BPC October 02 update

Lantheus LNTH to acquire Progenics PGNX ; Savara SVRA shares slide 58% on negative regulatory update

Price and Volume Movers

Durect Corporation (Nasdaq: DRRX) announced the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will meet on January 16, 2020 to discuss the NDA resubmission for Posimir. The FDA had previously assigned a PDUFA date of December 27, 2019. As a result of the meeting, a new PDUFA date will be assigned.

Savara Inc. (Nasdaq: SVRA) shares slid to close down 58% to $1.03 following news that the FDA has advised the company not to submit a Biologics License Application (BLA) for its pipeline candidate Molgradex, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The FDA noted that data from its previous trials do not provide sufficient evidence of efficacy and safety.

Lantheus Holdings, Inc. (NASDAQ: LNTH) announced the acquisition of Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) where it will acquire all shares of Progenics stock. Progenics shareholders will receive 0.2502 shares of Lantheus stock for each share of Progenics stock, representing approximately a 35% aggregate ownership stake in the combined company. Lantheus shares closed down 21% to $19.04 on the news, while Progenics shares closed up 11% to $5.50.

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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:

Aptose Biosciences Inc. (APTO): $2.23; +16%.

Soleno Therapeutics, Inc. (SLNO): $1.71; +16%.

Immuron Limited (IMRN): $3.03; +13%.

Aimmune Therapeutics, Inc. (AIMT): $22.92; +12%.

Neon Therapeutics, Inc. (NTGN): $1.90; +11%.

DECLINERS:

Enlivex Therapeutics Ltd. (ENLV): $19.81; -28%.

Satsuma Pharmaceuticals, Inc. (STSA): $11.33; -22%.

Tetraphase Pharmaceuticals, Inc. (TTPH): $4.31; -20%.

Minerva Neurosciences, Inc. (NERV): $4.97; -13%.

Ocugen, Inc., (NASDAQ: OCGN): $1.91; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARQL – ArQule Inc.
ARQ 092
Overgrowth Diseases

Phase 1/2 Phase 1/2 MOSAIC initiation of dosing announced October 2, 2019.
$1 billion

AXSM – Axsome Therapeutics Inc.
AXS-07 - MOMENTUM
Migraine

Phase 3 Phase 3 data due 4Q 2019.
$710.1 million

AXSM – Axsome Therapeutics Inc.
AXS-05 -GEMINI
Major Depressive Disorder

Phase 3 Phase 3 data due 4Q 2019.
$710.1 million

DRRX – DURECT Corporation
POSIMIR
Post-operative pain relief

PDUFA CRL Feb 12 2014. New PDUFA date December 27, 2019. Advisory Committee meeting scheduled for January 16, 2020 will result in PDUFA date extension.
$355.1 million

IGMS – IGM Biosciences Inc - Ordinary Shares
IGM-2323
Relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL)

Phase 1 Phase 1 trial initiation announced October 2, 2019.
$578.6 million

JNJ – Johnson & Johnson
Esketamine
Major depressive disorder (MDD)

sNDA Filing sNDA filing announced October 2, 2019.
$350.6 billion

MRK – Merck & Company Inc. (new)
DIFICID (fidaxomicin)
Clostridium difficile infections (CDI)

PDUFA PDUFA date January 24, 2020
$217.7 billion

NKTR – Nektar Therapeutics
NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers

Phase 1/2 Phase 1/2 updated data due at SITC November 9, 2019, 5:15 p.m.
$3 billion

RARX – Ra Pharmaceuticals Inc.
RA101495 zilucoplan
Myasthenia Gravis (MG)

Phase 3 Phase 3 data due early 2021.
$2.2 billion

REPL – Replimune Group Inc.
RP1 and nivolumab
Solid tumors

Phase 1/2 Phase 1 data to be presented at SITC November 8, 2019, 7:00 a.m. ET.
$443.6 million

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

Phase 3 Phase 3 data due 1H 2020.
$50.1 million

SVRA – Savara Inc.
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)

Phase 3 Phase 3 data June 12, 2019 did not meet primary endpoint. Noted October 2, 2019 that the FDA has recommended that a BLA not be filed.
$37.9 million

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

sNDA Filing sNDA filing announced October 2, 2019.
$955.8 million

VERU – Veru Inc.
Zuclomiphene citrate
Hot flashes

Phase 2 Phase 2 data due fall of 2019.
$136.8 million