BPC August 10 update

13 small and mid cap biotech stocks with upcoming PDUFA / Advisory Committee dates through to October

Weekly watchlist

A stream of price-moving clinical trial and regulatory related news, coupled with peak earnings season, saw last week as one of the most eventful in recent times. We review some of the key events, while our upcoming catalyst list looks at PDUFA dates and Advisory Committee meetings for small and mid-cap biotech companies through to the end of October.

Allakos Inc. (Nasdaq: ALLK) shares soared to close the week up 174% to $84.88 following news that it met all primary and secondary endpoints in its Phase 2 trial of AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis.

Avedro, Inc. (NASDAQ: AVDR) shares closed the week up 29% to $23.07 following Wednesday’s news of the proposed acquisition by Glaukos Corporation (NYSE: GKOS).

Nektar Therapeutics (NASDAQ: NKTR) shares closed Friday down 29% to $20.92 on news that suboptimal batches of NKTR-214, in combination with Bristol-Myers’ Opdivo, were given to some patients in trials, which caused a softening of responses.

Amarin Corporation plc (NASDAQ: AMRN) announced Thursday that the FDA plans to hold an Advisory Committee on November 14, 2019 to discuss its supplemental new drug application (sNDA) of Vascepa. The news took investors by surprise as no meeting had been expected. As a result, the PDUFA date will be extended, with Amarin estimating a three-month extension, which would render a PDUFA date in late-December. Shares closed Friday down 17% to $14.77.

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) shares closed the week down 13% to $5.02 following news that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The FDA indicated that efficacy data from its STRIDE 3 Phase 3 clinical trial, due in 4Q 2019, are required in order to resubmit the NDA.

Clovis Oncology, Inc. (NASDAQ: CLVS) shares closed the week down 39% to $5.68 following a double hit on Wednesday. Competitors AstraZeneca and Merck announced positive data from a Phase 3 trial of Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC). Clovis also announced an offering of $225m of convertible notes.

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares endured a tumultuous session on Thursday following reports of an adverse event (rhabdomyolysis) that was submitted to the FDA’s adverse event reporting system (FAERs), in a participant of its SRP-9001-102 micro-dystrophin gene therapy trial in patients with Duchenne muscular dystrophy. The company later announced that the report was erroneously submitted and the drug safety monitoring board has reviewed the issue and recommended the study continue uninterrupted. However, shares still closed lower for the week, down 14% to $126.11.

Upcoming PDUFA / Advisory Committee dates through to October:

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 2Q 2020.
$26.4 million

AGRX – Agile Therapeutics Inc.
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$157.6 million

AIMT – Aimmune Therapeutics Inc.
Peanut Allergy

Approved FDA approval announced January 31, 2020.
$963.3 million

ARDX – Ardelyx Inc.
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)

Approved FDA approval announced September 12, 2019.
$477.6 million

ASRT – Assertio Therapeutics Inc.
Cosyntropin depot
Adrenocortical insufficiency screening

CRL CRL announced October 21, 2019.
$55.3 million

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

NDA Filing CRL received October 18, 2019. To resubmit by the end of August 2020.
$72.2 million

ETON – Eton Pharmaceuticals Inc.
Injectable hospital product

Approved FDA Approval announced October 22, 2019.
$79.9 million

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

Approved FDA Approval announced October 24, 2019.

MNLO – Menlo Therapeutics Inc.

Approved FDA Approval announced October 18, 2019.
$62.9 million

NBRV – Nabriva Therapeutics plc
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Approved FDA approval announced August 19, 2019.
$53 million

PFNX – Pfenex Inc.

Approved FDA approval announced October 7, 2019.
$302.5 million

SRPT – Sarepta Therapeutics Inc.
Golodirsen - Exon 53
Duchenne muscular dystrophy

Approved FDA Approval announced December 12, 2019.
$7.8 billion

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$64.2 million