BPC July 16 update

Kadmon KDMN FDA approval for GVHD +21%; Kiromic KRBP CAR-T update -17%

Price and Volume Movers

FibroGen (Nasdaq:FGEN) shares closed Friday down 42% to $14.35 following news an FDA Advisory Committee delivered negative votes for its regulatory application for roxadustat for the treatment of anemia of chronic kidney disease. The committee voted 12-2 against recommending approval in patients on dialysis and 13-1 against approval for patients not on dialysis.

Kadmon Holdings, Inc. (Nasdaq:KDMN) announced that the FDA approved REZUROCK (belumosudil) for the treatment of patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The FDA approved this NDA six weeks ahead of the PDUFA goal date of August 30, 2021. Shares closed up 21% to $4.28.

Moderna Inc. (Nasdaq:MRNA) announced late-Thursday that it will replace Alexion Pharmaceuticals Inc. (Nasdaq:ALXN) in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. Shares closed Friday up 10.3% to $286.43.

Kiromic BioPharma, Inc. (Nasdaq:KRBP) fell 17% to $3.13 following an update regarding its IND for its CAR-T program for solid tumors. The FDA has noted questions regarding: tracing of all reagents used in manufacturing; flow chart of manufacturing processes; certificate of Analysis (COA) for its allogeneic CAR-T.

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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:

Ikena Oncology, Inc. (IKNA): $13.17; +13.3%

Freeline Therapeutics Holdings plc (FRLN): $7.38; +11.7%

Nurix Therapeutics, Inc. (NRIX): $25.98; +10.1%

Erasca, Inc. Common Stock (ERAS): $17.43; +9.6%

Repare Therapeutics Inc. (RPTX): $31.72; +8.3%

DECLINERS:

Atossa Therapeutics, Inc. (ATOS): $4.50; -19.9%

Unicycive Therapeutics, Inc. (UNCY): $3.20; -14.4%

TScan Therapeutics, Inc. Common Stock (TCRX): $10.50; -12.5%

Clene Inc. (CLNN): $8.90; -10.3%

TransCode Therapeutics, Inc. (RNAZ): $3.22; -9.0%

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABBV – AbbVie Inc.
RINVOQ (Upadacitinib)
Atopic Dermatitis

$116.30
-2.57  -2%
PDUFA PDUFA date early 3Q 2021 not met. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis for the delay.
$205.4 billion

BMY – Bristol-Myers Squibb Company
OPDIVO (nivolumab) + YERVOY (ipilimumab) - CM-651
First-line Head and Neck Cancer

$67.87
-0.28  -0%
Phase 3 Phase 3 trial did not meet primary endpoints - July 16, 2021.
$150.8 billion

FATE – Fate Therapeutics Inc.
FT516
Acute Myelogenous Leukemia / B-cell Lymphoma

$82.80
-3.24  -4%
Phase 1 Phase 1 interim data presented at ASCO June 4-8, 2021. 8/11 objective responses; 6/11 complete responses. Phase 1 interim data to be highlighted at virtual event August 19, 2021.
$7.8 billion

FATE – Fate Therapeutics Inc.
FT596
B-Cell Chronic Lymphoma, chronic lymphocytic leukemia

$82.80
-3.24  -4%
Phase 1 Phase 1 interim data to be highlighted at virtual event August 19, 2021.
$7.8 billion

GSK – GlaxoSmithKline PLC
DUVROQ (Daprodustat) - ASCEND
Anaemia in chronic kidney disease

$40.14
+0.04  +0%
Phase 3 Phase 3 data due 2H 2021.
$101 billion

INCY – Incyte Corporation
OLUMIANT (baricitinib)
Atopic dermatitis

$77.35
-0.05  -0%
PDUFA Noted FDA will not meet assigned July 2021 PDUFA date - July 16, 2021.
$17 billion

KDMN – Kadmon Holdings Inc.
REZUROCK (Belumosudil)
Chronic graft-versus-host disease (cGVHD)

$3.76
-0.05  -1%
Approved FDA approval announced July 16, 2021.
$646.6 million

KRBP – Kiromic BioPharma Inc.
KB-ISM (ALEXIS-ISO-1)
Solid tumors

$3.21
+0.06  +2%
Phase 1 Phase 1 dosing to commence 3Q 2021
$49.4 million

MRK – Merck & Company Inc. (new)
VAXNEUVANCE
Pneumococcal disease

$76.87
-0.06  -0%
Approved FDA approval announced July 16, 2021.
$194.6 billion