BPC October 11 update

Ocular OCUL+15% Approval; Protagonist PTGX +94% Clinical hold removed

Price and Volume Movers

Ocular Therapeutix (NASDAQ: OCUL) announced the FDA Approval of its Supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis. Shares closed up 15% at $11.25.

Protagonist Therapeutics (NASDAQ: PTGX) announced the FDA removed the clinical hold on the Rusfertide clinical development program. After this decision, all ongoing clinical trials will resume dosing. Protagonist has planned a Phase 3 trial to commence in 1Q 2022. Shares closed the day up 94% at $35.36.

Flexion Therapeutics (NASDAQ: FLXN) announced that it will be acquired by Pacira Biosciences (NASDAQ:PCRX) for $427 million. This acquisition will allow Pacira to gain access to several promising pain drugs and bolstering growth prospects. The deal consists of $8.50 per share in cash plus one non-tradeable contingent value right (CVR) worth up to $8 per share in cash. Shares closed up 59% at $9.17.

Adamas Pharmaceuticals Inc (NASDAQ: ADMS) announced that Supernus Pharma (NASDAQ: SUPN) will acquire the drugmaker for about $400 million, as it looks to expand its portfolio of treatments for Parkinson's disease and limit reliance on its top-seller epilepsy drug. Shares closed up 75% at $8.07.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$2.92+0.42  +16.80%
CNTX
Context Therapeutics Inc.
$6.90+0.73  +11.83%
ATHA
Athira Pharma Inc.
$10.56+0.93  +9.66%
RPTX
Repare Therapeutics Inc.
$24.50+1.74  +7.64%
CABA
Cabaletta Bio Inc.
$13.94+0.99  +7.64%
BFRA
Biofrontera AG
$5.90+0.4  +7.18%
TYRA
Tyra Biosciences Inc.
$22.85+1.38  +6.43%
KALA
Kala Pharmaceuticals Inc.
$2.02+0.12  +6.32%
CMPS
COMPASS Pathways Plc
$37.44+2.13  +6.03%
MNKD
MannKind Corporation
$4.64+0.23  +5.33%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.63-2.2  -57.44%
OCUL
Ocular Therapeutix Inc.
$6.99-3.84  -35.47%
AGEN
Agenus Inc.
$3.94-1.19  -23.10%
SIOX
Sio Gene Therapies Inc.
$2.04-0.32  -13.35%
CNTB
Connect Biopharma Holdings Limited
$15.40-2.27  -12.85%
STAB
Statera Biopharma Inc.
$3.40-0.47  -12.13%
XFOR
X4 Pharmaceuticals Inc.
$4.40-0.55  -11.02%
ICVX
Icosavax Inc.
$25.00-3.08  -10.97%
APLT
Applied Therapeutics Inc.
$14.03-1.66  -10.58%
RNLX
Renalytix AI plc
$24.61-2.79  -10.20%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AMTI – Applied Molecular Transport Inc.
AMT-101 combo with with anti-TNFα (MARKET)
Ulcerative colitis

$22.98
+0.24  +1%
Phase 2 Phase 2 top-line data due January 2022.
$883 million

ATNX – Athenex Inc.
Oraxol (Oral Paclitaxel)
Metastatic breast cancer

$2.55
-0.08  -3%
CRL CRL announced March 1, 2021. Design of new clinical trial to be presented to the FDA in 4Q 2021. FDA Type A meeting held - noted October 11, 2021.
$278.7 million

AZN – AstraZeneca PLC
AZD7442 (TACKLE)
COVID-19

$61.88
+0.66  +1%
Phase 3 Phase 3 trial met primary endpoint - October 11, 2021. The trial was generally well tolerated with 18 events recorded in the AZD7442 arm (18/407) and 37 in the placebo arm (37/415).
$191.7 billion

INBX – Inhibrx Inc.
INBRX-101
Alpha-1 Antitrypsin Deficiency

$37.71
+1.15  +3%
Phase 1 Phase 1 interim results showed favorable safety profile in patients and demonstrated the potential to achieve normal AAT levels with monthly dosing, noted October 12, 2021. Phase 1 functional AAT and bronchoalveolar lavage data from the doses of 80 or 120 mg/kg IV are expected in 1H 2022.
$1.4 billion

LABP – Landos Biopharma Inc.
LABP-104
Systemic Lupus Erythematosus (SLE)

$13.97
-0.80  -5%
Phase 1 Phase 1 trial to be initiated before YE, topline results due 1H 2022. Preclinical data to be presented at the American College of Rheumatology (ACR) Convergence 2021, November 3-10, 2021.
$560.4 million

MRK – Merck & Company Inc.
Molnupiravir (MOVe-OUT)
COVID-19

$81.01
-0.16  0%
Phase 3 Phase 3 interim analysis showed risk reduction of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo - noted October 1, 2021. Emergency Use Authorization (EUA), submitted October 11, 2021.
$205.1 billion

OCUL – Ocular Therapeutix Inc.
DEXTENZA
Allergic conjunctivitis

$6.99
-3.84  -35%
Approved sNDA approved October 11, 2021.
$535.2 million

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102)
Fabry disease

$1.16
-0.01  -1%
CRL Official Type A (End-of-Review) meeting from the FDA regarding the Complete Response Letter (CRL) announced October 11, 2021.
$52.6 million

PTGX – Protagonist Therapeutics Inc.
Rusfertide (PTG-300)
Polycythemia vera

$31.09
+0.04  +0%
Phase 3 Phase 3 trial to be initiated 1Q 2022, clinical hold removed on October 11, 2021.
$1.5 billion

SRPT – Sarepta Therapeutics Inc.
SRP-9003-101
Limb-girdle muscular dystrophy type 2E (LGMD2E)

$79.36
-1.56  -2%
Phase 1/2 Phase 1/2a 3-year safety and functional data presented at WMS September 20, 2021 showed all four patients demonstrated a clinically meaningful improvement on NSAA, with a mean change from baseline to Year 3 of +7.5 (3.42 SD) and trial met primary endpoint of safety. Results from most recent study found that treated participants (n=4, ages 4 to 7 years) improved 8.6 points on the NSAA compared to a matched natural history cohort 3 years after treatment- noted October 11, 2021.
$6.8 billion

SRPT – Sarepta Therapeutics Inc.
SRP-9001-301 (EMBARK)
Duchenne Muscular Dystrophy

$79.36
-1.56  -2%
Phase 3 Phase 3 pivotal trial to enroll 120 patients between ages 4 to 7 in the US, Europe and Asia, conducted in partnership with Roche.
$6.8 billion

TPTX – Turning Point Therapeutics Inc.
TPX-0022 (CARE)
Pediatric and young adult patients with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations

$42.97
-1.27  -3%
Phase 1/2 Phase 1/2 early clinical data to be presented at the Congress of the International Society of Pediatric Oncology (SIOP) from October 21-24, 2021.
$2.1 billion