BPC July 20 update

Endo ENDP +25% on reports of settlement offer, Glaukos GKOS -15% WF analyst downgrade

Price and Volume Movers

Ardelyx, Inc. (NASDAQ:ARDX) closed down 74% to $2.01. The company announced after hours Monday the FDA has identified deficiencies with its NDA 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.

Endo Pharmaceuticals (NASDAQ:ENDP) closed up 25% to $4.19 on reports that the company has made a settlement offer to counties in Tennessee regarding the Baby Doe opioid lawsuit trial. The trial, seeking damages from Endo, had been scheduled to begin on July 26, 2021. The lawsuit seeking over $2 billion in damages was filed on behalf of an infant who was born with Neonatal Abstinence Syndrome.

PLx Pharma Inc. (NASDAQ:PLXP) announced that its FDA-approved liquid-filled aspirin, VAZALORE, will be available in over 8,000 Walgreens stores nationwide later in August. Shares closed up 18% to $20.10.

Albireo Pharma, Inc. (NASDAQ:ALBO) announced the FDA approved Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Shares initially spiked on the news, only to close down 5% to $34.33.

Glaukos Corporation (NASDAQ:GKOS) closed down 15% to $47.93. Wells Fargo downgraded their analyst rating of the stock from equal weight to underweight with a price target of $41.00.

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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:

NeuroBo Pharmaceuticals, Inc. (NRBO): $3.97; +41%

Werewolf Therapeutics, Inc. (HOWL): $19.82; +18%

Lantern Pharma Inc. (LTRN): $14.93; +17%

Impel NeuroPharma, Inc. (IMPL): $12.16; +17%

Ikena Oncology, Inc. (IKNA): $13.36; +17%

DECLINERS:

Freeline Therapeutics Holdings plc (FRLN): $5.96; -11%

Tempest Therapeutics Inc. (TPST): $17.90; -10%

OptiNose, Inc. (OPTN): $2.81; -8%

Graphite Bio, Inc. (GRPH): $25.51; -7%

Akebia Therapeutics, Inc. (AKBA): $2.67; 7%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
BYLVAY (odevixibat)
Progressive familial intrahepatic cholestasis (PFIC)

$28.61
-0.70  -2%
Approved FDA approval announced July 20, 2021.
$549.2 million

CYAD – Celyad Oncology SA
CYAD-101 and KEYTRUDA (pembrolizumab) - (KEYNOTE-B79)
Colorectal cancer

$4.23
+0.12  +3%
Phase 1b Phase 1b trial to be initiated 4Q 2021.
$63.5 million

CYAD – Celyad Oncology SA
CYAD-02 CYCLE-1
Relapsed/refractory Acute myeloid leukemia (AML) and Myelodysplastic Syndrome (MDS)

$4.23
+0.12  +3%
Phase 1 Phase 1 additional data due mid-2021.
$63.5 million

CYAD – Celyad Oncology SA
CYAD-211 ( IMMUNICY-1)
Multiple Myeloma

$4.23
+0.12  +3%
Phase 1 Phase 1 initial data released at EHA meeting June 11, 2021. 2/5 partial responses. Additional data due 2H 2021.
$63.5 million

CYAD – Celyad Oncology SA
CYAD-203
Solid tumors

$4.23
+0.12  +3%
Phase 1 Phase 1 IND submission expected mid-2022.
$63.5 million

INFI – Infinity Pharmaceuticals Inc.
Eganelisib (IPI-549) + OPDIVO (nivolumab) - (MARIO-275)
Urothelial cancer

$2.12
-0.21  -9%
Phase 2 Phase 2 update July 27, 2021. Median overall survival 15.4 months compared to 7.9 months on nivolumab control arm. Program update due by end of 2021.
$188.1 million

LUMO – Lumos Pharma Inc.
LUM-201 (OraGrowtH210)
Pediatric Growth Hormone Deficiency (PGHD)

$7.60
+0.24  +3%
Phase 2 Phase 2 data due 2H 2023.
$63.4 million

MDWD – MediWound Ltd.
NexoBrid (CIDS)
Severe burns - pediatric

$3.80
-0.28  -7%
Phase 3 Phase 3 top-line data met primary endpoints - July 20, 2021.
$103.5 million

NBTX – Nanobiotix S.A.
NBTXR3 (Study 102)
Head and Neck Cancer

$14.73
+0.12  +1%
Phase 1 Phase 1 median follow up of 8.1 months demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR - ASCO June 2021. Phase 3 to be initiated 2H 2021.
$507.4 million

RAIN – Rain Therapeutics Inc.
Milademetan (RAIN-32) - (MANTRA)
Liposarcoma

$16.65
-0.73  -4%
Phase 3 Phase 3 trial initiation announced July 20, 2021.
$440.9 million

RAIN – Rain Therapeutics Inc.
Milademetan (RAIN-32) - (basket trial)
Solid tumors

$16.65
-0.73  -4%
Phase 2 Phase 2 trial to be initiated 2H 2021.
$440.9 million

RAIN – Rain Therapeutics Inc.
Milademetan (RAIN-32)
Intimal sarcoma

$16.65
-0.73  -4%
Phase 2 Phase 2 trial to be initiated early 2022.
$440.9 million

SRNE – Sorrento Therapeutics Inc.
SEMDEXA (SP-102)
Lumbosacral radicular pain (sciatica)

$8.21
-0.18  -2%
Phase 3 Phase 3 completion of enrollment announced July 20, 2021 with top-line data due 4Q 2021.
$2.4 billion

WVE – Wave Life Sciences Ltd.
WVE-004 (FOCUS-C9)
Amyotrophic Lateral Sclerosis and Frontotemporal Dementia

$5.51
-0.25  -4%
Phase 1/2 Phase 1b/2a initiation of dosing announced July 20, 2021. Data due 2022.
$277.2 million