BPC November 08 update

12 Small and Mid-Cap PDUFA and Advisory Committee dates through to January; Biotech Earnings Calendar; Week in Review

Weekly watchlist

A volatile week in the biotech sector saw a couple companies registering gains of over 100% for the week on the back of meeting abstracts, while another three saw more than half of their value wiped off following disappointing late-stage data. We summarize these stocks and other price movers for the week while also looking ahead to the final week of earnings for 2019 and upcoming PDUFA and Advisory Committee dates through to January. Most eyes will no doubt be on the Amarin Advisory Committee meeting to be held on Thursday November 14, with briefing notes likely to be released on the morning of Tuesday November 12.

Constellation Pharmaceuticals Inc (NASDAQ: CNST) shares surged to close the week up 119% to $30.91 following the release of its abstract of CPI-0610 for next month’s ASH conference. Preliminary data from the Phase 2 trial in patients with treatment naïve myelofibrosis noted that all 4 evaluable patients achieved both ≥35% SVR (spleen volume reduction) and ≥50% improvement in TSS (total symptom score) as early as 3 months after treatment.

NextCure, Inc. (NASDAQ: NXTC) was the other big mover, with shares closing the week up 203% to $82.89 following the release of its abstract of NC318 for the SITC conference. Data from its Phase 1/2 trial in patients with solid tumors noted single agent activity was evident in patients with non-small cell lung cancer (NSCLC). One complete response and one partial response (response rate 29% 2/7) was recorded, while the disease control rate was 71% (5/7).

AnaptysBio, Inc. (Nasdaq: ANAB) announced that its Phase 2b ATLAS trial of etokimab in moderate-to-severe atopic dermatitis failed to meet the primary endpoint. Shares slumped to close Friday down 72% to $10.18 In response, Dermira, Inc. (NASDAQ: DERM) shares rallied to close up 18% to $8.23 with its lead pipeline candidate, lebrikizumab, slated to release data from a Phase 3 trial for atopic dermatitis in 1H 2021.

FibroGen, Inc. (NASDAQ:FGEN) shares rallied to close Friday up 10% to $41.62 following the release of pooled analyses of data from six global pivotal Phase 3 trials investigating roxadustat, as a treatment for anemia in chronic kidney disease (CKD). In the Non-Dialysis Dependent (NDD) patient population risks of MACE (Major Adverse Cardiovascular Event), MACE+, in roxadustat patients were comparable to placebo and comparable or in some cases better than that of epoetin alfa in patients on dialysis.

ObsEva SA (NASDAQ: OBSV) announced Thursday its Phase 3 trial of nolasiban (IMPLANT 4) in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF) did not meet the primary endpoint of an increase in ongoing pregnancy rate. Shares closed the week down 62% to $3.00.

Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares slid to close the week down 64% to $2.00. The company announced that it met the primary endpoint in its Phase 3 URIROX-1 trial evaluating reloxaliase in patients with enteric hyperoxaluria (EH). However, the lead secondary endpoint was not met, with the proportion of patients on reloxaliase with a ≥20% reduction from baseline in 24-hour urinary oxalate excretion measuring 48.3%, compared to 31.6% for patients on placebo (p=0.06).

Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) announced its Phase 3 P301 trial of SPN-810 in patients with ADHD, did not meet its primary endpoint. Shares closed the week down 25% to $21.72.

Therapix Biosciences Ltd (NASDAQ: TRPX) announced that its proposed merger with Destiny Biosciences Global Corp will not proceed. Shares closed Friday down 28% to $1.76.

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Selection of 15 companies reporting 3Q earnings week of November 11:

Mon: FOLD FGEN FOMX

Tue: AKBA AVDL BDSI CPRX EGRX HALO NBRV ONCY RETA SAGE TOCA

Wed: ALPN


12 Small and Mid Cap PDUFA and Advisory Committee dates through to January:

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.
Twirla
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

AIMT – Aimmune Therapeutics Inc.
AR101
Peanut Allergy

PDUFA PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019 voted in favor of supporting approval.
$1.7 billion

AMRN – Amarin Corporation plc
Vascepa
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

AVDL – Avadel Pharmaceuticals plc
AV001
Hospital product

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

BHC – Bausch Health Companies Inc.
IDP-123
Psoriasis

PDUFA PDUFA date December 22, 2019.
$9.8 billion

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

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

DRRX – DURECT Corporation
POSIMIR
Post-operative pain relief

PDUFA CRL Feb 12 2014. New PDUFA date December 27, 2019. Advisory Committee meeting scheduled for January 16, 2020 will result in PDUFA date extension.
$342.4 million

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

PDUFA priority review PDUFA date priority review January 23, 2020.
$1.5 billion

ITCI – Intra-Cellular Therapies Inc.
Lumateperone
Schizophrenia

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

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

CRL CRL announced November 11, 2019.
$10.1 million