BPC June 23 update

Sarepta SRPT -11% AH Hold; invoX Pharma Acquires F-star Therapeutics FSTX +60%

Price and Volume Movers

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) shares are currently trading down 11% to $64 in the after hours following a clinical hold placed by the FDA on SRP-5051 (vesleteplirsen) to treat Duchenne Muscular Dystrophy after a serious adverse event of hypomagnesemia.

BioSig Technologies, Inc. (NASDAQ: BSGM) announced that it intends to offer shares of its common stock in a "best efforts" underwritten public offering. Shares are currently trading down 22% at $0.78 during after hours.

F-star Therapeutics, Inc. (NASDAQ: FSTX) shares closed up 60% at $6.36 after it announced that it will be acquired by invoX Pharma for $7.12 per share with a total deal value of approximately $161 million.

JonesTrading initiated coverage on Rain Therapeutics Inc. (NASDAQ: RAIN) with a buy rating and a price target at $17 per share. Rain shares closed up 33% at $3.44.

uniQure N.V. (NASDAQ: QURE) shares closed up 27% at $19.54 after it released data from the low-dose cohort of its Phase 1/2 trial of AMT-130 to treat Huntington’s disease. The gene-therapy was well-tolerated with no significant safety issue, with a mean reduction of 53.8% of mutant HTT (mHTT) observed in cerebral spinal fluid (CSF) at 12 months.

Valneva SE (NASDAQ: VALN) announced the closing of its equity investment deal with Pfizer Inc. (NYSE:PFE). Pfizer invested $95 million in Valneva, representing 8.1% of Valneva's share capital at a price of €9.49 per share, through a reserved capital increase. Valneva shares closed up 27% at $31.44.

Radius Health, Inc. (NASDAQ: RDUS) shares closed up 22% at $10.84 after it announced that it would be acquired by Gurnet Point Capital and Patient Square Capital in a transaction valued at approximately $890 million, $10.00 per Radius share.

Applied Therapeutics, Inc. (NASDAQ: APLT) priced its public offering of 20 million shares and 10 million pre-funded warrants. The gross proceeds are expected to be $30 million. Shares closed down 29% at $0.76.

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

ANEB – Anebulo Pharmaceuticals Inc.
Anebulo (ANEB-001)
Cannabinoid Intoxication

$5.49
+0.29  +6%
Phase 2 Phase 2 trial initiated, noted January 3, 2022. Top-line data due July 5, 2022.
$128.2 million

AZN – AstraZeneca PLC
ALXN1840 (WTX101) - (FoCus)
Wilson disease

$65.95
-0.12  0%
Phase 3 Phase 3 top-line data met primary endpoint August 26, 2021. Phase 3 data reported at the International Liver Congress noted greater improvements in neurological scores for those treated with ALXN1840 compared to SoC, however, there were no significant differences between treatment groups observed at 48 weeks, noted June 23, 2022.
$204.4 billion

CALA – Calithera Biosciences Inc.
Mivavotinib (CB-659)
Non-Hodgkin's lymphoma

$2.42
-0.04  -2%
Phase 2 Phase 2 trial first patient enrolled June 23, 2022. Phase 2 data due in 1Q 2023.
$11.8 million

CGTX – Cognition Therapeutics Inc.
CT1812 - (SHIMMER)
Dementia with Lewy Bodies (DLB)

$2.25
+0.14  +7%
Phase 2 Phase 2 first patient treated June 23, 2022.
$50.8 million

CING – Cingulate Inc.
CTx-2103 - (buspirone)
Anxiety therapeutic

$1.48
+0.02  +1%
Phase 1 Phase 1 enrollment completion, noted June 23, 2022. Results of the study are expected in August 2022.
$16.7 million

CNSP – CNS Pharmaceuticals Inc.
Berubicin
Glioblastoma (adult)

$0.26
-0.01  -5%
Phase 2 Phase 2 first patient dosing - September 30, 2021. Phase 2 interim analysis due in 1H 2023. FDA approved protocol amendment to ongoing potentially pivotal global trial, noted June 23, 2022.
$10.6 million

DFFN – Diffusion Pharmaceuticals Inc.
Trans sodium crocetinate (TSC) - (ALTITUDE)
Peripheral tissue oxygenation in healthy volunteers

$6.77
+0.09  +1%
Phase 1 Phase 1 trial results demonstrated "carry-over" effect in subjects treated versus those who received placebo first and treatment second. The change in pH from baseline to last study measurement was also significantly lower (p<0.05) when placebo was administered for the first ascent of the day, positive effects on oxygenation observed with the 2.5 mg/kg dose at the end of the exercise interval, noted June 23, 2022. Phase 2 trial expected to commence in 2H 2022.
$13.8 million

FUSN – Fusion Pharmaceuticals Inc.
FPI-2059
Solid tumors

$2.53
+0.04  +2%
Phase 1 IND cleared June 23, 2022. Phase 1 trial planned.
$109.7 million

KALV – KalVista Pharmaceuticals Inc.
Sebetralstat (KVD900) - (KONFIDENT)
Hereditary Angioedema (HAE)

$9.90
+0.06  +1%
Phase 2 Phase 2 data to be presented at EAACI July 2, 2022. Phase 3 trial initiated, noted March 7, 2022. Phase 3 data due in 2H 2023.
$243 million

NVS – Novartis AG
Tafinlar (dabrafenib) + Mekinist (trametinib)
Solid tumors in adult and pediatric patients

$84.36
-0.17  0%
Approved Approved June 22, 2022.
$186.7 billion

QURE – uniQure N.V.
AMT-130
Huntington's disease

$19.18
+0.54  +3%
Phase 1/2 Phase 1/2 treatment was well tolerated with no significant safety issues related to AMT-130 in first two treated patients through one year of follow-up. A total of 19 patient procedures have been performed, noted December 16, 2021. Enrollment complete in first two cohorts, noted March 21, 2022. Third cohort enrollment to commence in 2H 2022. Phase 1/2 low-dose data reported that treatment was well-tolerated, and in the 6 treated patients, the increase in mean CSF NfL peaked one month and at 12 months showed an 8% increase compared to baseline, noted June 23, 2022.
$894.7 million

SCYX – SCYNEXIS Inc.
Ibrexafungerp - (VANQUISH)
Vulvovaginal Candidiasis (VVC)

$1.87
+0.01  +1%
Phase 3 Phase 3b study initiated, noted June 23, 2022.
$60.9 million

SRPT – Sarepta Therapeutics Inc.
SRP-5051 (MOMENTUM)
Duchenne muscular dystrophy

$75.71
+0.75  +1%
Phase 2 Phase 2 30 mg/kg arm data presented May 3, 2021 - mean exon skipping of 10.79% and mean dystrophin expression of 6.55%. Part B of Phase 2 trial initiated in 4Q 2021. The FDA placed a clinical hold after a serious adverse event of hypomagnesemia, noted June 23, 2022.
$6.6 billion

TMBR – Timber Pharmaceuticals Inc.
TMB-001 - (ASCEND)
Congenital Ichthyosis

$0.30
-0.01  -3%
Phase 3 Phase 3 trial initiated June 23, 2022. Breakthrough Therapy Designation received by FDA, noted May 31, 2022.
$19.4 million