Equity Analyst Hartaj Singh of BTIG Equity Research reiterated his $12 price target on Progenics Pharmaceuticals, Inc.(NASDAQ:PGNX) October 3 in a research report titled ”Pipeline Focus Increasing.”
According to Hartaj Singh ”PGNX is more than a play on Relistor royalties, with three mid/late stage assets that are positioning the company closer to creating a valuation rerating. Company management continues to demonstrate that they are building franchises that meet important unmet needs in rare diseases and in the diagnosis and treatment of prostate cancer. We continue to be bullish.
Progenics Pharmaceuticals, Inc.(NASDAQ:PGNX) is developing innovative medicines for oncology, with a pipeline that includes several product candidates in later-stage clinical development. Progenics’ first-in-class PSMA-targeted technology platform for prostate cancer includes a small molecule imaging agent that has completed a phase 2 trial and an antibody drug conjugate therapeutic which has also completed a two-cohort phase 2 clinical trial.
Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is AZEDRA™, an ultra-orphan radiotherapy candidate currently in a phase 2 study under an SPA. Progenics’ first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Valeant Pharmaceuticals International, Inc.
Hartaj Singh continues ”For Azedra, Progenics’ rare disease asset targeting a rare tumor where few therapeutics options currently exist, the company indicated that an additional 15 patients had been recruited to the pivotal (registration enabling) phase 2 trial that is currently being conducted by the company. The company continues to expect enrollment to be complete by EY15 and data readout in late 2016/early 2017.
The imaging agent 1404 continues its development path, with a phase 3 initiating soon. A phase 2 is currently underway in Japan (initiated 04/15) with partner Fujifilm, and an investigator-sponsored trial at Weill Cornell will enroll mCRPC men. The range and scope of clinical activities around 1404 underscores its attractive profile.
The physician expert presenting 1404 indicated that ~20% of men having biopsies (~1.3m/year US) could be good candidates for it. Progenics indicated it will provide an update on PSMA ADC later in the year, but did review existing data and the phase 1 study design for its next PSMA-targeting ‘shot on goal’ drug, 1095. Animal data and a German compassionate use trial indicate a very intriguing profile. Valuation: Our price target of $12 is based on a blended DCF and 2016e P/E multiple approach.
Earlier this month PGNX the U.S. Food and Drug Administration (FDA) has accepted for review Valeant’s New Drug Application for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016.
RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.
In the clinical study in adult patients with opioid-induced constipation and chronic non-cancer pain, the most common adverse reactions (≥ 1%) were abdominal pain, nausea, diarrhea, and hyperhidrosis, hot flush, tremor, and chills. In clinical studies in adult patients with opioid-induced constipation and advanced illness, the most common adverse reactions (≥ 5%) were abdominal pain, flatulence, nausea, dizziness, and diarrhea.