BPC June 14 update

MorphoSys MOR +27% AH HIBio Deal; 180 Life Sciences ATNF -19% AH Regulatory feedback

Price and Volume Movers

Outset Medical, Inc. (NASDAQ: OM) shares closed down 34% at $13.46 after it announced it put a shipment hold on the distribution of its Tablo Hemodialysis System for home use while it is waiting for the FDA’s 510(k) clearance for device changes.

MorphoSys AG (NASDAQ: MOR) and Human Immunology Biosciences, Inc. entered into a license agreement to allow HIBio to develop and commercialize MorphoSys' felzartamab and MOR210. MorphoSys will receive a 15% equity stake in HIBio and up to $1 billion in milestone payments across programs. Shares are currently up 27% at $5.71 during after hours trading.

180 Life Sciences Corp. (NASDAQ: ATNF) shares are currently trading down 19% at $1.34 during after hours trading after it released an update from talks with regulators regarding adalimumab to treat Dupuytren's disease. The FDA noted that the proposed outcome measures are not clinical outcome measures that support a demonstration of efficacy in registrational studies. A pre-investigational new drug (PIND) meeting has been requested by 180.

Calithera Biosciences, Inc. (NASDAQ: CALA) announced that it will effect a 1-for-20 reverse stock split as of 5 p.m. ET today. Shares closed down 31% at $0.14.

HCW Biologics Inc. (NASDAQ: HCWB) shares closed up 31% at $2.67 after its Chief Executive Officer Wong Hing C filed a Form 4 with the SEC to buy 1,520 shares at $2.19.

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) shares closed up 26% at $16.32 after The Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of AMX0035 and Mitsubishi Tanabe Pharma’s oral edaravone to treat amyotrophic lateral sclerosis (ALS). Citigroup also raises its price target for Amylyx to $33 from $32 with a Buy rating.

GeoVax Labs, Inc. (NASDAQ: GOVX) shares closed up 23% at $1.42 after the World Well being Organization announced that it will convene an emergency committee to determine if the current monkeypox outbreak is a worldwide emergency. GeoVax has exposure to the monkeypox indication.

Advancers

CompanyPriceChange
OMER
Omeros Corporation
$1.01 +1.01  +100%
CLVS
Clovis Oncology Inc.
$1.01 +1.01  +100%
MREO
Mereo BioPharma Group plc
$1.01 +1.01  +100%
BLTE
Belite Bio Inc
$1.01 +1.01  +100%
INDP
Indaptus Therapeutics Inc.
$1.01 +1.01  +100%
TYRA
Tyra Biosciences Inc.
$1.01 +1.01  +100%
BLCM
Bellicum Pharmaceuticals Inc.
$1.01 +1.01  +100%
CRTX
Cortexyme Inc.
$1.01 +1.01  +100%
AUPH
Aurinia Pharmaceuticals Inc
$1.01 +1.01  +100%
ELYM
Eliem Therapeutics Inc
$1.01 +1.01  +100%

Decliners

CompanyPriceChange
TALS
Talaris Therapeutics Inc.
$1.01 -1.01  -100%
AKUS
Akouos Inc.
$1.01 -1.01  -100%
FEMY
Femasys Inc.
$1.01 -1.01  -100%
CLDX
Celldex Therapeutics Inc.
$1.01 -1.01  -100%
PRVB
Provention Bio Inc.
$1.01 -1.01  -100%
EPIX
ESSA Pharma Inc.
$1.01 -1.01  -100%
ADIL
Adial Pharmaceuticals Inc
$1.01 -1.01  -100%
CDAK
Codiak BioSciences Inc.
$1.01 -1.01  -100%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$1.01 -1.01  -100%
PPBT
Purple Biotech Ltd.
$1.01 -1.01  -100%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALNY – Alnylam Pharmaceuticals Inc.
AMVUTTRA (vutrisiran)
Hereditary transthyretin-mediated (hATTR) amyloidosis

$148.25
+2.40  +2%
Approved Approved June 14, 2022.
$17.9 billion

CLVS – Clovis Oncology Inc.
FAP-2286 - (LuMIERE)
FAP-positive tumors

$2.85
+1.05  +58%
Phase 1/2 Phase 1 initial data readout at SNMMI reported a confirmed RECIST partial response in one patient, noted June 14, 2022. Phase 1/2 clinical trial now enrolling patients with FAP-positive solid tumors - noted October 7, 2021. Phase 2 expansion cohorts to commence in 4Q 2022.
$410.1 million

DVAX – Dynavax Technologies Corporation
SCB-2019 (CpG 1018/Alum)
COVID-19 heterologous booster

$12.96
+0.37  +3%
Phase 3 Phase 3 study dosing initiated with initial data for 3rd dose booster groups (CoronaVac™and Comirnaty) in 3Q 2022 and the 4th dose booster group (CoronaVac) in 4Q 2022, noted June 14, 2022.-
$1.6 billion

EXAI – Exscientia Plc
EXS-21546
High adenosine signature cancers

$11.29
+0.40  +4%
Phase 1 Phase 1a data reported no CNS adverse events with dose-dependent inhibition of CREB phosphorylation in CD8-positive cells, noted June 14, 2022. Phase 1b/2 study to commence in 2H 2022.
$1.4 billion

FRLN – Freeline Therapeutics Holdings plc
FLT180a - (B-LIEVE)
Hemophilia B

$0.90
+0.03  +3%
Phase 1/2 Phase 1/2 first patient dosed, March 9, 2022. Phase 1/2 second cohort dosed June 14, 2022. Phase 1/2 interim data from first cohort to be presented at ISTH July 10, 2022. Additional data updates due in 2H 2022 and 1H 2023. Phase 3 trial planned for 1H 2023.
$58 million

IMAB – I-MAB
Eftansomatropin (TJ101) - (TALLER)
Growth hormone deficiency

$11.49
+0.19  +2%
BLA Filing Phase 3 enrollment completed June 14, 2022. BLA submission in 2023.
$949.6 million

INCY – Incyte Corporation
OLUMIANT (baricitinib)
Alopecia Areata

$77.67
+1.70  +2%
Approved Approved June 14, 2022.
$17.2 billion

MITO – Stealth BioTherapeutics Corp.
Elamipretide
Barth syndrome

$0.24
-0.01  -3%
NDA Filing NDA filed August 24, 2021. Refusal to file letter from FDA on October 20, 2021, due to issues with Phase 2 trial and open label extension. Type B meeting requested June 14, 2022.
$18 million

OTLK – Outlook Therapeutics Inc.
ONS-5010
Wet age-related macular degeneration (wet AMD)

$1.02
0.00  0%
BLA Filing BLA submitted March 31, 2022. BLA voluntarily withdrawn due to FDA information request. BLA resubmission following receipt of additional correspondence from FDA due in September 2022, noted June 1, 2022.
$230.5 million