BPC November 18 update

Aptevo APVO receives buyout offer +31% AH; Corcept CORT patent win +23% AH

Price and Volume Movers

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced data from the final efficacy analysis from its Phase 3 trial from their COVID-19 vaccine candidate, BNT162b2. The trial met all of the primary efficacy endpoints, showing a vaccine efficacy rate of 95%. Of the 170 cases of COVID-19 in subjects in the trial, 162 were observed in the placebo group versus 8 cases in the BNT162b2 group. The observed efficacy in adults over 65 years of age was over 94%. The safety milestone required by the FDA for Emergency Use Authorization (EUA) has also been achieved and they intend to submit a request for an EUA within the next few days. BioNTech shares closed up 4% to $90.44.

Aptevo Therapeutics Inc. (NASDAQ:APVO) shares have spiked after hours, currently trading up 31% to $46.47 following a proposal from Tang Capital Management, which increased its ownership share of the company to 54% just earlier this month, to acquire the company for $50 per share in cash.

CorMedix Inc. (NYSE:CRMD) announced that the FDA has decided to cancel the Antimicrobial Drug Advisory Committee meeting tentatively scheduled for January 14, 2021 to discuss the New Drug Application (NDA) for Defencath. The PDUFA date remains set for February 28, 2021. Shares closed up 8% to $6.50.

MeiraGTx Holdings plc (NASDAQ:MGTX) shares are trading down 8% after hours to $13.19 on news it has commenced an underwritten public offering of 5m of its ordinary shares.

Stoke Therapeutics, Inc. (NASDAQ:STOK) also announced a public offering of 2.5m shares of its common stock. Shares are trading down 3% to $40.10 after hours.

Kazia Therapeutics Limited (NASDAQ: KZIA) shares closed up 36% to $13.47 following the release of updated data from its Phase 2 trial of paxalisib that will be presented at the Society for Neuro-Oncology (SNO) Annual Meeting from November 19-21, 2020. In patients with glioblastoma, median progression-free survival of 8.4 months was reported (versus 5.3 months for temozolomide, the existing standard of care). Median overall survival of 17.5 months reported (versus 12.7 months for temozolomide).

Corcept Therapeutics Incorporated (NASDAQ:CORT) announced after hours the U.S. Patent and Trademark Office upheld its patent for Korlym following a challenge from Teva Pharmaceuticals. Shares are trading up 23% to $23.00 after hours. Korlym was awarded FDA approval in 2012 for the treatment of patients with Cushing's syndrome.

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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:

Bellus Health Inc. (BLU): $3.08; +29%.

Greenwich LifeSciences, Inc. (GLSI): $4.98; +20%.

Liminal BioSciences Inc. (LMNL): $1.20; +14%.

Daré Bioscience, Inc. (DARE): $1.23; +13%.

Idera Pharmaceuticals, Inc. (IDRA): $3.33; +11%.

DECLINERS:

Oncternal Therapeutics, Inc. (ONCT): $2.89; -30%.

BeyondSpring Inc. (BYSI): $11.53; -18%.

Alterity Therapeutics Limited (ATHE): $1.82; -18%.

Miragen Therapeutics, Inc. (MGEN): $17.65; -15%.

Lexicon Pharmaceuticals, Inc. (LXRX): $1.60; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BLRX – BioLineRx Ltd.
Motixafortide
Acute respiratory distress syndrome (ARDS) secondary to COVID-19

Phase 1b Phase 1b initiation announced November 18, 2020. Initial results due 1H 2021.
$48.4 million

CHMA – Chiasma Inc.
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly

Phase 3 Phase 3 trial met primary non-inferiority endpoint - November 18, 2020.
$247.4 million

CRMD – CorMedix Inc.
Defencath (Neutrolin)
Hemodialysis patients with central venous catheters

PDUFA priority review PDUFA date February 28, 2021. Advisory Committee tentatively scheduled for January 14, 2021 is no longer needed.
$289.2 million

GILD – Gilead Sciences Inc.
Lenacapavir capsid inhibitor
HIV

Phase 2/3 Phase 2/3 trial met primary endpoint - November 18, 2020.
$76.1 billion

GTHX – G1 Therapeutics Inc.
Trilaciclib
Triple-negative breast cancer

Phase 2 Phase 2 additional data at SABCS December 9, 2020.
$694.7 million

HEPA – Hepion Pharmaceuticals Inc.
CRV431 - AMBITION
Non-alcoholic steatohepatitis

Phase 2a Phase 2a to continue to next dose cohort following interim independent Data Safety Monitoring Board review November 18, 2020.
$15.1 million

MIST – Milestone Pharmaceuticals Inc.
Etripamil - RAPID
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Phase 3 commencement of enrollment announced November 18, 2020. Data due late 2021/early 2022.
$199.8 million

OMER – Omeros Corporation
OMS721
Hematopoietic stem cell-associated TMA (HSCT-TMA)

BLA Filing BLA submission announced November 18, 2020.
$714.6 million

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

PSTI – Pluristem Therapeutics Inc.
PLX-R18
Incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT)

Phase 1 Phase 1 data to be presented at ASH December 5, 2020.
$259.2 million

SNY – Sanofi
Avalglucosidase alfa
Pompe disease

PDUFA priority review PDUFA date under priority review May 18, 2021.
$126.1 billion

SPRB – Spruce Biosciences Inc.
Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia

Phase 2 Phase 2 trial to be initiated 2H 2021.
$665.1 million