BPC November 15 update
Amarin AMRN shares advance 12% on positive Adcom; resTORbio TORC tumbles 87% on failure of late-stage trial
Price and Volume Movers
resTORbio, Inc., (Nasdaq: TORC) announced that top line data from its Phase 3 PROTECTOR 1 trial evaluating RTB101 in preventing clinically symptomatic respiratory illness (CSRI) in adults age 65 and older, did not meet its primary endpoint. Shares plummeted to close down 87% to $1.09.
Amarin Corporation plc (NASDAQ:AMRN) shares closed up 12% to $24.02 following Thursday's 16-0 vote by an FDA Advisory Committee to recommend approval of an indication and label expansion for Vascepa capsules to reduce the risk of cardiovascular events in high-risk patients. The PDUFA date for a final decision by the FDA is December 28, 2019.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) shares closed down 25% to $1.65 following its announcement of a public offering of shares and warrants for gross proceeds of $9m.
Anchiano Therapeutics Ltd. (Nasdaq: ANCN) announced the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). Anchiano determined that there was a low probability of surpassing the pre-defined futility threshold at the planned interim analysis. Shares closed down 18% to $1.92.
Novartis (NYSE: NVS) announced the FDA approved Adakveo (crizanlizumab) to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients aged 16 years and older with sickle cell disease.
Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) announced that the U.S. Federal Trade Commission (FTC) has approved their pending merger under the requirement that Celgene sells its psoriasis drug, Otezla. The transaction is expected to close on November 20, 2019.
Major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume
ADVANCERS:
Melinta Therapeutics, Inc. (MLNT): $1.68; +20%.
BioXcel Therapeutics, Inc. (BTAI): $5.15; +18%.
89bio, Inc. (ETNB): $27.00; +17%.
Kodiak Sciences Inc. (KOD): $29.18; +17%.
Matinas BioPharma Holdings, Inc. (MTNB): $1.04; +16%.
DECLINERS:
Agile Therapeutics, Inc. (AGRX): $1.49; -37%.
SELLAS Life Sciences Group, Inc. (SLS): $5.15; -17%.
PDS Biotechnology Corporation (PDSB): $2.12; -13%.
Celsion Corporation (CLSN): $1.23; -12%.
Galera Therapeutics, Inc. (GRTX): $11.79; -11%.
Pipeline updates below:
Pipeline Database Updates
AIM – AIM ImmunoTech Inc.
Ampligen, Intron A, celecoxib and pembrolizumab
Triple-Negative Breast Cancer
Phase 1 Phase 1 data due around 2Q 2020.
Ampligen, cisplatin and pembrolizumab
Phase 2 Phase 2 interim data due around 4Q 2020.
Ampligen plus Intron A
Phase 1/2 Phase 1 interim data to be presented 1Q 2020.
ANCN – Anchiano Therapeutics Ltd.
Inodiftagene - Codex
Non-muscle invasive bladder cancer (NMIBC)
Phase 2 Phase 2 trial discontinued due to lack of efficacy - November 15, 2019.
IDYA – IDEAYA Biosciences Inc.
IDE196
Phase 2 Phase 2 interim data expected in 2Q/3Q 2020.
$203.9 million
NVS – Novartis AG
Crizanlizumab
Approved FDA Approval announced November 15, 2019.
TORC – resTORbio Inc.
RTB101 - PROTECTOR 1
Respiratory Tract Infections
Phase 3 Phase 3 top-line data did not meet primary endpoint - November 15, 2019.