BPC July 19 update

Cytokinetics CYTK rallies on positive data +41%; FDA identifies deficiencies with Ardelyx ARDX NDA -71% AH

Price and Volume Movers

Cytokinetics, Incorporated (NASDAQ:CYTK) shares rallied to close up 41% to $27.04 following the announcement of positive data from its Phase 2 REDWOOD-HCM clinical trial of CK-3773274 (CK-274) for the potential treatment of hypertrophic cardiomyopathy (HCM). 78.6% of patients in the low dose cohort and 92.9% of patients in the high dose cohort met the set left ventricular outflow tract pressure gradient (LVOT-G) level, the target goal of treatment, compared to only 7.7% in the placebo arm. The company took advantage of the price surge when it announced after hours plans to offer $200 million of shares in an underwritten public offering.

Ardelyx, Inc. (Nasdaq: ARDX) announced after hours the FDA has identified deficiencies with its New Drug Application for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, with the FDA noting the size of the treatment effect and its clinical relevance as one of the key issues. As a result of the deficiencies, labeling and post-marketing requirements/commitments will not be able to be discussed. Shares have slid after hours, currently trading down 71% to $2.25 after hours.

COVID-19 vaccine stocks continued to see favor, likely due to investors looking at recent increased numbers of COVID-19 cases. Notable movers below:

Novavax, Inc. (NVAX): $210.51; +13%.

Ocugen, Inc. (OCGN): $7.52; +13%.

Moderna, Inc. (MRNA): $313.59; +9%.

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Other major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Brooklyn ImmunoTherapeutics, Inc. (BTX): $12.20; +21%.

NanoViricides, Inc. (NNVC): $4.45; +13%.

Adamis Pharmaceuticals Corporation (ADMP): $1.04; +13%.

Connect Biopharma Holdings Limited (CNTB): $24.77; +13%.

Landos Biopharma, Inc. (LABP): $11.15; +12%.

DECLINERS:

Unicycive Therapeutics, Inc. (UNCY): $2.70; -16%.

Aridis Pharmaceuticals, Inc. (ARDS): $5.00; -15%.

Atossa Therapeutics, Inc. (ATOS): $3.90; -13%.

Ikena Oncology, Inc. (IKNA): $11.44; -13%.

Alpha Teknova, Inc. (TKNO): $18.06; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
BYLVAY (odevixibat) - (BOLD)
Biliary atresia

$28.61
-0.70  -2%
Phase 3 Phase 3 commencement of enrolment announced July 14, 2020. Data due 2024.
$549.2 million

ALBO – Albireo Pharma Inc.
BYLVAY (odevixibat) - (ASSERT)
Alagille syndrome

$28.61
-0.70  -2%
Phase 3 Phase 3 data due 2022.
$549.2 million

AQST – Aquestive Therapeutics Inc.
Libervant (diazepam)
Epileptic seizures

$3.25
-0.20  -6%
PDUFA CRL announced September 25, 2020. NDA resubmitted with new PDUFA date December 23, 2021.
$118.9 million

ARDX – Ardelyx Inc.
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis

$1.74
+0.03  +2%
CRL FDA issued CRL on July 29 2021.
$171.8 million

ATHA – Athira Pharma Inc.
ATH-1017
Alzheimer’s disease

$9.61
-0.16  -2%
Phase 2 Phase 2 top-line data due by end of 2022.
$357.7 million

CGEN – Compugen Ltd.
COM701, OPDIVO (nivolumab) and BMS-986207
Solid tumors

$6.79
-0.09  -1%
Phase 1/2 Phase 1/2 initial dose escalation data due 4Q 2021.
$569.8 million

CYTK – Cytokinetics Incorporated
CK-3773274 - Redwood-HCM
Hypertrophic cardiomyopathy (HCM)

$29.68
+0.32  +1%
Phase 2 Phase 2 Cohort 1 and Cohort 2 data released July 18, 2021. Target goal of treatment achieved by 78.6% in low dose cohort and 92.9% in high dose (resting gradient <30 mmHg and post Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%)).
$2.5 billion

PFE – Pfizer Inc.
VLA15
Lyme disease vaccine

$42.81
+0.02  +0%
Phase 2 Phase 2 completion of recruitment announced July 19, 2021. Proof of concept due January 2022.
$239.6 billion

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

$6.44
-0.16  -2%
Phase 2/3 Phase 2/3 trial to be completed in the coming weeks - noted July 19, 2021.
$300.9 million

RXDX – Prometheus Biosciences Inc.
PRA023
Ulcerative colitis

$20.97
-1.04  -5%
Phase 1/2 Phase 2 trial initiation announced July 19, 2021. Final Phase 1 data due 4Q 2021.
$815 million

RXDX – Prometheus Biosciences Inc.
PRA023
Crohn’s Disease

$20.97
-1.04  -5%
Phase 2a Phase 2a trial to be initiated 3Q 2021.
$815 million

VRTX – Vertex Pharmaceuticals Incorporated
VX-548
Acute Pain following bunionectomy surgery

$201.58
+1.20  +1%
Phase 2 Phase 2 data due early 2022.
$52.2 billion