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

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.

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

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

ADVANCERS:

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%.

DECLINERS:

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:

Drug Stage Catalyst Market Cap

ACHN – Achillion Pharmaceuticals Inc., ALXN – Alexion Pharmaceuticals Inc.

ACH-5228

Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 1 Phase 2 trial planned to commence 1H 2020.
$888.3 million

ALDX – Aldeyra Therapeutics Inc.

ADX-102 - topical ocular reproxalap - RENEW

Dry eye syndrome

Phase 3 Phase 3 (Part 1) to be completed 4Q 2019.
$158.9 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.
$52.6 million

ALRN – Aileron Therapeutics Inc.

ALRN-6924

Small Cell Lung Cancer (SCLC)

Phase 1/2 Phase 1b/2 dose-optimization data due 2Q 2020.
$14.5 million

ARPO – Aerpio Pharmaceuticals Inc.

AKB-9778

Primary open-angle glaucoma (POAG)

Phase 1b Phase 1b full data due 1Q 2020.
$21.9 million

ATNX – Athenex Inc.

Tirbanibulin ointment

Actinic keratosis

NDA Filing NDA filing due 1Q 2020.
$902 million

AVEO – AVEO Pharmaceuticals Inc.

Ficlatuzumab and cytarabine

Acute myeloid leukemia (AML)

Phase 2 Phase 2 trial initiation announced November 7, 2019.
$82.6 million

AXSM – Axsome Therapeutics Inc.

AXS-05 STRIDE-1

Treatment resistant depression

Phase 3 Phase 3 data due 1Q 2020.
$800.9 million

CRBP – Corbus Pharmaceuticals Holdings Inc.

Resunab - RESOLVE-1

Systemic Sclerosis

Phase 3 Phase 3 top-line data due summer 2020.
$291.6 million

KALA – Kala Pharmaceuticals Inc.

KPI‑121 0.25% STRIDE 3

Dry eye disease

Phase 3 Phase 3 data due 1Q 2020.
$126.2 million

PCRX – Pacira BioSciences Inc.

EXPAREL - pediatric patients

Postoperative Pain Management

Phase 3 Phase 3 data due 4Q 2019.
$1.8 billion

SCYX – SCYNEXIS Inc.

SCY-078 - oral ibrexafungerp - VANISH 303

Vulvovaginal candidiasis (VVC)

Phase 3 Phase 3 data met primary endpoint - November 7, 2019.
$66.3 million

XERS – Xeris Pharmaceuticals Inc.

Self administered glucagon

Post-Bariatric Hypoglycemia

Phase 2 Phase 2b data due 4Q 2019.
$222.1 million

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