BPC June 01 update

Paratek PRTK rallies on FDA Approval +20%; Immunovant IMVT downgraded - shares fall 38%

Price and Volume Movers

Alkermes plc (Nasdaq: ALKS) announced that the FDA approved LYBALVI (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. Shares closed up 2% to $23.15.

BridgeBio Pharma, Inc. (Nasdaq: BBIO) also announced the FDA approved TRUSELTIQ (infigratinib) for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA). Shares closed up 2% to $60.37.

Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) shares rallied to close up 20% to $9.83 following news the FDA approved its supplemental New Drug Application (sNDA) for the oral-only dosing regimen of NUZYRA for the treatment of adults with Community-Acquired Bacterial Pneumonia (CABP).

Stealth BioTherapeutics Corp (NASDAQ:MITO) shares are trading up 32% after hours to $1.91. The company announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of Barth syndrome.

Immunovant, Inc. (NASDAQ: IMVT) shares fell 38% to $9.40 following an analyst downgrade by Stifel from Buy to Hold and reduced its price target from $28 to $9. The company also announced that its Chief Medical Officer is stepping down to pursue other opportunities.

Annovis Bio, Inc. (NASDAQ: ANVS) shares closed up 27% to $57.47 following the release of additional data from its Phase 2 trial of ANVS401 in patients with Alzheimer's disease (AD) and Parkinson's disease (PD) where it noted improvements in speed and accuracy.

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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:

Lineage Cell Therapeutics, Inc. (LCTX): $3.00; +27%.

Atossa Therapeutics, Inc. (ATOS): $3.87; +20%.

Sesen Bio, Inc. (SESN): $3.87; +16%.

Brooklyn ImmunoTherapeutics, Inc. (BTX): $16.63; +15%.

Purple Biotech Ltd. (PPBT): $6.17; +13%.

DECLINERS:

Eton Pharmaceuticals, Inc. (ETON): $6.21; -12%.

NuCana plc (NCNA): $2.70; -12%.

PDS Biotechnology Corporation (PDSB): $10.86; -11%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $5.07; -11%.

Impel NeuroPharma, Inc. (IMPL): $10.00; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AKBA – Akebia Therapeutics Inc.
Vadadustat
Anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis.

$3.62
-0.02  -1%
PDUFA PDUFA date March 29, 2022.
$579.6 million

ALKS – Alkermes plc
LYBALVI (olanzapine/samidorphan)
Schizophrenia, bipolar

$24.24
-0.50  -2%
Approved FDA approval announced June 1, 2021.
$3.9 billion

ALNY – Alnylam Pharmaceuticals Inc.
ONPATTRO (patisiran) - APOLLO-B
Wild-type ATTR amyloidosis patients with cardiomyopathy

$172.95
+1.69  +1%
Phase 3 Phase 3 completion of enrollment announced June 1, 2021. Top-line data due mid-2022.
$20.3 billion

BBIO – BridgeBio Pharma Inc.
TRUSELTIQ (Infigratinib)
Cholangiocarcinoma

$60.34
-2.79  -4%
Approved FDA approval announced June 1, 2021.
$9 billion

BIIB – Biogen Inc.
BAT1806
Rheumatoid arthritis (RA)

$374.40
-6.51  -2%
Phase 3 Phase 3 trial met primary endpoint - June 1, 2021.
$56.4 billion

BYSI – BeyondSpring Inc.
Plinabulin + G-CSF Combination
Chemotherapy-induced neutropenia (CIN)

$11.24
-0.41  -4%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$342.7 million

CTIC – CTI BioPharma Corp.
Pacritinib
Myelofibrosis

$2.29
+0.02  +1%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$213.6 million

CTIC – CTI BioPharma Corp.
Pacritinib (PRE-VENT)
COVID-19

$2.29
+0.02  +1%
Phase 3 Phase 3 interim data due 3Q 2021.
$213.6 million

IMVT – Immunovant Inc.
IMVT-1401
Myasthenia Gravis (MG)

$11.09
-0.16  -1%
Phase 2 Phase 2 data released August 25, 2020. Phase 3 trial to be initiated in late 2021 or early 2022.
$907.3 million

LCTX – Lineage Cell Therapeutics, Inc.
OpRegen
Dry age-related macular degeneration (AMD)

$2.74
+0.06  +2%
Phase 1/2 Phase 1/2a updated data noted restoration of retinal tissue was observed in two additional patients - June 1, 2021.
$410.9 million

PRTK – Paratek Pharmaceuticals Inc.
NUZYRA (omadacycline) - oral
Acute bacterial skin and skin structure infections (ABSSSI)

$7.01
-0.20  -3%
Approved FDA approval announced June 1, 2021.
$329 million

SNY – Sanofi
Venglustat
Autosomal dominant polycystic kidney disease (ADPKD)

$52.30
-0.32  -1%
Phase 2/3 Phase 2/3 trial stopped due to futility - June 1, 2021.
$130.8 billion

SPPI – Spectrum Pharmaceuticals Inc.
ROLONTIS ((eflapegrastim))
Chemotherapy-Induced Neutropenia.

$3.93
-0.25  -6%
PDUFA PDUFA date was October 24, 2020. However, action by the FDA has been deferred due to COVID-19. Pre-approval inspection of manufacturing site has been initiated - noted June 1, 2021.
$634.8 million

TCON – TRACON Pharmaceuticals Inc.
Envafolimab (ENVASARC)
Sarcomas

$6.38
-0.29  -4%
Phase 3 Phase 3 trial to continue as planned following initial review by DSMB. Next safety data review 3Q 2021. Interim efficacy data 4Q 2021.
$98.9 million