BPC November 05 update

NextCure NXTC shares soar 249% on early cancer data; Supernus SUPN releases negative ADHD data - 23% AH

Price and Volume Movers

NextCure, Inc. (NASDAQ: NXTC) shares closed up 249% to $92.22 following the release of its abstract for this week's SITC conference, featuring data from its Phase 1/2 trial of NC318 in patients with solid tumors. Single agent activity was evident in patients with non-small cell lung cancer (NSCLC). One complete response and one partial response (response rate 29% 2/7) was noted, while the disease control rate was 71% (5/7).

Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) announced after hours that its Phase 3 P301 trial of SPN-810 in patients with ADHD, did not meet its primary endpoint. Patients receiving SPN-810 36mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant (p= 0.092) compared to placebo. Shares traded down 23% to $22.40 during the after-hours session.

Sesen Bio (NASDAQ:SESN) shares closed the after-hours session up 21% to $1.33 following a an update regarding design of its post-marketing confirmatory trial for Vicinium. The company maintained previous guidance that it intends to file a rolling BLA in December 2019. A meeting with the FDA is scheduled for December 4, 2019.

Agile Therapeutics, Inc. (Nasdaq: AGRX) shares continued their rally adding 35% to $2.40, following Monday’s rise of 32%. An FDA Advisory Committee delivered last week a 14 to 1 vote supporting approval of the New Drug Application (NDA) for its contraceptive patch, Twirla.

Viking Therapeutics, Inc. (NASDAQ: VKTX) shares closed up 19% to $7.82. The company reported third-quarter earnings, noting a balance sheet of $290m in cash. The company also noted it has filed an IND application for a Phase 2b trial of VK2809 in biopsy-confirmed NASH.

Strongbridge Biopharma plc, (Nasdaq: SBBP) shares closed down 34% to $1.59. The company announced in its third-quarter earnings release that its CEO is stepping down, effective immediately. The company also noted that data from its Phase 3 LOGICS trial of levoketoconazole in endogenous Cushing’s syndrome have been pushed back to 2Q/3Q 2020, a delay from previous guidance of 1Q 2020.

Curis, Inc. (NASDAQ: CRIS) announced that it does not intend to enroll additional patients in its Phase 1 trial of CA-170 following initial analysis of data from its trial which suggest it may not be an effective monotherapy agent in mesothelioma patients. Shares closed down 20% to $1.95.

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Major price movers (stocks priced > $1.00, volume > 50k):

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

ADVANCERS:

Paratek Pharmaceuticals, Inc. (PRTK): $3.96; +25%.

ImmunoGen, Inc. (IMGN): $3.73; +23%.

Acorda Therapeutics, Inc. (ACOR): $2.38; +19%.

Epizyme, Inc. (EPZM): $14.76; +18%.

RAPT Therapeutics, Inc. (RAPT): $14.49; +18%.

DECLINERS:

Oncolytics Biotech Inc. (ONCY): $1.14; -14%.

Mallinckrodt Public Limited Company (MNK): $3.33; -14%.

Bicycle Therapeutics plc (BCYC): $8.21; -13%.

VistaGen Therapeutics, Inc. (VTGN): $1.09; -11%.

Mylan N.V. (MYL): $17.79; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKCA – Akcea Therapeutics Inc.
AKCEA-ANGPTL3-LRx
Non-alcoholic fatty liver disease (NAFLD), Hypertriglyceridemia and Type 2 Diabetes Mellitus

Phase 2b Phase 2b data met primary endpoint - January 28, 2020.
$1.4 billion

ALLO – Allogene Therapeutics Inc.
ALLO-501 - ALPHA
Non-Hodgkin lymphoma (NHL)

Phase 1 Phase 1 initial data at ASCO May 29, 2020. Overall Response Rate (ORR) of 63% and CR Rate of 37%.
$6.3 billion

APLS – Apellis Pharmaceuticals Inc.
Pegcetacoplan (APL-2) PEGASUS
Paroxysmal Nocturnal Hemoglobinuria (PNH)

NDA Filing NDA filing due 2H 2020.
$2.4 billion

CMRX – Chimerix Inc.
DSTAT (CX-01)
Acute Myeloid Leukemia (AML)

Phase 3 Phase 3 trial initiation delayed due to COVID-19.
$197.2 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone ITI-007-402
Bipolar depression

Phase 3 Phase 3 top-line data due mid-2020.
$1.6 billion

JAZZ – Jazz Pharmaceuticals plc
JZP-258
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

PDUFA priority review PDUFA data under priority review July 21, 2020.
$6.2 billion

NVS – Novartis AG
Biosimilar pegfilgrastim
Pegfilgrastim biosimilar

Approved FDA Approval announced November 5, 2019.
$202.6 billion

PRTA – Prothena Corporation plc
PRX002 (PASADENA)
Parkinson's disease

Phase 2 Phase 2 (Part 1) trial did not meet primary endpoint - April 22, 2020. Part 2 is ongoing.
$424.3 million

REGN – Regeneron Pharmaceuticals Inc.
Cemiplimab
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 trial stopped early due to significant improvement in overall survival - April 27, 2020.
$64.9 billion

SBBP – Strongbridge Biopharma plc
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome

Phase 3 Phase 3 top-line data expected 3Q 2020.
$204 million

SUPN – Supernus Pharmaceuticals Inc.
SPN-812 (P301)
ADHD

PDUFA PDUFA date November 8, 2020
$1.3 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-810
Impulsive Aggression in ADHD

Phase 3 Phase 3 trial did not meet primary endpoint - November 5, 2019.
$1.3 billion