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.

-

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

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

NDA Filing Phase 3 trial met co-primary endpoints - December 30, 2019. NDA filing due 2H 2020.
$2.9 billion

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

NDA Filing Phase 3 data released December 16, 2019 met primary endpoint. NDA filing due 2H 2020.
$2.9 billion

DRRX – DURECT Corporation
POSIMIR
Post-operative pain relief

PDUFA CRL Feb 12 2014. Advisory Committee meeting voted 6-6 January 16, 2020 regarding approval. PDUFA date of December 27, 2019 was not met due to the meeting. No guidance announced regarding new timeline.
$340.5 million

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

Phase 1 Phase 1 initial data due 2H 2020.
$1.6 billion

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

sNDA Filing sNDA filing announced October 2, 2019.
$354.3 billion

MRK – Merck & Company Inc. (new)
ARQ 092
Overgrowth Diseases

Phase 1/2 Phase 1/2 MOSAIC initiation of dosing announced October 2, 2019.
$194.2 billion

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

Approved FDA Approval announced January 27, 2020.
$194.2 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 at SITC November 9, 2019 noted ORR was 53% (20/38) with 34% (13/38) complete response (CR) rate. Further data due 2020.
$3.7 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
Melanoma

Phase 1/2 Phase 1/2 further data due mid-2020.
$508.3 million

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

Phase 3 Phase 3 data due 1H 2020.
$124 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. Open label data due 1Q 2020.
$94.4 million

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

PDUFA sNDA filing announced October 2, 2019. PDUFA date 2Q 2020. Estimate August 2, 2020 using 10-month timeline.
$1.5 billion

VERU – Veru Inc.
Zuclomiphene citrate
Hot flashes

Phase 2 Phase 3 trial to commence by early summer 2020.
$269.2 million