BPC June 04 update

​Biogen BIIB adds 5% ahead of binary event of the year - likely Monday

Price and Volume Movers

Biogen Inc. (NASDAQ:BIIB) shares closed up 5% to $286.14 ahead of the FDA’s expected decision on Monday regarding the regulatory application for aducanumab in patients with Alzheimer’s disease. Widely regarded as the binary event of the year, shares are expected to move markedly in one direction or the other, depending on whether the drug is approved or not.

Liminal BioSciences Inc. (Nasdaq: LMNL) announced the FDA approved Ryplazim (plasminogen) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia). Ryplazim becomes the first FDA approved therapy for this rare genetic disorder. Shares are trading up 59% after hours to $6.39.

Chimerix (NASDAQ:CMRX) also announced it received approval from the FDA for TEMBEXA (brincidofovir) tablets and oral suspension approval for the treatment of smallpox.

The annual ASCO conference, regarded as the premier oncology conference of the year, commenced Friday in virtual format. Notable movers from companies who have or are set to present are noted below:

-

PDS Biotechnology Corporation (PDSB): $12.78; +13% (presenting next week).

Cullinan Oncology, Inc. (CGEM): $33.11; +11%.

Harpoon Therapeutics, Inc. (HARP): 15.86; -24%.

Cellectar Biosciences, Inc. (CLRB): $1.55; -15%.

-

Other 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:

Windtree Therapeutics, Inc. (WINT): $2.70; +36%.

Galmed Pharmaceuticals Ltd. (GLMD): $3.40; +24%.

Pluristem Therapeutics Inc. (PSTI): $4.26; +16%.

Decibel Therapeutics, Inc. (DBTX): $8.63; +12%.

Idera Pharmaceuticals, Inc. (IDRA): $1.31; +11%.

DECLINERS:

BriaCell Therapeutics Corp. (BCTX): $5.15; -15%.

Brooklyn ImmunoTherapeutics, Inc. (BTX): $16.25; -14%.

Salarius Pharmaceuticals, Inc. (SLRX): $1.21; -14%.

Purple Biotech Ltd. (PPBT): $5.93; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALKS – Alkermes plc
Nemvaleukin (ALKS 4230) - ARTISTRY-1
Solid tumors

$24.24
-0.50  -2%
Phase 1 Phase 1/2 data presented at ASCO June 4, 2021. 2/6 patients in melanoma monotherapy cohort showed partial responses.
$3.9 billion

ARPO – Aerpio Pharmaceuticals Inc.
FYARRO
PEComa​

$1.80
-0.01  -1%
NDA Filing Rolling NDA filing completed (by Aadi) in May 2021.
$85.3 million

BYSI – BeyondSpring Inc.
Plinabulin + PD-1/PD-L1 inhibitor and radiotherapy
Solid Tumors

$11.24
-0.41  -4%
Phase 1/2 Phase 1b initiation of dosing announced June 4, 2021. Data due 2022.
$342.7 million

CGEM – Cullinan Oncology Inc.
CLN-081
Non-Small Cell Lung Cancer

$24.96
-1.07  -4%
Phase 1/2 Phase 1/2 updated data at ASCO June 4-8, 2021 noted objective partial responses (PR) were observed in 21 of 42 (50%) patients.
$1.1 billion

CMRX – Chimerix Inc.
TEMBEXA (brincidofovir)
Smallpox

$7.84
-0.36  -4%
Approved FDA approval announced June 4, 2021.
$675.9 million

GILD – Gilead Sciences Inc.
TECARTUS (brexucabtagene autoleucel) - (ZUMA-3)
Adult patients with r/r ALL - cancer

$67.05
-0.30  -0%
PDUFA priority review PDUFA date with priority review October 1, 2021.
$84.1 billion

HARP – Harpoon Therapeutics Inc.
HPN424
Metastatic castration-resistant prostate cancer

$14.75
-0.20  -1%
Phase 1/2 Phase 1/2 preliminary data presented at ASCO June 4, 2021. One partial response noted.
$479.7 million

IMCR – Immunocore Holdings plc
Tebentafusp
Uveal melanoma

$37.49
-1.75  -4%
BLA Filing BLA filing due 3Q 2021.
$1.6 billion

LMNL – Liminal BioSciences Inc.
RYPLAZIM (plasminogen)
Congenital plasminogen deficiency (C-PLGD)

$4.09
+0.05  +1%
Approved FDA approval announced June 4, 2021.
$122.5 million

MRUS – Merus N.V.
Zenocutuzumab (MCLA-128)
Solid tumors - NRG1

$21.75
-0.10  -0%
Phase 1/2 Phase 1/2 interim data presented at ASCO June 4, 2021. Partial responses in 5 of 12 patients with pancreatic cancer (42%) and in 13 of 45 patients across several NRG1+ tumor types (29%) shown.
$834.1 million

NTLA – Intellia Therapeutics Inc.
NTLA-2001
transthyretin amyloidosis (ATTR)

$78.91
-0.31  -0%
Phase 1 Phase 1 initial data to be presented June 26, 2021 at Peripheral Nerve Society Annual Meeting.
$5.4 billion

SLRX – Salarius Pharmaceuticals Inc.
Seclidemstat
Ewing sarcoma

$1.04
+0.02  +2%
Phase 1 Phase 1 data presented at ASCO June 4, 2021. No objective responses.
$46.6 million

SURF – Surface Oncology Inc.
SRF388
Solid tumors

$6.96
+0.02  +0%
Phase 2 Phase 1 data at ASCO June 4, 2021 noted stable disease of 6 of 18 (33%) patients.
$277.7 million

VIRI – Virios Therapeutics Inc.
IMC-1 (FORTRESS)
Fibromyalgia

$6.50
-0.28  -4%
Phase 2b Phase 2b data due mid-2022.
$54.1 million