BPC April 17 update

Puma (PBYI) Advisory Committee Meeting for Neratinib set for May 24; OncoMed (OMED) suffers another trial setback; Offerings galore after the bell

Price and Volume Movers

As noted on Friday the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of baricitinib in patients with moderate-to-severe rheumatoid arthritis (RA). The news sent shares of Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) down 4.1% ($82.38) and 10% ($126.07), respectively, in Monday's trading session.

On the flipside, shares of competing RA companies exhibited moves to the upside. Galapagos NV (ADR) (NASDAQ:GLPG), which initiated its Phase 3 FINCH program in August, 2016, set another all-time high in normal trading hours, before announcing after-hours that it intends to issue shares to the value of $275m. The news saw it pare back gains to see it currently trading at $90, almost flat on Thursday’s close.

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for May 24, 2017 in regard to Puma’s New Drug Application (NDA) for neratinib. The PDUFA date is estimated for on or about July 20, 2017. Shares closed up 11% to $39.60.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED) shares plunged for a second consecutive week following the announcement of a further trial failure. Shares slid 17% to $4.01, a significant drop from mid-March when shares were trading over $10 per share. Monday’s fall was on the release of top-line data from its Phase 2 PINNACLE trial of tarextumab in combination with etoposide plus chemotherapy for the treatment of small cell lung cancer. The trial did not meet endpoints of progression-free survival (primary) and overall survival. The company also announced that it will discontinue enrollment in its Phase 1b trial of brontictuzumab in combination with trifluridine/tipiracil (Lonsurf) in third-line colorectal cancer patients due to lack of tolerability.

Cleveland BioLabs, Inc. (NASDAQ: CBLI) shares soared to close up 194% to $4.80. The company announced that the European Medicines Agency (EMA) has accepted its pediatric investigation plan (PIP), which allows it to submit its Marketing Authorization Application (MAA) for entolimod as a medical radiation countermeasure.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that it intends to offer shares of its common stock in an underwritten public offering. Shares are currently down 18% to $1.21 in the after-hours session.

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO) also announced that it is offering to sell up to 4.5m shares of its common stock in an underwritten public offering. Shares are currently down 3.2% to $53.74 in the after-hours session.

Audentes Therapeutics, Inc. (Nasdaq: BOLD), another company to announce an offering after-hours, said it intends to issue 4.75m shares of its common stock.

AmpliPhi Biosciences Corporation (NYSE MKT: APHB) announced Friday that it intends to enforce a 1:10 reverse split after the close of trading on April 24, 2017.

 

Other major price movers:

ADVANCERS:

Infinity Pharmaceuticals Inc. (NASDAQ:INFI): $2.19; +19%.

Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $4.15; +17%.

OHR Pharmaceutical Inc (NASDAQ:OHRP): $0.92; +15%.

Verastem Inc (NASDAQ:VSTM): $2.10; +14%.

Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI): $4.03; +10%.


DECLINERS:

Apricus Biosciences Inc (NASDAQ:APRI): $1.54; -21%.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $13.31; -17%.

DelMar Pharmaceuticals Inc (NASDAQ:DMPI): $2.69; -12%.

Immune Pharmaceuticals Inc (NASDAQ:IMNP): $2.26; -11%.

Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN): $0.411; -10%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

AMAG
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy

sNDA Filing sNDA filing announced April 17, 2017. PDUFA date estimated October 17, 2017 assuming 6-month priority review.

OMED
Tarextumab - PINNACLE trial
Small cell lung cancer

Phase 2 Phase 2 data released April 17, 2017 - primary endpoint not met.

PBYI
PB272 ExteNET trial
Extended adjuvant HER2-positive early stage breast cancer

PDUFA Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 20, 2017. Noted April 17, 2017 that Advisory Committee Meeting has been scheduled for May 24, 2017. Read briefing documents here (click on date above for those using the FDA Calendar).

RIGL
Fostamatinib
Immune Thrombocytopenic Purpura (ITP)

NDA Filing Phase 3 data from the first trial released August 30 2016. Primary endpoint met. Data from second trial did not meet the primary endpoint. NDA submission announced April 17, 2017.