Mylan Finally Gets a Yes Years-Long in the Making from the FDA
Mylan N.V. (NASDAQ:MYL) shares are thundering 19% upward after many years of FDA hurdles have come to a successful green light for the drug maker, who garnered the nod it has been seeking from the FDA for its generic versions of Teva’s multiple sclerosis treatment Copaxone 20 mg and 40 mg.
Cantor analyst Louise Chen for one is breathing a sigh of relief that “after years of back and forth with the FDA,” Mylan scored a key victory, exclaiming: “It has finally happened,” believing that this “Copaxone 40mg approval is upside to ’17 EPS” for Mylan.
Obviously, this may not bode all that well for Teva, as the analyst believes: “We think the Mylan approval is already reflected in Teva’s valuation multiple, but Teva’s numbers may have to come down for ’17. This is not positive for Teva since there was already concerns regarding its ’17 EPS.” Chen goes on to add that the Israeli pharma giant’s outlook for the year takes under account no generic competition facing Copaxone 40mg domestically this year, but projects rivalry will hit EPS $0.25 to $0.25 each quarter.
Mylan investors can be content though, as Chen comments, “This is good for Mylan since we think it represents upside to its ’17 EPS number since Mylan had moved this launch and others to ’18. This should be a meaningful/large generic opportunity for Mylan.”
In addition, the analyst offers some context regarding generic drug exclusivity: “According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.”
For now, the analyst welcomes the drug maker’s FDA triumph from the sidelines, reiterating a Neutral rating on MYL stock with a price target of $34, which represents a 12% downside from where the stock is currently trading. (To watch Chen’s track record, click here)
Wall Street is torn when it comes to whether to sing this biotech firm’s praises or assess with an apprehensive gaze, as according to TipRanks, out of 10 analysts polled in the last 3 months, half are bullish on Mylan stock while half remain sidelined. With a loss potential of 2%, the stock’s consensus target price stands at $37.56.
CytomX Nabs Sixth Strategic Probody Alliance
CytomX Therapeutics Inc (NASDAQ:CTMX) shares are zooming almost 16% after the small biotech fish has at long last inked a deal with biotech shark Amgen to develop an immune-oncology product centered on CTMX’s t-cell therapies in its Probody platform. In creating together EGFRxCD3 bispecific antibodies, CTMX will gain $40 million upfront along with a $20 million equity investment from Amgen.
Cowen analyst Boris Peaker chocks this up as CytomX’s sixth consecutive win for its Probody platform, as the drug maker continues to “execute high-value collaborations” with its “6th notable partnership,” with a “growing list of high profile partnerships” further showing off “the breath and utility of the Probody technology.”
In reaction, Peaker trumpets along in the bullish parade on Wall Street today, maintaining an Outperform rating on shares of CTMX without suggesting a price target. (To watch Peaker’s track record, click here)
Peaker highlights, “CTMX’s continued execution of business development deals with notable partners has steadily provided non-dilutive capital for its internal programs and continues to highlight the utility of the Probody platform across all antibody-based therapies. We look forward to initial proof-of-concept data for the platform in 2018 through CX-072 (PD-L1 Probody) and CX-2009 (CD166 Probody-drug conjugate) Phase I studies.”
Additionally, the analyst notes, “In contrast to CD19 targeting in B-cell malignancies, T-cell-recruiting bispecific antibodies have been particularly difficult to develop against solid tumors in part because those targets are frequently also present on important healthy cells and the toxicity can be difficult to manage. In these instances, CytomX believes that the Probody platform has the potential to limit the toxicity for such therapies,” which will put the drug maker at an advantage.
Most analysts back Peaker’s confident take on the biotech firm, as TipRanks analytics showcase CTMX as a Strong Buy. Based on 4 analysts polled by TipRanks in the last 3 months, 3 rate a Buy on CytomX stock while 1 maintains a Hold. The 12-month average price target stands at $31.00, marking a nearly 41% upside from where the stock is currently trading.