BPC November 09 update

Pfizer PFE and BioNTech BNTX deliver positive COVID-19 vaccine data; Supernus SUPN issued double CRL and RTF letters;

Price and Volume Movers

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced their Phase 3 trial of the COVID-19 vaccine candidate, BNT162b2, demonstrated evidence of efficacy against COVID-19. After receiving two doses, the vaccine was found to be more than 90% effective in preventing COVID-19. Submission for Emergency Use Authorization (EUA) to the FDA is planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. The companies expect that they will be able to produce up to 50m vaccine doses in 2020 for 25m people and up to 1.3b doses (650m people) in 2021. Shares of Pfizer closed up 2% to $39.91 while BioNTech closed 14% higher at $104.80.

Calliditas Therapeutics AB (NASDAQ:CALT) shares closed up 35% to $33.95 on news top-line data from Part A of its Phase 3 clinical trial of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN) met its primary endpoint, demonstrating a statistically significant reduction in urine protein creatinine ratio compared to placebo.

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients. In further bad news, the company also received a Refusal to File (RTF) letter from the FDA regarding its NDA for SPN-830 for the treatment of motor fluctuations in Parkinson's disease (PD). Shares are currently halted after hours as of 6:45pm ET.

Biogen Inc. (NASDAQ:BIIB) shares closed down 28% to $236.26 following its appearance Friday before the FDA Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee Friday, to discuss its regulatory application of aducanumab for the treatment Alzheimer’s disease. Panelists voted overwhelmingly against the efficacy of aducanumab. The PDUFA date for a final decision by the FDA is March 7, 2021.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares are trading down 18% to $71.65 on news its Phase 2b trial of etrasimod, for the treatment of moderate-to-severe atopic dermatitis (AD), failed to meet the primary endpoint.

Revance Therapeutics, Inc. (NASDAQ:RVNC) announced that its PDUFA date of November 25, 2020, for the treatment of glabellar (frown) lines, is likely to be delayed, with the timing of an inspection of its manufacturing site, a prerequisite for FDA approval, yet to be scheduled. The company also announced its Phase 2 trial for plantar fasciitis did not meet the primary endpoint.

TherapeuticsMD, Inc. (NASDAQ:TXMD) announced an underwritten public offering of its common stock. Shares are trading down 14% after hours to $1.31 following closing 25% higher during normal trading hours.

Affimed N.V. (NASDAQ:AFMD) shares are trading up 10% after hours on news of an oncology collaboration with Roviant for its preclinical molecule AFM32. Affimed will receive $60m upfront.

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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:

Aptevo Therapeutics Inc. (APVO): $32.74; +38%.

Reata Pharmaceuticals, Inc. (RETA): $174.66; +32%.

Oncternal Therapeutics, Inc. (ONCT): $5.10; +30%.

Intercept Pharmaceuticals, Inc. (ICPT): $34.84; +24%.

Recro Pharma, Inc. (REPH): $1.98; +24%.

DECLINERS:

Arcturus Therapeutics Holdings Inc. (ARCT): $34.61; -45%.

Altimmune, Inc. (ALT): $7.84; -37%.

Humanigen, Inc. (HGEN): $7.97; -32%.

Vaxart, Inc. (VXRT): $3.50; -32%.

Leap Therapeutics, Inc. (LPTX): -30%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
MAGE-A4 (ADP-A2M4CD8 - SURPASS)
Solid tumors

Phase 1 Phase 1 dose update at SITC meeting November, 2020. Partial responses in 2/6 patients. Phase 2 trial to commence 1H 2021.
$775.4 million

ALT – Altimmune Inc.
AdCOVID
COVID-19 vaccine

Phase 1 Phase 1 trial to commence December 2020 with data due 1Q 2021.
$404.5 million

ARNA – Arena Pharmaceuticals Inc.
Etrasimod
Atopic dermatitis (AD)

Phase 2b Phase 2b trial did not meet primary endpoint - November 9, 2020. Phase 3 trial planned.
$3.8 billion

LLY – Eli Lilly and Company
BamlanivimabLY-CoV555
COVID-19 Antibody

Approved Emergency Use Authorization (EUA) announced November 9, 2020.
$139.3 billion

MRK – Merck & Company Inc. (new)
Keytruda (pembrolizumab) and Ipilimumab
Non-Small Cell Lung Cancer

Phase 3 Phase 3 trial to discontinue due to futility - November 9, 2020.
$203.4 billion

NBIX – Neurocrine Biosciences Inc.
VY-AADC02 (RESTORE-1)
Parkinson's Disease

Phase 2 Phase 2 dosing paused pending review by the DSMB of additional data - November 2020.
$8.9 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

Phase 2/3 Phase 3 U.K. interim data due 1Q 2021. Completion of enrollment announced November 30, 2020. Phase 3 U.S. trial to commence December 2020 or early 2021.
$8.9 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 3 Phase 3 final efficacy analysis noted vaccine was 95% effective in preventing COVID-19. EUA filing announced November 20, 2020. Advisory Committee meeting December 10, 2020.
$212.9 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Moderate to severe glabellar (frown) lines

PDUFA PDUFA date November 25, 2020. Decision has been deferred by the the FDA as it was unable to conduct a required inspection of a manufacturing facility due to travel restrictions associated with the COVID-19 pandemic.
$1.6 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Plantar fasciitis

Phase 2 Phase 2 data did not meet primary endpoint - November 9, 2020.
$1.6 billion

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

CRL CRL announced November 9, 2020.
$1.1 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-830
Motor fluctuations in Parkinson’s disease (PD)

NDA Filing Refusal to file letter announced November 9, 2020.
$1.1 billion