In the name of the biotech game, it matters to have a PDUFA success in a company’s deck of cards. As far as two analysts are concerned, the path to unlocking big biotech catalysts looks promising for two companies: Scpharmaceuticals Inc (NASDAQ:SCPH) and Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL). As anticipation soars around lead indications up for FDA assessment within a matter of weeks and months, analysts are setting favorable probabilities on two drug approvals ahead.
Let’s dive in:
Scpharmaceuticals: 75% Odds on Success of FDA Approval for Main Asset
Scpharmaceuticals could have a key catalyst on its hands this summer when it comes to lead asset Furoscix, designed to treat patients with worsening or decompensated heart failure outside of the inpatient setting.
Leerink analyst Ami Fadia sounds off from the bulls, maintaining her bet for an FDA win for a drug that could offer this biotech player hundreds of millions in sales.
When sizing up hospital-based events, the analyst wagers SCPH’s Furoscix could magnetize robust early adoption, driving three quarters of IV furosemide use; keep in mind, this is all in the scope of “a market where over 90% of IV diuresis is through IV furosemide.”
SCPH’s Furoscix has a PDUFA date with destiny likely set for June 23rd, and the analyst expects over 75% odds that the lead drug gets a green light. By 2025, Fadia projects more than $600 million in potential sales for the drug.
As such, the analyst reiterates an Outperform rating on SCPH stock with a $20 price target, which implies an 82% upside from where the shares last closed. (To watch Fadia’s track record, click here)
“We believe that Furoscix provides a strong pharmacoeconomic incentive to move care from a high cost hospital setting to an at-home setting,” cheers Fadia, who notes that the company intends to bolster the lead asset’s clinical profile when it initiates a heart failure health economics and outcomes trial in the second quarter.
At Fadia’s recent Global Healthcare Conference, it seems SCPH’s management team seeks a roughly 40-person sales force team to target hospitals taking up 40% of the yearly IV furosemide doses in the U.S. piece of the pie, or 349 hospitals. SCPH has a bull’s eye plan for the leading 10 Medicare Part D plans, notes the analyst.
The bottom line looks positive from where the analyst stands, as she contends: “Pricing has not yet been established, but management’s preliminary estimate is that cost of care would be ~$500/day over the course of 4 days, and this would compare favorably to the costs of ~$9-12K per hospital admissions. Health economics studies will be looking at reducing hospital readmission rates and assessing the added value Furoscix can provide, which will also help in the company’s eventual decision on pricing. First patient enrollment is expected in the 2Q18 timeframe.”
Moving forward, as Fadia sees the bigger picture, Scpharmaceuticals’ PDUFA action date for Foroscix holds the limelight; investors should keep their eyes peeled to this significant catalyst waiting in the biotech wings.
TipRanks indicates early word on this drug maker points to the bulls: all 3 analysts in the last 3 months rate a Buy on SCPH stock. With a whopping return potential of 112%, the stock’s consensus target price stands tall at $23.33.
Rigel Pharmaceuticals Primed for FDA Victory in ITP
Cantor analyst Elemer Piros sees a triumphant asset on Rigel’s table with experimental drug candidate fostamatinib (TAVALISSE) for its lead indication in immune thrombocytopenia (ITP).
For context, ITP is an autoimmune disorder known for its impaired platelet production and SYK-mediated platelet destruction macrophages; or in other words, easy or excessive bruising and bleeding that comes from these severely low levels of platelets- the very cells that assist blood clot. Rigel’s drug is an oral SYK inhibitor with a PDUFA date set for April 17th, less than two weeks away. The bull sings the praises of a drug he sees “poised to achieve FDA approval” very soon- and one that has enticing “opportunity to expand” following the FDA decision.
Here’s why Piros takes a bullish gamble on success for Rigel’s asset in ITP: “With over 5,000 patient-years of treatment experience and a robust Phase 3 clinical package, we anticipate a positive decision in April. Rigel has begun pre-commercial activities for a potential launch and has outlined its plans for a full commercial team of 50-60 individuals. Based on the mixed efficacy of currently available treatments, fragmentation of the therapeutic landscape and concentration of prescribing physicians (3,000 hematologists and hematologist-oncologists), we believe Rigel will be successful at commercializing the drug.”
However, notably the drug maker slipped almost 14% in the market yesterday for a different indication- IgA nephropathy (IgAN). On back of top-line data from a 24-week Phase 2 trial evaluating fostamatinib in IgAN where the treatment failed to achieve statistical significance in proteinuria, Piros scales back his probability of success here from 25% to 15%. Though “IgAN dampens [the] mood,” the analyst continues to be ultimately “positive on ITP PDUFA” for RIGL’s key asset, where the “focus remains.”
As such, the analyst reiterates an Overweight rating on RIGL stock while cutting the price target from $7 to $6, which implies a close to 97% upside from where the shares last closed. (To watch Piros’ track record, click here)
TipRanks showcases Rigel stock as a strong favorite among sell-side analysts on the Street. Out of 3 analysts polled in the last 3 months, all 3 bet bullish on the stock. The 12-month average price target of $6.35 reflects robust upside potential of 108% compared to where the shares last closed.