Phase 3 trial (New Zealand) completed recruitment of Cohort 1 September 14, 2021. Top-line data from Cohort 1 expected early 2022.
$1.7 billion

EPZM – Epizyme Inc.
TAZVERIK (tazemetostat) + PARPi or Durvalumab
Solid tumors

$5.73
+0.32  +6%
Phase 1/2 Phase 1b/2 trial data to be present at ESMO September 16-21, 2021.
$585.9 million

KALV – KalVista Pharmaceuticals Inc.
KVD824 (KOMPLETE)
Hereditary angioedema

$19.25
-0.27  -1%
Phase 2 Phase 2 clinical hold removed by FDA September 14, 2021. Regulatory submissions approved in Canada, Australia, and the UK with patient enrollment underway September 9, 2021.
$470.4 million

MDNA – Medicenna Therapeutics Corp.
MDNA11 (ABILITY)
Solid tumors

$2.50
+0.09  +4%
Phase 1/2 Phase 1/2 trial to be initiated 3Q 2021 with top-line safety, PK/PD and biomarker data due end of 2021 and initial efficacy data in 2022.
$134.4 million

NLSP – NLS Pharmaceutics Ltd.
Quilience
Narcolepsy

$2.63
-0.11  -4%
Phase 2 Phase 2 clinical trial initiated, first patient enrolled September 14, 2021.
$31.7 million

RCKT – Rocket Pharmaceuticals Inc.
RP-A501
Danon disease

$34.20
+0.53  +2%
Phase 1 Phase 1 clinical hold lifted August 16, 2021. Phase 1 low-dose pediatric patient cohort expected to commence in 3Q 2021. Full data update due 4Q 2021.
$2.2 billion

RDHL – Redhill Biopharma Ltd.
YELIVA (Opaganib)
COVID-19

$4.89
+0.07  +1%
Phase 2/3 Phase 2/3 preliminary top-line data results did not meet its primary endpoint September 14, 2021.
$228.5 million

SRPT – Sarepta Therapeutics Inc.
SRP-4045 + SRP-4053 (ESSENCE)
Duchenne muscular dystrophy

$86.38
+0.75  +1%
Phase 3 Phase 3 interim data to be presented at WMS September 20, 2021.
$6.9 billion

SRPT – Sarepta Therapeutics Inc.
SRP-9001-102
Duchenne muscular dystrophy

$86.38
+0.75  +1%
Phase 2 Phase 2 safety and efficacy data to be presented at WMS September 20, 2021.
$6.9 billion