BPC September 10 update

Mallinckrodt MNK shares surge 85% on sale of manufacturing unit; Lexicon LXRX +30% AH on settlement with Sanofi

Price and Volume Movers

Mallinckrodt Plc (NYSE: MNK) shares surged to close up 85% to $3.88 following news that it will sell its contract development and manufacturing organization (CDMO), BioVectra Inc, for approximately $250m, including fixed consideration of $175m, comprised of an upfront payment of $135m and a long-term note for $40m. The news appears to put to rest earlier reports by Bloomberg that the company had hired a law firm to explore restructuring and potential bankruptcy. The report originally saw shares lose 39% during last Thursday’s session.

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced the termination of its alliance with Sanofi for the development and commercialization of Zynquista (sotagliflozin). Lexicon will regain all rights to Zynquista and will receive from Sanofi $260m, of which $208m is payable upfront and the remainder is payable within twelve months. Shares, which closed up 21% to $1.72 ahead of the after-hours announcement, are up a further 30% after hours to $2.24.

Aurinia Pharmaceuticals (NASDAQ:AUPH) shares closed up 13% to $6.54 following the initiation of coverage by Oppenheimer with an Outperform rating and a $14 price target.

AVEO Oncology (NASDAQ: AVEO) announced overall survival (OS) data from its Phase 3 TIVO-3 trial comparing tivozanib to sorafenib in patients with highly refractory metastatic renal cell carcinoma (RCC). An OS hazard ratio (HR) of 0.99 was noted with median OS of 16.4 months for tivozanib compared with 19.7 months for sorafenib. Shares closed up 31% to $0.92.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced that the FDA has informed the company that it does not have plans to schedule an Advisory Committee meeting in connection with its review of its New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The PDUFA date, originally delayed by three months, is December 27, 2019. Shares retraced all initial loses to close flat for the day at $10.40, after opening sharply lower.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the FDA issued approval for Gvoke (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. Shares closed down 11% to $9.74.

Celyad (NASDAQ:CYAD) announced after hours it intends to offer and sell up to 2m ordinary shares (American Depositary Shares).

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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:

Endo International plc (ENDP): $4.00; +30%.

Acorda Therapeutics, Inc. (ACOR): $4.00; +27%.

Akebia Therapeutics, Inc. (AKBA): $5.40; +26%.

Melinta Therapeutics, Inc. (MLNT): $3.18; +24%.

Adaptimmune Therapeutics plc (ADAP): $2.11; +24%.

DECLINERS:

Protagonist Therapeutics, Inc. (PTGX): $13.72; -17%.

Stoke Therapeutics, Inc. (STOK): $28.80; -14%.

Atreca, Inc. (BCEL): $13.22; -10%.

Citius Pharmaceuticals, Inc. (CTXR): $1.12; -8%.

Autolus Therapeutics Plc (AUTL): $13.20; -8%.

Rubius Therapeutics, Inc. (RUBY): $8.75; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AVEO – AVEO Pharmaceuticals Inc.
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

NDA Filing NDA to be filed in 1Q 2020. Will withdraw if overall survival data in 2Q 2020 yields an OS HR above 1.00.
$90.1 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Vazegepant
Acute treatment of migraine

Phase 2/3 Phase 2/3 top-line data due 4Q 2019.
$2.6 billion

CLBS – Caladrius Biosciences Inc.
CLBS16 (CLBS14-CMD) - ESCaPE-CMD
Coronary microvascular dysfunction (CMD)

Phase 2 Phase 2 data to be presented at AHA November 16, 2019.
$23.5 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-938
Respiratory Syncytial Virus

Phase 2 Phase 2b trial to commence by end of 2019.
$1.2 billion

MGTX – MeiraGTx Holdings plc
AAV-RPE65
RPE65-Deficiency

Phase 1/2 Data presented at AAO October 12, 2019.
$554.8 million

PRVL – Prevail Therapeutics Inc.
PR001
Neuronopathic Gaucher disease

Phase 1/2 Phase 1/2 trial to be initiated 1H 2020.
$376.6 million

PRVL – Prevail Therapeutics Inc.
PR001
Parkinson’s disease with GBA1 mutation

Phase 1/2 Phase 1/2 trial to be initiated 2H 2019.
$376.6 million

RARE – Ultragenyx Pharmaceutical Inc.
KRN23 Burosumab
Tumor-induced osteomalacia (TIO)

Phase 2 sBLA planned for 1H 2020.
$2.1 billion

TLSA – Tiziana Life Sciences plc
Foralumab
Healthy human volunteers

Phase 1 Phase 1 nasal data released September 10, 2019 - well tolerated.
$81.9 million

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$221.1 million