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.


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

PDUFA PDUFA date October 31, 2019. Company noted as of November 4, 2019 no communication has been received from the FDA.
$65.7 million

AGRX – Agile Therapeutics Inc.
Contraceptive patch

PDUFA CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor.
$103.2 million

AMRN – Amarin Corporation plc
High Triglycerides With Mixed Dyslipidemia

PDUFA priority review PDUFA date December 28, 2019. Advisory Committee meeting November 14, 2019 voted 16-0 in favor.
$7.4 billion

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

PDUFA PDUFA date November 30, 2019.
$155.3 million

ASRT – Assertio Therapeutics Inc.
Cosyntropin depot
Adrenocortical insufficiency screening

CRL CRL announced October 21, 2019.
$60 million

AVDL – Avadel Pharmaceuticals plc
Hospital product

PDUFA PDUFA date extended by three months to December 15, 2019.
$216.8 million

CORV – Correvio Pharma Corp.
Atrial fibrillation (AF)

PDUFA PDUFA date December 24, 2019. FDA Advisory Committee meeting December 10, 2019.
$111.1 million

ETON – Eton Pharmaceuticals Inc.
Injectable hospital product

Approved FDA Approval announced October 22, 2019.
$107.5 million

FOMX – Foamix Pharmaceuticals Ltd.

Approved FDA Approval announced October 18, 2019.
$202.5 million

ITCI – Intra-Cellular Therapies Inc.

PDUFA PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
$523.9 million

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

CRL CRL announced November 11, 2019.
$10.1 million

MLNT – Melinta Therapeutics Inc.
Community-acquired bacterial pneumonia (CABP)

Approved FDA Approval announced October 24, 2019.
$18.7 million

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

Approved FDA Approval announced November 4, 2019.
$203.2 million

XLRN – Acceleron Pharma Inc.

Approved FDA Approval announced November 8, 2019.
$2.3 billion