BPC September 09 update

Apellis APLS -30% AH mixed P3 topline data release; Iveric Bio ISEE +58% AH, Catalyst Biosciences CBIO +10% AH shares react

Price and Volume Movers

Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) reported top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplanto, a C3 therapy to treat geographic atrophy (GA). DERBY did not meet the primary endpoint, OAKS did meet the primary endpoint with an expected New Drug Application to be filled in the first half of 2022. Shares are trading after hours down 30% at $39.

In response to Apellis’ data release, Iveric Bio, Inc. (NASDAQ: ISEE) shares are trading after hours up 58% at $13.37. T is also developing a treatment for geographic atrophy.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) shares have also reacted positively to Apellis’s news, currently up 13% in after-hours trading at $4.88. In collaboration with Biogen, Catalyst is due to advance its preclinical C3 therapy, CB 2782-PEG, for the potential treatment of dry age-related macular degeneration (AMD).

Humanigen, Inc. (NASDAQ: HGEN) announced the FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. The FDA was unable to conclude that the potential benefits of lenzilumab outweighed the potential risks of its use as a treatment for COVID-19. Shares closed down 47% at $7.97.

Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) announced that the FDA has granted Fast Track designation for ELX-02 to treat cystic fibrosis patients with nonsense mutations. ELX-02 is currently in a Phase 2 trial with data to be presented in the fourth quarter of 2021. Shares closed up 10% at $1.53.

Biogen, Inc. (NASDAQ: BIIB) in its presentation at the Morgan Stanley Global Healthcare Conference today, noted that the launch of its Alzheimer's drug Aduhelm has been slower than anticipated. Shares fell 7% to close at $300.15.

Advancers

CompanyPriceChange
CRVS
Corvus Pharmaceuticals Inc.
$5.32+3.06  +135.40%
IPHA
Innate Pharma S.A.
$8.10+2.35  +40.87%
CYDY
Cytodyn Inc
$2.01+0.37  +22.56%
SURF
Surface Oncology Inc.
$7.10+1.09  +18.14%
ATNM
Actinium Pharmaceuticals Inc. (Delaware)
$7.83+1.15  +17.22%
EVLO
Evelo Biosciences Inc.
$8.34+1.03  +14.09%
MGTA
Magenta Therapeutics Inc.
$7.79+0.92  +13.39%
CNTB
Connect Biopharma Holdings Limited
$23.06+2.51  +12.21%
TRVN
Trevena Inc.
$1.36+0.14  +11.48%
FULC
Fulcrum Therapeutics Inc.
$30.83+3.14  +11.34%

Decliners

CompanyPriceChange
PTGX
Protagonist Therapeutics Inc.
$17.53-28.6  -62.00%
TCRR
TCR2 Therapeutics Inc.
$9.99-5.73  -36.45%
ELYM
Eliem Therapeutics Inc
$18.77-5.27  -21.92%
JANX
Janux Therapeutics Inc.
$27.39-6.96  -20.26%
ICVX
Icosavax Inc.
$33.06-6.4  -16.22%
IPSC
Century Therapeutics Inc.
$24.76-4.49  -15.35%
GRTS
Gritstone bio Inc.
$11.50-2.04  -15.07%
VERV
Verve Therapeutics Inc.
$59.88-9.99  -14.30%
INAB
IN8bio Inc.
$7.00-1.09  -13.47%
TNYA
Tenaya Therapeutics Inc.
$20.85-3.2  -13.31%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALEC – Alector Inc.
AL001
Amyotrophic lateral sclerosis (ALS)

$26.81
+1.35  +5%
Phase 2 Phase 2 trial initiated dosing, September 9, 2021.
$2.2 billion

APLS – Apellis Pharmaceuticals Inc.
EMPAVELI (pegcetacoplan) - DERBY
Geographic atrophy (GA)

$34.21
+0.21  +1%
Phase 3 Phase 3 data did not meet primary endpoints September 9, 2021.
$3 billion

APLS – Apellis Pharmaceuticals Inc.
EMPAVELI (pegcetacoplan) - OAKS
Geographic atrophy (GA) associated with age-related macular degeneration (AMD)

$34.21
+0.21  +1%
NDA Filing Phase 3 data met primary endpoint September 9, 2021. NDA expected to be filed in the first half of 2022.
$3 billion

AZN – AstraZeneca PLC
IMFINZI (Durvalumab) + tremelimumab (POSEIDON)
Non-small cell lung cancer (NSCLC)

$55.56
-1.04  -2%
Phase 3 Phase 3 data showed statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy noted September 9, 2021.
$172.1 billion

CNTA – Centessa Pharmaceuticals plc
SerpinPC (ApcinteX)
Hemophilia A

$18.78
-0.46  -2%
Phase 2a Phase 2a top-line data released September 9, 2021. 88% reduction in median Annualized Bleeding Rate (ABR) for all bleeds and 94% reduction in median ABR for spontaneous joint bleeds in highest dose tested. Open label extension (OLE) data due 2H 2022.
$1.7 billion

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystic fibrosis

$1.87
+0.12  +7%
Phase 2 Phase 2 data due 4Q 2021.
$161.2 million

ERAS – Erasca Inc.
ERAS-007 (HERKULES-2)
Non-small-cell Lung Cancer

$19.42
-1.19  -6%
Phase 1/2 Phase 1b/2 first patient dosed September 9, 2021.
$2.4 billion

FRLN – Freeline Therapeutics Holdings plc
FLT201
Gaucher disease

$3.95
-0.06  -2%
Phase 1/2 Phase 1/2 dose-finding trial to be initiated by 4Q 2021. Data expected in 2022.
$141.4 million

ICVX – Icosavax Inc.
IVX-121
Respiratory syncytial virus (RSV) vaccine

$33.06
-6.40  -16%
Phase 1 Phase 1 trial initiated September 9, 2021 with top-line data due 1H 2022.
$1.3 billion

PDSB – PDS Biotechnology Corporation
PDS0101 (VERSATILE-002)
Head and neck cancer

$14.93
-0.21  -1%
Phase 2 Phase 2 initial data due 4Q 2021 / 1Q 2022. Enrollment completed September 9, 2021.
$424.4 million

PFE – Pfizer Inc.
MYFEMBREE (Relugolix)
Endometriosis-associated pain

$43.89
-0.58  -1%
PDUFA sNDA filed July 6, 2021. PDUFA date May 6, 2022.
$246.1 billion

RZLT – Rezolute Inc.
RZ358 (RIZE)
Congenital hyperinsulinism (HI)

$8.10
-0.73  -8%
Phase 2b Phase 2b begun dosing patients in the second cohort September 9, 2021. Top-line data due 1Q 2022.
$69.8 million

VERU – Veru Inc.
Sabizabulin (VERU-111) - VERACITY
Castration Resistant Prostate Cancer

$8.94
+0.16  +2%
Phase 1/2 Phase 3 commencement of enrollment announced June 25, 2021. Updated Phase 1b/2 data to be presented at ESMO September 19, 2021.
$713.9 million