BPC June 15 update

ACADIA ACAD +16% Advisory Committee briefing documents released; Evoke EVOK +47% Makes the Medicaid Preferred Drug List

Price and Volume Movers

Evoke Pharma, Inc. (NASDAQ: EVOK) shares closed up 47% at $3 after the Florida Medicaid Pharmaceutical & Therapeutics Committee approved its treatment for diabetic gastroparesis, GIMOTI, for the Florida Medicaid Preferred Drug List (PDL).

Aquestive Therapeutics, Inc. (NASDAQ: AQST) reported topline data from Part 3 of its Phase 1 EPIPHAST trial of AQST-109 to treat allergic reactions, including anaphylaxis. Data reported that treatment is safe and that the fastest median time to maximum concentration (Tmax) was at 12 minutes. Shares are currently trading up 31% at $1.15 during the after hours.

Pfizer (NYSE: PFE), BioNTech (NASDAQ: BNTX) and Moderna (NASDAQ: MRNA) both closed up today after an FDA Advisory Committee recommended emergency use authorization for both companies’ COVID-19 vaccine for children as young as 6 months old. Pfizer shares closed up 1% at $48.51, BioNTech shares closed up 2% at $137.99, and Moderna shares closed up 6% at $128.53.

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) closed up 16% to $18.77 after the FDA posted briefing documents ahead of the Advisory Committee for NUPLAZID (pimavanserin) to treat Alzheimer’s disease psychosis. The FDA previously issued a complete response rate (CRL) for its application after noting that no statistical separation was observed from placebo in any dementia subgroup other than the Parkinson’s disease dementia (PDD) subgroup. No safety issues were identified in the application.

VectivBio Holding AG (NASDAQ: VECT) announced the pricing of its public offering of 5,715,000 shares at $5.25 per share. The gross proceeds are to be approximately $30 million. Shares closed down 12% at $5.25.

Clovis Oncology (NASDAQ: CLVS) released Phase 1 data for its radionuclide therapy FAP-2286 in solid tumors. Data reported that one patient had a confirmed partial response. Shares closed up 19% at $0.96.

Kintara Therapeutics, Inc. (NASDAQ: KTRA) shares closed up 25% to $0.23 after the FDA granted Fast Track Designation to VAL-083.

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

HEPA – Hepion Pharmaceuticals Inc.
Rencofilstat (CRV431) - (ASCEND-NASH)
Non-alcoholic steatohepatitis

$0.58
+0.01  +2%
Phase 2a Phase 2a data released July 13, 2021. Primary endpoints met. Phase 2b activities initiated September 13, 2021. Phase 2b screening and enrollment to begin in 3Q 2022.
$44.6 million

IMUX – Immunic Inc.
Vidofludimus calcium (IMU-838) - (EMPhaSIS)
Relapsing-remitting multiple sclerosis (RMS)

$3.47
0.00  0%
Phase 3 Phase 3 trial met its primary and key secondary endpoints for suppressing the number of combined unique active magnetic resonance imaging lesions, noted June 15, 2022.
$106 million

KYMR – Kymera Therapeutics Inc.
KT-413 - (IRAKIMiD)
Diffuse large B-cell lymphoma (DLBCL)

$21.10
+1.41  +7%
Phase 1 Phase 1 first patient dosed noted June 15, 2022. Phase 1 data due in 2H 2022.
$1.1 billion

KYMR – Kymera Therapeutics Inc.
KT-333 - (STAT3)
Solid tumors

$21.10
+1.41  +7%
Phase 1 Phase 1 first patient dosed June 15, 2022. Phase 1 data due in 2H 2022.
$1.1 billion