BPC June 18 update

​Biogen BIIB key patent invalidated -8%; FDA approvals for Epizyme EPZM and Ultragenyx RARE

Price and Volume Movers

Biogen Inc. (NASDAQ:BIIB) shares closed down 8% to $260.30 on news that a U.S. District ruled in favor of Mylan, Inc. (NASDAQ:MYL) noting that Biogen’s ‘514 patent for its multiple sclerosis drug Tecfidera is invalid. Biogen expects to appeal the decision. The decision clears the way for Mylan's launch of its dimethyl fumarate product upon the receipt of FDA approval. The '514 patent could have otherwise delayed generic competition until 2028. Biogen's sales of Tecfidera in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78b.

Alpine Immune Sciences, Inc. (NASDAQ: ALPN) announced a license agreement with AbbVie Inc. (NYSE: ABBV) for ALPN-101, a Phase 2-ready drug for systemic lupus erythematosus. Alpine will receive $60m in an upfront cash payment and is eligible to receive up to $805m in milestone payments. Shares surged to close up 125% to $10.95.

Epizyme, Inc. (Nasdaq:EPZM) announced that the FDA has approved the supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in patients with relapsed or refractory follicular lymphoma. Shares closed up 5% to $20.46.

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) also received approval from the FDA, for Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO). Shares closed up 1% to $72.48.

Sarepta Therapeutics (NASDAQ: SRPT) and Selecta Biosciences, Inc. (NASDAQ: SELB) announced a license agreement granting Sarepta an option to license the rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). Shares of Selecta closed up 7% to $2.70.

BeyondSpring Inc. (NASDAQ:BYSI) announced an underwritten public offering of its ordinary shares. Shares are trading down 17% after hours to $13.84.

Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) shares closed up 23% to $3.50 on news of a reverse merger with Ocuphire Pharma, Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company. Rexahn stockholders will own 14.3% of the new company, with 85.7% owned by Ocuphire holders. The combined company will be called Ocuphire Pharma, Inc. and will trade under the ticker “OCUP.” The deal is expected to close in the second half of 2020.

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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:

IVERIC bio, Inc. (ISEE): $6.13; +38%.

Ovid Therapeutics Inc. (OVID): $7.37; +36%.

Anavex Life Sciences Corp. (AVXL): $5.19; +21%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $6.43; +17%.

Geron Corporation (GERN): $2.03; +16%.

DECLINERS:

IDEAYA Biosciences, Inc. (IDYA): $14.26; -23%.

Brickell Biotech, Inc. (BBI): $1.00; -22%.

Leap Therapeutics, Inc. (LPTX): $2.04; -19%.

Millendo Therapeutics, Inc. (MLND): $2.71; -17%.

Nymox Pharmaceutical Corporation (NYMX): $3.14; -16%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Upadacitinib
Atopic dermatitis

Phase 3 Phase 3 data met co-primary endpoints - June 18, 2020.
$174.3 billion

APTX – Aptinyx Inc.
NYX-783
Post-traumatic stress disorder (PTSD)

Phase 2 Phase 2 completion of enrolment announced June 18, 2020 with data due late-2020.
$227.8 million

CYCN – Cyclerion Therapeutics Inc.
IW-6463
Healthy volunteers

Phase 1 Phase 1 translational pharmacology top-line data due late-summer 2020.
$162.9 million

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

Approved FDA approval announced June 18, 2020.
$1.6 billion

MYL – Mylan N.V.
Dimethyl fumarate (generic)
Multiple sclerosis - Tecfidera generic

PDUFA BsUFA date November 16, 2020.
$8.2 billion

NVO – Novo Nordisk A/S
AM833
Obesity

Phase 2 Phase 2 primary endpoint met - June 18, 2020.
$154.8 billion

RARE – Ultragenyx Pharmaceutical Inc.
Burosumab
Tumor-induced osteomalacia (TIO)

Approved FDA Approval announced June 18, 2020.
$5.1 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tecentriq + chemo - IMpassion 031
Neoadjuvant triple negative breast cancer

Phase 3 Phase 3 trial met primary endpoint - June 18, 2020.
$299.8 billion

SGMO – Sangamo Therapeutics Inc.
SB-525 AFFINE
Hemophilia A

Phase 3 Phase 3 trial to be initiated 2H 2020.
$1.4 billion

TFFP – TFF Pharmaceuticals Inc - Ordinary Shares
Tacrolimus Inhalation Powder
Prophylaxis of lung allograft rejection

Phase 1 Phase 1 initiation announced June 29, 2020.
$115.6 million

TLSA – Tiziana Life Sciences plc
Foralumab
Crohn’s Disease

Phase 2 Phase 2 trial to commence 2H 2020.
$215.9 million

UROV – Urovant Sciences Ltd.
Vibegron
Irritable bowel syndrome (IBS)

Phase 2a Phase 2a top-line data due 4Q 2020.
$323.4 million

UROV – Urovant Sciences Ltd.
URO-902
Overactive bladder (OAB)

Phase 2a Data and safety monitoring board data review and decision to move from cohort 1 to cohort 2 expected in 4Q 2020.
$323.4 million

XERS – Xeris Pharmaceuticals Inc.
Pramlintide and insulin
Type 1 diabetes

Phase 2 Phase 2 data released June 18, 2020. 62% reduction of hyperglycemia after a glucose challenge.
$104.9 million