BPC May 27 update

Iterum ITRM says Advisory Committee not necessary - PDUFA on track +26% AH

Price and Volume Movers

Lantheus Holdings, Inc. (NASDAQ:LNTH) shares closed up 23% to $16.76 following its announcement the FDA approved PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis or recurrence of prostate cancer.

Iterum Therapeutics plc (NASDAQ:ITRM) provided an update on its New drug application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections. The company noted that the previously postponed Advisory Committee meeting is now not currently necessary and the FDA is working toward the PDUFA goal date of July 25, 2021. Shares are trading up 26% to $1.55 (as of 6pm ET) on the news.

Bristol Myers Squibb (NYSE:BMY) announced the FDA approved Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Provention Bio, Inc. (NASDAQ:PRVB) appeared before an FDA Advisory Committee which met to discuss its regulatory application of teplizumab. The panel voted 10-7 that the benefits outweigh the risks in support of approval to delay Type 1 diabetes. Shares were halted during the meeting.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) also received FDA approval for its preventive treatment of migraine, NURTEC ODT. Shares are trading up 5% to $86.90 after hours.

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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:

Reviva Pharmaceuticals Holdings, Inc. (RVPH): $5.55; +26%.

Immunome, Inc. (IMNM): $23.09; +18%.

Syros Pharmaceuticals, Inc. (SYRS): $6.55; +17%.

Prothena Corporation plc (PRTA): $22.78; +17%.

Werewolf Therapeutics, Inc. (HOWL): $14.63; +14%.

DECLINERS:

Novan, Inc. (NOVN): $8.04; -13%.

Virpax Pharmaceuticals, Inc. (VRPX): $4.59; -11%.

Annovis Bio, Inc. (ANVS): $44.60; -8%.

Nabriva Therapeutics plc (NBRV): $1.40; -7%.

CymaBay Therapeutics, Inc. (CBAY): $4.21; -6%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ASND – Ascendis Pharma A/S
TransCon CNP - ACcomplisH
Achondroplasia

$139.99
-0.93  -1%
Phase 2 Phase 2 update due 4Q 2021.
$7.5 billion

ASND – Ascendis Pharma A/S
TransCon - PaTHway
Hypoparathyroidism

$139.99
-0.93  -1%
Phase 3 Phase 3 top-line data due 4Q 2021.
$7.5 billion

ASND – Ascendis Pharma A/S
TransCon hGH - foresiGHt
Growth Hormone Deficiency - adults

$139.99
-0.93  -1%
Phase 3 Phase 3 enrollment to be completed late-2021 or early-2022.
$7.5 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
NURTEC ODT (Rimegepant)
Migraine - preventative

$97.20
+0.20  +0%
Approved FDA approval announced May 27, 2021.
$6.3 billion

BMY – Bristol-Myers Squibb Company
ZEPOSIA (ozanimod)
Ulcerative Colitis

$65.94
-0.89  -1%
Approved FDA approval announced May 27, 2021.
$147.2 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson (CF101)
Psoriasis

$2.16
-0.01  -0%
Phase 3 Phase 3 top-line data due 4Q 2021.
$37.1 million

CNCE – Concert Pharmaceuticals Inc.
CTP-543 (THRIVE-AA2)
Alopecia Areata

$4.08
-0.10  -2%
Phase 3 Phase 3 trial initiation announced May 27, 2021.
$131.3 million

DRNA – Dicerna Pharmaceuticals Inc.
LY3819469
Cardiometabolic diseases

$37.21
-0.22  -1%
Phase 1 Phase 1 IND acceptance announced May 27, 2021.
$2.9 billion

GSK – GlaxoSmithKline PLC
Adjuvanted COVID-19 vaccine
COVID-19 vaccine

$39.08
-0.70  -2%
Phase 3 Phase 3 trial initiation announced May 27, 2021 with data due around 4Q 2021.
$98.3 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

$2.02
-0.02  -1%
PDUFA priority review PDUFA date July 25, 2021. Advisory committee meeting initially postponed is not currently necessary - noted May 27, 2021.
$361.9 million

LNTH – Lantheus Holdings Inc.
PYLARIFY (piflufolastat F 18)
Prostate cancer

$25.53
+0.37  +1%
Approved FDA Approval announced May 27, 2021.
$1.7 billion

PRVB – Provention Bio Inc.
Teplizumab (PRV-031)
Type 1 diabetes

$8.37
-0.21  -2%
PDUFA priority review Advisory Committee meeting May 27, 2021 voted 10-7 in favor that benefits outweigh the risks. PDUFA date under priority review July 2, 2021. Noted April 8, 2021 that FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.
$530.4 million

QURE – uniQure N.V.
AMT-130
Huntington's disease

$30.53
-2.31  -7%
Phase 1/2 Phase 1/2 trial first two patient procedures have been completed in the higher dose, second cohort - noted June 16, 2021. Initial imaging and biomarker data due before the end of 2021.
$1.4 billion

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

$6.86
-0.06  -1%
Phase 2/3 Phase 2/3 enrollment has been completed - June 7, 2021.
$320.5 million