BPC April 10 update

​Axovant announces David Hung as new CEO - shares +22%; OncoMed (OMED) fails YOSEMITE trial - shares down 37%; FDA notes deficiencies with TherapeuticsMD (TXMD) NDA filing

Price and Volume Movers

Axovant Sciences (NYSE: AXON) announced that David Hung, MD, has been named Chief Executive Officer of the company, effective April 7, 2017. Hung was the founder, President, and Chief Executive Officer of Medivation through its acquisition by Pfizer for approximately $14 billion in September 2016. Shares rallied in response to the news, closing up 22% to $18.54. The company took advantage of the positive price action by announcing after-hours that it has commenced an underwritten public offering of $100m of its common shares. Shares are currently flat in the after-hours session.

TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced that, on April 7, 2017, the company received a letter from the FDA noting that the agency has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments for the review of the New drug application (NDA) for TX-004HR, for the treatment of moderate to severe dyspareunia (pain during intercourse). Shares closed down 19% to $6.20.

OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED) shares suffered a double blow Monday following news that its Phase 2 YOSEMITE clinical trial of demcizumab in combination with Abraxane plus gemcitabine in previously untreated patients with metastatic pancreatic cancer, did not meet the primary endpoint of progression-free survival. Shortly after the news the company noted that Bayer Pharma will not exercise its option to license the first-in-class Wnt pathway inhibitors vantictumab and ipafricept. Shares tumbled to close down 37% to $5.55.

Geron Corporation (Nasdaq:GERN) shares closed up 20% to $2.57 following the second internal data reviews of IMerge and IMbark, the clinical trials of imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively. Development for both programs will continue for the time being with long-term development plans dependent on feedback from the FDA while also assessing available data and other treatment options for MDS and MF. If the green light is given for further development the company expects the Phase 3 part of the IMerge trial to be opened for patient enrollment in 4Q 2017.

Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced that it has received clearance to initiate a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injury. While the news was hardly significant, traders sent shares up 26% to close at $1.72. One contributing factor to the price surge was the use of “FDA Approval” in the title of its press release. The company took full advantage of the price action when it announced after hours that it intends to offer and sell shares of its common stock in an underwritten public offering. Shares have retraced all gains to be currently trading down 24% to $1.30 in the after-hours session.


Other major price movers:

ADVANCERS:

Aralez Pharmaceuticals Inc (NASDAQ:ARLZ): $1.86; +16%.

Windtree Therapeutics Inc (NASDAQ:WINT): $1.24; +14%.

Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE): $24.78; +12%.

Bellicum Pharmaceuticals Inc (NASDAQ:BLCM): $13.48; +11%.

Biopharmx Corp (NYSEMKT:BPMX): $0.72; +11%.

 

DECLINERS: 

Dipexium Pharmaceuticals Inc (NASDAQ:DPRX): $1.25; -11%.

Ritter Pharmaceuticals Inc (NASDAQ:RTTR): $1.04; -9%.

Ampio Pharmaceuticals Inc (NYSEMKT:AMPE): $0.57; -9%.

Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $2.21; -9%.

Nektar Therapeutics (NASDAQ:NKTR): $18.50; -8%.

 

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

ANTH
Blisibimod
IgA nephropathy

Phase 2 Phase 2 primary endpoint not met following interim analysis, June 2016. Trial to continue. Noted April 10, 2017 that dosing has been completed with data due 3Q 2017.

CELG
Demcizumab plus Abraxane - YOSEMITE
First-line pancreatic cancer

Phase 2 Phase 2 data released April 10, 2017 - primary endpoint not met.

FPRX
Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)

Phase 1/2 Phase 2 dose expansion phase initiated May 2016. Completion of enrollment announced April 10, 2017. Data due at ASCO June 4, 2017. Abstract 11078.

GERN
Imetelstat - IMbarkStudy
Myelofibrosis

Phase 2 Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review conducted September 2016. Low dose discontinued, high dose enrollment suspended. Further review conducted April 2017 - further development pending FDA feedback and longer term data.

JNJ
Imetelstat - IMbarkStudy
Myelofibrosis

Phase 2 Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review conducted September 2016. Low dose discontinued, high dose enrollment suspended. Further review conducted April 2017 - further development pending FDA feedback and longer term data.

MESO
MPC-150-IM
Chronic heart failure (CHF)

Phase 3 Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.

OMED
Demcizumab plus Abraxane - YOSEMITE
First-line pancreatic cancer

Phase 2 Phase 2 data released April 10, 2017 - primary endpoint not met.

OHRP
OHR-102
Neovascular (Wet) Age-related Macular Degeneration (AMD)

Phase 3 Phase 3 data due late 2017 or early 2018.

RPRX
Proellex
Uterine fibroids (oral treatment)

Phase 2b Phase 2b data released November 14, 2016. Noted January 30, 2017 that an end of Phase 2 meeting scheduled with FDA before the end of April, 2017. However, company noted April 10, 2017 that they meeting was in fact a Type C Guidance Meeting rather than an end of Phase 2 Type B meeting. Partial clinical hold remains in place.

TXMD
Yuvvexy
Moderate-to-severe vaginal pain

PDUFA PDUFA date May 7, 2016. Noted April 10, 2017 that FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements. Further noted April 19, 2017 that it expects a decision on or before the PDUFA date - (reading between the lines this seems to infer that the NDA will be rejected).