BPC December 02 update

​Audentes BOLD to be acquired +106% AH; Aldeyra ALDX Phase 3 data to be released Tuesday

Price and Volume Movers

Audentes Therapeutics, Inc (NASDAQ: BOLD) announced after hours it will be acquired by Astellas Pharma Inc. for $60 per share in cash, representing a total equity value of approximately US$3 billion. Shares are trading up 106% after hours to $59.05.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced it will release top-line data pre-market on Tuesday December 3 from Part 1 of its Phase 3 RENEW trial of topical ocular reproxalap in patients with dry eye disease. A conference call is scheduled for 8am EST. Shares are currently trading up 7% after hours to $8.05.

Kodiak Sciences Inc. (Nasdaq: KOD) shares closed up 72% to $51.05 on news of a funding agreement to sell a capped 4.5% royalty right on global net sales of KSI-301 to Baker Bros. Advisors (BBA) for $225m. BBA is required to pay the first $100m of the funding amount at the closing of the funding transaction, expected to occur on January 10, 2020. The company also announced after hours it has commenced an underwritten public offering of $250m of shares. Shares are trading down 8% to $46.80 after hours.

Evofem Biosciences, Inc. (NASDAQ: EVFM) shares closed up 12% to $6.86 on news that it met primary and secondary endpoints in its Phase 2b Amprevence trial evaluating Amphora for the prevention of urogenital chlamydia and gonorrhea in women.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) shares closed down 10% to $3.16 on news that the Office of New Drugs of the FDA has denied its appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin (Zynquista) in type 1 diabetes, issued in March 2019. Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research (CDER).

Applied Genetic Technologies Corporation (Nasdaq: AGTC) shares are trading down 9% after hours to $2.50 on news its Chief Medical Officer has resigned to pursue other opportunities. The company is due to release updated data from both of its Phase 1/2 trials of X-linked Retinitis Pigmentosa (XLRP) and achromatopsia trials in January 2020.

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) announced its intention to offer and sell 4m shares in an underwritten offering. Shares closed down 13% and are trading down a further 3% after hours to $61.25.

ASLAN Pharmaceuticals (Nasdaq:ASLN) shares traded up as high as $8.18 following the release preliminary data from the lowest dose cohort of its ongoing multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate-to-severe atopic dermatitis (AD). The company took advantage of the price action when it announced an intra-day public offering. Shares pulled back to close the day up 36% to $5.20.

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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:

Oramed Pharmaceuticals Inc. (ORMP): $5.72;

Galmed Pharmaceuticals Ltd. (GLMD): $5.82; +29%.

Alimera Sciences, Inc. (ALIM): $6.83; +21%.

Jounce Therapeutics, Inc. (JNCE): $6.52; +21%.

Clearside Biomedical, Inc. (CLSD): $1.72; +19%.

DECLINERS:

RAPT Therapeutics, Inc. (RAPT): $21.73; -16%.

Akebia Therapeutics, Inc. (AKBA): $5.32; -15%.

Hepion Pharmaceuticals, Inc. (HEPA): $6.05; -13%.

NantKwest, Inc. (NK): $1.51; -12%.

IGM Biosciences, Inc. (IGMS): $20:02; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGTC – Applied Genetic Technologies Corporation
AAV-based gene therapy
X-linked Retinitis Pigmentosa (XLRP)

Phase 1/2 Phase 1/2 dose expansion data due January 2020.
$52.3 million

AKTX – Akari Therapeutics Plc
Coversin
Hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)

Phase 3 Phase 3 trial to commence by end of 2019.
$41.6 million

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.
$132.2 million

AQST – Aquestive Therapeutics Inc.
Libervant - AQST-203
Epileptic seizures

NDA Filing Completion of rolling NDA announced December 2, 2019.
$200.6 million

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

Phase 1 Phase 1 interim data due early 2020.
$75.6 million

CLLS – Cellectis S.A.
UCART22
Relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)

Phase 1 Phase 1 commencement of enrolment announced December 2, 2019.
$623.1 million

CNCE – Concert Pharmaceuticals Inc.
CTP-692
Schizophrenia

Phase 2 Phase 2 trial initiation announced December 2, 2019. Data due end of 2020.
$174.5 million

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

PDUFA priority review PDUFA date priority review January 23, 2020. FDA Advisory Committee meeting December 18, 2019 from 1pm ET.
$1.7 billion

EVFM – Evofem Biosciences Inc.
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women

Phase 2/3 Phase 2b data met primary endpoint - December 2, 2019.
$322.1 million

LXRX – Lexicon Pharmaceuticals Inc.
Sotagliflozin
Type 1 Diabetes

CRL CRL issued March 22, 2019. Appeal rejected by FDA - December 2, 2019.
$517.5 million

NK – NantKwest Inc.
PD-L1 t-haNK
Solid tumors

Phase 1 Phase 1 preliminary data released December 2, 2019.
$155.4 million

OGEN – Oragenics Inc.
AG013
Oral mucositis (OM)

Phase 2 Phase 2 completion of enrolment announced December 2, 2019 with data due early 2020.
$25.2 million

SGEN – Seattle Genetics Inc.
Enfortumab vedotin and Keytruda
Urothelial cancer

Phase 3 Phase 3 trial to be initiated 1H 2020.
$20.1 billion