BPC November 17 update

​Alkermes ALKS issued Complete Response Letter; BrainStorm BCLI misses late-stage trial goals -66%

Price and Volume Movers

Alkermes plc (NASDAQ:ALKS) announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for ALKS 3831 for the treatment of adults with schizophrenia and adults with bipolar I disorder. The FDA stated that resolution of certain conditions related to the tablet coating process at the one of its facilities is required before ALKS 3831 may be approved. The CRL did not raise any concerns about the data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) shares plunged to closed down 66% to $4.02 on news its Phase 3 trial evaluating NurOwn as a treatment for Amyotrophic lateral sclerosis (ALS) did not meet the primary and key secondary efficacy endpoints of the trial.

BeyondSpring Inc. (NASDAQ:BYSI) announced after hours an underwritten public offering of $75m of its ordinary shares. Shares, which closed normal trading down 10%, are trading down a further 2% after hours to $13.80.

Oncternal Therapeutics, Inc. (NASDAQ:ONCT) also announced an offering of 6,451,613 shares at a price of $3.10 per share, for gross proceeds of $20m. Shares are trading down 18% to $3.41 after hours.

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) shares closed up 40% to $1.81. The company presented data at the American Heart Association (AHA) Scientific Sessions from its Phase 3 SOLOIST and SCORED trials. The primary endpoints were met demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

-

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:

Miragen Therapeutics, Inc. (MGEN): $20.84; +32%.

ALX Oncology Holdings Inc. (ALXO): $65.58; +23%.

PLx Pharma Inc. (PLXP): $5.00; +15%.

9 Meters Biopharma, Inc. (NMTR): $1.02; +14%.

Pandion Therapeutics, Inc. (PAND): $15.50; +11%.

DECLINERS:

Alterity Therapeutics Limited (ATHE): $2.23; -21%.

iBio, Inc. (IBIO): $1.71; -17%.

Applied Genetic Technologies Corporation (AGTC): $4.33; -12%.

CureVac N.V. (CVAC): $76.49; -11%.

Achieve Life Sciences, Inc. (ACHV): $9.35; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
ALKS 3831 (olanzapine/samidorphan)
Schizophrenia, bipolar

CRL CRL announced November 17, 2020
$2.9 billion

ATNX – Athenex Inc.
Oraxol (Oral Paclitaxel)
Angiosarcoma

Phase 2 Phase 2 poster at SABCS December 9, 2020.
$1.3 billion

AYLA – Ayala Pharmaceuticals Inc.
AL101 TENACITY
Triple negative breast cancer

Phase 2 Phase 2 trial to commence 2H 2020.
$124.6 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Amytrophic lateral sclerosis (ALS)

Phase 3 Phase 3 trial did not meet primary endpoint - November 17, 2020.
$174.4 million

BGNE – BeiGene Ltd.
Tislelizumab - RATIONALE 303
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 trial met primary endpoint of overall survival - November 17, 2020.
$23.3 billion

CNSP – CNS Pharmaceuticals Inc.
Berubicin
Glioblastoma

Phase 2 Phase 2 trial planned for 1Q 2021.
$37.3 million

INFI – Infinity Pharmaceuticals Inc.
IPI-549 + Tecentriq and Abraxane and IPI-549 + Tecentriq and Avastin (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

Phase 2 Phase 2 data to be presented at SABCS meeting December 8-11, 2020.
$128.4 million

LXRX – Lexicon Pharmaceuticals Inc.
Sotagliflozin
Heart failure

Phase 3 Phase 3 trial met primary endpoint.
$179.7 million

ONCY – Oncolytics Biotech Inc.
Pelareorep, paclitaxel and avelumab - BRACELET-1
HR+ / HER2- breast cancer

Phase 2 Phase 2 update at SABCS December 9, 2020.
$145.4 million

PBYI – Puma Biotechnology Inc
Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer

Phase 2 Phase 2 poster at SABCS December 9, 2020.
$447.3 million

PTCT – PTC Therapeutics Inc.
PTC518
Healthy volunteers

Phase 1 Phase 1 trial initiation announced November 17, 2020. Initial data due 1H 2021.
$4.3 billion

PTN – Palatin Technologies Inc.
PL-8177
Ulcerative colitis

Phase 2 Phase 2 trial to commence 1H 2021 with data due 1H 2022.
$101.4 million

PTN – Palatin Technologies Inc.
PL9643
Dry eye disease (DED)

Phase 2 Phase 2 data due December 2020.
$101.4 million

RDHL – Redhill Biopharma Ltd.
RHB-107 (upamostat)
COVID-19 (outpatients)

Phase 3 Phase 2/3 trial to commence enrollment in 2021.
$333.2 million