BPC November 07 update

​ObsEva OBSV and Allena ALNA shares slide on late-stage data readouts; ​Clovis CLVS +21% on earnings

Price and Volume Movers

ObsEva SA (NASDAQ: OBSV) shares slumped to close down 65% to $2.81 following news 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 at 10 weeks, (39.1 % placebo vs 40.5 % nolasiban) (p = 0.745).

Clovis Oncology, Inc. (NASDAQ: CLVS) shares closed up 21% to $4.32 following its report of third quarter earnings. Net product revenue for the first nine months of 2019 was $103.7m compared to $65m for same period in 2018. Revenue also increased 14% in the quarter compared with the second quarter of 2019.

Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares closed down 62% to $2.24 following its announcement of top-line data from its Phase 3 URIROX-1 trial evaluating reloxaliase in patients with enteric hyperoxaluria (EH). The company noted the trial met its primary endpoint, demonstrating a statistically significant change from baseline in 24-hour urinary oxalate (UOx) excretion compared to placebo (p=0.004). However, the lead secondary endpoint was not met, with the proportion of patients on reloxaliase with a ≥20% reduction from baseline in 24-hour UOx excretion of 48.3%, compared to 31.6% for patients on placebo (p=0.06).

Collegium Pharmaceutical, Inc. (NASDAQ: COLL) shares closed up 31% to $18.00 following its third quarter earnings release Wednesday. Xtampza ER net revenues were $26.5m for 3Q 2019, a 56% increase compared with the same period in 2018.

Therapix Biosciences Ltd (NASDAQ: TRPX) announced that its proposed merger with Destiny Biosciences Global Corp will not proceed. Shares closed the after hours session down 18% to $2.00.

Alimera Sciences, Inc. (NASDAQ:ALIM) announced that it will effect a 1-for-15 reverse stock split effective on November 14, 2019. Shares closed after hours down 21% to $0.22.

EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) shares closed down 28% to $1.66 following its earnings report. Revenue for the quarter of $2.5m fell short of expectations.

Affimed N.V. (Nasdaq: AFMD) announced that it has commenced an underwritten public offering of its common shares.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced top-line data from its Phase 3 VANISH-303 trial of oral ibrexafungerp as a treatment for women with vulvovaginal candidiasis (VVC) met the primary endpoint, achieving superiority over placebo at a highly statistically significant level (p≤0.001). Shares, however, sold off on the news, closing down 7% to $1.19.


Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume


RAPT Therapeutics, Inc. (RAPT): $22.27; +48%.

NextCure, Inc. (NXTC): $79.41; +19%.

Coherus BioSciences, Inc. (CHRS): $19.00; +15%.

AxoGen, Inc. (AXGN): $15.14; +14%.

Constellation Pharmaceuticals, Inc. (CNST): $31.82; +13%.


Cytokinetics, Incorporated (CYTK): $8.28; -24%.

Aerie Pharmaceuticals, Inc. (AERI): $18.48; -22%.

Melinta Therapeutics, Inc. (MLNT): $2.21; -21%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.62; -20%.

Agile Therapeutics, Inc. (AGRX): $2.03; -18%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
ADX-102 - topical ocular reproxalap - RENEW
Dry eye syndrome

Phase 3 Phase 3 (Part 1) data December 3, 2019 noted one co-primary endpoint was met while the other missed. Part 2 to be initiated 1H 2020.
$161.8 million

ALNA – Allena Pharmaceuticals Inc.
Reloxaliase ALLN-177 (URIROX-1)
Enteric Hyperoxaluria

Phase 3 Phase 3 trial met primary endpoint, key secondary endpoint missed - November 7, 2019.
$51.4 million

ALRN – Aileron Therapeutics Inc.
Small Cell Lung Cancer (SCLC)

Phase 1/2 Phase 1b/2 dose-optimization data due 2Q 2020.
$20.3 million

ALXN – Alexion Pharmaceuticals Inc.
Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 1 Phase 2 trial planned to commence 1H 2020.
$23.7 billion

ARPO – Aerpio Pharmaceuticals Inc.
Primary open-angle glaucoma (POAG)

Phase 1b Further development to continue through partnership.
$26.8 million

ATNX – Athenex Inc.
Tirbanibulin ointment
Actinic keratosis

NDA Filing NDA filing due 1Q 2020.
$1.1 billion

AVEO – AVEO Pharmaceuticals Inc.
Ficlatuzumab and cytarabine
Acute myeloid leukemia (AML)

Phase 2 Phase 2 trial initiation announced November 7, 2019.
$85.3 million

AXSM – Axsome Therapeutics Inc.
Treatment resistant depression

Phase 3 Phase 3 data due 1Q 2020.
$3.2 billion

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab - RESOLVE-1
Systemic Sclerosis

Phase 3 Phase 3 top-line data due summer 2020.
$430.7 million

KALA – Kala Pharmaceuticals Inc.
KPI‑121 0.25% STRIDE 3
Dry eye disease

Phase 3 Phase 3 completion of enrolment announced January 15, 2020 with data due 1Q 2020.
$258 million

PCRX – Pacira BioSciences Inc.
EXPAREL - pediatric patients
Postoperative Pain Management

sNDA Filing sNDA due 1H 2020.
$1.8 billion

SCY-078 - oral ibrexafungerp - VANISH 303
Vulvovaginal candidiasis (VVC)

Phase 3 NDA filing due 2H 2020.
$92.4 million

XERS – Xeris Pharmaceuticals Inc.
Self administered glucagon
Post-Bariatric Hypoglycemia

Phase 2 Phase 2b data released December 10, 2019. Further data due 1H 2020.
$164.9 million