BPC November 11 update

Lipocine LPCN issued CRL - shares slide 71%; ​NextCure NXTC and Aslan ASLN shares slump on respective data readouts

Price and Volume Movers

NextCure, Inc. (NASDAQ: NXTC) shares slumped to close down 53% to $39.02. Shares of the company initially surged over 200% last week following the release of its abstract of NC318 for the SITC conference. However, updated data released at the conference noted that there were no further responses in additional patients with non-small cell lung cancer (NSCLC).

ASLAN Pharmaceuticals (NASDAQ:ASLN) announced top-line data from its Phase 2/3 TreeTopp trial of varlitinib in patients with biliary tract cancer, did not met the primary endpoints of progression-free survival (PFS) and overall response rate (ORR). Shares closed down 68% to $0.67.

Lipocine Inc. (NASDAQ: LPCN) announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Tlando in males with conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The CRL identified the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations. Shares plunged to close down 71% to $0.80.

MyoKardia, Inc. (Nasdaq: MYOK) announced top-line data from its Phase 2 MAVERICK-HCM trial of mavacamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM). The company noted the trial met its primary objective of establishing safety and tolerability of mavacamten in non-obstructive HCM over a treatment period of 16 weeks. However, shares sold off on safety concerns with five patients exhibiting ejection fraction reductions (amount of blood that is pumped out of the ventricles with each contraction) below the protocol-defined threshold of 45%. Shares closed down 8% to $55.45.

Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) and Menlo Therapeutics Inc. (Nasdaq: MNLO) announced a merger of the two companies where Foamix shareholders will own approximately 59% of the combined company and Menlo shareholders will own approximately 41%. Shares of Foamix closed down 20% to $3.48, while Menlo shares closed 7% lower to $4.85.

Kadmon Holdings, Inc. (NYSE: KDMN) shares are trading up 21% after hours to $3.63 following its announcement interim data from its of ROCKstar trial of KD025 in patients with chronic graft-versus-host disease (cGVHD), met the primary endpoint of Overall Response Rate (ORR).

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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:

Cabaletta Bio, Inc. (CABA): $13.92; +25%.

Jounce Therapeutics, Inc. (JNCE): $4.70; +16%.

Fulcrum Therapeutics, Inc. (FULC): $7.92; +13%.

Constellation Pharmaceuticals, Inc. (CNST): $34.38; +11%.

Aquestive Therapeutics, Inc. (AQST): $5.99; +11%.

DECLINERS:

RAPT Therapeutics, Inc. (RAPT): $19.60; -30%.

Assembly Biosciences, Inc. (ASMB): $14.48; -15%.

FibroGen, Inc. (FGEN): $35.40; -15%.

Celsion Corporation (CLSN): $1.24; -14%.

Ocular Therapeutix, Inc. (OCUL): $2.93; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ASLN – ASLAN Pharmaceuticals Limited
Varlitinib - TREETOPP
Biliary tract cancer

Phase 2/3 Phase 3 trial did not meet primary endpoint - November 11, 2019.
$62.7 million

BLRX – BioLineRx Ltd.
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation

Phase 3 Phase 3 interim analysis due 2H 2020 with top-line data due 1H 2021.
$42.3 million

BLRX – BioLineRx Ltd.
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer

Phase 2 Phase 2 PFS and OS data due 2H 2020.
$42.3 million

FOLD – Amicus Therapeutics Inc.
CLN6 Gene Therapy
Batten disease

Phase 1/2 Phase 1/2 additional data due at Child Neurology Society Annual Meeting in October 19 - 23, 2020.
$3.9 billion

KDMN – Kadmon Holdings Inc.
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)

NDA Filing NDA filing 4Q 2020.
$728.2 million

LPCN – Lipocine Inc.
TLANDO - LPCN 1021
Men with low testosterone (Low T)

PDUFA PDUFA date August 28, 2020
$140 million

MNK – Mallinckrodt plc
Terlipressin
Hepatorenal syndrome (HRS) Type 1

PDUFA PDUFA date September 12, 2020. Advisory Committee Meeting July 15, 2020 voted 8-7 that the benefits outweigh the risks.
$127.5 million

MYOK – MyoKardia Inc.
Mavacamten - VALOR-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 3 Phase 3 initiation of dosing announced August 3, 2020.
$5.5 billion

PIRS – Pieris Pharmaceuticals Inc.
PRS-343 and atezolizumab (Tecentriq)
HER2-positive solid tumors

Phase 1 Phase 1 dose escalation data to be presented at ESMO September 20, 2020, 10:32 AM EDT.
$146.8 million

RETA – Reata Pharmaceuticals Inc.
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome

Phase 3 Phase 3 Year 2 data due 4Q 2020.
$3.5 billion

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

PDUFA PDUFA date November 8, 2020
$1.2 billion

VBIV – VBI Vaccines Inc.
VBI-1901 and GM-CSF or AS01
Recurrent glioblastoma multiforme (rGBM)

Phase 2a Phase 1/2 presentation at AACR June 22, 2020. 1/6 partial responses recorded. Part B immunologic and tumor data of VBI-1901 in combination with AS01 due 4Q 2020.
$950.2 million