BPC November 16 update

Moderna MRNA COVID-19 vaccine 94.5% effective +10%; ​Adamis ADMP issued CRL -41%

Price and Volume Movers

Moderna, Inc. (NASDAQ:MRNA) shares rallied to close up 10% to $97.95 on news interim data from its Phase 3 trial of mRNA-1273, its vaccine candidate against COVID-19, exhibited an efficacy rate of 94.5% among 95 participants with confirmed cases, meeting the primary endpoint. Of note, all 11 severe cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. Moderna intends to submit an Emergency Use Authorization (EUA) with the FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. The company also announced its vaccine candidate remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days.

BioNTech SE (NASDAQ:BNTX), which announced last week efficacy rates of 90% for its COVID-19 vaccine, saw its shares fall 14% to $91.52 in reaction to the news from Moderna.

Inovio (NASDAQ:INO) announced the initiation of the Phase 2 segment of its Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. The Phase 2 part will evaluate the safety, tolerability and immunogenicity of INO-4800. The Phase 3 part remains on partial clinical hold until it resolves questions related to the device that will be used to deliver the vaccine. Shares closed up 14% to $12.83.

Bristol Myers Squibb (NYSE:BMY) announced that the PDUFA date of November 16, 2020 of its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma, has been delayed, with the FDA unable to conduct an inspection of a manufacturing facility in Texas due to travel restrictions related to the COVID-19 pandemic. The FDA did not provide a new PDUFA date.

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Adamis' ZIMHI high dose naloxone injection product for the treatment of opioid overdose. The company noted the FDA raised questions related to Chemistry, Manufacturing and Controls (CMC) issues. Shares fell 41% to $0.40.

RAPT Therapeutics, Inc. (Nasdaq: RAPT) shares closed down 46% to $16.41 following the release of initial data from its Phase 1/2 clinical trial of FLX475 in various cancer indications. Across the three Phase 2 monotherapy cohorts, just 1 out of 22 patients exhibited a partial response.

Kodiak Sciences Inc. (NASDAQ:KOD) announced an underwritten public offering of $400m of shares of its common stock. Shares are trading down 5% after hours to $108.00.

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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:

Alterity Therapeutics Limited (ATHE): $2.83; +146%.

Greenwich LifeSciences, Inc. (GLSI): $4.59; +32%.

SQZ Biotechnologies Company (SQZ): $30.33; +26%.

Keros Therapeutics, Inc. (KROS): $68.02; +15%.

iBio, Inc. (IBIO): $2.05; +15%.

DECLINERS:

Armata Pharmaceuticals Inc. (ARMP): $3.14; -14%.

Aclaris Therapeutics, Inc. (ACRS): $3.19; -12%.

Scholar Rock Holding Corporation (SRRK): $38.12; -12%.

Lineage Cell Therapeutics, Inc. (LCTX): $1.32; -10%.

TFF Pharmaceuticals, Inc. (TFFP): $15.27; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
ZIMHI (naloxone HCI Injection)
Opioid overdose

CRL CRL announced November 16, 2020.
$40.6 million

APLS – Apellis Pharmaceuticals Inc.
Pegcetacoplan
Paroxysmal Nocturnal Hemoglobinuria (PNH)

PDUFA priority review PDUFA date under priority review May 14, 2021. Phase 3 48-week data due 4Q 2020.
$3.6 billion

APVO – Aptevo Therapeutics Inc.
ALG.APV-527
Solid tumors

Phase 1 Phase 1 trial to be initiated in 2021.
$181.3 million

BMY – Bristol-Myers Squibb Company
liso-cel (JCAR017)
Relapsed or refractory (R/R) large B-cell lymphoma

PDUFA priority review PDUFA date under priority review scheduled for November 16, 2020 has been delayed as the FDA was unable to conduct an inspection of a manufacturing facility due to COVID-19. New date not supplied.
$141 billion

DVAX – Dynavax Technologies Corporation
Biological E. vaccine with CpG 1018
COVID-19

Phase 1/2 Phase 1/2 initiation announced November 16, 2020 with data due by February 2021.
$559.7 million

INO – Inovio Pharmaceuticals Inc.
INO-4800
COVID-19 vaccine

Phase 2 Phase 2 part of Phase 2/3 trial has been initiated - November 16, 2020. Phase 3 part remains on partial clinical hold.
$2.1 billion

KOD – Kodiak Sciences Inc
KSI-301 (DAZZLE)
Wet age-related macular degeneration (AMD)

Phase 2 Phase 2 pivotal trial top-line data due early 2022.
$6.9 billion

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

Phase 3 Phase 3 data released November 30, 2020 with94.1% efficacy rate. EUA filed. FDA Advisory Committee meeting scheduled for December 17, 2020.
$60.4 billion

NYMX – Nymox Pharmaceutical Corporation
NX-1207 Fexapotide
BPH

NDA Filing NDA filing planned 1Q 2021.
$155.2 million

PLXP – PLx Pharma Inc.
VAZALORE 325 mg and 81 mg doses
Aspirin - cardiovascular and stroke patients patients

sNDA Filing sNDA filing announced November 16, 2020.
$54.8 million

RAPT – RAPT Therapeutics Inc.
FLX475
Advanced Cancer

Phase 1/2 Phase 2 initial data presented November 16, 2020. ORR 7/43 (16%) across six cohorts including 1/22 across three monotherapy cohorts.
$532.1 million

SCPH – scPharmaceuticals Inc.
FUROSCIX (FREEDOM-HF)
Heart Failure

Phase 3 Phase 3 data due 2Q 2021.
$251.9 million