BPC June 21 update

Paratek PRTK +36% AH Granted Fast Track Designation; 9 Meters NMTR -44% Phase 3 terminated

Price and Volume Movers

9 Meters Biopharma, Inc. (NASDAQ: NMTR) shares fell 44% closing at $0.29 after it announced the termination of its Phase 3 trial of Larazotide to treat celiac disease. The termination follows an interim analysis that had limited enrollment and a lack of statistical significance.

Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) shares are trading up 36% at $2.56 during after hours trading following the FDA granting Fast Track designation for NUZYRA to treat Pulmonary Nontuberculous Mycobacterial (NTM) Disease caused by Mycobacterium Avium Complex (MAC) and Mycobacterium Abscessus (MAB).

Kiromic BioPharma, Inc. (NASDAQ: KRBP) laid out its plans for its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT. Kiromic will submit three Investigational New Drug (IND) applications, including one for Deltacel in combination with a standard antitumor modality in the second half of 2022. Shares closed up 23% at $0.49.

BeiGene (NASDAQ: BGNE) shares closed up 16% at $152.67 after it announced the acceptance of its supplemental biologics license application (sBLA) in China for tislelizumab with chemotherapy to treat metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

Valneva SE (NASDAQ: VALN) shares closed up 93% at $26.48 after Pfizer Inc (NYSE: PFE) announced that it will invest €90.5 million ($95 million) for an 8.1% stake in Valneva in a collaborative agreement with to develop the lyme disease vaccine candidate, VLA15.

Acer Therapeutics, Inc (NASDAQ: ACER) and its collaboration partner, Relief Therapeutics Holding SA's (OTC: RLFTF) received a Complete Response Letter for its New Drug Application (NDA) of ACER-001 (sodium phenylbutyrate) to treat urea cycle disorders (UCDs). The CRL was due to FDA’s inability to investigate Acer's third-party contract packaging manufacturer. A resubmission of the NDA is due in third quarter 2022. Acer shares closed down 21% at $1.39 and RLFTF shares closed down 12% at $0.03.

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

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

$1.28
+0.02  +2%
NDA Filing CRL announced June 21, 2022. NDA resubmission planned for early to mid-3Q 2022.
$20 million

AZN – AstraZeneca PLC
LYNPARZA (olaparib) - (PROpel)
Castration-resistant prostate cancer -first line

$65.95
-0.12  0%
Phase 3 Phase 3 trial met primary endpoint, reporting that treatment reduced the risk of disease progression or death by 34% versus abiraterone alone, noted June 21, 2022.
$204.4 billion

CLDX – Celldex Therapeutics Inc.
Barzolvolimab (CDX-0159)
Chronic spontaneous urticaria (CSU)

$22.70
-4.26  -16%
Phase 2 Phase 1b data reported a complete response rate of 57.1% in 1.5 mg/kg dose group at week 12 and 44.4% at 8 weeks in 3 mg/kg dose group, noted June 30, 2022. Phase 2 trial initiated June 21, 2022.
$1.1 billion

CLSN – Celsion Corporation
GEN-1 - (OVATION 2)
Ovarian cancer

$1.93
+0.09  +5%
Phase 2 Data Safety Monitoring Board (DSMB) has unanimously recommended that the study continue treating patients with the dose of 100 mg/m2, noted June 21, 2022.
$13.7 million

ETNB – 89bio Inc.
BIO89-100
Nonalcoholic steatohepatitis (NASH)

$3.24
+0.02  +1%
Phase 1/2 Phase 1b/2a data reported that treatment reduced spleen volume by an average of 11.8% in NASH patients, noted November 14, 2021. Additional Phase 1b/2a data reported that 63% of patients achieved 2-point or greater improvement in NAS without worsening of fibrosis, noted January 24, 2022. Additional Phase 1b/2a data presented at EASL reported that in the cohort of NASH subjects PGZ led to a meaningful reductions in extra-hepatic metabolic parameters, noted June 27, 2022.
$65.9 million

EXEL – Exelixis Inc.
XL092 with atezolizumab - (STELLAR-303)
Colorectal Cancer (CRC)

$21.57
+0.75  +4%
Phase 3 Phase 3 trial initiated June 21, 2022.
$6.9 billion

IONS – Ionis Pharmaceuticals Inc.
AKCEA-TTR-LRx (NEURO-TTRansform)
ATTR Amyloidosis

$38.06
+1.04  +3%
Phase 3 Phase 3 35-week interim analysis demonstrated a statistically significant and clinically meaningful change from baseline for the co-primary endpoints of percent change in serum transthyretin (TTR) concentration and the modified Neuropathy Impairment Score +7 (mNIS+7) versus the historical placebo group, noted June 21, 2022. Additional data and NDA to be submitted in 2022.
$5.4 billion

MRK – Merck & Company Inc.
V116-001
Pneumococcal conjugate vaccine

$92.42
+1.25  +1%
Phase 1/2 Breakthrough Therapy designation granted April 14, 2022. Phase 1/2 study met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX 2 (Pneumococcal Vaccine Polyvalent) across age groups, noted June 21, 2022. Phase 3 trial planned for 2022.
$233.7 billion

NMTR – 9 Meters Biopharma Inc.
Larazotide
Celiac disease

$0.22
-0.04  -14%
Phase 3 Phase 3 interim analysis reported that the additional number of patients needed to determine a significant clinical outcome between placebo and larazotide is too large to support trial continuation, noted June 21, 2022.
$58.3 million

NVCR – NovoCure Limited
Tumor Treating Fields (TTFields) with KEYTRUDA (pembrolizumab) - (KEYNOTE-B36)
Non-small cell lung cancer (NSCLC)

$73.30
+3.80  +5%
Phase 2 Phase 2 pilot study, first patient enrolled June 21, 2022.
$7.7 billion

PRTK – Paratek Pharmaceuticals Inc.
NUZYRA (omadacycline)
Non-tuberculous mycobacteria (NTM)

$1.96
+0.03  +2%
Phase 2b Phase 2b first patient enrolled October 18, 2021. Enrollment ongoing.
$106.8 million