BPC October 15 update

Upcoming small and mid-cap regulatory events for this quarter; Biotech week in review

Weekly watchlist

This week we will follow our preview of the fourth quarter with regulatory events such as PDUFA dates and Advisory Committee meetings upcoming. As earnings season lies around the corner, next week we will highlight notable earnings releases and near term catalysts.

First, let’s review the week that was with notable price-moving events in the healthcare sector.

REGULATORY UPDATES:

Ocugen, Inc. (NASDAQ: OCGN) shares traded up 22% closing the week at $8.66, after the Indian government approved its partner Bharat Biotech's COVID-19 vaccine for children aged 2-18.

An FDA advisory committee voted unanimously to recommend the COVID-19 booster shot developed by Moderna, Inc. (NASDAQ: MRNA) for use in those 65 and older or at high risk due to medical conditions or occupation. Shares closed the week up 8% at $324.

The advisory committee also voted 19-0 to recommend the COVID-19 vaccine booster shot developed by Johnson & Johnson (NYSE: JNJ) for people aged 18 and older at least two months after the first dose.

Revance Therapeutics, Inc. (NASDAQ: RVNC) announced that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA to treat moderate to severe glabellar lines.

CLINICAL UPDATES:

Inhibrx, Inc. (NASDAQ: INBX) released data from its Phase 1 trial of INBRX-101 to treat alpha-1 antitrypsin deficiency, noting that functional alpha-1 antitrypsin levels exceeded the current standard found with plasma-derived AAT. Shares closed the week up 50% at $39.71.

NRx Pharmaceuticals (NASDAQ: NRXP) announced that an open-label study of subjects ineligible to participate in its Phase 2b/3 trial of aviptadil for the treatment of COVID-19 reported an increase in 60-day overall survival compared to the standard of care. Shares closed the week up 55% at $10.26.

OTHER

A public posting of Form 483 from July 2021 dropped Revance Therapeutics, Inc. (NASDAQ: RVNC) shares lower this week closing down 18% at $22.71. The form noted that a new cell bank has yet to be qualified following a working cell bank being identified as a cause of rejected GMP lots.

Drug Price Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
ZIMHI (naloxone HCI Injection)
Opioid overdose

$0.81
0.00  -1%
Approved Approved October 18, 2021.
$121.2 million

AGEN – Agenus Inc.
Balstilimab
Cervical cancer

$3.23
-0.11  -3%
BLA Filing BLA voluntarily withdrawn October 22, 2021.
$829.6 million

AQST – Aquestive Therapeutics Inc.
Libervant (diazepam)
Epileptic seizures

$6.37
+0.13  +2%
PDUFA CRL announced September 25, 2020. NDA resubmitted with new PDUFA date December 23, 2021.
$255.8 million

BYSI – BeyondSpring Inc.
Plinabulin + G-CSF Combination
Chemotherapy-induced neutropenia (CIN)

$14.35
+1.07  +8%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$437.6 million

CLSD – Clearside Biomedical Inc.
XIPERE (Suprachoroidal CLS-TA)
Macular edema associated with uveitis

$3.95
-0.09  -2%
Approved Approved October 25, 2021.
$235.7 million

CTIC – CTI BioPharma Corp.
Pacritinib
Myelofibrosis

$2.48
+0.14  +6%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$239.8 million

ETON – Eton Pharmaceuticals Inc.
EPRONTIA (topiramate) - Oral Solution
Seizures/migraine

$4.22
-0.10  -2%
Approved FDA Approval November 8, 2021.
$103.8 million

EYEN – Eyenovia Inc.
MydCombi
Mydriasis - pupil dilation

$3.74
0.00  0%
CRL CRL issued October 25, 2021.
$106.2 million

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss

$9.64
-0.21  -2%
PDUFA CRL announced August 10, 2020. NDA resubmitted with new PDUFA date of November 27, 2021.
$250.7 million

LEGN – Legend Biotech Corporation
Ciltacabtagene autoleucel (cilta-cel) (LCAR-B38M/JNJ-4528) - CARTITUDE-1
Multiple myeloma

$54.14
-0.90  -2%
PDUFA priority review PDUFA priority review date extended to February 28, 2022.
$7.8 billion

LQDA – Liquidia Corporation
YUTREPIA (treprostinil)
Pulmonary arterial hypertension

$4.11
-0.07  -2%
Approved Tentative approval November 8, 2021. Final approval due in October 2022 or earlier upon resolution of on-going litigation.
$213.6 million

MNKD – MannKind Corporation
TYVASO (treprostinil) DPI
Pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease (PH-ILD) (WHO Group 3)

$4.63
-0.22  -5%
CRL CRL issued October 15, 2021. Resubmission planned with approval expected in summer 2022.
$1.2 billion

OYST – Oyster Point Pharma Inc.
TYRVAYA (varenicline solution)
Dry eye disease

$10.56
-0.19  -2%
Approved Approved October 18, 2021.
$276.3 million

RETA – Reata Pharmaceuticals Inc.
Bardoxolone methyl
Alport Syndrome

$81.40
-3.45  -4%
PDUFA PDUFA date February 25, 2022. Advisory committee meeting December 8, 2021.
$3 billion