BPC September 08 update

Kadmon KDMN +73% acquired by Sanofi SNY; Cardiff CRDF +21% Phase 1/2 data

Price and Volume Movers

Kadmon Holdings, Inc. (NASDAQ: KDMN) announced that it has been acquired by Sanofi (NASDAQ: SNY). Shareholders of Kadmon will receive $9.50 per share in cash. The acquisition will immediately add Rezurock (belumosudil) to Santofi’s transplant portfolio. Rezurock is a recently FDA-approved treatment for chronic graft-versus-host disease (cGVHD). Shares closed up 73% at $9.13.

Gain Therapeutic (NASDAQ: GANX) released preclinical data for a study evaluating STAR compounds as a treatment for Gaucher and Parkinson's disease. Following the news, Gain announced that Investigational New Drug (IND) trials are expected to commence in the fourth quarter of 2021. Shares closed up 15% at $9.10.

Cardiff Oncology, Inc. (NASDAQ: CRDF) released Phase 1/2 trial data of Onvansertib, FOLFIRI, and AVASTIN (bevacizumab) to treat KRAS-Mutated Colorectal Cancer. Data showed the treatment to be well-tolerated with only 10% of patients reported treatment-emergent adverse events. 7 of 19 (37%) participants have achieved a confirmed partial response (PR). Shares are trading up 21% in after-hours trading at $8.49.

ProQR Therapeutics N.V. (NASDAQ: PRQR) announced a licensing agreement with Eli Lilly to use ProQR's Axiomer RNA editing platform. ProQR will receive a $50 million upfront payment and is eligible to receive up to $1.25 billion in milestone payments. Shares are trading after hours up 16% at $7.92.

Alector Inc. (NASDAQ: ALEC) announced that Shehnaaz Suliman will be stepping down as operating chief and president. Robert Paul will also be stepping down as chief medical officer. Alector said each will continue to serve for a transition period and plan to remain available as advisors until the end of 2021. Sam Jackson, senior vice president of clinical sciences, will assume the role of interim chief medical officer. Shares closed down 19% at $21.65.

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

AFMD – Affimed N.V.
AFM24-101
EGFR-expressing solid tumors

$6.39
+0.04  +1%
Phase 1/2 Phase 1/2a update on the dose escalation and initiation of the dose expansion cohorts due 2H 2021.
$765.1 million

AFMD – Affimed N.V.
AFM13 + NK cells (AFM13-104)
CD30-positive lymphomas

$6.39
+0.04  +1%
Phase 1 Phase 1 early data released April 9, 2021 noted 100% response rate (2/4 partial responses and 2/4 complete responses). Trial is fully enrolled September 8, 2021. Data update expected 4Q 2021.
$765.1 million

AZRX – AzurRx BioPharma Inc.
Niclosamide - FW-420 (PASSPORT)
Colitis and diarrhea in oncology patients

$3.75
-0.09  -2%
Phase 1/2 IND filed September 8, 2021. Phase 1b/2a planned.
$35 million

CADL – Candel Therapeutics Inc.
CAN-3110
Glioma

$7.84
-0.49  -6%
Phase 1 Phase 1 biomarker data to be presented at the European Association of Neuro-Oncology meeting September 25-26, 2021.
$224.9 million

CADL – Candel Therapeutics Inc.
CAN-2409 with OPDIVO (nivolumab)
Glioma

$7.84
-0.49  -6%
Phase 1 Phase 1 trial has completed enrollment. Phase 1 initial efficacy and safety data expected 4Q 2021.
$224.9 million

CADL – Candel Therapeutics Inc.
CAN-2409 (ULYSSES)
Prostate Cancer (Active Surveillance)

$7.84
-0.49  -6%
Phase 2 Phase 2 safety data to be presented at the Global Summit on Precision Diagnosis and Treatment of Prostate Cancer on September 25, 2021.
$224.9 million

DVAX – Dynavax Technologies Corporation
VLA2001-301 + alum and CpG 1018 (COV-COMPARE)
COVID-19 vaccine

$14.89
+0.45  +3%
Phase 3 Phase 3 top-line data due early-4Q 2021. Phase 3 trial completed enrollment September 7, 2021.
$1.7 billion

EYEG – Eyegate Pharmaceuticals Inc.
PP-001
Dry eye disease

$2.00
+0.10  +5%
Phase 2 Phase 2 completed target enrollment - September 8, 2021. Top-line data and IND filing due 4Q 2021.
$25.2 million

GANX – Gain Therapeutics Inc.
GT-02287, GT-02329
Gaucher and Parkinson's Disease

$7.94
+0.52  +7%
Phase 1 Preclinical positive topline data released September 8, 2021. IND-enabling studies initiation anticipated 4Q 2021.
$94.3 million

GRTX – Galera Therapeutics Inc.
Avasopasem (GC4419)
Pancreatic cancer

$7.42
+0.22  +3%
Phase 1/2 Phase 1/2 trial final results announced - GC4419 was well tolerated, with similar rates of early and late adverse events in the active and placebo arms September 8, 2021. Final data due 3Q 2021.
$195.6 million

PHAT – Phathom Pharmaceuticals Inc.
Vonoprazan PHALCON-HP
H. pylori

$33.65
+0.22  +1%
NDA Filing Phase 3 top-line data met primary endpoints - April 29, 2021. NDA filed September 8, 2021.
$1.1 billion

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - (c602)
Prader-Willi syndrome (PWS)

$0.95
+0.03  +3%
Phase 3 Phase 3 announced top-line results from ongoing open-label extension study C602, September 8, 2021. On track for data submission to the FDA in Q3 2021
$75.8 million

TERN – Terns Pharmaceuticals Inc.
TERN-201 (AVIATION)
Nonalcoholic steatohepatitis (NASH)

$10.51
-0.46  -4%
Phase 1b Phase 1b trial completed September 8, 2021, with preliminary top-line data due 1Q 2022.
$264.1 million

VALN – Valneva SE
VLA1553
Chikungunya Virus Infection

$27.25
-0.85  -3%
Phase 3 Phase 3 trial met primary endpoint - August 5, 2021. Phase 3 final data due 1Q 2022.
$1.4 billion