BPC July 06 update

Provention PRVB issued CRL - shares fall 26%; ChemoCentryx CCXI PDUFA date extended - October 7, 2021

Price and Volume Movers

Advaxis, Inc.(NASDAQ:ADXS) shares closed up 23% to $0.58 following news of a merger with Biosight Ltd. Shareholders of Biosight will own 75% of the combined company, which is expected to occur in the second half of 2021. Advaxis will be renamed Biosight Therapeutics under the ticker symbol "BSTX".

Provention Bio, Inc. (Nasdaq: PRVB) announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. The CRL noted that the planned commercial product failed to show pharmacokinetic (PK) comparability with drug product originating from drug substance manufactured for historic clinical trials. The company expects relevant additional PK/PD will be available later this quarter and following review of the data a decision will be made whether to submit the data to the FDA or justify why PK comparability is not necessary. Shares fell 26% to $6.11.

ChemoCentryx, Inc., (Nasdaq: CCXI) announced that it filed an amendment to its New Drug Application (NDA) for avacopan for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on May 6, 2021. The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new PDUFA goal date of October 7, 2021. Shares closed up 7% to $14.05.

Alector Inc (NASDAQ: ALEC) shares gained a further 12% to $39.44, adding to Friday’s surge of 57% following news of a collaboration with GlaxoSmithKline plc (NYSE: GSK) for development of treatments for various neurodegenerative diseases including Parkinson's disease and Alzheimer's disease. Alector recives $700 million upfront and up to $1.5 billion in milestone payments.

IDEAYA Biosciences, Inc. (Nasdaq:IDYA) announced that it intends to offer and sell $80 million of shares of its common stock in an underwritten public offering. Shares are trading down 10% to $20.50.

OncoSec Medical Incorporated (NASDAQ:ONCS) shares are trading up 24% after hours to $3.46 on news of a collaboration with Merck to evaluate TAVO (tavokinogene telseplasmid) with Merck's KEYTRUDA (pembrolizumab), in a Phase 3 randomized clinical trial, KEYNOTE-C87, in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.

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Other major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Soligenix, Inc. (SNGX): $1.31; +26%.

Tempest Therapeutics Inc. (TPST): $13.24; +18%.

Larimar Therapeutics, Inc. (LRMR): $11.43; +16%.

Taiwan Liposome Company, Ltd. (TLC): $6.57; +15%.

Connect Biopharma Holdings Limited (CNTB): $21.98; +12%.

DECLINERS:

Passage Bio, Inc. (PASG):$13.26; -15%.

Werewolf Therapeutics, Inc. (HOWL): $17.43; -14%.

Beam Therapeutics Inc. (BEAM): $112.97; -13%.

Replimune Group, Inc. (REPL): $34.64; -12%.

Achilles Therapeutics plc (ACHL):

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADIL – Adial Pharmaceuticals Inc
AD04 (ONWARD)
Alcohol use disorder

$4.19
+0.01  +0%
Phase 3 Phase 3 trial enrollment closed August 20, 2021 with data due 1Q 2022.
$85.7 million

ANIP – ANI Pharmaceuticals Inc.
Cortrophin Gel
Acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis

$28.89
+0.91  +3%
PDUFA Refusal to File (RTF) letter announced April 29, 2020. sNDA resubmitted with PDUFA date of October 29, 2021.
$368.4 million

ARWR – Arrowhead Pharmaceuticals Inc.
ARO-HIF2
Clear Cell Renal Cell Carcinoma

$64.93
+1.27  +2%
Phase 1b Phase 1b interim data released July 6, 2021. 1/10 partial responses in cohort 2.
$6.8 billion

ASND – Ascendis Pharma A/S
TransCon - PaTHway
Hypoparathyroidism

$161.51
+2.29  +1%
Phase 3 Phase 3 top-line data due 1Q 2022.
$9.2 billion

CCXI – ChemoCentryx Inc.
Avacopan (CCX168) - (ADVOCATE)
Associated vasculitis (AAV)

$16.57
+0.58  +4%
PDUFA Advisory Committee May 6, 2021 voted 10-8 that the benefit-risk and safety profiles are adequate to support approval and 9-9 that the efficacy data supports approval. PDUFA date extended by three months to October 7, 2021.
$1.2 billion

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystic fibrosis

$1.87
+0.12  +7%
Phase 2 Phase 2 data due 4Q 2021.
$161.2 million

IPHA – Innate Pharma S.A.
Avdoralimab - (FORCE)
COVID-19

$8.10
+2.35  +41%
Phase 2 Phase 2 trial did not meet primary endpoints - July 6, 2021.
$641.1 million

KURA – Kura Oncology Inc.
Tipifarnib and PIQRAY​ (alpelisib) - (KURRENT)
Head and Neck Squamous Cell Carcinoma

$20.96
+0.78  +4%
Phase 1/2 Phase 1/2 trial to commence 4Q 2021.
$1.4 billion

LGVN – Longeveron Inc.
Lomecel-B (ELPIS II)
Hypoplastic Left Heart Syndrome

$3.62
+0.03  +1%
Phase 2 Phase 2 trial initiation of dosing announced July 6, 2021. Phase 1 met primary safety endpoint, secondary endpoints suggest Lomecel-B may improve patient long-term clinical outcome after surgery: 100% (10) of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years after cardiac surgery. Noted September 9, 2021.
$69.2 million

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab)
Cutaneous squamous cell carcinoma (cSCC)

$71.68
-0.29  -0%
Approved FDA approval announced July 6, 2021.
$181.4 billion

OPNT – Opiant Pharmaceuticals Inc.
OPNT003
Opioid Overdose

$22.38
-0.96  -4%
Phase 1 PD data due 4Q 2021.
$98.5 million

PRVB – Provention Bio Inc.
Teplizumab (PRV-031)
Type 1 diabetes

$6.67
+0.22  +3%
CRL CRL issued on July 2, 2021. FDA Type A meeting on PK Model in 4Q 2021.
$422.7 million

SEEL – Seelos Therapeutics Inc.
SLS-002
Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD)

$2.00
+0.03  +2%
Phase 2 Phase 2 Part 1 data released May 17, 2021. 76.5% response rate in the primary endpoint on MADRS 24 hours after dosing. Mean reduction from 39.4 to 14.5 points. Initiation of Part 2 dosing announced July 6, 2021.
$204.6 million

TRIL – Trillium Therapeutics Inc.
TTI-622
Refractory multiple myeloma

$17.34
+0.04  +0%
Phase 1/2 Phase 1b/2 initiation of dosing of azacitidine and venetoclax combo announced July 6, 2021.
$1.8 billion