BPC October 11 update

14 small/mid-cap PDUFA and Advisory Committee Meeting dates through to December; Biotech week in review

Weekly watchlist

Over the past two weeks we have highlighted key upcoming Phase 1/2 and Phase 3 clinical readouts slated for release this quarter. We complete our preview this week, highlighting regulatory events for small and mid-cap biotech stocks. Such events cover both Advisory Committee Meeting and PDUFA dates.

First, let’s review the week that was with a summary of price-moving events.

Pfenex Inc. (NYSE American: PFNX) announced Monday that the FDA approved the New Drug Application (NDA) for PF708 for the treatment of osteoporosis. Shares closed the week up 19% to $8.88.

Akcea Therapeutics, Inc. (NASDAQ: AKCA) shares closed the week up 31% to $19.75 following news of a license agreement with Pfizer Inc. (NYSE:PFE) for AKCEA-ANGPTL3-LRx, a therapy being developed to treat patients with certain cardiovascular and metabolic diseases. Akcea, and its parent company, Ionis, will each receive $125m upfront, and will also be eligible to receive milestone payments of up to $1.3b.

Clinuvel Pharmaceuticals Limited (OTC: CLVLY) received FDA approval Tuesday for Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. Shares closed the week up 37% to $24.80.

Ra Pharmaceuticals Inc. (NASDAQ: RARX, Ra Pharma) shares surged Thursday to close up 101% to $45.64 on news that it is set to be acquired by UCB for $48 per share, equivalent to approximately $2.1b.

OncoSec (NASDAQ: ONCS) shares closed Thursday up 35% to $2.21 following its announcement it will receive a $30m investment from China Grand Pharmaceutical (CGP) and its affiliate Sirtex at $2.50 per share, for a 53% share of the company and an option to acquire the remaining shares.

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) announced it is reacquiring rights to bardoxolone methyl (bardoxolone) and omaveloxolone from Abbvie. AbbVie will receive a total of $330m in cash. Reata will make an upfront payment of $75m in 2019, with the remainder payable in 2020-21. Shares closed the week up 19% to $95.81.

Aclaris Therapeutics, Inc. (Nasdaq: ACRS) announced Thursday it has divested Rhofade, a topical treatment of persistent facial erythema (redness) associated with rosacea, to EPI Health. Aclaris will receive $35m upfront and potential sales milestone payments of up to $20m. Shares closed Friday up 19% to $1.42.

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14 small/mid-cap PDUFA and Advisory Committee Meeting dates through to December:

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
Higher Dose Naloxone Injection
Opioid overdose

NDA Filing CRL announced November 25, 2019. NDA to be refiled early-2Q 2020.
$34.9 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$232.9 million

AMRN – Amarin Corporation plc
Vascepa
High Triglycerides With Mixed Dyslipidemia

Approved FDA Approval announced December 13, 2019.
$5.3 billion

AQST – Aquestive Therapeutics Inc.
Exservan (riluzole) Oral Film
Amyotrophic Lateral Sclerosis

Approved FDA Approval announced November 22, 2019.
$123.4 million

ASRT – Assertio Therapeutics Inc.
Cosyntropin depot
Adrenocortical insufficiency screening

CRL CRL announced October 21, 2019.
$87.1 million

AVDL – Avadel Pharmaceuticals plc
AV001
Neonate Patients Requiring Total Parental Nutrition (TPN)

Approved FDA Approval announced December 16, 2019.
$375.4 million

CORV – Correvio Pharma Corp.
Brinavess
Atrial fibrillation (AF)

CRL CRL announced December 24, 2019.
$23.2 million

ETON – Eton Pharmaceuticals Inc.
ET-202
Injectable hospital product

Approved FDA Approval announced October 22, 2019.
$96.2 million

FOMX – Foamix Pharmaceuticals Ltd.
FMX101
Acne

Approved FDA Approval announced October 18, 2019.
$220.5 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone
Schizophrenia

Approved FDA Approval announced December 23, 2019.
$1.2 billion

LPCN – Lipocine Inc.
TLANDO - LPCN 1021
Men with low testosterone (Low T)

NDA Filing CRL announced November 11, 2019. NDA to be resubmitted 1Q 2020.
$18.7 million

MLNT – Melinta Therapeutics Inc - Ordinary Shares
Baxdela
Community-acquired bacterial pneumonia (CABP)

Approved FDA Approval announced October 24, 2019.
$

RDHL – Redhill Biopharma Ltd.
Talicia RHB-105
H. pylori

Approved FDA Approval announced November 4, 2019.
$145.7 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Beta-thalassemia

Approved FDA Approval announced November 8, 2019.
$4.6 billion