BPC June 09 update

DBV Technologies DBVT +80% Secures $194m private placement; Zynerba ZYNE +35% Files patent for CBD

Price and Volume Movers

DBV Technologies (NASDAQ: DBVT) announced a $194 million private placement of 32,855,669 shares of stock, pre-funded warrants to purchase up to 28,276,331 shares of stock. Shares closed up 80% at $3.25.

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) filed an international patent application covering a cannabidiol (CBD) in a transdermal gel as a method for treating refractory seizures in humans. Shares closed up 35% at $1.29.

Sonnet BioTherapeutics (NASDAQ: SONN) released preclinical data from its combination study of SON-1010 with an anti-PD1 compound, noting that it increased the survival rate and demonstrated efficacy in a B16F10 mouse melanoma model. Shares closed up 23% at $0.3.

William Blair downgraded Precision BioSciences (NASDAQ: DTIL) from an Outperform rating to Market Perform. Shares closed down 20% at $1.45.

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) shares closed up 26% at $1.63 after the FDA has agreed to consider a De Novo submission pathway for Symphony IL-6 Test, a near-patient testing system that provides quantitative measurements of specific biomarkers.

The FDA noted that it will need to review changes to Novavax, Inc’s (NASDAQ: NVAX) manufacturing process for its Covid-19 vaccine, after it notified the regulatory agency of changes on June 3. The review is necessary before US authorization can be granted. Shares closed down 17% at $41.48.

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

ADVM – Adverum Biotechnologies Inc.
ADVM-022 - (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
$1.18
-0.02  -2% 		Phase 1 Phase 1 additional and safety data demonstrated reductions in mean annualized anti-VEGF injections ranged from 81% in all patients to 94%, noted May 1, Phase 1 result from study reported that mean annualized anti-VEGF injections range from 81% in all OPTIC subjects to 93% in subjects with neutralizing antibody titers, with continuous and consistent therapeutic aflibercept expression levels through three years, noted June 9, 2022. Phase 2 study expected to initiate in 3Q 2022.
$116.5 million

ALNY – Alnylam Pharmaceuticals Inc.
Cemdisiran
IgA nephropathy
$148.25
+2.40  +2% 		Phase 2 Phase 2 data reported a 37% mean reduction from baseline in the 24-hour urine protein to creatinine ratio relative to placebo, noted June 9, 2022.
$17.9 billion

BBIO – BridgeBio Pharma Inc.
Encaleret
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
$9.92
+0.84  +9% 		Phase 3 Phase 2b treatment data presented at ENDO resulted in rapid and sustained restoration of normal mineral homeostasis, with mean values of blood calcium, urinary calcium, and blood PTH within the normal range by day 5 of therapy and sustained at 24 weeks, and was well-tolerated without any reported serious adverse events, noted June 13, 2022. Phase 3 trial planned to initiate in 2022, with top-line data due in 2023.
$1.5 billion

BPMC – Blueprint Medicines Corporation
AYVAKIT (avapritinib) - (PIONEER)
Indolent and smoldering systemic mastocytosis (SM)
$49.93
-0.58  -1% 		Phase 2 Phase 2 trial primary endpoint to be updated to mean change in total symptom score, previously a key secondary endpoint, based on U.S. FDA recommendation, noted June 9, 2022. Phase 2 top-line data (Part 2) due in late-summer 2022. NDA planned for 2H 2022.
$3 billion

BPMC – Blueprint Medicines Corporation
AYVAKIT (avapritinib) - (EXPLORER)
Advanced Systemic mastocytosis (SM)
$49.93
-0.58  -1% 		Phase 1 Phase 1 top-line data released September 22, 2020. 76% confirmed ORR, with a median duration of response of 46.9 months, noted from EHA abstract on June 9, 2022.
$3 billion

CLBS – Caladrius Biosciences Inc.
CEND-1 in combination with gemcitabine and nab-paclitaxel - (ASCEND)
1L metastatic pancreatic ductal adenocarcinoma
$0.53
0.00  0% 		Phase 2b Phase 2b first patient dosed, noted June 9, 2022.
$32.1 million

FUSN – Fusion Pharmaceuticals Inc.
FPI-1434
Solid tumors
$2.53
+0.04  +2% 		Phase 1 Phase 1 pre-administration data reported a favorable gain in tumor lesion uptake versus normal tissue, noted June 14, 2022. Phase 1 multi-dose safety and imaging data due in 1H 2023.
$109.7 million

IMNM – Immunome Inc.
IMM-BCP-01
COVID-19
$3.39
+0.18  +6% 		Phase 1b The FDA issued a clinical hold letter requesting further information related to the preparation and administration of the dose cocktail, noted January 10, 2022. Clinical hold lifted March 11, 2022. Phase 1b dosing initiated, noted June 9, 2022. Phase 1b topline data expected 2H 2022.
$41.1 million

OLMA – Olema Pharmaceuticals Inc.
OP-1250
HR+, HER2- Breast Cancer
$4.18
+0.11  +3% 		Phase 1/2 Phase 1/2 continues to enroll patients, with selection of recommended Phase 2 dose expected June 2022 followed by enrollment into Phase 2 portion of trial. Phase 1/2 monotherapy and combination data due in 2H 2022. Pivotal monotherapy trial to be initiated in 2023.
$168.7 million

RHHBY – Roche Holding AG ADR
TPST-1120 and OPDIVO (nivolumab)
Hepatocellular Carcinoma (HCC), Solid tumors
$42.01
+0.30  +1% 		Phase 1/2 Phase 1 monotherapy and combination data reported an 30% ORR in two highest doses and only stable disease in the monotherpy, noted June 9, 2022. Phase 1b/2 objective response data expected by year-end 2022 or early 2023.
$269 billion

STSA – Satsuma Pharmaceuticals Inc.
STS101 - (ASCEND)
Migraine
$4.32
+0.18  +4% 		Phase 3 Phase 3 initial data presented at AHA reported that when asked at the 3-month and 6-month assessments to compare STS101 to their usual migraine medication, patients reported that 68.9% and 75.5% of subjects agreed or strongly agreed that STS101 helped them return to normal faster than their usual medication, noted June 13, 2022. Phase 3 top-line data due in 2H 2022.
$136.3 million

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
TAK-003 - (TIDES)
Dengue Vaccine
$14.09
+0.05  +0% 		Phase 3 Phase 3 data reported that treatment prevented 84% of hospitalizations and 61% of symptomatic dengue illness overall, with identified safety risks, noted June 9, 2022.
$43.8 billion

VRNA – Verona Pharma plc
Ensifentrine (RPL554) - (ENHANCE-1 and ENHANCE-2)
Chronic obstructive pulmonary disease (COPD)
$4.30
+0.11  +3% 		Phase 3 Phase 3 ENHANCE-2 topline data due in 3Q 2022 and ENHANCE-1 by year end 2022. Phase 3 ENHANCE-2 enrollment completed in January 24, 2022. Phase 3 ENHANCE-1 enrollment complete noted June 9, 2022. NDA filing due 1H 2023.
$259.6 million

ZLAB – Zai Lab Limited
SUL-DUR - (ATTACK)
Acinetobacter baumannii infections
$38.54
+3.86  +11% 		NDA Filing Phase 3 data presented at ATS reported that twice as many deaths occurred in the colistin arm than in the SUL-DUR arm through Day 28, noted May 17, 2022. NDA filing due in 4Q 2022.
$2.9 billion